Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06400264
Status:
WITHDRAWN
Last Update Posted:
2024-05-06
First Post:
2024-05-03
Brief Title:
Testing Nivolumab and BMS-986016 Relatlimab as Potentially Targeting Treatment in Cancers That Are LAG-3 and Have Mismatch Repair Deficiency MATCH - Subprotocol Z1M
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
MATCH Treatment Subprotocol Z1M Phase 2 Study of Nivolumab and BMS-986016 Relatlimab in Patients With LAG-3 Tumors With Mismatch Repair Deficiency MMR-d After Progression on Anti-PD-1PD-L1 Therapy
Status:
WITHDRAWN
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No result will be reported- no patient accrued Status Withdrawn Study halted prematurely prior to enrollment of first participant
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II MATCH treatment trial tests how well nivolumab and BMS-986016 relatlimab works in treating patients with cancer that has certain genetic changes called LAG-3 mutations with mismatch repair deficiency A monoclonal antibody is a type of protein that can bind to certain targets in the body such as molecules that cause the body to make an immune response antigens Immunotherapy with monoclonal antibodies such as nivolumab and BMS-986016 relatlimab may help the bodys immune system attack the cancer and may interfere with the ability of cancer cells to grow and spread
Detailed Description:
PRIMARY OBJECTIVE
I To evaluate the proportion of patients with objective response OR to targeted study agents in patients with advanced refractory cancerslymphomasmultiple myeloma
SECONDARY OBJECTIVES
I To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancerslymphomasmultiple myeloma
II To evaluate time until death or disease progression III To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic ribonucleic acid RNA protein and imaging-based assessment platforms
IV To assess whether radiomic phenotypes obtained from pre-treatment imaging and changes from pre- through post-therapy imaging can predict objective response and progression free survival and to evaluate the association between pre-treatment radiomic phenotypes and targeted gene mutation patterns of tumor biopsy specimens
OUTLINE
Patients receive nivolumab intravenously IV over 30 minutes on day 1 and BMS-986016 relatlimab over 30 minutes on day 1 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Additionally patients undergo computed tomography CT or magnetic resonance imaging MRI during screening and on study as well as during follow-up as clinically necessary Patients also undergo echocardiography ECHO during screening as clinically indicated Patients undergo a biopsy during screening and blood sample collection during screening and on study
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for 1 year
I To evaluate the proportion of patients with objective response OR to targeted study agents in patients with advanced refractory cancerslymphomasmultiple myeloma
SECONDARY OBJECTIVES
I To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancerslymphomasmultiple myeloma
II To evaluate time until death or disease progression III To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic ribonucleic acid RNA protein and imaging-based assessment platforms
IV To assess whether radiomic phenotypes obtained from pre-treatment imaging and changes from pre- through post-therapy imaging can predict objective response and progression free survival and to evaluate the association between pre-treatment radiomic phenotypes and targeted gene mutation patterns of tumor biopsy specimens
OUTLINE
Patients receive nivolumab intravenously IV over 30 minutes on day 1 and BMS-986016 relatlimab over 30 minutes on day 1 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Additionally patients undergo computed tomography CT or magnetic resonance imaging MRI during screening and on study as well as during follow-up as clinically necessary Patients also undergo echocardiography ECHO during screening as clinically indicated Patients undergo a biopsy during screening and blood sample collection during screening and on study
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for 1 year
Study Oversight
Has Oversight DMC:
None
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-01195 | REGISTRY | None | None |
| EAY131-Z1M | OTHER | None | None |
| EAY131-Z1M | OTHER | None | None |
| U10CA180820 | NIH | CTEP | httpsreporternihgovquickSearchU10CA180820 |