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Pepinemab in Treating Younger Patients With Recurrent, Relapsed, or Refractory Solid Tumors

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: NCT03320330
Recruitment Status : Active, not recruiting
First Posted : October 25, 2017
Results First Posted : April 26, 2022
Last Update Posted : April 26, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Recurrent Malignant Solid Neoplasm
Recurrent Osteosarcoma
Refractory Malignant Solid Neoplasm
Refractory Osteosarcoma
Interventions Other: Laboratory Biomarker Analysis
Biological: Pepinemab
Other: Pharmacological Study
Enrollment 26
Recruitment Details A Phase I/II Study of VX15/2503 in Children, Adolescents, or Young Adults with Recurrent or Relapsed Solid Tumors. This trial studies the side effects and best dose of pepinemab to see how well it works in treating younger patients that have come back after treatment, or do not respond to treatment. Immunotherapy with monoclonal antibodies, such as pepinemab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Pre-assignment Details Part A (phase 1) portion of the study was to determine if Dose Level 1 (DL1), 20mg/kg pepinemab, was the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D). There were no dose levels above DL1. However, there was a possible lower dose level of 10mg/kg pepinemab if DL1 was too toxic. Since were no patients with dose-limiting toxicities, all patients in Part A PK (Expansion) and Part B (phase 2) received 20mg/kg pepinemab
Arm/Group Title Part A: 20 mg/kg (Phase 1) Part A PK: 20 mg/kg (Expansion) Part B: 20 mg/kg (Phase 2)
Hide Arm/Group Description

Patients ≥ 12 months and ≤ 21 years of age with recurrent or refractory solid tumors, excluding CNS tumors, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies

Patients ≥ 12 months and ≤ 21 years of age with recurrent or refractory solid tumors, excluding CNS tumors, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies

Patients ≥ 12 months and ≤ 30 years with recurrent or refractory osteosarcoma, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies

Period Title: Overall Study
Started 6 6 14
Completed 0 1 0
Not Completed 6 5 14
Reason Not Completed
Lack of Efficacy             5             5             14
Physician Decision             1             0             0
Arm/Group Title Part A Part A PK Part B Total
Hide Arm/Group Description Patients must be ≥ 12 months and ≤ 21 years of age, recurrent or refractory solid tumors are eligible, excluding CNS tumors. Patients must be ≥ 12 months and ≤ 21 years of age, recurrent or refractory solid tumors are eligible, excluding CNS tumors. Patients must be ≥ 12 months and ≤ 21 years of age, recurrent or refractory solid tumors are eligible, excluding CNS tumors. Total of all reporting groups
Overall Number of Baseline Participants 6 6 14 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 14 participants 26 participants
<=18 years
4
  66.7%
6
 100.0%
6
  42.9%
16
  61.5%
Between 18 and 65 years
2
  33.3%
0
   0.0%
8
  57.1%
10
  38.5%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Year
Number Analyzed 6 participants 6 participants 14 participants 26 participants
17.5  (2.3) 7.7  (4.2) 17.4  (7.1) 15.2  (7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 14 participants 26 participants
Female
2
  33.3%
2
  33.3%
8
  57.1%
12
  46.2%
Male
4
  66.7%
4
  66.7%
6
  42.9%
14
  53.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 14 participants 26 participants
Hispanic or Latino
1
  16.7%
1
  16.7%
4
  28.6%
6
  23.1%
Not Hispanic or Latino
5
  83.3%
4
  66.7%
8
  57.1%
17
  65.4%
Unknown or Not Reported
0
   0.0%
1
  16.7%
2
  14.3%
3
  11.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 14 participants 26 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
  16.7%
0
   0.0%
1
   3.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
  16.7%
2
  14.3%
3
  11.5%
White
2
  33.3%
3
  50.0%
7
  50.0%
12
  46.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
  66.7%
1
  16.7%
5
  35.7%
10
  38.5%
1.Primary Outcome
Title Number of Participants With Dose Limiting Toxicities
Hide Description Frequency (%) of patients with dose limiting toxicities by dose level and study part.
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
The patients who had DLT in dose escalation course.
Arm/Group Title Part A: 20 mg/kg (Phase 1) Part A PK: 20 mg/kg (Expansion) Part B: 20 mg/kg (Phase 2)
Hide Arm/Group Description:

Patients ≥ 12 months and ≤ 21 years of age with recurrent or refractory solid tumors, excluding CNS tumors, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies

Patients ≥ 12 months and ≤ 21 years of age with recurrent or refractory solid tumors, excluding CNS tumors, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies

Patients ≥ 12 months and ≤ 30 years with recurrent or refractory osteosarcoma, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies

