Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Efficacy of CRS-207 With Epacadostat in Platinum Resistant Ovarian, Fallopian or Peritoneal Cancer (SEASCAPE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02575807
Recruitment Status : Terminated (Study was stopped due to low enrollment and lack of clinical activity.)
First Posted : October 15, 2015
Results First Posted : April 4, 2019
Last Update Posted : April 4, 2019
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
Aduro Biotech, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Platinum-resistant Ovarian Cancer
Platinum-resistant Fallopian Cancer
Platinum-resistant Peritoneal Cancer
Interventions Biological: CRS-207
Drug: Epacadostat
Biological: Pembrolizumab
Enrollment 35
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phase 1: CRS-207 Phase 1: CRS-207/IDO 100 mg Phase 1: CRS-207/IDO 300 mg Phase 2: CRS-207/Pembro/IDO Phase 2: CRS-207/Pembro
Hide Arm/Group Description

CRS-207 administered in 3-week cycles.

* CRS-207 (1 x 10e9 colony forming units [CFU]) administered by intravenous (IV) infusion. For Cycle 1 through Cycle 6, CRS-207 will be administered on Day 1 of each cycle. After 6 cycles, CRS-207 will be administered on Day 1 once every 6 weeks (every other cycle).

CRS-207 administered in 3-week cycles, epacadostat (IDO) administered twice daily (BID).

  • CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
  • IDO (100 milligrams [mg]) administered by mouth (PO) BID, starting on Day 2 of the first CRS-207 treatment cycle.

CRS-207 administered in 3-week cycles, IDO administered BID.

  • CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
  • IDO (300 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.

CRS-207 and pembrolizumab (pembro) administered in 3-week cycles, IDO administered BID.

  • CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
  • Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
  • IDO (300 mg) administered PO BID, starting on Day 3 of the first CRS-207 treatment cycle.

CRS-207 and pembro administered in 3-week cycles.

  • CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
  • Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
Period Title: Overall Study
Started 9 4 16 2 4
Treated [1] 8 4 16 1 3
Completed [2] 0 [3] 0 [3] 0 [3] 0 [3] 0 [3]
Not Completed 9 4 16 2 4
Reason Not Completed
Death             8             3             7             0             1
Study terminated by Sponsor             0             1             7             0             1
Terminated due to FDA clinical hold             1             0             0             0             0
Terminated due to physician decision             0             0             1             0             0
Subject ineligible - medical implant             0             0             0             1             0
Withdrawal by Subject             0             0             1             1             2
[1]
Subjects who received at least 1 dose of protocol-specified drug.
[2]
No predetermined study completion date or study completion event specified in protocol.
[3]
Subjects followed until lost to follow-up/consent withdrawn/study termination/death.
Arm/Group Title Phase 1: CRS-207 Phase 1: CRS-207/IDO 100 mg Phase 1: CRS-207/IDO 300 mg Phase 2: CRS-207/Pembro/IDO Phase 2: CRS-207/Pembro Total
Hide Arm/Group Description

CRS-207 administered in 3-week cycles.

* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 will be administered on Day 1 of each cycle. After 6 cycles, CRS-207 will be administered on Day 1 once every 6 weeks (every other cycle).

CRS-207 administered in 3-week cycles, IDO administered BID.

  • CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
  • IDO (100 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.

CRS-207 administered in 3-week cycles, IDO administered BID.

  • CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
  • IDO (300 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.

CRS-207 and pembro administered in 3-week cycles, IDO administered BID.

  • CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
  • Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
  • IDO (300 mg) administered PO BID, starting on Day 3 of the first CRS-207 treatment cycle.

CRS-207 and pembro administered in 3-week cycles.

  • CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
  • Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
Total of all reporting groups
Overall Number of Baseline Participants 8 4 16 1 3 32
Hide Baseline Analysis Population Description
Baseline analysis provided for all subjects who were administered at least 1 dose of protocol-specified drug (the Safety Analysis Set [SAF]).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 4 participants 16 participants 1 participants 3 participants 32 participants
61.1  (11.03) 62.0  (12.99) 62.4  (9.35) 60.0 [1]   (NA) 61.7  (5.13) 61.9  (9.39)
[1]
Only 1 subject in the SAF for this study arm; standard deviation could not be calculated
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 4 participants 16 participants 1 participants 3 participants 32 participants
Female 8 4 16 1 3 32
Male 0 0 0 0 0 0
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 4 participants 16 participants 1 participants 3 participants 32 participants
Hispanic or Latino 1 0 1 0 0 2
Not Hispanic or Latino 7 4 15 1 3 30
Unknown or Not Reported 0 0 0 0 0 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 4 participants 16 participants 1 participants 3 participants 32 participants
American Indian or Alaska Native 0 0 0 0 0 0
Asian 0 0 0 0 1 1
Native Hawaiian or Other Pacific Islander 0 0 0 0 0 0
Black or African American 0 0 0 0 0 0
White 8 3 15 1 2 29
More than one race 0 0 0 0 0 0
Unknown or Not Reported 0 1 1 0 0 2
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 4 participants 16 participants 1 participants 3 participants 32 participants
Canada 0 0 2 0 0 2
United States 8 4 14 1 3 30
1.Primary Outcome
Title Phase 1: Number of Subjects Reporting Hematologic and/or Non-hematologic Dose-limiting Toxicity (DLT)
Hide Description

Count of subjects in the Phase 1 cohorts who reported a hematologic and/or non-hematologic DLT. Non-hematological DLTs are defined as follows, excluding the safety events specified for exemption in Section 5.3.1 of the study protocol:

  • any treatment-emergent adverse event (TEAE) not attributable to disease or disease-related processes that occurs during the DLT observation period (Cycle 1) and is Grade 3 or higher according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4;
  • any use of systemic steroids; and/or
  • a study drug dose interruption lasting ≥ 7 days for an adverse event with an unclear relationship to study drug.

