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Study of Intratumoral G100 With Or Without Pembrolizumab or Rituximab In Participants With Follicular Non-Hodgkin's Lymphoma (MK-3475-174/IMDZ-G142)

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ClinicalTrials.gov Identifier: NCT02501473
Recruitment Status : Terminated (Business reasons)
First Posted : July 17, 2015
Results First Posted : September 9, 2020
Last Update Posted : September 9, 2020
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Immune Design

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Follicular Low Grade Non-Hodgkin's Lymphoma
Interventions Drug: G100
Drug: Pembrolizumab
Drug: Rituximab
Enrollment 52
Recruitment Details Participants were enrolled in the study at clinical sites in the United States and Europe.
Pre-assignment Details Part 5, G100 plus Rituximab, Dose Escalation: 12 to 24 participants were planned; no participant was enrolled or dosed.
Arm/Group Title Part 1: Local Radiation + G100 5μg/Tumor Part 1: Local Radiation + G100 10μg/Tumor Part 2: Local Radiation + G100 10μg/Tumor Part 2: Local Radiation + G100 10μg/Tumor+Pembrolizumab 200mg Part 2: Local Radiation, G100 20 μg/Tumor in Large Tumors Part 3: Local Radiation + G100 20μg/Tumor Part 4: G100 20μg/Tumor and Pembrolizumab 200mg Part 5: G100 + Rituximab 375 mg/m^2
Hide Arm/Group Description Part 1: Local radiation and G100 [glucopyranosyl lipid A stable emulsion, GLA-SE] at 5μg/tumor administered intratumorally (IT) into accessible tumors for up to 8 weeks. Part 1: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks. Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks. Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks; pembrolizumab 200mg intravenously (IV) administered every 3 weeks (Q3W) IV for up to 2 years. Part 2: Local radiation and G100 at 20 μg/tumor administered IT into accessible large tumors (injectable lymphoma mass(es) ≥ 4 cm in total size) for up to 8 weeks. Part 3: Local radiation and G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks. Part 4: G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks and pembrolizumab 200mg IV and administered Q3W for up to 2 years. Part 5: G100 administered at 20, 40, 60, or 80 μg/tumor for up to 6 weeks and rituximab (anti-CD20 antibody). Rituximab dose administered as an IV infusion at 375 mg/m^2 administered on Day 0 and then once weekly for 4 doses up to 3 weeks.
Period Title: Overall Study
Started 3 3 13 14 4 14 1 0
Treated 3 3 13 13 4 14 1 0
Completed 0 0 0 0 0 0 0 0
Not Completed 3 3 13 14 4 14 1 0
Reason Not Completed
Study Terminated             2             3             7             9             2             10             1             0
Withdrawal by Subject             0             0             3             3             2             2             0             0
Death             0             0             1             1             0             1             0             0
Lost to Follow-up             1             0             1             0             0             1             0             0
Reason not specified             0             0             1             1             0             0             0             0
Arm/Group Title Part 1: Local Radiation + G100 5μg/Tumor Part 1: Local Radiation + G100 10μg/Tumor Part 2: Local Radiation + G100 10μg/Tumor Part 2: Local Radiation + G100 10μg/Tumor+Pembrolizumab 200mg Part 2: Local Radiation, G100 20 μg/Tumor in Large Tumors Part 3: Local Radiation + G100 20μg/Tumor Part 4: G100 20μg/Tumor and Pembrolizumab 200mg Total
Hide Arm/Group Description Part 1: Local radiation and G100 [glucopyranosyl lipid A stable emulsion, GLA-SE] at 5μg/tumor administered intratumorally (IT) into accessible tumors for up to 8 weeks. Part 1: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks. Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks. Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks; pembrolizumab 200mg intravenously (IV) administered every 3 weeks (Q3W) IV for up to 2 years. Part 2: Local radiation and G100 at 20 μg/tumor administered IT into accessible large tumors (injectable lymphoma mass(es) ≥ 4 cm in total size) for up to 8 weeks. Part 3: Local radiation and G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks. Part 4: G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks and pembrolizumab 200mg IV and administered Q3W for up to 2 years. Total of all reporting groups
Overall Number of Baseline Participants 3 3 13 13 4 14 1 51
Hide Baseline Analysis Population Description
The analysis population included all randomized and treated participants. Part 5, G100 plus Rituximab, Dose Escalation: 12 to 24 participants were planned; no participant was enrolled or dosed.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 13 participants 13 participants 4 participants 14 participants 1 participants 51 participants
54.0  (13.45) 56.3  (16.07) 60.2  (10.26) 57.6  (10.98) 59.3  (5.85) 63.9  (8.74) NA [1]   (NA) 60.3  (10.47)
[1]
Age not reported due to risk of identification of a person.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 13 participants 13 participants 4 participants 14 participants 1 participants 51 participants
Female
1
  33.3%
2
  66.7%
3
  23.1%
3
  23.1%
1
  25.0%
5
  35.7%
1
 100.0%
16
  31.4%
Male
2
  66.7%
1
  33.3%
10
  76.9%
10
  76.9%
3
  75.0%
9
  64.3%
0
   0.0%
35
  68.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 13 participants 13 participants 4 participants 14 participants 1 participants 51 participants
Hispanic or Latino
0
   0.0%
1
  33.3%
1
   7.7%
3
  23.1%
0
   0.0%
0
   0.0%
0
   0.0%
5
   9.8%
Not Hispanic or Latino
2
  66.7%
2
  66.7%
12
  92.3%
10
  76.9%
4
 100.0%
13
  92.9%
1
 100.0%
44
  86.3%
Unknown or Not Reported
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   7.1%
0
   0.0%
2
   3.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 13 participants 13 participants 4 participants 14 participants 1 participants 51 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
1
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
1
   7.7%
0
   0.0%
0
   0.0%
1
   7.1%
0
   0.0%
2
   3.9%
White
2
  66.7%
3
 100.0%
11
  84.6%
12
  92.3%
2
  50.0%
12
  85.7%
1
 100.0%
43
  84.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
  33.3%
0
   0.0%
1
   7.7%
1
   7.7%
1
  25.0%
1
   7.1%
0
   0.0%
5
   9.8%
1.Primary Outcome
Title Number of Participants With an Adverse Event (AE)
Hide Description An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Time Frame Up to approximately 42 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all enrolled participants who received at least 1 injection of G100 after standard local radiation.
