Pepinemab in Treating Younger Patients With Recurrent, Relapsed, or Refractory Solid Tumors
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|ClinicalTrials.gov Identifier: NCT03320330|
Recruitment Status : Recruiting
First Posted : October 25, 2017
Last Update Posted : April 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Malignant Solid Neoplasm Recurrent Osteosarcoma Refractory Malignant Solid Neoplasm Refractory Osteosarcoma||Other: Laboratory Biomarker Analysis Biological: Pepinemab Other: Pharmacological Study||Phase 1 Phase 2|
I. To estimate the maximum tolerated dose (MTD) and/or recommended phase 2 dose of pepinemab (VX15/2503) administered as an intravenous infusion every 14 days to children with recurrent or refractory solid tumors. (Part A) II. To define and describe the toxicities of VX15/2503 administered on this schedule. (Parts A-B) III. To characterize the pharmacokinetics of VX15/2503 in children with recurrent or refractory cancer. (Parts A-B) IV. To preliminarily define the antitumor activity of VX15/2503 for the treatment of relapsed or refractory osteosarcoma. (Part B) V. To determine if VX15/2503 either improves the disease control rate at 4 months in patients with recurrent measurable osteosarcoma or produces an objective response rate in patients with relapsed or refractory osteosarcoma. (Part B)
I. To assess the pharmacodynamics of VX15/2503 through VX15/2503 saturation of T-lymphocytes.
II. To assess the immunogenicity of VX15/2503 in pediatric patients with recurrent or refractory cancer.
I. To evaluate potential biomarkers of VX15/2503 sensitivity including SEMA4D, PlexinB1, and other markers of immune cell infiltration in archival tumor tissues.
OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.
Patients receive pepinemab intravenously (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.
After completion of study treatment, patients are followed up periodically.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1/2 Study of VX15/2503 in Children, Adolescents, or Young Adults With Recurrent or Relapsed Solid Tumors|
|Actual Study Start Date :||January 12, 2018|
|Estimated Primary Completion Date :||September 19, 2021|
|Estimated Study Completion Date :||September 19, 2021|
Experimental: Treatment (pepinemab)
Patients receive 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.
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
- Maximum tolerated dose and/or recommended phase 2 dose of pepinemab (Part A) [ Time Frame: Up to 28 days ]Will be defined as the maximum dose at which fewer than one-third of patients experience dose limiting toxicities and graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
- Incidence of toxicities of pepinemab (Parts A-B) [ Time Frame: Up to 3 years ]Will be graded according to the NCI CTCAE version 5.0.
- Pharmacokinetics of pepinemab in serum (Parts A-B) [ 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+ ]Will be assessed by a qualified enzyme-linked immunosorbent assay (ELISA). Will be summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit).
- Disease control rate (Part B) [ Time Frame: At 4 months ]Disease control success will be defined as complete response, partial response or stable disease.
- Response (complete response or partial response) (Part B) [ Time Frame: Up to 3 years ]Will be assessed by Response Evaluation Criteria in Solid Tumors 1.1.
- Pharmacodynamics of pepinemab defined as pepinemab saturation of T-lymphocytes [ Time Frame: Up to 3 years ]Will be assessed in blood and will utilize a validated flow-cytometry based assay. Analyses will be descriptive and exploratory and hypotheses generating in nature.
- Immunogenicity of pepinemab [ Time Frame: Up to 3 years ]Will be assessed in serum through a qualified ELISA. Analyses will be descriptive and exploratory and hypotheses generating in nature.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03320330
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|Principal Investigator:||Emily G Greengard||COG Phase I Consortium|