Hematological DLTs are defined as:

  • Grade 4 neutropenia lasting >7 days;
  • Grade ≥3 febrile neutropenia;
  • Grade 4 anemia;
  • Grade 4 thrombocytopenia or ≥ Grade 3 thrombocytopenia lasting >7 days or associated with bleeding; and/or
  • Dose delay >7 days secondary to myelosuppression.
Time Frame Subjects followed for DLTs for 21 days following the first dose of CRS-207 (treatment Cycle 1 for CRS-207).
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis performed on subjects in the Phase 1 safety analysis set (SAF).
Arm/Group Title Phase 1: CRS-207 Phase 1: CRS-207/IDO 100 mg Phase 1: CRS-207/IDO 300 mg
Hide Arm/Group Description:

CRS-207 administered in 3-week cycles.

* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 will be administered on Day 1 of each cycle. After 6 cycles, CRS-207 will be administered on Day 1 once every 6 weeks (every other cycle).

CRS-207 administered in 3-week cycles, IDO administered BID.

  • CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
  • IDO (100 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.

CRS-207 administered in 3-week cycles, IDO administered BID.

  • CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
  • IDO (300 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.
Overall Number of Participants Analyzed 8 4 16
Measure Type: Count of Participants
Unit of Measure: Participants
1
  12.5%
0
   0.0%
1
   6.3%
2.Primary Outcome
Title Phase 1: Adverse Events (AEs) by CTCAE Grade 3 or Higher
Hide Description Count of subjects in the Phase 1 cohorts with incidences of CTCAE Grade 3 or higher AEs.
Time Frame Subjects followed from the start of study treatment until 30 days following the final dose of study drug, an average of 3 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis performed on subjects in the Phase 1 safety analysis set.
Arm/Group Title Phase 1: CRS-207 Phase 1: CRS-207/IDO 100 mg Phase 1: CRS-207/IDO 300 mg
Hide Arm/Group Description:

CRS-207 administered in 3-week cycles.

* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 will be administered on Day 1 of each cycle. After 6 cycles, CRS-207 will be administered on Day 1 once every 6 weeks (every other cycle).

CRS-207 administered in 3-week cycles, IDO administered BID.

  • CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
  • IDO (100 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.

CRS-207 administered in 3-week cycles, IDO administered BID.

  • CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
  • IDO (300 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.
Overall Number of Participants Analyzed 8 4 16
Measure Type: Count of Participants
Unit of Measure: Participants
6
  75.0%
3
  75.0%
14
  87.5%
3.Primary Outcome
Title Phase 2: Adverse Events (AEs)
Hide Description Count of subjects in the Phase 2 cohorts with incidences of AEs.
Time Frame Subjects followed from the start of study treatment until 30 days following the final dose of study drug, an average of 2 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis performed on subjects in the Phase 2 safety analysis set.
Arm/Group Title Phase 2: CRS-207/Pembro/IDO Phase 2: CRS-207/Pembro
Hide Arm/Group Description:

CRS-207 and pembro administered in 3-week cycles, IDO administered BID.

  • CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
  • Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
  • IDO (300 mg) administered PO BID, starting on Day 3 of the first CRS-207 treatment cycle.

CRS-207 and pembro administered in 3-week cycles.

  • CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
  • Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
Overall Number of Participants Analyzed 1 3
Measure Type: Count of Participants
Unit of Measure: Participants
1
 100.0%
3
 100.0%
4.Primary Outcome
Title Phase 2: Objective Response Rate (ORR)
Hide Description ORR was evaluated for Phase 2 subjects based upon the best overall response (BOR) for individual study subjects. BOR was determined by the highest post-baseline qualitative response value for each assessed subject as measured by modified response evaluation criteria in solid tumors (mRECIST) and given the following hierarchy of overall response results: complete response (CR) > partial response (PR) > stable disease (SD) > progressive disease (PD) > not evaluable (NE). The protocol-specified ORR was defined as the percentage of evaluable subjects with a BOR of CR or PR; however, this percentage was not calculated per the final study Statistical Analysis Plan (SAP). Therefore, the number of evaluable subjects with BOR mRECIST values of CR, PR, SD, PD, and NE are provided for this outcome measure.
Time Frame BOR was assessed from the first dose of study treatment until documented disease progression, initiation of a new cancer treatment, death, or study termination, whichever comes first, assessed up to 20 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis performed on subjects in the SAF who had ≥1 post-baseline response assessment. One subject in the Phase 2 SAF did not complete ≥1 post-baseline response assessment and was therefore not evaluated for this outcome measure.
Arm/Group Title Phase 2: CRS-207/Pembro/IDO Phase 2: CRS-207/Pembro
Hide Arm/Group Description:

CRS-207 and pembro administered in 3-week cycles, IDO administered BID.

  • CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
  • Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
  • IDO (300 mg) administered PO BID, starting on Day 3 of the first CRS-207 treatment cycle.

CRS-207 and pembro administered in 3-week cycles.

  • CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
  • Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
Overall Number of Participants Analyzed 1 2
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
0
   0.0%
0
   0.0%
Partial Response
0
   0.0%
0
   0.0%
Stable Disease
0
   0.0%
0
   0.0%
Progressive Disease
1
 100.0%
2
 100.0%
Not Evaluable
0
   0.0%
0
   0.0%
5.Primary Outcome
Title Phase 2: Progression Free Survival (PFS)
Hide Description Number of weeks from the date of first dose of study treatment to the first date of objectively determined progressive disease (PD) or death from any cause, estimated using Kaplan-Meier (KM) methods with 95% confidence intervals (CIs). PD is determined by mRECIST.
Time Frame Subjects followed for disease progression from first dose of study treatment until 30 days after last dose of study treatment or initiation of new cancer treatment, whichever comes first, assessed up to 20 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis performed on subjects in the Phase 2 SAF.
Arm/Group Title Phase 2: CRS-207/Pembro/IDO Phase 2: CRS-207/Pembro
Hide Arm/Group Description:

CRS-207 and pembro administered in 3-week cycles, IDO administered BID.

  • CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
  • Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
  • IDO (300 mg) administered PO BID, starting on Day 3 of the first CRS-207 treatment cycle.

CRS-207 and pembro administered in 3-week cycles.

  • CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
  • Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
Overall Number of Participants Analyzed 1 3
Median (95% Confidence Interval)
Unit of Measure: weeks
5.71
7.36
(6.14 to 8.57)
6.Secondary Outcome
Title Phase 1: Objective Response Rate (ORR) by mRECIST
Hide Description ORR was evaluated for Phase 1 subjects based upon the best overall response (BOR) for individual study subjects. BOR was determined by the highest post-baseline qualitative response value for each assessed subject as measured by modified response evaluation criteria in solid tumors (mRECIST), RECIST v1.1, and GCIG CA-125 criteria and given the following hierarchy of overall response results: complete response (CR) > partial response (PR) > stable disease (SD) > progressive disease (PD) > not evaluable (NE). The protocol-specified ORR was defined as the percentage of evaluable subjects with a BOR of CR or PR; however, this percentage was not calculated per the final study Statistical Analysis Plan (SAP). Therefore, the number of evaluable subjects with BOR mRECIST values of CR, PR, SD, PD, and NE are provided for this outcome measure.
Time Frame BOR was assessed from the first dose of study treatment until documented disease progression, starting of a new cancer treatment, death, or study termination, whichever is earlier, assessed up to 100 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis performed on subjects in the SAF who had ≥1 post-baseline response assessment. Three subjects in the Phase 1 SAF did not complete ≥1 post-baseline response assessment and were therefore not evaluated for this outcome measure.
Arm/Group Title Phase 1: CRS-207 Phase 1: CRS-207/IDO 100 mg Phase 1: CRS-207/IDO 300 mg
Hide Arm/Group Description:

CRS-207 administered in 3-week cycles.

* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 will be administered on Day 1 of each cycle. After 6 cycles, CRS-207 will be administered on Day 1 once every 6 weeks (every other cycle).

CRS-207 administered in 3-week cycles, IDO administered BID.

  • CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
  • IDO (100 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.

CRS-207 administered in 3-week cycles, IDO administered BID.

  • CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
  • IDO (300 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.
Overall Number of Participants Analyzed 8 4 13
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
0
   0.0%
0
   0.0%
0
   0.0%
Partial Response
0
   0.0%
0
   0.0%
0
   0.0%
Stable Disease
1
  12.5%
1
  25.0%
4
  30.8%
Progressive Disease
7
  87.5%
3
  75.0%
6
  46.2%
Not Evaluable
0
   0.0%
0
   0.0%
3
  23.1%
7.Secondary Outcome
Title Phase 1: Progression Free Survival (PFS)
Hide Description Number of weeks from the date of first dose of study treatment to the first date of objectively determined progressive disease (PD) or death due to any cause, estimated using Kaplan-Meier (KM) methods with 95% confidence intervals (CIs). PD is determined by mRECIST, RECIST v1.1, and GCIG CA-125.
Time Frame Subjects followed for disease progression from first dose of study treatment until 30 days after last dose of study treatment or initiation of new cancer treatment, whichever comes first, assessed up to 100 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis performed on subjects in the Phase 1 SAF.
Arm/Group Title Phase 1: CRS-207 Phase 1: CRS-207/IDO 100 mg Phase 1: CRS-207/IDO 300 mg
Hide Arm/Group Description:

CRS-207 administered in 3-week cycles.

* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 will be administered on Day 1 of each cycle. After 6 cycles, CRS-207 will be administered on Day 1 once every 6 weeks (every other cycle).

CRS-207 administered in 3-week cycles, IDO administered BID.

  • CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
  • IDO (100 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.

CRS-207 administered in 3-week cycles, IDO administered BID.

  • CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
  • IDO (300 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.
Overall Number of Participants Analyzed 8 4 16
Median (95% Confidence Interval)
Unit of Measure: weeks
8.43
(3.00 to 9.71)
4.71
(3.29 to 17.14)
8.43
(4.29 to 36.00)
8.Secondary Outcome
Title Disease Control Rate (DCR)
Hide Description The protocol-specified DCR was defined as the percentage of evaluable subjects with a BOR of CR or PR, or SD as determined by mRECIST, RECIST v1.1, and GCIG CA-125 criteria.
Time Frame BOR was assessed from the first dose of study treatment until documented disease progression, starting of a new cancer treatment, death, or study termination, whichever comes first, assessed up to 100 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis performed on subjects in the Phase 1 and Phase 2 SAF.
Arm/Group Title Phase 1: CRS-207 Phase 1: CRS-207/IDO 100 mg Phase 1: CRS-207/IDO 300 mg Phase 2: CRS-207/Pembro/IDO Phase 2: CRS-207/Pembro
Hide Arm/Group Description:

CRS-207 administered in 3-week cycles.

* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 will be administered on Day 1 of each cycle. After 6 cycles, CRS-207 will be administered on Day 1 once every 6 weeks (every other cycle).

CRS-207 administered in 3-week cycles, IDO administered BID.

  • CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
  • IDO (100 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.

CRS-207 administered in 3-week cycles, IDO administered BID.

  • CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
  • IDO (300 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.

CRS-207 and pembro administered in 3-week cycles, IDO administered BID.

  • CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
  • Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
  • IDO (300 mg) administered PO BID, starting on Day 3 of the first CRS-207 treatment cycle.

CRS-207 and pembro administered in 3-week cycles.

  • CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
  • Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
Overall Number of Participants Analyzed 8 4 16 1 3
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response (CR)
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Partial Response (PR)
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Stable Disease (SD)
1
  12.5%
1
  25.0%
4
  25.0%
0
   0.0%
0
   0.0%
9.Secondary Outcome
Title Duration of Response (DOR)
Hide Description Number of weeks from date of CR or PR designation until PD designation, as determined by mRECIST, RECIST v1.1 and GCIG CA-125 criteria.
Time Frame Subjects followed for disease progression from date of CR or PR designation until documented disease progression or study termination, whichever comes first, assessed up to 100 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
No study subjects achieved CR or PR designation; therefore, per the final SAP DOR was not derived.
Arm/Group Title Phase 1: CRS-207 Phase 1: CRS-207/IDO 100 mg Phase 1: CRS-207/IDO 300 mg Phase 2: CRS-207/Pembro/IDO Phase 2: CRS-207/Pembro
Hide Arm/Group Description:

CRS-207 administered in 3-week cycles.

* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 will be administered on Day 1 of each cycle. After 6 cycles, CRS-207 will be administered on Day 1 once every 6 weeks (every other cycle).

CRS-207 administered in 3-week cycles, IDO administered BID.

  • CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
  • IDO (100 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.

CRS-207 administered in 3-week cycles, IDO administered BID.

  • CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
  • IDO (300 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.

CRS-207 and pembro administered in 3-week cycles, IDO administered BID.

  • CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
  • Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
  • IDO (300 mg) administered PO BID, starting on Day 3 of the first CRS-207 treatment cycle.

CRS-207 and pembro administered in 3-week cycles.

  • CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
  • Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
Overall Number of Participants Analyzed 8 4 16 1 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
10.Secondary Outcome
Title Overall Survival (OS)
Hide Description Number of weeks from the date of first dose of study treatment to the date of death from any cause, estimated using KM methods with 95% CIs for subjects in the SAF. Subjects without documentation of death at the time of analysis were censored as of the date the subject was last known to be alive. For subjects lost to follow up, the last visit or last contact date where the subject is documented to be alive will be used to estimate last known date alive.
Time Frame OS was assessed from the first dose of study treatment until death or study termination, whichever comes first, assessed up to 100 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis performed on subjects in the Phase 1 and Phase 2 SAF.
Arm/Group Title Phase 1: CRS-207 Phase 1: CRS-207/IDO 100 mg Phase 1: CRS-207/IDO 300 mg Phase 2: CRS-207/Pembro/IDO Phase 2: CRS-207/Pembro
Hide Arm/Group Description:

CRS-207 administered in 3-week cycles.

* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 will be administered on Day 1 of each cycle. After 6 cycles, CRS-207 will be administered on Day 1 once every 6 weeks (every other cycle).

CRS-207 administered in 3-week cycles, IDO administered BID.

  • CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
  • IDO (100 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.

CRS-207 administered in 3-week cycles, IDO administered BID.

  • CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
  • IDO (300 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.

CRS-207 and pembro administered in 3-week cycles, IDO administered BID.

  • CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
  • Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
  • IDO (300 mg) administered PO BID, starting on Day 3 of the first CRS-207 treatment cycle.

CRS-207 and pembro administered in 3-week cycles.

  • CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
  • Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
Overall Number of Participants Analyzed 8 4 16 1 3
Median (95% Confidence Interval)
Unit of Measure: weeks
49.07
(4.71 to 69.29)
30.00
(18.71 to 88.71)
27.00
(18.14 to 51.29)
9.29
18.43
(10.43 to 18.57)
Time Frame Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
Adverse Event Reporting Description AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
 
Arm/Group Title Phase 1: CRS-207 Phase 1: CRS-207/IDO 100 mg Phase 1: CRS-207/IDO 300 mg Phase 2: CRS-207/Pembro/IDO Phase 2: CRS-207/Pembro
Hide Arm/Group Description

CRS-207 administered in 3-week cycles.

* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 will be administered on Day 1 of each cycle. After 6 cycles, CRS-207 will be administered on Day 1 once every 6 weeks (every other cycle).

CRS-207 administered in 3-week cycles, IDO administered BID.

  • CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
  • IDO (100 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.

CRS-207 administered in 3-week cycles, IDO administered BID.

  • CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
  • IDO (300 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.

CRS-207 and pembro administered in 3-week cycles, IDO administered BID.

  • CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
  • Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
  • IDO (300 mg) administered PO BID, starting on Day 3 of the first CRS-207 treatment cycle.

CRS-207 and pembro administered in 3-week cycles.

  • CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
  • Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
All-Cause Mortality
Phase 1: CRS-207 Phase 1: CRS-207/IDO 100 mg Phase 1: CRS-207/IDO 300 mg Phase 2: CRS-207/Pembro/IDO Phase 2: CRS-207/Pembro
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/8 (100.00%)   3/4 (75.00%)   7/16 (43.75%)   1/1 (100.00%)   1/3 (33.33%) 
Hide Serious Adverse Events
Phase 1: CRS-207 Phase 1: CRS-207/IDO 100 mg Phase 1: CRS-207/IDO 300 mg Phase 2: CRS-207/Pembro/IDO Phase 2: CRS-207/Pembro
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/8 (25.00%)   1/4 (25.00%)   9/16 (56.25%)   1/1 (100.00%)   1/3 (33.33%) 
Gastrointestinal disorders           
Abdominal pain * 1  0/8 (0.00%)  0/4 (0.00%)  3/16 (18.75%)  0/1 (0.00%)  0/3 (0.00%) 
Small intestinal obstruction * 1  0/8 (0.00%)  0/4 (0.00%)  2/16 (12.50%)  1/1 (100.00%)  0/3 (0.00%) 
Ascites * 1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Enterovesical fistula * 1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Intestinal perforation * 1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Pancreatitis * 1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Constipation  1  0/8 (0.00%)  0/4 (0.00%)  0/16 (0.00%)  0/1 (0.00%)  1/3 (33.33%) 
Large intestine perforation * 1  0/8 (0.00%)  0/4 (0.00%)  0/16 (0.00%)  0/1 (0.00%)  1/3 (33.33%) 
General disorders           
Disease progression * 1  0/8 (0.00%)  0/4 (0.00%)  0/16 (0.00%)  1/1 (100.00%)  0/3 (0.00%) 
Infections and infestations           
Bacteraemia * 1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Sepsis  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Injury, poisoning and procedural complications           
Infusion related reaction * 1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Investigations           
Amylase increased * 1  0/8 (0.00%)  1/4 (25.00%)  0/16 (0.00%)  0/1 (0.00%)  0/3 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Cancer pain  1  0/8 (0.00%)  0/4 (0.00%)  0/16 (0.00%)  0/1 (0.00%)  1/3 (33.33%) 
Nervous system disorders           
Seizure * 1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Syncope  1  1/8 (12.50%)  0/4 (0.00%)  0/16 (0.00%)  0/1 (0.00%)  0/3 (0.00%) 
Renal and urinary disorders           
Hydronephrosis * 1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Pleural effusion  1  1/8 (12.50%)  0/4 (0.00%)  0/16 (0.00%)  0/1 (0.00%)  0/3 (0.00%) 
1
Term from vocabulary, MedDRA (19.0)
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Phase 1: CRS-207 Phase 1: CRS-207/IDO 100 mg Phase 1: CRS-207/IDO 300 mg Phase 2: CRS-207/Pembro/IDO Phase 2: CRS-207/Pembro
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/8 (100.00%)   4/4 (100.00%)   16/16 (100.00%)   1/1 (100.00%)   3/3 (100.00%) 
Blood and lymphatic system disorders           
Anaemia * 1  0/8 (0.00%)  0/4 (0.00%)  2/16 (12.50%)  0/1 (0.00%)  0/3 (0.00%) 
Leukocytosis  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Lymphadenopathy  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Cardiac disorders           
Tachycardia * 1  2/8 (25.00%)  0/4 (0.00%)  2/16 (12.50%)  0/1 (0.00%)  0/3 (0.00%) 
Bradycardia  1  1/8 (12.50%)  0/4 (0.00%)  0/16 (0.00%)  0/1 (0.00%)  0/3 (0.00%) 
Ear and labyrinth disorders           
Ear discomfort * 1  1/8 (12.50%)  0/4 (0.00%)  0/16 (0.00%)  0/1 (0.00%)  0/3 (0.00%) 
Tinnitus  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Eye disorders           
Vision blurred * 1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Visual acuity reduced  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Gastrointestinal disorders           
Nausea * 1  6/8 (75.00%)  1/4 (25.00%)  10/16 (62.50%)  0/1 (0.00%)  1/3 (33.33%) 
Vomiting  1  6/8 (75.00%)  1/4 (25.00%)  9/16 (56.25%)  0/1 (0.00%)  0/3 (0.00%) 
Abdominal pain  1  4/8 (50.00%)  1/4 (25.00%)  8/16 (50.00%)  0/1 (0.00%)  0/3 (0.00%) 
Constipation  1  1/8 (12.50%)  0/4 (0.00%)  6/16 (37.50%)  0/1 (0.00%)  1/3 (33.33%) 
Diarrhoea  1  2/8 (25.00%)  1/4 (25.00%)  4/16 (25.00%)  0/1 (0.00%)  0/3 (0.00%) 
Abdominal distension  1  1/8 (12.50%)  1/4 (25.00%)  4/16 (25.00%)  0/1 (0.00%)  0/3 (0.00%) 
Ascites  1  1/8 (12.50%)  1/4 (25.00%)  4/16 (25.00%)  0/1 (0.00%)  0/3 (0.00%) 
Abdominal pain upper  1  0/8 (0.00%)  0/4 (0.00%)  2/16 (12.50%)  1/1 (100.00%)  0/3 (0.00%) 
Dry mouth  1  1/8 (12.50%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Enterovesical fistula * 1  0/8 (0.00%)  0/4 (0.00%)  2/16 (12.50%)  0/1 (0.00%)  0/3 (0.00%) 
Small intestinal obstruction  1  0/8 (0.00%)  0/4 (0.00%)  2/16 (12.50%)  1/1 (100.00%)  0/3 (0.00%) 
Abdominal tenderness  1  0/8 (0.00%)  1/4 (25.00%)  0/16 (0.00%)  0/1 (0.00%)  0/3 (0.00%) 
Aphthous ulcer * 1  1/8 (12.50%)  0/4 (0.00%)  0/16 (0.00%)  0/1 (0.00%)  0/3 (0.00%) 
Flatulence  1  1/8 (12.50%)  0/4 (0.00%)  0/16 (0.00%)  0/1 (0.00%)  0/3 (0.00%) 
Gastrooesophageal reflux disease  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Gingival bleeding  1  1/8 (12.50%)  0/4 (0.00%)  0/16 (0.00%)  0/1 (0.00%)  0/3 (0.00%) 
Intestinal perforation  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Lip blister  1  1/8 (12.50%)  0/4 (0.00%)  0/16 (0.00%)  0/1 (0.00%)  0/3 (0.00%) 
Mucous stools  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Pancreatitis  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Dysphagia  1  0/8 (0.00%)  0/4 (0.00%)  0/16 (0.00%)  0/1 (0.00%)  1/3 (33.33%) 