Arm/Group Title Part 1: Local Radiation + G100 5μg/Tumor Part 1: Local Radiation + G100 10μg/Tumor Part 2: Local Radiation + G100 10μg/Tumor Part 2: Local Radiation + G100 10μg/Tumor+Pembrolizumab 200mg Part 2: Local Radiation, G100 20 μg/Tumor in Large Tumors Part 3: Local Radiation + G100 20μg/Tumor Part 4: G100 20μg/Tumor and Pembrolizumab 200mg
Hide Arm/Group Description:
Part 1: Local radiation and G100 [glucopyranosyl lipid A stable emulsion, GLA-SE] at 5μg/tumor administered intratumorally (IT) into accessible tumors for up to 8 weeks.
Part 1: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks.
Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks.
Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks; pembrolizumab 200mg intravenously (IV) administered every 3 weeks (Q3W) IV for up to 2 years.
Part 2: Local radiation and G100 at 20 μg/tumor administered IT into accessible large tumors (injectable lymphoma mass(es) ≥ 4 cm in total size) for up to 8 weeks.
Part 3: Local radiation and G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks.
Part 4: G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks and pembrolizumab 200mg IV and administered Q3W for up to 2 years.
Overall Number of Participants Analyzed 3 3 13 13 4 14 1
Measure Type: Count of Participants
Unit of Measure: Participants
3
 100.0%
3
 100.0%
13
 100.0%
13
 100.0%
4
 100.0%
14
 100.0%
1
 100.0%
2.Primary Outcome
Title Number of Participants Who Discontinued Study Drug Due to an Adverse Event
Hide Description An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Time Frame Up to approximately 105 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all enrolled participants who received at least 1 injection of G100 after standard local radiation.
Arm/Group Title Part 1: Local Radiation + G100 5μg/Tumor Part 1: Local Radiation + G100 10μg/Tumor Part 2: Local Radiation + G100 10μg/Tumor Part 2: Local Radiation + G100 10μg/Tumor+Pembrolizumab 200mg Part 2: Local Radiation, G100 20 μg/Tumor in Large Tumors Part 3: Local Radiation + G100 20μg/Tumor Part 4: G100 20μg/Tumor and Pembrolizumab 200mg
Hide Arm/Group Description:
Part 1: Local radiation and G100 [glucopyranosyl lipid A stable emulsion, GLA-SE] at 5μg/tumor administered intratumorally (IT) into accessible tumors for up to 8 weeks.
Part 1: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks.
Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks.
Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks; pembrolizumab 200mg intravenously (IV) administered every 3 weeks (Q3W) IV for up to 2 years.
Part 2: Local radiation and G100 at 20 μg/tumor administered IT into accessible large tumors (injectable lymphoma mass(es) ≥ 4 cm in total size) for up to 8 weeks.
Part 3: Local radiation and G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks.
Part 4: G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks and pembrolizumab 200mg IV and administered Q3W for up to 2 years.
Overall Number of Participants Analyzed 3 3 13 13 4 14 1
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
2
  15.4%
0
   0.0%
1
   7.1%
0
   0.0%
3.Secondary Outcome
Title Overall Response Rate (ORR) by Immune-related Response Criteria (irRC)
Hide Description Overall response rate was defined as the number and percent of participants with best overall response of immune-related complete response (irCR) or immune-related partial response (irPR). irRC requires confirmatory restaging to determine if tumor size increase is due to true progression instead of immune inflammation and that new tumors add to tumor size calculations are not determinants of progressive disease by themselves. An immune-related Complete Response (irCR) is the disappearance of all tumors, measured or unmeasured, and no new tumors; an immune-related Partial Response (irPR) is a ≥50% drop in tumour burden from baseline as defined by the irRC; and immune-related Progressive Disease (irPD) is a ≥25% increase in tumour burden from the lowest level recorded. Everything else is considered immune-related Stable Disease (irSD). Tumor staging using bi-dimensional measurements was performed by CT or MRI.
Time Frame Up to approximately 42 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all enrolled participants without major protocol deviations, who received at least 1 injection of G100, and had baseline and at least 1 post-baseline disease assessment.
Arm/Group Title Part 1: Local Radiation + G100 5μg/Tumor Part 1: Local Radiation + G100 10μg/Tumor Part 2: Local Radiation + G100 10μg/Tumor Part 2: Local Radiation + G100 10μg/Tumor+Pembrolizumab 200mg Part 2: Local Radiation, G100 20 μg/Tumor in Large Tumors Part 3: Local Radiation + G100 20μg/Tumor Part 4: G100 20μg/Tumor and Pembrolizumab 200mg
Hide Arm/Group Description:
Part 1: Local radiation and G100 [glucopyranosyl lipid A stable emulsion, GLA-SE] at 5μg/tumor administered intratumorally (IT) into accessible tumors for up to 8 weeks.
Part 1: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks.
Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks.
Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks; pembrolizumab 200mg intravenously (IV) administered every 3 weeks (Q3W) IV for up to 2 years.
Part 2: Local radiation and G100 at 20 μg/tumor administered IT into accessible large tumors (injectable lymphoma mass(es) ≥ 4 cm in total size) for up to 8 weeks.
Part 3: Local radiation and G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks.
Part 4: G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks and pembrolizumab 200mg IV and administered Q3W for up to 2 years.
Overall Number of Participants Analyzed 3 3 13 13 4 14 1
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response (irCR)
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Partial Response (irPR)
1
  33.3%
2
  66.7%
3
  23.1%
6
  46.2%
1
  25.0%
6
  42.9%
0
   0.0%
Stable Disease (irSD)
2
  66.7%
1
  33.3%
8
  61.5%
6
  46.2%
3
  75.0%
7
  50.0%
1
 100.0%
Progressive Disease (irPD)
0
   0.0%
0
   0.0%
2
  15.4%
1
   7.7%
0
   0.0%
1
   7.1%
0
   0.0%
4.Secondary Outcome
Title Clinical Benefit Rate (CBR) Using Immune-related Response Criteria (irRC)
Hide Description Clinical benefit rate (CBR) was defined as the number and percent of participants with best overall response of complete response, partial response or stable disease (irCR+irPR+irSD). Clinical response was assessed by Immune-related Response Criteria (irRC) using bi-dimensional measurements as a preliminary indication of efficacy. irRC requires confirmatory restaging to determine if tumor size increase is due to true progression instead of immune inflammation and that new tumors add to tumor size calculations are not determinants of progressive disease by themselves. An immune-related Complete Response (irCR) is the disappearance of all tumors, and no new tumors; an immune-related Partial Response (irPR) is a ≥50% drop in tumor burden from baseline; and immune-related Progressive Disease (irPD) is a ≥25% increase in tumor burden from the lowest level recorded. Everything else is considered immune-related Stable Disease (irSD). Tumor staging by CT or MRI was performed.