Overall Number of Participants Analyzed 6 6 14
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
1
   7.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part A: 20 mg/kg (Phase 1)
Comments [Not Specified]
Type of Statistical Test Other
Comments Recommended Phase 2 dose of pepinemab (VX15/2503), administered to children with recurrent or refractory solid tumors (Part A), was determined by the rolling-6 design.
Method of Estimation Estimation Parameter Recommended Phase 2 dose
Estimated Value 20
Estimation Comments Recommended Phase 2 dose of pepinemab (VX15/2503) is 20 mg/kg.
2.Primary Outcome
Title Patients Who Had Grade 3 or Above Toxicities With the Three Attributions, 'DEFINITE', 'POSSIBLE','PROBABLE'
Hide Description Frequency of patients experiencing at least grade 3 toxicity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 by dose level and study part.
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Part A and B Patients
Arm/Group Title Part A: 20 mg/kg (Phase 1) Part A PK: 20 mg/kg (Expansion) Part B: 20 mg/kg (Phase 2)
Hide Arm/Group Description:

Patients ≥ 12 months and ≤ 21 years of age with recurrent or refractory solid tumors, excluding CNS tumors, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies

Patients ≥ 12 months and ≤ 21 years of age with recurrent or refractory solid tumors, excluding CNS tumors, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies

Patients ≥ 12 months and ≤ 30 years with recurrent or refractory osteosarcoma, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies

Overall Number of Participants Analyzed 6 6 14
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
  16.7%
3
  21.4%
3.Primary Outcome
Title Half-life
Hide Description Mean and standard deviation for the time required for the serum concentration to fall to 50% of its starting dose by dose level and study part.
Time Frame Prior to, at the end of, and 2 hours after infusion on day 1 of cycles 1-2; days 4 & 8 of cycle 1; prior to and the end of infusion on day 15 of cycle 1; prior to start of infusion on day 15 of cycle 2; prior to start of infusion on day 1 of cycles 3+
Hide Outcome Measure Data
Hide Analysis Population Description
all toxicity evaluable patients
Arm/Group Title Part A: 20 mg/kg (Phase 1) Part A PK: 20 mg/kg (Expansion) Part B: 20 mg/kg (Phase 2)
Hide Arm/Group Description:

Patients ≥ 12 months and ≤ 21 years of age with recurrent or refractory solid tumors, excluding CNS tumors, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies

Patients ≥ 12 months and ≤ 21 years of age with recurrent or refractory solid tumors, excluding CNS tumors, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies

Patients ≥ 12 months and ≤ 30 years with recurrent or refractory osteosarcoma, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies

Overall Number of Participants Analyzed 6 6 13
Mean (Standard Deviation)
Unit of Measure: hours
281  (176) 221  (48) 162  (64)
4.Primary Outcome
Title Time to Maximum Concentration (T Max)
Hide Description Mean and standard deviation for the time at which the maximum (peak) serum concentration occurs by dose level and study part.
Time Frame Prior to, at the end of, and 2 hours after infusion on day 1 of cycles 1-2; days 4 & 8 of cycle 1; prior to and the end of infusion on day 15 of cycle 1; prior to start of infusion on day 15 of cycle 2; prior to start of infusion on day 1 of cycles 3+
Hide Outcome Measure Data
Hide Analysis Population Description
All toxicity evaluable patients
Arm/Group Title Part A: 20 mg/kg (Phase 1) Part A PK: 20 mg/kg (Expansion) Part B: 20 mg/kg (Phase 2)
Hide Arm/Group Description:

Patients ≥ 12 months and ≤ 21 years of age with recurrent or refractory solid tumors, excluding CNS tumors, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies

Patients ≥ 12 months and ≤ 21 years of age with recurrent or refractory solid tumors, excluding CNS tumors, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies

Patients ≥ 12 months and ≤ 30 years with recurrent or refractory osteosarcoma, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies

Overall Number of Participants Analyzed 6 6 13
Mean (Standard Deviation)
Unit of Measure: hours
1.9  (1.1) 1.7  (1) 1.7  (0.9)
5.Primary Outcome
Title Maximum Concentration (C Max)
Hide Description Mean and standard deviation for the maximum (peak) serum concentration by dose level and study part.
Time Frame Prior to, at the end of, and 2 hours after infusion on day 1 of cycles 1-2; days 4 & 8 of cycle 1; prior to and the end of infusion on day 15 of cycle 1; prior to start of infusion on day 15 of cycle 2; prior to start of infusion on day 1 of cycles 3+
Hide Outcome Measure Data
Hide Analysis Population Description
All toxicity evaluable patients
Arm/Group Title Part A: 20 mg/kg (Phase 1) Part A PK: 20 mg/kg (Expansion) Part B: 20 mg/kg (Phase 2)
Hide Arm/Group Description:

