Pepinemab in Treating Younger Patients With Recurrent, Relapsed, or Refractory Solid Tumors
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ClinicalTrials.gov Identifier: NCT03320330 |
Recruitment Status :
Active, not recruiting
First Posted : October 25, 2017
Results First Posted : April 26, 2022
Last Update Posted : October 5, 2023
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Study Type | Interventional |
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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) |
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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 | |
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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 | |
Baseline Analysis Population Description |
[Not Specified]
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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%
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|
>=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%
|
Name/Title: | Results Reporting Coordinator |
Organization: | Children's Oncology Group |
Phone: | 626-447-0064 |
EMail: | resultsreportingcoordinator@childrensoncologygroup.org |
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: | October 5, 2023 |