Time Frame Up to approximately 42 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all enrolled participants without major protocol deviations, who received at least 1 injection of G100, and had baseline and at least 1 post-baseline disease assessment.
Arm/Group Title Part 1: Local Radiation + G100 5μg/Tumor Part 1: Local Radiation + G100 10μg/Tumor Part 2: Local Radiation + G100 10μg/Tumor Part 2: Local Radiation + G100 10μg/Tumor+Pembrolizumab 200mg Part 2: Local Radiation, G100 20 μg/Tumor in Large Tumors Part 3: Local Radiation + G100 20μg/Tumor Part 4: G100 20μg/Tumor and Pembrolizumab 200mg
Hide Arm/Group Description:
Part 1: Local radiation and G100 [glucopyranosyl lipid A stable emulsion, GLA-SE] at 5μg/tumor administered intratumorally (IT) into accessible tumors for up to 8 weeks.
Part 1: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks.
Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks.
Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks; pembrolizumab 200mg intravenously (IV) administered every 3 weeks (Q3W) IV for up to 2 years.
Part 2: Local radiation and G100 at 20 μg/tumor administered IT into accessible large tumors (injectable lymphoma mass(es) ≥ 4 cm in total size) for up to 8 weeks.
Part 3: Local radiation and G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks.
Part 4: G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks and pembrolizumab 200mg IV and administered Q3W for up to 2 years.
Overall Number of Participants Analyzed 3 3 13 13 4 14 1
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent of participants
100
(29.2 to 100)
100
(29.2 to 100)
84.6
(54.6 to 98.1)
92.3
(64.0 to 99.8)
100
(39.8 to 100)
92.9
(66.1 to 99.8)
100
(2.5 to 100)
5.Secondary Outcome
Title Clinical Benefit Rate (CBR) Using International Working Group (IWG) Criteria
Hide Description Clinical benefit rate (CBR) will be defined as the number and percent of participants with best overall response of complete response, partial response or stable disease (CR+PR+SD). The IWG criteria (Cheson et al 2014) for a CR is a complete radiologic response (target nodes/nodal masses must regress to ≤1.5 cm in longest transverse diameter (LDi), no extralymphatic sites of disease, and no new tumors. A PR is a ≥50% decrease in SPD (sum of the product of the perpendicular diameters for multiple tumors) of up to 6 target measurable nodes and extranodal sites, spleen must have regressed by >50% in length beyond normal, and no new tumors. Stable disease is a <50% decrease from baseline in SPD of up to 6 dominant, measurable nodes and extranodal sites; no criteria for progressive disease are met, and no new tumors.
Time Frame Up to approximately 42 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all enrolled participants without major protocol deviations, who received at least 1 injection of G100, and had baseline and at least 1 post-baseline disease assessment.
Arm/Group Title Part 1: Local Radiation + G100 5μg/Tumor Part 1: Local Radiation + G100 10μg/Tumor Part 2: Local Radiation + G100 10μg/Tumor Part 2: Local Radiation + G100 10μg/Tumor+Pembrolizumab 200mg Part 2: Local Radiation, G100 20 μg/Tumor in Large Tumors Part 3: Local Radiation + G100 20μg/Tumor Part 4: G100 20μg/Tumor and Pembrolizumab 200mg
Hide Arm/Group Description:
Part 1: Local radiation and G100 [glucopyranosyl lipid A stable emulsion, GLA-SE] at 5μg/tumor administered intratumorally (IT) into accessible tumors for up to 8 weeks.
Part 1: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks.
Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks.
Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks; pembrolizumab 200mg intravenously (IV) administered every 3 weeks (Q3W) IV for up to 2 years.
Part 2: Local radiation and G100 at 20 μg/tumor administered IT into accessible large tumors (injectable lymphoma mass(es) ≥ 4 cm in total size) for up to 8 weeks.
Part 3: Local radiation and G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks.
Part 4: G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks and pembrolizumab 200mg IV and administered Q3W for up to 2 years.
Overall Number of Participants Analyzed 3 3 13 13 4 14 1
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
100
(29.2 to 100)
100
(29.2 to 100)
84.6
(54.6 to 98.1)
92.3
(64.0 to 99.8)
100
(39.8 to 100)
78.6
(49.2 to 95.3)
100
(2.5 to 100)
6.Secondary Outcome
Title Duration of Response (DOR) by Immune-related Response Criteria (irRC)
Hide Description Duration of response (DOR) was defined as the time interval between the date of the earliest qualifying confirmed/unconfirmed response using irRC and the date of disease progression (PD) or death for any cause, whichever occurs first. DOR in months was calculated as: (date of PD or death minus date of first confirmed/unconfirmed irCR/CR or irPR/PR + 1)/30.4375. DOR analysis included only participants with confirmed/unconfirmed response of irCR/irPR using irRC. Immune-related Progressive Disease (irPD) is a ≥25% increase in tumor burden from the lowest level recorded. Summary of DOR including median was estimated using the Kaplan-Meier method in each treatment group.
Time Frame Up to approximately 42 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all enrolled participants who received at least 1 injection of G100 after standard local radiation and had a confirmed/unconfirmed response of irCR/irPR using irRC.
Arm/Group Title Part 1: Local Radiation + G100 5μg/Tumor Part 1: Local Radiation + G100 10μg/Tumor Part 2: Local Radiation + G100 10μg/Tumor Part 2: Local Radiation + G100 10μg/Tumor+Pembrolizumab 200mg Part 2: Local Radiation, G100 20 μg/Tumor in Large Tumors Part 3: Local Radiation + G100 20μg/Tumor Part 4: G100 20μg/Tumor and Pembrolizumab 200mg
Hide Arm/Group Description:
Part 1: Local radiation and G100 [glucopyranosyl lipid A stable emulsion, GLA-SE] at 5μg/tumor administered intratumorally (IT) into accessible tumors for up to 8 weeks.
Part 1: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks.
Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks.
Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks; pembrolizumab 200mg intravenously (IV) administered every 3 weeks (Q3W) IV for up to 2 years.
Part 2: Local radiation and G100 at 20 μg/tumor administered IT into accessible large tumors (injectable lymphoma mass(es) ≥ 4 cm in total size) for up to 8 weeks.
Part 3: Local radiation and G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks.
Part 4: G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks and pembrolizumab 200mg IV and administered Q3W for up to 2 years.