Patients ≥ 12 months and ≤ 21 years of age with recurrent or refractory solid tumors, excluding CNS tumors, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies

Patients ≥ 12 months and ≤ 21 years of age with recurrent or refractory solid tumors, excluding CNS tumors, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies

Patients ≥ 12 months and ≤ 30 years with recurrent or refractory osteosarcoma, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies

Overall Number of Participants Analyzed 6 6 13
Mean (Standard Deviation)
Unit of Measure: ug/ml
175  (78) 203  (85) 168  (75)
6.Primary Outcome
Title Area Under Curve (AUC)
Hide Description Mean and standard deviation for the area under the drug concentration over time curve by dose level and study part.
Time Frame Prior to, at the end of, and 2 hours after infusion on day 1 of cycles 1-2; days 4 & 8 of cycle 1; prior to and the end of infusion on day 15 of cycle 1; prior to start of infusion on day 15 of cycle 2; prior to start of infusion on day 1 of cycles 3+
Hide Outcome Measure Data
Hide Analysis Population Description
All toxicity evaluable patients
Arm/Group Title Part A: 20 mg/kg (Phase 1) Part A PK: 20 mg/kg (Expansion) Part B: 20 mg/kg (Phase 2)
Hide Arm/Group Description:

Patients ≥ 12 months and ≤ 21 years of age with recurrent or refractory solid tumors, excluding CNS tumors, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies

Patients ≥ 12 months and ≤ 21 years of age with recurrent or refractory solid tumors, excluding CNS tumors, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies

Patients ≥ 12 months and ≤ 30 years with recurrent or refractory osteosarcoma, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies

Overall Number of Participants Analyzed 6 6 13
Mean (Standard Deviation)
Unit of Measure: hr*ug/ml
46913  (29902) 41328  (9251) 36811  (17641)
7.Primary Outcome
Title Clearance
Hide Description Mean and standard deviation for the rate of elimination of the drug by dose level and study part.
Time Frame Prior to, at the end of, and 2 hours after infusion on day 1 of cycles 1-2; days 4 & 8 of cycle 1; prior to and the end of infusion on day 15 of cycle 1; prior to start of infusion on day 15 of cycle 2; prior to start of infusion on day 1 of cycles 3+
Hide Outcome Measure Data
Hide Analysis Population Description
All toxicity evaluable patients
Arm/Group Title Part A: 20 mg/kg (Phase 1) Part A PK: 20 mg/kg (Expansion) Part B: 20 mg/kg (Phase 2)
Hide Arm/Group Description:

Patients ≥ 12 months and ≤ 21 years of age with recurrent or refractory solid tumors, excluding CNS tumors, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies

Patients ≥ 12 months and ≤ 21 years of age with recurrent or refractory solid tumors, excluding CNS tumors, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies

Patients ≥ 12 months and ≤ 30 years with recurrent or refractory osteosarcoma, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies

Overall Number of Participants Analyzed 6 6 13
Mean (Standard Deviation)
Unit of Measure: ml/hr
40.03  (34.9) 13.4  (4.6) 33.2  (25.3)
8.Primary Outcome
Title Disease Control Rate (Part A)
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no new lesions detected and <20% increase in sum of smallest diameters of lesions; Disease Control Rate = CR + PR + SD
Time Frame Up to 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part A: 20 mg/kg (Phase 1) Part A PK: 20 mg/kg (Expansion)
Hide Arm/Group Description:

Patients ≥ 12 months and ≤ 21 years of age with recurrent or refractory solid tumors, excluding CNS tumors, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies

Patients ≥ 12 months and ≤ 21 years of age with recurrent or refractory solid tumors, excluding CNS tumors, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies

Overall Number of Participants Analyzed 6 6
Measure Type: Number
Unit of Measure: participants
0 0
9.Primary Outcome
Title Response (Complete Response or Partial Response) (Part B)
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no new lesions detected and <20% increase in sum of smallest diameters of lesions; Disease Control Rate = CR + PR + SD
Time Frame Up to 168 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part B: 20 mg/kg (Phase 2)
Hide Arm/Group Description:

Patients ≥ 12 months and ≤ 30 years with recurrent or refractory osteosarcoma, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies

Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: participants
0
10.Secondary Outcome
Title T-lymphocyte Saturation
Hide Description Mean and standard deviation for blood samples that will be evaluated for T-lymphocyte saturation by VX15/2503 utilizing a validated flow-cytometry based assay.
Time Frame Up to 3 years
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Total Soluble SEMA4D
Hide Description Mean and standard deviation of blood and serum samples evaluated for total soluble SEMA4D through a qualified enzyme-linked immunosorbent assay (ELISA) assay.
Time Frame Up to 3 years
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Immunogenicity of Pepinemab
Hide Description Mean and standard deviation of immunogenicity assessed in serum through a qualified ELISA.
Time Frame Up to 3 years
Outcome Measure Data Not Reported
Time Frame Up to 28 months
Adverse Event Reporting Description Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
 
