Ignite Creation Date:
2025-12-26 @ 10:18 PM
Ignite Modification Date:
2025-12-26 @ 10:18 PM
Study NCT ID:
NCT05347212
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-10
First Post:
2022-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase II Trial of Immunotherapy in Patients With Carcinomas Arising From the Renal Medulla
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Phase II Trial of Immunotherapy in Patients With Carcinomas Arising From the Renal Medulla
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To learn if the combination of nivolumab and relatlimab can help to control renal medullary carcinoma (RMC) that is locally advanced or metastatic (has spread).
Detailed Description:
OBJECTIVES
Primary objective:
To determine the objective response rate (ORR) of patients with locally advanced or metastatic RMC treated with combination nivolumab plus relatlimab. ORR is defined as the proportion of patients with a best response of complete response (CR) or partial response (PR) by the Response Evaluation Criteria. In Solid Tumors (RECIST 1.1) criteria recorded between Day 1 of the study and the date of objectively documented progression per RECIST 1.1 or the date of subsequent anti-cancer therapy, whichever occurs first. Our goal is to significantly improve the ORR compared with the historical ORR of 29% achieved in our institution using conventional cytotoxic chemotherapies.
Secondary objectives:
* To determine the efficacy and safety of the combination of nivolumab plus relatlimab in patients with RMC. Efficacy will be measured by overall survival (OS), progression-free survival (PFS), time to ORR, duration of response, and the disease control rate (DCR).
* 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.
Primary objective:
To determine the objective response rate (ORR) of patients with locally advanced or metastatic RMC treated with combination nivolumab plus relatlimab. ORR is defined as the proportion of patients with a best response of complete response (CR) or partial response (PR) by the Response Evaluation Criteria. In Solid Tumors (RECIST 1.1) criteria recorded between Day 1 of the study and the date of objectively documented progression per RECIST 1.1 or the date of subsequent anti-cancer therapy, whichever occurs first. Our goal is to significantly improve the ORR compared with the historical ORR of 29% achieved in our institution using conventional cytotoxic chemotherapies.
Secondary objectives:
* To determine the efficacy and safety of the combination of nivolumab plus relatlimab in patients with RMC. Efficacy will be measured by overall survival (OS), progression-free survival (PFS), time to ORR, duration of response, and the disease control rate (DCR).
* 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.
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-2022-03632 | OTHER | NCI-CTRP-Clinical Trial Reporting Registry | View |