Overall Number of Participants Analyzed 1 1 3 4 1 5 0
Median (Full Range)
Unit of Measure: Months
1.8
(1.8 to 1.8)
15.6
(15.6 to 15.6)
NA [1] 
(NA to NA)
18.4
(3.8 to 27.2)
NA [1] 
(NA to NA)
5.6
(2.8 to 16.1)
[1]
NA = Median DOR and DOR upper and lower limits were not reached as there was no progressive disease by the time of last disease assessment.
7.Secondary Outcome
Title Duration of Clinical Benefit by Immune-related Response Criteria (irRC)
Hide Description Duration of clinical benefit was defined as the time interval between the date of the earliest qualifying confirmed/unconfirmed best response using irRC and the date of progression disease (PD) or death for any cause, whichever occurred first. Duration of clinical benefit in months was calculated as: (date of PD or death - date of first confirmed/unconfirmed irCR/irPR or irSD + 1)/30.4375. Duration of clinical benefit included only participants with confirmed/unconfirmed response of irCR/irPR or irSD using irRC. For participants who were alive without documentation of disease progression following the qualifying response, duration of clinical benefit was censored following the same rule defined for PFS. Summary of duration of clinical benefit including median was estimated using the Kaplan Meier method in each treatment group.
Time Frame Up to approximately 42 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all enrolled participants who received at least 1 injection of G100 after standard local radiation and had a confirmed/unconfirmed response of irCR/irPR or irSD using irRC.
Arm/Group Title Part 1: Local Radiation + G100 5μg/Tumor Part 1: Local Radiation + G100 10μg/Tumor Part 2: Local Radiation + G100 10μg/Tumor Part 2: Local Radiation + G100 10μg/Tumor+Pembrolizumab 200mg Part 2: Local Radiation, G100 20 μg/Tumor in Large Tumors Part 3: Local Radiation + G100 20μg/Tumor Part 4: G100 20μg/Tumor and Pembrolizumab 200mg
Hide Arm/Group Description:
Part 1: Local radiation and G100 [glucopyranosyl lipid A stable emulsion, GLA-SE] at 5μg/tumor administered intratumorally (IT) into accessible tumors for up to 8 weeks.
Part 1: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks.
Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks.
Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks; pembrolizumab 200mg intravenously (IV) administered every 3 weeks (Q3W) IV for up to 2 years.
Part 2: Local radiation and G100 at 20 μg/tumor administered IT into accessible large tumors (injectable lymphoma mass(es) ≥ 4 cm in total size) for up to 8 weeks.
Part 3: Local radiation and G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks.
Part 4: G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks and pembrolizumab 200mg IV and administered Q3W for up to 2 years.
Overall Number of Participants Analyzed 3 3 11 12 4 13 0
Median (Full Range)
Unit of Measure: Months
2.5
(1.8 to 3.4)
20.8
(0.0 to 26.0)
6.9
(0.0 to 16.2)
9.2
(2.8 to 27.2)
7.2
(0.0 to 20.1)
4.3
(0.0 to 20.0)
8.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description PFS was defined as time from date of first study treatment to date of first disease progression by irRC criteria, symptomatic deterioration, or death due to any cause, whichever occurs first. Progression-free survival in months is calculated as: (date of first progression, symptomatic deterioration, or death (any reason) - date of first dose +1)/30.4375. The irRC modification required a PD confirmation no less than 4 weeks from first documentation of PD; once confirmed, the date of progression was defined as date of the first PD. Participants without progression, symptomatic deterioration, or death were censored at the date of the last tumor assessment. Immune-related Progressive Disease (irPD) is a ≥25% increase in tumor burden from the lowest level recorded. Summary of PFS including median was estimated using the Kaplan-Meier method in each treatment group.
Time Frame Up to approximately 42 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all enrolled participants without major protocol deviations, who received at least 1 injection of G100, and had baseline and at least 1 post-baseline disease assessment.
Arm/Group Title Part 1: Local Radiation + G100 5μg/Tumor Part 1: Local Radiation + G100 10μg/Tumor Part 2: Local Radiation + G100 10μg/Tumor Part 2: Local Radiation + G100 10μg/Tumor+Pembrolizumab 200mg Part 2: Local Radiation, G100 20 μg/Tumor in Large Tumors Part 3: Local Radiation + G100 20μg/Tumor Part 4: G100 20μg/Tumor and Pembrolizumab 200mg
Hide Arm/Group Description:
Part 1: Local radiation and G100 [glucopyranosyl lipid A stable emulsion, GLA-SE] at 5μg/tumor administered intratumorally (IT) into accessible tumors for up to 8 weeks.
Part 1: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks.
Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks.
Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks; pembrolizumab 200mg intravenously (IV) administered every 3 weeks (Q3W) IV for up to 2 years.
Part 2: Local radiation and G100 at 20 μg/tumor administered IT into accessible large tumors (injectable lymphoma mass(es) ≥ 4 cm in total size) for up to 8 weeks.
Part 3: Local radiation and G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks.
Part 4: G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks and pembrolizumab 200mg IV and administered Q3W for up to 2 years.
Overall Number of Participants Analyzed 3 3 13 13 4 14 1
Median (Full Range)
Unit of Measure: Months
4.9
(3.7 to 5.3)
22.6
(1.9 to 27.7)
7.4
(1.7 to 33.7)
11.1
(1.9 to 32.5)
9.8
(1.9 to 21.9)
7.7
(1.4 to 22.6)
NA [1] 
(NA to NA)
[1]
NA = Median PFS and PFS upper and lower limits were not reached as there was no disease progression or death by time of last disease assessment.
9.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall Survival (OS) was defined as the time from date of first study treatment to death due to any cause. Overall survival in months was calculated as: (date of death - date of first dose) +1)/30.4375. Participants who were alive at the end of study were censored at the last date the participant was known to be alive or data analysis cutoff date, whichever was earlier. Summary of OS including median was estimated using the Kaplan-Meier method in each treatment group.
Time Frame Up to approximately 42 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all enrolled participants without major protocol deviations, who received at least 1 injection of G100, and had baseline and at least 1 post-baseline disease assessment.
Arm/Group Title Part 1: Local Radiation + G100 5μg/Tumor Part 1: Local Radiation + G100 10μg/Tumor Part 2: Local Radiation + G100 10μg/Tumor Part 2: Local Radiation + G100 10μg/Tumor+Pembrolizumab 200mg Part 2: Local Radiation, G100 20 μg/Tumor in Large Tumors Part 3: Local Radiation + G100 20μg/Tumor Part 4: G100 20μg/Tumor and Pembrolizumab 200mg
Hide Arm/Group Description:
Part 1: Local radiation and G100 [glucopyranosyl lipid A stable emulsion, GLA-SE] at 5μg/tumor administered intratumorally (IT) into accessible tumors for up to 8 weeks.