Large intestine perforation  1  0/8 (0.00%)  0/4 (0.00%)  0/16 (0.00%)  0/1 (0.00%)  1/3 (33.33%) 
General disorders           
Chills  1  7/8 (87.50%)  4/4 (100.00%)  12/16 (75.00%)  1/1 (100.00%)  3/3 (100.00%) 
Pyrexia  1  7/8 (87.50%)  2/4 (50.00%)  14/16 (87.50%)  0/1 (0.00%)  2/3 (66.67%) 
Fatigue  1  3/8 (37.50%)  2/4 (50.00%)  11/16 (68.75%)  0/1 (0.00%)  1/3 (33.33%) 
Influenza like illness  1  1/8 (12.50%)  0/4 (0.00%)  3/16 (18.75%)  0/1 (0.00%)  1/3 (33.33%) 
Early satiety  1  0/8 (0.00%)  0/4 (0.00%)  2/16 (12.50%)  0/1 (0.00%)  0/3 (0.00%) 
Malaise  1  1/8 (12.50%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Oedema  1  0/8 (0.00%)  0/4 (0.00%)  2/16 (12.50%)  0/1 (0.00%)  0/3 (0.00%) 
Pain  1  1/8 (12.50%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  1/3 (33.33%) 
Asthenia  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Catheter site pain  1  1/8 (12.50%)  0/4 (0.00%)  0/16 (0.00%)  0/1 (0.00%)  0/3 (0.00%) 
Hunger  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Injection site erythema  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Oedema peripheral  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Disease progression  1  0/8 (0.00%)  0/4 (0.00%)  0/16 (0.00%)  1/1 (100.00%)  0/3 (0.00%) 
Immune system disorders           
Hypersensitivity * 1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  1/1 (100.00%)  0/3 (0.00%) 
Infections and infestations           
Bacteraemia * 1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Listeriosis  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Oral herpes  1  1/8 (12.50%)  0/4 (0.00%)  0/16 (0.00%)  0/1 (0.00%)  0/3 (0.00%) 
Sepsis  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Upper respiratory tract infection  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Urinary tract infection  1  0/8 (0.00%)  0/4 (0.00%)  0/16 (0.00%)  0/1 (0.00%)  1/3 (33.33%) 
Injury, poisoning and procedural complications           
Infusion related reaction * 1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Procedural pain  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Investigations           
Lymphocyte count decreased * 1  1/8 (12.50%)  2/4 (50.00%)  5/16 (31.25%)  0/1 (0.00%)  0/3 (0.00%) 
Aspartate aminotransferase increased  1  1/8 (12.50%)  0/4 (0.00%)  5/16 (31.25%)  0/1 (0.00%)  0/3 (0.00%) 
Alanine aminotransferase increased  1  1/8 (12.50%)  0/4 (0.00%)  4/16 (25.00%)  0/1 (0.00%)  0/3 (0.00%) 
Blood creatinine increased  1  0/8 (0.00%)  0/4 (0.00%)  2/16 (12.50%)  0/1 (0.00%)  0/3 (0.00%) 
Amylase increased  1  0/8 (0.00%)  1/4 (25.00%)  0/16 (0.00%)  0/1 (0.00%)  0/3 (0.00%) 
Blood bilirubin increased  1  1/8 (12.50%)  0/4 (0.00%)  0/16 (0.00%)  0/1 (0.00%)  0/3 (0.00%) 
Blood magnesium decreased  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Blood urea increased  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Glomerular filtration rate decreased  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Lipase increased  1  0/8 (0.00%)  1/4 (25.00%)  0/16 (0.00%)  0/1 (0.00%)  0/3 (0.00%) 
Neutrophil count decreased  1  0/8 (0.00%)  1/4 (25.00%)  0/16 (0.00%)  0/1 (0.00%)  0/3 (0.00%) 
Neutrophil count increased  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Weight decreased  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
White blood cell count decreased  1  0/8 (0.00%)  1/4 (25.00%)  0/16 (0.00%)  0/1 (0.00%)  0/3 (0.00%) 
Metabolism and nutrition disorders           
Decreased appetite * 1  3/8 (37.50%)  0/4 (0.00%)  6/16 (37.50%)  0/1 (0.00%)  1/3 (33.33%) 
Hypokalaemia  1  1/8 (12.50%)  0/4 (0.00%)  4/16 (25.00%)  0/1 (0.00%)  0/3 (0.00%) 
Hypomagnesaemia  1  1/8 (12.50%)  0/4 (0.00%)  2/16 (12.50%)  0/1 (0.00%)  0/3 (0.00%) 
Hyponatraemia  1  0/8 (0.00%)  0/4 (0.00%)  3/16 (18.75%)  0/1 (0.00%)  0/3 (0.00%) 
Dehydration  1  1/8 (12.50%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Hypophosphataemia  1  1/8 (12.50%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Malnutrition  1  0/8 (0.00%)  0/4 (0.00%)  2/16 (12.50%)  0/1 (0.00%)  0/3 (0.00%) 
Hyperglycaemia  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  1/1 (100.00%)  0/3 (0.00%) 
Hypoalbuminaemia  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Iron deficiency  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Polydipsia  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Musculoskeletal and connective tissue disorders           
Back pain * 1  6/8 (75.00%)  0/4 (0.00%)  2/16 (12.50%)  0/1 (0.00%)  0/3 (0.00%) 
Myalgia  1  2/8 (25.00%)  0/4 (0.00%)  3/16 (18.75%)  0/1 (0.00%)  0/3 (0.00%) 
Arthralgia  1  1/8 (12.50%)  0/4 (0.00%)  3/16 (18.75%)  0/1 (0.00%)  1/3 (33.33%) 
Muscle spasms  1  0/8 (0.00%)  0/4 (0.00%)  4/16 (25.00%)  0/1 (0.00%)  0/3 (0.00%) 
Muscle tightness  1  0/8 (0.00%)  0/4 (0.00%)  2/16 (12.50%)  0/1 (0.00%)  0/3 (0.00%) 
Musculoskeletal pain  1  0/8 (0.00%)  0/4 (0.00%)  2/16 (12.50%)  0/1 (0.00%)  1/3 (33.33%) 
Neck pain  1  0/8 (0.00%)  0/4 (0.00%)  2/16 (12.50%)  0/1 (0.00%)  0/3 (0.00%) 
Flank pain  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Groin pain  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Joint stiffness  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Muscle twitching * 1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Pain in extremity  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Bone pain  1  0/8 (0.00%)  0/4 (0.00%)  0/16 (0.00%)  0/1 (0.00%)  1/3 (33.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Cancer pain * 1  0/8 (0.00%)  0/4 (0.00%)  2/16 (12.50%)  0/1 (0.00%)  1/3 (33.33%) 