Arm/Group Title Part A: 20 mg/kg (Phase 1) Part A PK: 20 mg/kg (Expansion) Part B: 20 mg/kg (Phase 2)
Hide Arm/Group Description

Patients ≥ 12 months and ≤ 21 years of age with recurrent or refractory solid tumors, excluding CNS tumors, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies

Patients ≥ 12 months and ≤ 21 years of age with recurrent or refractory solid tumors, excluding CNS tumors, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies

Patients ≥ 12 months and ≤ 30 years with recurrent or refractory osteosarcoma, receive 20 mg/kg of pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies Pepinemab: Given IV Pharmacological Study: Correlative studies

All-Cause Mortality
Part A: 20 mg/kg (Phase 1) Part A PK: 20 mg/kg (Expansion) Part B: 20 mg/kg (Phase 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/6 (16.67%)   0/6 (0.00%)   3/14 (21.43%) 
Hide Serious Adverse Events
Part A: 20 mg/kg (Phase 1) Part A PK: 20 mg/kg (Expansion) Part B: 20 mg/kg (Phase 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/6 (66.67%)   4/6 (66.67%)   10/14 (71.43%) 
Blood and lymphatic system disorders       
Anemia   1/6 (16.67%)  1/6 (16.67%)  6/14 (42.86%) 
Cardiac disorders       
Pericardial effusion   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Ear and labyrinth disorders       
Hearing impaired   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Gastrointestinal disorders       
Esophagitis   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Nausea   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Vomiting   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
General disorders       
Fatigue   1/6 (16.67%)  0/6 (0.00%)  0/14 (0.00%) 
Non-cardiac chest pain   1/6 (16.67%)  0/6 (0.00%)  1/14 (7.14%) 
Pain   1/6 (16.67%)  0/6 (0.00%)  1/14 (7.14%) 
Infections and infestations       
Mucosal infection   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Urinary tract infection   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Injury, poisoning and procedural complications       
Fracture   1/6 (16.67%)  1/6 (16.67%)  0/14 (0.00%) 
Investigations       
Alkaline phosphatase increased   0/6 (0.00%)  1/6 (16.67%)  1/14 (7.14%) 
Creatinine increased   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Electrocardiogram QT corrected interval prolonged   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Lymphocyte count decreased   1/6 (16.67%)  0/6 (0.00%)  5/14 (35.71%) 
Neutrophil count decreased   0/6 (0.00%)  1/6 (16.67%)  1/14 (7.14%) 
Platelet count decreased   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
White blood cell decreased   0/6 (0.00%)  1/6 (16.67%)  0/14 (0.00%) 
Metabolism and nutrition disorders       
Anorexia   2/6 (33.33%)  0/6 (0.00%)  1/14 (7.14%) 
Dehydration   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Hyperglycemia   0/6 (0.00%)  1/6 (16.67%)  0/14 (0.00%) 
Hypokalemia   1/6 (16.67%)  1/6 (16.67%)  1/14 (7.14%) 
Hyponatremia   0/6 (0.00%)  1/6 (16.67%)  0/14 (0.00%) 
Hypophosphatemia   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Obesity   1/6 (16.67%)  0/6 (0.00%)  0/14 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Back pain   2/6 (33.33%)  0/6 (0.00%)  0/14 (0.00%) 
Myalgia   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, PROGRESSIVE DISEASE   1/6 (16.67%)  0/6 (0.00%)  0/14 (0.00%) 
Nervous system disorders       
Depressed level of consciousness   1/6 (16.67%)  0/6 (0.00%)  0/14 (0.00%) 
Headache   1/6 (16.67%)  0/6 (0.00%)  1/14 (7.14%) 
Peripheral motor neuropathy   0/6 (0.00%)  0/6 (0.00%)  2/14 (14.29%) 
Peripheral sensory neuropathy   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Syncope   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Psychiatric disorders       
Anxiety   1/6 (16.67%)  0/6 (0.00%)  0/14 (0.00%) 
Renal and urinary disorders       
Acute kidney injury   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Reproductive system and breast disorders       
