Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-01-06 @ 9:24 AM
Study NCT ID:
NCT03274258
Status:
TERMINATED
Last Update Posted:
2025-12-03
First Post:
2017-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Trial of Nivolumab Plus Ipilimumab in Patients With Renal Medullary Carcinoma
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Phase II Trial of Nivolumab Plus Ipilimumab in Patients With Renal Medullary Carcinoma
Status:
TERMINATED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study met its prespecified futility criteria during the prespecified interim futility analysis after enrolling the first cohort of 10 patients.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies how well nivolumab and ipilimumab work in treating patients with kidney cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the objective response rate (ORR) of patients with locally advanced or metastatic renal medullary carcinoma (RMC) treated with combination of nivolumab plus ipilimumab.
SECONDARY OBJECTIVES:
I. To determine the efficacy and safety of the combination of nivolumab plus ipilimumab in patients with RMC.
II. To evaluate potential biomarkers for patient stratification and treatment response, as well as tumor antigen-specific immune responses, such as antibody and T cell responses, as surrogates for anti-tumor activity.
OUTLINE:
Patients receive nivolumab intravenously (IV) over 60 minutes and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab IV over 60 minutes on day 1. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
I. To determine the objective response rate (ORR) of patients with locally advanced or metastatic renal medullary carcinoma (RMC) treated with combination of nivolumab plus ipilimumab.
SECONDARY OBJECTIVES:
I. To determine the efficacy and safety of the combination of nivolumab plus ipilimumab in patients with RMC.
II. To evaluate potential biomarkers for patient stratification and treatment response, as well as tumor antigen-specific immune responses, such as antibody and T cell responses, as surrogates for anti-tumor activity.
OUTLINE:
Patients receive nivolumab intravenously (IV) over 60 minutes and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab IV over 60 minutes on day 1. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
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?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2018-01066 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 2017-0201 | OTHER | M D Anderson Cancer Center | View | |
| P30CA016672 | NIH | None | https://reporter.nih.gov/quic… | View |