Part 1: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks.
Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks.
Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks; pembrolizumab 200mg intravenously (IV) administered every 3 weeks (Q3W) IV for up to 2 years.
Part 2: Local radiation and G100 at 20 μg/tumor administered IT into accessible large tumors (injectable lymphoma mass(es) ≥ 4 cm in total size) for up to 8 weeks.
Part 3: Local radiation and G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks.
Part 4: G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks and pembrolizumab 200mg IV and administered Q3W for up to 2 years.
Overall Number of Participants Analyzed 3 3 13 13 4 14 1
Median (Full Range)
Unit of Measure: Months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
NA = Median OS and OS upper and lower limits were not reached as there was an insufficient number of deaths by time of last disease assessment.
10.Secondary Outcome
Title Overall Tumor Response Based on irRC Abscopal Sites
Hide Description Abscopal tumor responses were assessed in non-treated, distal tumor sites. Clinical response was assessed by Immune-related Response Criteria (irRC) using bi-dimensional measurements as a preliminary indication of efficacy. irRC requires confirmatory restaging to determine if tumor size increase is due to true progression instead of immune inflammation and that new tumors add to tumor size calculations are not determinants of progressive disease by themselves. An immune-related Complete Response (irCR) is the disappearance of all tumors, measured or unmeasured, and no new tumors; an immune-related Partial Response (irPR) is a ≥50% drop in tumour burden from baseline as defined by the irRC; and immune-related Progressive Disease (irPD) is a ≥25% increase in tumour burden from the lowest level recorded. Everything else was considered immune-related Stable Disease (irSD). Tumor staging by CT or MRI was performed.
Time Frame Up to approximately 42 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all enrolled participants without major protocol deviations, who received at least 1 injection of G100, and had baseline and at least 1 post-baseline disease assessment.
Arm/Group Title Part 1: Local Radiation + G100 5μg/Tumor Part 1: Local Radiation + G100 10μg/Tumor Part 2: Local Radiation + G100 10μg/Tumor Part 2: Local Radiation + G100 10μg/Tumor+Pembrolizumab 200mg Part 2: Local Radiation, G100 20 μg/Tumor in Large Tumors Part 3: Local Radiation + G100 20μg/Tumor Part 4: G100 20μg/Tumor and Pembrolizumab 200mg
Hide Arm/Group Description:
Part 1: Local radiation and G100 [glucopyranosyl lipid A stable emulsion, GLA-SE] at 5μg/tumor administered intratumorally (IT) into accessible tumors for up to 8 weeks.
Part 1: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks.
Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks.
Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks; pembrolizumab 200mg intravenously (IV) administered every 3 weeks (Q3W) IV for up to 2 years.
Part 2: Local radiation and G100 at 20 μg/tumor administered IT into accessible large tumors (injectable lymphoma mass(es) ≥ 4 cm in total size) for up to 8 weeks.
Part 3: Local radiation and G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks.
Part 4: G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks and pembrolizumab 200mg IV and administered Q3W for up to 2 years.
Overall Number of Participants Analyzed 3 3 13 13 4 14 1
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response (irCR)
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Partial Response (irPR)
0
   0.0%
1
  33.3%
4
  30.8%
3
  23.1%
0
   0.0%
3
  21.4%
0
   0.0%
Stable Disease (irSD)
1
  33.3%
2
  66.7%
4
  30.8%
8
  61.5%
3
  75.0%
9
  64.3%
1
 100.0%
Progressive Disease (irPD)
1
  33.3%
0
   0.0%
4
  30.8%
2
  15.4%
1
  25.0%
2
  14.3%
0
   0.0%
11.Secondary Outcome
Title Time to Response for Complete Response and Partial Response Participants
Hide Description Time to Response for CR and PR participants was defined as time from date of first study treatment to the date of CR or PR response first documented. Complete Response (irCR) is the disappearance of all tumors, and no new tumors; an immune-related Partial Response (irPR) is a ≥50% drop in tumor burden from baseline. Time to response in months was calculated as: (date of first CR or PR minus date of first dose +1)/30.4375. Summary of Time to Response including median was estimated using Kaplan-Meier method in each treatment group.
Time Frame Up to approximately 42 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all enrolled participants without major protocol deviations, who received at least 1 injection of G100, had baseline and at least 1 post-baseline disease assessment, and had a best response of CR or PR.
Arm/Group Title Part 1: Local Radiation + G100 5μg/Tumor Part 1: Local Radiation + G100 10μg/Tumor Part 2: Local Radiation + G100 10μg/Tumor Part 2: Local Radiation + G100 10μg/Tumor+Pembrolizumab 200mg Part 2: Local Radiation, G100 20 μg/Tumor in Large Tumors Part 3: Local Radiation + G100 20μg/Tumor Part 4: G100 20μg/Tumor and Pembrolizumab 200mg
Hide Arm/Group Description:
Part 1: Local radiation and G100 [glucopyranosyl lipid A stable emulsion, GLA-SE] at 5μg/tumor administered intratumorally (IT) into accessible tumors for up to 8 weeks.
Part 1: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks.
Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks.
Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks; pembrolizumab 200mg intravenously (IV) administered every 3 weeks (Q3W) IV for up to 2 years.
Part 2: Local radiation and G100 at 20 μg/tumor administered IT into accessible large tumors (injectable lymphoma mass(es) ≥ 4 cm in total size) for up to 8 weeks.
Part 3: Local radiation and G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks.
Part 4: G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks and pembrolizumab 200mg IV and administered Q3W for up to 2 years.
Overall Number of Participants Analyzed 1 2 3 6 1 6 0
Median (Full Range)
Unit of Measure: Months
1.9
(1.9 to 1.9)
1.9
(1.9 to 1.9)
2.3
(1.7 to 18.1)
4.1
(2.2 to 14.1)
2.6
(2.6 to 2.6)
5.2
(1.9 to 7.3)
12.Secondary Outcome
Title Time to Next Treatment (TTNT)
Hide Description Time to next treatment was defined as the time from the date of first study treatment to the start date of subsequent therapy after PD. Immune-related Progressive Disease (irPD) is a ≥25% increase in tumor burden from the lowest level recorded. Participants who did not receive subsequent therapy after PD were censored at the date of last contact or death. Summary of TTNT including median was estimated using the Kaplan-Meier method in each treatment group.