Irregular menstruation   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Respiratory, thoracic and mediastinal disorders       
Atelectasis   0/6 (0.00%)  1/6 (16.67%)  0/14 (0.00%) 
Dyspnea   1/6 (16.67%)  0/6 (0.00%)  3/14 (21.43%) 
Hypoxia   1/6 (16.67%)  1/6 (16.67%)  3/14 (21.43%) 
Pleural effusion   0/6 (0.00%)  1/6 (16.67%)  1/14 (7.14%) 
Pneumothorax   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Respiratory failure   0/6 (0.00%)  1/6 (16.67%)  1/14 (7.14%) 
Vascular disorders       
Hypertension   1/6 (16.67%)  0/6 (0.00%)  0/14 (0.00%) 
Thromboembolic event   2/6 (33.33%)  0/6 (0.00%)  0/14 (0.00%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Part A: 20 mg/kg (Phase 1) Part A PK: 20 mg/kg (Expansion) Part B: 20 mg/kg (Phase 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/6 (100.00%)   6/6 (100.00%)   14/14 (100.00%) 
Blood and lymphatic system disorders       
Anemia   4/6 (66.67%)  4/6 (66.67%)  10/14 (71.43%) 
Blood and lymphatic system disorders - Other, Neutrophil count increased   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Blood and lymphatic system disorders - Other, RBC decreased   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Blood and lymphatic system disorders - Other, White Blood Cell Count Increased   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Cardiac disorders       
Pericardial effusion   1/6 (16.67%)  0/6 (0.00%)  1/14 (7.14%) 
Sinus bradycardia   1/6 (16.67%)  0/6 (0.00%)  1/14 (7.14%) 
Sinus tachycardia   5/6 (83.33%)  2/6 (33.33%)  7/14 (50.00%) 
Ear and labyrinth disorders       
Ear and labyrinth disorders - Other,   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Hearing impaired   1/6 (16.67%)  0/6 (0.00%)  0/14 (0.00%) 
Endocrine disorders       
Cushingoid   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Hypothyroidism   0/6 (0.00%)  2/6 (33.33%)  0/14 (0.00%) 
Eye disorders       
Blurred vision   1/6 (16.67%)  0/6 (0.00%)  1/14 (7.14%) 
Eye disorders - Other, Anisocoria   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Eye disorders - Other, Vision decreased   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Keratitis   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Optic nerve disorder   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Photophobia   0/6 (0.00%)  1/6 (16.67%)  0/14 (0.00%) 
Gastrointestinal disorders       
Abdominal distension   1/6 (16.67%)  0/6 (0.00%)  1/14 (7.14%) 
Abdominal pain   1/6 (16.67%)  0/6 (0.00%)  2/14 (14.29%) 
Constipation   2/6 (33.33%)  0/6 (0.00%)  5/14 (35.71%) 
Diarrhea   1/6 (16.67%)  0/6 (0.00%)  2/14 (14.29%) 
Dry mouth   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Dyspepsia   1/6 (16.67%)  0/6 (0.00%)  0/14 (0.00%) 
Dysphagia   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Fecal incontinence   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Gastroesophageal reflux disease   1/6 (16.67%)  0/6 (0.00%)  2/14 (14.29%) 
Mucositis oral   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Nausea   4/6 (66.67%)  1/6 (16.67%)  7/14 (50.00%) 
Oral pain   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Stomach pain   0/6 (0.00%)  1/6 (16.67%)  0/14 (0.00%) 
Vomiting   3/6 (50.00%)  1/6 (16.67%)  4/14 (28.57%) 
General disorders       
Chills   2/6 (33.33%)  1/6 (16.67%)  4/14 (28.57%) 
Edema limbs   1/6 (16.67%)  1/6 (16.67%)  3/14 (21.43%) 
Fatigue   3/6 (50.00%)  3/6 (50.00%)  6/14 (42.86%) 
Fever   3/6 (50.00%)  2/6 (33.33%)  10/14 (71.43%) 
Gait disturbance   2/6 (33.33%)  0/6 (0.00%)  2/14 (14.29%) 
General disorders and administration site conditions - Other, Generalized edema   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
General disorders and administration site conditions - Other, SWEATING   1/6 (16.67%)  0/6 (0.00%)  0/14 (0.00%) 
Infusion related reaction   3/6 (50.00%)  2/6 (33.33%)  3/14 (21.43%) 
Infusion site extravasation   1/6 (16.67%)  0/6 (0.00%)  0/14 (0.00%) 
