Ignite Creation Date:
2025-12-24 @ 12:07 PM
Ignite Modification Date:
2025-12-28 @ 12:46 PM
Study NCT ID:
NCT03425461
Status:
TERMINATED
Last Update Posted:
2021-04-02
First Post:
2018-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti-SEMA4D Monoclonal Antibody VX15/2503 With Nivolumab or Ipilimumab in Treating Patients With Stage III or IV Melanoma
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
Phase I Study Combining an Anti-SEMA4D Antibody VX15/2503 With Checkpoint Inhibitors for Patients With Advanced Melanoma Who Have Progressed on Prior Anti-PD1/L1 Based Therapies
Status:
TERMINATED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
funding
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized pilot phase I trial studies the side effects and best dose of anti-SEMA4D monoclonal antibody VX15/2503 when given together with nivolumab or ipilimumab in treating patients with stage III or IV melanoma. Monoclonal antibodies, such as anti-SEMA4D monoclonal antibody VX15/2503, nivolumab, and ipilimumab, may interfere with the ability of tumor cells to grow and spread.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the safety and tolerability of the combination of anti-SEMA4D monoclonal antibody VX15/2503 (anti-SEMA4D VX15/2503) with nivolumab, or ipilimumab, in melanoma patients who have progressed on anti-PD1/L1 based checkpoint inhibitors.
II. To determine the recommended phase II dose and schedule of the combination of anti-SEMA4D VX15/2503 with nivolumab, or ipilimumab, in melanoma patients who have progressed on anti-PD1/L1 based checkpoint inhibitors.
SECONDARY OBJECTIVES:
I. Define the adverse event profile for the agent combinations and determine attribution (i.e. drug related adverse events \[AEs\]); II. To evaluate clinical response of patients treated with maximum tolerated dose (MTD) or maximum administered dose (MAD) of the combination of anti-SEMA4D with nivolumab, or ipilimumab.
III. To evaluate whether adding anti-SEMA4D to PD1 or CTLA-4 blockade can increase T-cell infiltration into tumors and whether change in T-cell infiltration is associated with response.
OUTLINE: This is a dose-escalation study of anti-SEMA4D monoclonal antibody VX15/2503. Patients are randomized to 1 of 2 arms.
ARM A: Patients receive anti-SEMA4D monoclonal antibody VX15/2503 intravenously (IV) over 60 minutes and nivolumab IV over 30 minutes every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive anti-SEMA4D monoclonal antibody VX15/2503 IV over 60 minutes and ipilimumab IV over 30 minutes every 21 days for courses 1-4, then receive anti-SEMA4D monoclonal antibody VX15/2503 every 28 days for subsequent courses for up to 12 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 12 weeks for 2 years, every 6 months for 3 years, then annually thereafter.
I. To determine the safety and tolerability of the combination of anti-SEMA4D monoclonal antibody VX15/2503 (anti-SEMA4D VX15/2503) with nivolumab, or ipilimumab, in melanoma patients who have progressed on anti-PD1/L1 based checkpoint inhibitors.
II. To determine the recommended phase II dose and schedule of the combination of anti-SEMA4D VX15/2503 with nivolumab, or ipilimumab, in melanoma patients who have progressed on anti-PD1/L1 based checkpoint inhibitors.
SECONDARY OBJECTIVES:
I. Define the adverse event profile for the agent combinations and determine attribution (i.e. drug related adverse events \[AEs\]); II. To evaluate clinical response of patients treated with maximum tolerated dose (MTD) or maximum administered dose (MAD) of the combination of anti-SEMA4D with nivolumab, or ipilimumab.
III. To evaluate whether adding anti-SEMA4D to PD1 or CTLA-4 blockade can increase T-cell infiltration into tumors and whether change in T-cell infiltration is associated with response.
OUTLINE: This is a dose-escalation study of anti-SEMA4D monoclonal antibody VX15/2503. Patients are randomized to 1 of 2 arms.
ARM A: Patients receive anti-SEMA4D monoclonal antibody VX15/2503 intravenously (IV) over 60 minutes and nivolumab IV over 30 minutes every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive anti-SEMA4D monoclonal antibody VX15/2503 IV over 60 minutes and ipilimumab IV over 30 minutes every 21 days for courses 1-4, then receive anti-SEMA4D monoclonal antibody VX15/2503 every 28 days for subsequent courses for up to 12 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 12 weeks for 2 years, every 6 months for 3 years, then annually thereafter.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2017-02395 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 17-001570 | OTHER | UCLA / Jonsson Comprehensive Cancer Center | View | |
| P30CA016042 | NIH | None | https://reporter.nih.gov/quic… | View |