Time Frame Up to approximately 42 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all enrolled participants without major protocol deviations, who received at least 1 injection of G100, had baseline and at least 1 post-baseline disease assessment, and had subsequent therapy with PD.
Arm/Group Title Part 1: Local Radiation + G100 5μg/Tumor Part 1: Local Radiation + G100 10μg/Tumor Part 2: Local Radiation + G100 10μg/Tumor Part 2: Local Radiation + G100 10μg/Tumor+Pembrolizumab 200mg Part 2: Local Radiation, G100 20 μg/Tumor in Large Tumors Part 3: Local Radiation + G100 20μg/Tumor Part 4: G100 20μg/Tumor and Pembrolizumab 200mg
Hide Arm/Group Description:
Part 1: Local radiation and G100 [glucopyranosyl lipid A stable emulsion, GLA-SE] at 5μg/tumor administered intratumorally (IT) into accessible tumors for up to 8 weeks.
Part 1: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks.
Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks.
Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks; pembrolizumab 200mg intravenously (IV) administered every 3 weeks (Q3W) IV for up to 2 years.
Part 2: Local radiation and G100 at 20 μg/tumor administered IT into accessible large tumors (injectable lymphoma mass(es) ≥ 4 cm in total size) for up to 8 weeks.
Part 3: Local radiation and G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks.
Part 4: G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks and pembrolizumab 200mg IV and administered Q3W for up to 2 years.
Overall Number of Participants Analyzed 3 1 8 6 1 6 0
Median (Full Range)
Unit of Measure: Months
5.4
(4.1 to 6.6)
NA [1] 
(NA to NA)
12.7
(1.9 to 33.7)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
NA = Median TTNT and TTNT upper and lower limits were not reached as there was an insufficient number of treatments by time of last assessment.
Time Frame Up to approximately 42 months
Adverse Event Reporting Description The analysis population included all enrolled and treated participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered treatment-related. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Part 5, G100 plus Rituximab, Dose Escalation: no participant was enrolled or dosed.
 
Arm/Group Title Part 1: Local Radiation + G100 5μg/Tumor Part 1: Local Radiation + G100 10μg/Tumor Part 2: Local Radiation + G100 10μg/Tumor Part 2: Local Radiation + G100 10μg/Tumor+Pembrolizumab 200mg Part 2: Local Radiation, G100 20 μg/Tumor in Large Tumors Part 3: Local Radiation + G100 20μg/Tumor Part 4: G100 20μg/Tumor and Pembrolizumab 200mg
Hide Arm/Group Description Part 1: Local radiation and G100 [glucopyranosyl lipid A stable emulsion, GLA-SE] at 5μg/tumor administered intratumorally (IT) into accessible tumors for up to 8 weeks. Part 1: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks. Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks. Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks; pembrolizumab 200mg intravenously (IV) administered every 3 weeks (Q3W) IV for up to 2 years. Part 2: Local radiation and G100 at 20 μg/tumor administered IT into accessible large tumors (injectable lymphoma mass(es) ≥ 4 cm in total size) for up to 8 weeks. Part 3: Local radiation and G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks. Part 4: G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks and pembrolizumab 200mg IV and administered Q3W for up to 2 years.
All-Cause Mortality
Part 1: Local Radiation + G100 5μg/Tumor Part 1: Local Radiation + G100 10μg/Tumor Part 2: Local Radiation + G100 10μg/Tumor Part 2: Local Radiation + G100 10μg/Tumor+Pembrolizumab 200mg Part 2: Local Radiation, G100 20 μg/Tumor in Large Tumors Part 3: Local Radiation + G100 20μg/Tumor Part 4: G100 20μg/Tumor and Pembrolizumab 200mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)      0/3 (0.00%)      1/13 (7.69%)      1/14 (7.14%)      0/4 (0.00%)      1/14 (7.14%)      0/1 (0.00%)    
Hide Serious Adverse Events
Part 1: Local Radiation + G100 5μg/Tumor Part 1: Local Radiation + G100 10μg/Tumor Part 2: Local Radiation + G100 10μg/Tumor Part 2: Local Radiation + G100 10μg/Tumor+Pembrolizumab 200mg Part 2: Local Radiation, G100 20 μg/Tumor in Large Tumors Part 3: Local Radiation + G100 20μg/Tumor Part 4: G100 20μg/Tumor and Pembrolizumab 200mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/3 (0.00%)      1/13 (7.69%)      4/13 (30.77%)      0/4 (0.00%)      0/14 (0.00%)      0/1 (0.00%)    
Endocrine disorders               
Adrenal insufficiency  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Gastrointestinal disorders               
Abdominal pain upper  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
General disorders               
Pyrexia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Infections and infestations               
Septic shock  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Injury, poisoning and procedural complications               
Multiple fractures  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
1
Term from vocabulary, MedDRA Version 22.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part 1: Local Radiation + G100 5μg/Tumor Part 1: Local Radiation + G100 10μg/Tumor Part 2: Local Radiation + G100 10μg/Tumor Part 2: Local Radiation + G100 10μg/Tumor+Pembrolizumab 200mg Part 2: Local Radiation, G100 20 μg/Tumor in Large Tumors Part 3: Local Radiation + G100 20μg/Tumor Part 4: G100 20μg/Tumor and Pembrolizumab 200mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      3/3 (100.00%)      13/13 (100.00%)      13/13 (100.00%)      4/4 (100.00%)      14/14 (100.00%)      1/1 (100.00%)    
Blood and lymphatic system disorders               
Anaemia  1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/13 (7.69%)  2 2/13 (15.38%)  3 1/4 (25.00%)  4 0/14 (0.00%)  0 0/1 (0.00%)  0
Blood loss anaemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Leukocytosis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/13 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1 0/1 (0.00%)  0
Leukopenia  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/13 (0.00%)  0 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Lymph node pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Cardiac disorders               
Coronary artery disease  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/13 (0.00%)  0 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Myocardial fibrosis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Sinus bradycardia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/13 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1 0/1 (0.00%)  0
Tachycardia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 1/14 (7.14%)  1 0/1 (0.00%)  0
Ear and labyrinth disorders               
Ear congestion  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Tinnitus  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Vertigo  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/13 (0.00%)  0 1/4 (25.00%)  1 1/14 (7.14%)  2 0/1 (0.00%)  0
Endocrine disorders               
Hyperthyroidism  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Hypothyroidism  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  2 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Eye disorders               
Diplopia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/13 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1 0/1 (0.00%)  0
Eyelid ptosis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/13 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1 0/1 (0.00%)  0
Periorbital oedema  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/13 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1 0/1 (0.00%)  0
Vision blurred  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/13 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  2 0/1 (0.00%)  0
Gastrointestinal disorders               
Abdominal discomfort  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/13 (0.00%)  0 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Abdominal distension  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/13 (0.00%)  0 1/4 (25.00%)  1 1/14 (7.14%)  1 0/1 (0.00%)  0
Abdominal pain  1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/13 (7.69%)  2 2/13 (15.38%)  4 2/4 (50.00%)  3 2/14 (14.29%)  2 0/1 (0.00%)  0
Colitis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  2 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Constipation  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 2/13 (15.38%)  2 1/4 (25.00%)  2 1/14 (7.14%)  1 0/1 (0.00%)  0
Dental caries  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/13 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1 0/1 (0.00%)  0