Irritability   1/6 (16.67%)  0/6 (0.00%)  0/14 (0.00%) 
Localized edema   1/6 (16.67%)  0/6 (0.00%)  1/14 (7.14%) 
Malaise   1/6 (16.67%)  0/6 (0.00%)  0/14 (0.00%) 
Non-cardiac chest pain   1/6 (16.67%)  1/6 (16.67%)  5/14 (35.71%) 
Pain   2/6 (33.33%)  1/6 (16.67%)  3/14 (21.43%) 
Infections and infestations       
Lung infection   0/6 (0.00%)  1/6 (16.67%)  1/14 (7.14%) 
Upper respiratory infection   0/6 (0.00%)  1/6 (16.67%)  1/14 (7.14%) 
Urinary tract infection   0/6 (0.00%)  0/6 (0.00%)  2/14 (14.29%) 
Injury, poisoning and procedural complications       
Bruising   2/6 (33.33%)  0/6 (0.00%)  2/14 (14.29%) 
Burn   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Fall   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Infusion related reaction   3/6 (50.00%)  2/6 (33.33%)  2/14 (14.29%) 
Injury, poisoning and procedural complications - Other, OPEN WOUND   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Radiation recall reaction (dermatologic)   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Investigations       
Activated partial thromboplastin time prolonged   0/6 (0.00%)  0/6 (0.00%)  2/14 (14.29%) 
Alanine aminotransferase increased   2/6 (33.33%)  3/6 (50.00%)  4/14 (28.57%) 
Alkaline phosphatase increased   6/6 (100.00%)  1/6 (16.67%)  8/14 (57.14%) 
Aspartate aminotransferase increased   2/6 (33.33%)  4/6 (66.67%)  4/14 (28.57%) 
Blood bilirubin increased   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Cholesterol high   0/6 (0.00%)  1/6 (16.67%)  0/14 (0.00%) 
Creatinine increased   1/6 (16.67%)  0/6 (0.00%)  1/14 (7.14%) 
Hemoglobin increased   0/6 (0.00%)  0/6 (0.00%)  2/14 (14.29%) 
INR increased   0/6 (0.00%)  0/6 (0.00%)  2/14 (14.29%) 
Investigations - Other, BICARBONATE LOW   2/6 (33.33%)  0/6 (0.00%)  0/14 (0.00%) 
Investigations - Other, ELEVATED BICARBONATE SERUM LOW   1/6 (16.67%)  0/6 (0.00%)  0/14 (0.00%) 
Investigations - Other, ELEVATED LDH   1/6 (16.67%)  0/6 (0.00%)  1/14 (7.14%) 
Investigations - Other, HYOCHLOREMIA   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Investigations - Other, HYPOCHLOREMIA   1/6 (16.67%)  0/6 (0.00%)  1/14 (7.14%) 
Investigations - Other, LDH INCREASED   1/6 (16.67%)  0/6 (0.00%)  0/14 (0.00%) 
Investigations - Other, LDH increased   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Investigations - Other, Monocytes Decrease   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Investigations - Other, Monocytes Increased   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Investigations - Other, bicarbonate serum low   0/6 (0.00%)  1/6 (16.67%)  0/14 (0.00%) 
Investigations - Other, elevated BUN   0/6 (0.00%)  1/6 (16.67%)  0/14 (0.00%) 
Investigations - Other, elevated LDH   0/6 (0.00%)  1/6 (16.67%)  0/14 (0.00%) 
Lipase increased   0/6 (0.00%)  1/6 (16.67%)  0/14 (0.00%) 
Lymphocyte count decreased   0/6 (0.00%)  3/6 (50.00%)  9/14 (64.29%) 
Neutrophil count decreased   1/6 (16.67%)  1/6 (16.67%)  3/14 (21.43%) 
Platelet count decreased   0/6 (0.00%)  1/6 (16.67%)  5/14 (35.71%) 
Serum amylase increased   0/6 (0.00%)  1/6 (16.67%)  0/14 (0.00%) 
Weight gain   0/6 (0.00%)  1/6 (16.67%)  1/14 (7.14%) 
Weight loss   2/6 (33.33%)  0/6 (0.00%)  2/14 (14.29%) 
White blood cell decreased   2/6 (33.33%)  3/6 (50.00%)  5/14 (35.71%) 
Metabolism and nutrition disorders       
Anorexia   2/6 (33.33%)  3/6 (50.00%)  7/14 (50.00%) 
Dehydration   2/6 (33.33%)  0/6 (0.00%)  0/14 (0.00%) 
Hyperglycemia   3/6 (50.00%)  4/6 (66.67%)  9/14 (64.29%) 
Hyperkalemia   0/6 (0.00%)  1/6 (16.67%)  0/14 (0.00%) 
Hypermagnesemia   0/6 (0.00%)  1/6 (16.67%)  2/14 (14.29%) 
Hypernatremia   0/6 (0.00%)  0/6 (0.00%)  2/14 (14.29%) 
Hypoalbuminemia   3/6 (50.00%)  1/6 (16.67%)  8/14 (57.14%) 
Hypocalcemia   2/6 (33.33%)  1/6 (16.67%)  5/14 (35.71%) 
Hypoglycemia   1/6 (16.67%)  0/6 (0.00%)  2/14 (14.29%) 
Hypokalemia   1/6 (16.67%)  1/6 (16.67%)  8/14 (57.14%) 
Hypomagnesemia   2/6 (33.33%)  1/6 (16.67%)  2/14 (14.29%) 