Nervous system disorders           
Headache * 1  4/8 (50.00%)  2/4 (50.00%)  10/16 (62.50%)  0/1 (0.00%)  2/3 (66.67%) 
Dizziness  1  2/8 (25.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Syncope  1  1/8 (12.50%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Dysgeusia * 1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Myoclonus  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Neuropathy peripheral  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Presyncope  1  1/8 (12.50%)  0/4 (0.00%)  0/16 (0.00%)  0/1 (0.00%)  0/3 (0.00%) 
Seizure  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Psychiatric disorders           
Confusional state * 1  1/8 (12.50%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Insomnia  1  2/8 (25.00%)  0/4 (0.00%)  0/16 (0.00%)  0/1 (0.00%)  0/3 (0.00%) 
Anxiety  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Bruxism  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Hallucination  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Renal and urinary disorders           
Acute kidney injury * 1  0/8 (0.00%)  0/4 (0.00%)  2/16 (12.50%)  0/1 (0.00%)  0/3 (0.00%) 
Dysuria  1  1/8 (12.50%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  1/3 (33.33%) 
Hydronephrosis  1  0/8 (0.00%)  0/4 (0.00%)  2/16 (12.50%)  0/1 (0.00%)  0/3 (0.00%) 
Haematuria  1  1/8 (12.50%)  0/4 (0.00%)  0/16 (0.00%)  0/1 (0.00%)  0/3 (0.00%) 
Incontinence  1  1/8 (12.50%)  0/4 (0.00%)  0/16 (0.00%)  0/1 (0.00%)  0/3 (0.00%) 
Micturition urgency  1  1/8 (12.50%)  0/4 (0.00%)  0/16 (0.00%)  0/1 (0.00%)  0/3 (0.00%) 
Pollakiuria  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Urinary incontinence  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Reproductive system and breast disorders           
Vaginal haemorrhage * 1  1/8 (12.50%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Oedema genital  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Hypoxia * 1  3/8 (37.50%)  0/4 (0.00%)  5/16 (31.25%)  0/1 (0.00%)  0/3 (0.00%) 
Dyspnoea  1  2/8 (25.00%)  0/4 (0.00%)  5/16 (31.25%)  0/1 (0.00%)  0/3 (0.00%) 
Cough  1  0/8 (0.00%)  2/4 (50.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Pleural effusion  1  1/8 (12.50%)  1/4 (25.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Nasal congestion  1  1/8 (12.50%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Rhinorrhoea  1  0/8 (0.00%)  0/4 (0.00%)  2/16 (12.50%)  0/1 (0.00%)  0/3 (0.00%) 
Chronic obstructive pulmonary disease  1  1/8 (12.50%)  0/4 (0.00%)  0/16 (0.00%)  0/1 (0.00%)  0/3 (0.00%) 
Dyspnoea exertional  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Oropharyngeal pain  1  0/8 (0.00%)  1/4 (25.00%)  0/16 (0.00%)  0/1 (0.00%)  0/3 (0.00%) 
Paranasal sinus hypersecretion  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Productive cough  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Upper-airway cough syndrome  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Hiccups  1  0/8 (0.00%)  0/4 (0.00%)  0/16 (0.00%)  0/1 (0.00%)  1/3 (33.33%) 
Skin and subcutaneous tissue disorders           
Rash * 1  0/8 (0.00%)  0/4 (0.00%)  2/16 (12.50%)  0/1 (0.00%)  0/3 (0.00%) 
Dry skin  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Pain of skin  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Pruritus  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Rash maculo-papular  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Rash pruritic  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
Skin irritation  1  1/8 (12.50%)  0/4 (0.00%)  0/16 (0.00%)  0/1 (0.00%)  0/3 (0.00%) 
Urticaria  1  0/8 (0.00%)  1/4 (25.00%)  0/16 (0.00%)  0/1 (0.00%)  0/3 (0.00%) 
Vascular disorders           
Hypotension * 1  3/8 (37.50%)  2/4 (50.00%)  3/16 (18.75%)  0/1 (0.00%)  0/3 (0.00%) 
Hypertension  1  1/8 (12.50%)  0/4 (0.00%)  2/16 (12.50%)  0/1 (0.00%)  0/3 (0.00%) 
Hot flush  1  0/8 (0.00%)  0/4 (0.00%)  1/16 (6.25%)  0/1 (0.00%)  0/3 (0.00%) 
1
Term from vocabulary, MedDRA (19.0)
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Study was terminated early and included a small number of subjects, and insufficient data were available to evaluate the clinical activity of the study treatment. Due to low enrollment, some protocol-specified outcome measures were not evaluated.
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 only disclosure restriction is that study results will first be published in a joint multi-center paper unless (a) written confirmation is provided to the site or PI indicating that there will be no multi-center publication, or (b) at least 12 months have passed after the completion of data analysis at all study sites. Publications will be submitted for sponsor review ≥ 45 days prior to the publication date. Sponsor cannot require changes to the communication or extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Affairs
Organization: Aduro Biotech, Inc.
Phone: 510.809.2452
EMail: MedicalAffairs@aduro.com
Layout table for additonal information
Responsible Party: Aduro Biotech, Inc.
ClinicalTrials.gov Identifier: NCT02575807    
Other Study ID Numbers: ADU-CL-11
First Submitted: October 12, 2015
First Posted: October 15, 2015
Results First Submitted: December 14, 2018
Results First Posted: April 4, 2019
Last Update Posted: April 4, 2019