Diarrhoea  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/13 (15.38%)  2 4/13 (30.77%)  4 0/4 (0.00%)  0 2/14 (14.29%)  2 0/1 (0.00%)  0
Dyspepsia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/13 (0.00%)  0 1/4 (25.00%)  1 0/14 (0.00%)  0 0/1 (0.00%)  0
Dysphagia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Flatulence  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 1/14 (7.14%)  1 0/1 (0.00%)  0
Hiatus hernia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Hypoaesthesia oral  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Inguinal hernia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Nausea  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  2 6/13 (46.15%)  7 1/4 (25.00%)  2 3/14 (21.43%)  4 0/1 (0.00%)  0
Rectal tenesmus  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Toothache  1  2/3 (66.67%)  2 0/3 (0.00%)  0 0/13 (0.00%)  0 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Vomiting  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 3/13 (23.08%)  3 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
General disorders               
Administration site pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Asthenia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 4/13 (30.77%)  7 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Chest pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 2/13 (15.38%)  2 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Chills  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 1/13 (7.69%)  1 0/4 (0.00%)  0 3/14 (21.43%)  3 0/1 (0.00%)  0
Fatigue  1  1/3 (33.33%)  1 2/3 (66.67%)  2 0/13 (0.00%)  0 4/13 (30.77%)  4 2/4 (50.00%)  2 3/14 (21.43%)  3 1/1 (100.00%)  1
Feeling hot  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Influenza like illness  1  0/3 (0.00%)  0 1/3 (33.33%)  2 0/13 (0.00%)  0 2/13 (15.38%)  2 0/4 (0.00%)  0 2/14 (14.29%)  2 0/1 (0.00%)  0
Infusion site swelling  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Injection site bruising  1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1 0/1 (0.00%)  0
Injection site discomfort  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Injection site erythema  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/13 (0.00%)  0 0/4 (0.00%)  0 2/14 (14.29%)  2 0/1 (0.00%)  0
Injection site pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 3/13 (23.08%)  5 1/13 (7.69%)  1 0/4 (0.00%)  0 2/14 (14.29%)  3 0/1 (0.00%)  0
Injection site reaction  1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/13 (7.69%)  5 2/13 (15.38%)  4 0/4 (0.00%)  0 1/14 (7.14%)  8 0/1 (0.00%)  0
Injection site swelling  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Oedema peripheral  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/13 (0.00%)  0 0/4 (0.00%)  0 3/14 (21.43%)  3 0/1 (0.00%)  0
Peripheral swelling  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 1/14 (7.14%)  1 0/1 (0.00%)  0
Pyrexia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 1/4 (25.00%)  4 2/14 (14.29%)  2 0/1 (0.00%)  0
Immune system disorders               
Drug hypersensitivity  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/13 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1 0/1 (0.00%)  0
Seasonal allergy  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Infections and infestations               
Candida infection  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Cellulitis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Conjunctivitis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 2/13 (15.38%)  2 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Diverticulitis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/13 (0.00%)  0 1/4 (25.00%)  1 0/14 (0.00%)  0 0/1 (0.00%)  0
Helicobacter duodenitis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Herpes virus infection  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/13 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1 0/1 (0.00%)  0
Influenza  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 1/13 (7.69%)  1 0/4 (0.00%)  0 1/14 (7.14%)  1 0/1 (0.00%)  0
Nasopharyngitis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 2/13 (15.38%)  3 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Oesophagitis bacterial  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Oral herpes  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/13 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1 0/1 (0.00%)  0
Rhinovirus infection  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Sinusitis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/13 (15.38%)  3 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Tooth infection  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/13 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1 0/1 (0.00%)  0
Upper respiratory tract infection  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/13 (15.38%)  5 2/13 (15.38%)  2 1/4 (25.00%)  1 1/14 (7.14%)  1 0/1 (0.00%)  0
Urinary tract infection  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/13 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1 0/1 (0.00%)  0
Injury, poisoning and procedural complications               
Contusion  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  3 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Expired product administered  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 2/13 (15.38%)  3 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Fall  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Procedural pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 1/13 (7.69%)  2 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Radiation associated pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/13 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1 0/1 (0.00%)  0
Radiation skin injury  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/13 (0.00%)  0 1/4 (25.00%)  1 0/14 (0.00%)  0 0/1 (0.00%)  0
Skin laceration  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Investigations               
Alanine aminotransferase increased  1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/13 (7.69%)  1 3/13 (23.08%)  5 1/4 (25.00%)  1 0/14 (0.00%)  0 0/1 (0.00%)  0
Aspartate aminotransferase increased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  2 2/13 (15.38%)  2 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Blast cell count increased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Blood alkaline phosphatase increased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  2 2/13 (15.38%)  5 1/4 (25.00%)  2 0/14 (0.00%)  0 0/1 (0.00%)  0
Blood bilirubin decreased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Blood bilirubin increased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/13 (15.38%)  2 0/13 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  5 0/1 (0.00%)  0
Blood creatinine decreased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Blood creatinine increased  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/13 (0.00%)  0 0/13 (0.00%)  0 0/4 (0.00%)  0 2/14 (14.29%)  3 0/1 (0.00%)  0
Blood glucose increased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/13 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1 0/1 (0.00%)  0
Breath sounds abnormal  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Haemoglobin increased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 1/14 (7.14%)  1 0/1 (0.00%)  0
Lymphocyte count decreased  1  0/3 (0.00%)  0 1/3 (33.33%)  1 2/13 (15.38%)  3 0/13 (0.00%)  0 1/4 (25.00%)  1 3/14 (21.43%)  6 0/1 (0.00%)  0
Neutrophil count decreased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  2 0/13 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  2 0/1 (0.00%)  0
Platelet count decreased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/13 (15.38%)  2 0/13 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1 0/1 (0.00%)  0
White blood cell count decreased  1  0/3 (0.00%)  0 1/3 (33.33%)  1 2/13 (15.38%)  4 1/13 (7.69%)  1 0/4 (0.00%)  0 1/14 (7.14%)  1 0/1 (0.00%)  0
Metabolism and nutrition disorders               
Decreased appetite  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Hyperglycaemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  3 3/13 (23.08%)  5 0/4 (0.00%)  0 1/14 (7.14%)  2 0/1 (0.00%)  0
Hyperkalaemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/13 (0.00%)  0 1/4 (25.00%)  7 2/14 (14.29%)  2 0/1 (0.00%)  0
Hyperlipidaemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/13 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1 0/1 (0.00%)  0
Hypernatraemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Hyperuricaemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  2 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Hypoalbuminaemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Hypocalcaemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Hypokalaemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/13 (0.00%)  0 1/4 (25.00%)  1 0/14 (0.00%)  0 0/1 (0.00%)  0
Hyponatraemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 2/13 (15.38%)  3 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Musculoskeletal and connective tissue disorders               
Arthralgia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 3/13 (23.08%)  3 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Back pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/13 (15.38%)  2 0/13 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1 0/1 (0.00%)  0
Bone pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Flank pain  1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Gouty arthritis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/13 (0.00%)  0 1/4 (25.00%)  1 0/14 (0.00%)  0 0/1 (0.00%)  0
Groin pain  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/13 (0.00%)  0 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Muscle spasms  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/13 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1 0/1 (0.00%)  0
Musculoskeletal chest pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 2/13 (15.38%)  2 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Musculoskeletal pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 2/13 (15.38%)  2 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Myalgia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 2/13 (15.38%)  2 0/4 (0.00%)  0 2/14 (14.29%)  3 0/1 (0.00%)  0
Pain in extremity  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  2 2/4 (50.00%)  2 0/14 (0.00%)  0 0/1 (0.00%)  0
Plantar fasciitis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Nervous system disorders               
Carpal tunnel syndrome  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Dizziness  1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/13 (7.69%)  1 2/13 (15.38%)  3 0/4 (0.00%)  0 2/14 (14.29%)  3 0/1 (0.00%)  0
Dysgeusia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/13 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1 0/1 (0.00%)  0
Headache  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 1/14 (7.14%)  1 0/1 (0.00%)  0
Neuropathy peripheral  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Nystagmus  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/13 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1 0/1 (0.00%)  0
Presyncope  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Psychiatric disorders               
Depression  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 1/4 (25.00%)  1 0/14 (0.00%)  0 0/1 (0.00%)  0
Insomnia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/13 (0.00%)  0 1/4 (25.00%)  1 1/14 (7.14%)  1 0/1 (0.00%)  0
Libido decreased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Restlessness  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/13 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1 0/1 (0.00%)  0
Sleep disorder  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Renal and urinary disorders               
Dysuria  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Hydronephrosis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Urinary hesitation  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Reproductive system and breast disorders               
Epididymal cyst  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Oedema genital  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Testicular atrophy  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Testis discomfort  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Vulvovaginal inflammation  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Respiratory, thoracic and mediastinal disorders               
Asthma  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Cough  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/13 (15.38%)  2 4/13 (30.77%)  5 0/4 (0.00%)  0 1/14 (7.14%)  1 0/1 (0.00%)  0
Dyspnoea  1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/13 (7.69%)  1 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Nasal congestion  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/13 (15.38%)  2 2/13 (15.38%)  4 0/4 (0.00%)  0 1/14 (7.14%)  1 1/1 (100.00%)  1
Oropharyngeal pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 4/13 (30.77%)  4 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Pleural effusion  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Productive cough  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Pulmonary congestion  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Sinus congestion  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Throat irritation  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/13 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1 0/1 (0.00%)  0
Upper-airway cough syndrome  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  3 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Skin and subcutaneous tissue disorders               
Alopecia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Dry skin  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Ecchymosis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 1/1 (100.00%)  1
Erythema  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  2 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Hyperhidrosis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/13 (0.00%)  0 0/4 (0.00%)  0 2/14 (14.29%)  4 0/1 (0.00%)  0
Night sweats  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Pruritus  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 1/13 (7.69%)  1 1/4 (25.00%)  1 0/14 (0.00%)  0 0/1 (0.00%)  0
Rash  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/13 (15.38%)  3 3/13 (23.08%)  5 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Rash papular  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Skin discolouration  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Skin hyperpigmentation  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/13 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1 0/1 (0.00%)  0
Skin reaction  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/13 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1 0/1 (0.00%)  0
Skin swelling  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/13 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1 0/1 (0.00%)  0
Skin texture abnormal  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Vascular disorders               
Diastolic hypertension  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Embolism  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Flushing  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Haematoma  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Hot flush  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/13 (0.00%)  0 1/4 (25.00%)  1 0/14 (0.00%)  0 0/1 (0.00%)  0
Hypertension  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/13 (7.69%)  2 2/13 (15.38%)  4 0/4 (0.00%)  0 1/14 (7.14%)  1 0/1 (0.00%)  0
Hypotension  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Systolic hypertension  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0 0/1 (0.00%)  0
Varicose vein  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/13 (0.00%)  0 0/13 (0.00%)  0 0/4 (0.00%)  0 1/14 (7.14%)  1 0/1 (0.00%)  0
1
Term from vocabulary, MedDRA Version 22.0
Indicates events were collected by systematic assessment
The study was terminated (halted prematurely) for business reasons.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor will have 30 days for review/ comment on any manuscripts from results of this clinical trial, and can request an additional 30 days in order to protect the Sponsor's confidential, proprietary data, and intellectual property rights. Abstracts, press releases, and other media presentations must also be forwarded to the Sponsor prior to release. No publication, manuscript, or other form of public disclosure shall contain any of the Sponsor's confidential/ proprietary information.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Immune Design
ClinicalTrials.gov Identifier: NCT02501473    
Other Study ID Numbers: 3475-174
IMDZ-G142 ( Other Identifier: Immune Design Protocol Number )
MK-3475-174 ( Other Identifier: Merck Protocol Number )
2015-005382-23 ( EudraCT Number )
First Submitted: July 8, 2015
First Posted: July 17, 2015
Results First Submitted: July 21, 2020
Results First Posted: September 9, 2020
Last Update Posted: September 9, 2020