Hyponatremia   2/6 (33.33%)  0/6 (0.00%)  6/14 (42.86%) 
Hypophosphatemia   1/6 (16.67%)  1/6 (16.67%)  7/14 (50.00%) 
Metabolism and nutrition disorders - Other, HYPOCHLOREMIA   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Metabolism and nutrition disorders - Other, Hyperchloremia   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Metabolism and nutrition disorders - Other, Increased bicarbonates   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Metabolism and nutrition disorders - Other, Increased phosphorus level   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Musculoskeletal and connective tissue disorders       
Arthralgia   1/6 (16.67%)  1/6 (16.67%)  1/14 (7.14%) 
Back pain   2/6 (33.33%)  1/6 (16.67%)  8/14 (57.14%) 
Bone pain   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Buttock pain   1/6 (16.67%)  0/6 (0.00%)  0/14 (0.00%) 
Chest wall pain   1/6 (16.67%)  0/6 (0.00%)  0/14 (0.00%) 
Flank pain   1/6 (16.67%)  0/6 (0.00%)  0/14 (0.00%) 
Joint range of motion decreased   1/6 (16.67%)  0/6 (0.00%)  4/14 (28.57%) 
Kyphosis   1/6 (16.67%)  0/6 (0.00%)  0/14 (0.00%) 
Muscle weakness lower limb   0/6 (0.00%)  1/6 (16.67%)  4/14 (28.57%) 
Muscle weakness trunk   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Musculoskeletal and connective tissue disorder - Other, DIFFICULTY FULLY EXTENDING LEFT LEG   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Musculoskeletal and connective tissue disorder - Other, LEFT MEDIAL THIGH SWELLING   1/6 (16.67%)  0/6 (0.00%)  0/14 (0.00%) 
Musculoskeletal and connective tissue disorder - Other, LIMP   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Musculoskeletal and connective tissue disorder - Other, MUSCLE ACHES/PAIN   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Musculoskeletal and connective tissue disorder - Other, muscle spasm   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Myalgia   0/6 (0.00%)  1/6 (16.67%)  0/14 (0.00%) 
Neck pain   1/6 (16.67%)  1/6 (16.67%)  0/14 (0.00%) 
Pain in extremity   3/6 (50.00%)  3/6 (50.00%)  6/14 (42.86%) 
Nervous system disorders       
Concentration impairment   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Dizziness   0/6 (0.00%)  1/6 (16.67%)  1/14 (7.14%) 
Headache   2/6 (33.33%)  3/6 (50.00%)  7/14 (50.00%) 
Lethargy   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Memory impairment   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Nervous system disorders - Other, Spinal cord compression   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Neuralgia   1/6 (16.67%)  0/6 (0.00%)  0/14 (0.00%) 
Paresthesia   1/6 (16.67%)  1/6 (16.67%)  2/14 (14.29%) 
Peripheral sensory neuropathy   1/6 (16.67%)  1/6 (16.67%)  3/14 (21.43%) 
Phantom pain   2/6 (33.33%)  0/6 (0.00%)  0/14 (0.00%) 
Somnolence   2/6 (33.33%)  1/6 (16.67%)  1/14 (7.14%) 
Psychiatric disorders       
Agitation   0/6 (0.00%)  1/6 (16.67%)  0/14 (0.00%) 
Anxiety   3/6 (50.00%)  1/6 (16.67%)  7/14 (50.00%) 
Confusion   1/6 (16.67%)  0/6 (0.00%)  2/14 (14.29%) 
Depression   3/6 (50.00%)  2/6 (33.33%)  2/14 (14.29%) 
Hallucinations   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Insomnia   2/6 (33.33%)  0/6 (0.00%)  5/14 (35.71%) 
Restlessness   1/6 (16.67%)  0/6 (0.00%)  1/14 (7.14%) 
Renal and urinary disorders       
Hematuria   2/6 (33.33%)  1/6 (16.67%)  2/14 (14.29%) 
Hemoglobinuria   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Proteinuria   1/6 (16.67%)  2/6 (33.33%)  5/14 (35.71%) 
Urinary retention   0/6 (0.00%)  0/6 (0.00%)  3/14 (21.43%) 
Urinary urgency   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Reproductive system and breast disorders       
Breast pain   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Erectile dysfunction   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Genital edema   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Gynecomastia   1/6 (16.67%)  0/6 (0.00%)  0/14 (0.00%) 
Pelvic pain   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Reproductive system and breast disorders - Other, GENITAL HYPERSENSITIVITY   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Testicular pain   0/6 (0.00%)  1/6 (16.67%)  0/14 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Allergic rhinitis   0/6 (0.00%)  1/6 (16.67%)  2/14 (14.29%) 
Atelectasis   2/6 (33.33%)  0/6 (0.00%)  0/14 (0.00%) 
Cough   4/6 (66.67%)  1/6 (16.67%)  9/14 (64.29%) 
Dyspnea   3/6 (50.00%)  1/6 (16.67%)  4/14 (28.57%) 
Epistaxis   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Hoarseness   1/6 (16.67%)  0/6 (0.00%)  0/14 (0.00%) 
Hypoxia   0/6 (0.00%)  0/6 (0.00%)  2/14 (14.29%) 
Nasal congestion   0/6 (0.00%)  1/6 (16.67%)  1/14 (7.14%) 
Pleural effusion   3/6 (50.00%)  0/6 (0.00%)  6/14 (42.86%) 
Pleural hemorrhage   0/6 (0.00%)  1/6 (16.67%)  0/14 (0.00%) 
Productive cough   1/6 (16.67%)  0/6 (0.00%)  2/14 (14.29%) 
Respiratory, thoracic and mediastinal disorders - Other, HEMOPTYSIS   1/6 (16.67%)  0/6 (0.00%)  0/14 (0.00%) 
Respiratory, thoracic and mediastinal disorders - Other, Hemoptysis   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Respiratory, thoracic and mediastinal disorders - Other, MILD RHINORREA G1   1/6 (16.67%)  0/6 (0.00%)  0/14 (0.00%) 
Respiratory, thoracic and mediastinal disorders - Other, RHINORRHEA   1/6 (16.67%)  0/6 (0.00%)  0/14 (0.00%) 
Sore throat   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Wheezing   1/6 (16.67%)  1/6 (16.67%)  0/14 (0.00%) 
Skin and subcutaneous tissue disorders       
Alopecia   2/6 (33.33%)  0/6 (0.00%)  5/14 (35.71%) 
Body odor   1/6 (16.67%)  0/6 (0.00%)  0/14 (0.00%) 
Bullous dermatitis   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Dry skin   0/6 (0.00%)  0/6 (0.00%)  2/14 (14.29%) 
Hyperhidrosis   0/6 (0.00%)  1/6 (16.67%)  1/14 (7.14%) 
Nail discoloration   1/6 (16.67%)  0/6 (0.00%)  0/14 (0.00%) 
Pruritus   1/6 (16.67%)  0/6 (0.00%)  1/14 (7.14%) 
Rash acneiform   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Rash maculo-papular   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Skin and subcutaneous tissue disorders - Other, FACIAL SORES   1/6 (16.67%)  0/6 (0.00%)  0/14 (0.00%) 
Skin and subcutaneous tissue disorders - Other, FISTULA - SUPERIOR LATERAL STUMP WOUND   1/6 (16.67%)  0/6 (0.00%)  0/14 (0.00%) 
Skin and subcutaneous tissue disorders - Other, MOTTLING OF FINGERS   1/6 (16.67%)  0/6 (0.00%)  0/14 (0.00%) 
Skin and subcutaneous tissue disorders - Other, SEBORRHEIC DERMATITIS   1/6 (16.67%)  0/6 (0.00%)  0/14 (0.00%) 
Skin and subcutaneous tissue disorders - Other, Skin breakdown   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Skin hyperpigmentation   0/6 (0.00%)  1/6 (16.67%)  0/14 (0.00%) 
Vascular disorders       
Flushing   1/6 (16.67%)  2/6 (33.33%)  0/14 (0.00%) 
Hot flashes   0/6 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Hypertension   4/6 (66.67%)  2/6 (33.33%)  1/14 (7.14%) 
Hypotension   1/6 (16.67%)  2/6 (33.33%)  3/14 (21.43%) 
Thromboembolic event   0/6 (0.00%)  0/6 (0.00%)  2/14 (14.29%) 
Indicates events were collected by systematic assessment
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.
Must obtain prior sponsor approval
Results Point of Contact
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Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
Phone: 626-447-0064
EMail: resultsreportingcoordinator@childrensoncologygroup.org
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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT03320330    
Other Study ID Numbers: ADVL1614
NCI-2017-01103 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ADVL1614 ( Other Identifier: Pediatric Early Phase Clinical Trial Network )
ADVL1614 ( Other Identifier: CTEP )
UM1CA097452 ( U.S. NIH Grant/Contract )
First Submitted: October 13, 2017
First Posted: October 25, 2017
Results First Submitted: December 2, 2021
Results First Posted: April 26, 2022
Last Update Posted: April 26, 2022