RecruitingPhase 2NCT06029270

Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer

A Randomized Phase II Study of Nivolumab Versus Nivolumab and BMS-986016 (Relatlimab) as Maintenance Treatment After First-Line Treatment With Platinum-Gemcitabine-Nivolumab for Patients With Epstein-Barr Virus-Associated Recurrent/Metastatic Nasopharyngeal Carcinoma (REMAIN)


Sponsor

National Cancer Institute (NCI)

Enrollment

156 participants

Start Date

Jul 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial tests the addition of BMS-986016 (relatlimab) to the usual immunotherapy after initial treatment for nasopharyngeal cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Relatlimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. The usual approach of treatment is initial treatment with chemotherapy such as the combination of cisplatin (or carboplatin) and gemcitabine, along with immunotherapy such as nivolumab. After the initial treatment is finished, patients may continue to receive additional immunotherapy. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Giving BMS-986016 in addition to the usual immunotherapy after initial treatment may extend the time without the tumor cells growing or spreading longer than the usual approach in patients with recurrent or metastatic nasopharyngeal cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding relatlimab (an immunotherapy drug targeting the LAG-3 pathway) to the standard immunotherapy nivolumab (anti-PD-1) is more effective than nivolumab alone for people with recurrent or metastatic nasopharyngeal cancer (NPC) — a cancer of the back of the nose and throat — after completing initial treatment with chemotherapy and immunotherapy. **You may be eligible if...** - You are 18 or older with confirmed nasopharyngeal carcinoma that has returned or spread - Your tumor tests positive for Epstein-Barr virus (EBV), which is associated with NPC - You have not received prior chemotherapy for recurrent or metastatic NPC - You have not received prior immunotherapy for metastatic disease (prior immunotherapy for early-stage NPC is acceptable) - Your heart, liver, kidneys, and blood counts are within acceptable ranges **You may NOT be eligible if...** - You have active, untreated brain metastases - You have an autoimmune disease requiring systemic treatment in the past 2 years - You have active hepatitis, HIV, or active tuberculosis - You have had a heart attack or unstable heart condition within the last 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Scan

Undergo bone scan

DRUGCarboplatin

Given IV

DRUGCisplatin

Given IV

PROCEDUREComputed Tomography

Undergo CT or PET/CT

DRUGGemcitabine

Given IV

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

BIOLOGICALNivolumab

Given IV

PROCEDUREPositron Emission Tomography

Undergo PET/CT

BIOLOGICALRelatlimab

Given IV


Locations(78)

Kaiser Permanente Dublin

Dublin, California, United States

Kaiser Permanente-Fremont

Fremont, California, United States

Kaiser Permanente Fresno Orchard Plaza

Fresno, California, United States

Kaiser Permanente-Fresno

Fresno, California, United States

Keck Medicine of USC Koreatown

Los Angeles, California, United States

Los Angeles General Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Kaiser Permanente- Modesto MOB II

Modesto, California, United States

Kaiser Permanente-Modesto

Modesto, California, United States

USC Norris Oncology/Hematology-Newport Beach

Newport Beach, California, United States

Kaiser Permanente-Oakland

Oakland, California, United States

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

Kaiser Permanente-Roseville

Roseville, California, United States

Kaiser Permanente Downtown Commons

Sacramento, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Kaiser Permanente-South Sacramento

Sacramento, California, United States

Kaiser Permanente-San Francisco

San Francisco, California, United States

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, United States

Kaiser Permanente San Leandro

San Leandro, California, United States

Kaiser San Rafael-Gallinas

San Rafael, California, United States

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Kaiser Permanente-Santa Rosa

Santa Rosa, California, United States

Kaiser Permanente-South San Francisco

South San Francisco, California, United States

Kaiser Permanente-Vallejo

Vallejo, California, United States

Kaiser Permanente-Walnut Creek

Walnut Creek, California, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Kaiser Permanente Moanalua Medical Center

Honolulu, Hawaii, United States

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, United States

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, United States

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, United States

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, United States

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, United States

Northwestern University

Chicago, Illinois, United States

University of Illinois

Chicago, Illinois, United States

Carle at The Riverfront

Danville, Illinois, United States

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, United States

Carle Physician Group-Effingham

Effingham, Illinois, United States

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, United States

Northwestern Medicine Glenview Outpatient Center

Glenview, Illinois, United States

Northwestern Medicine Grayslake Outpatient Center

Grayslake, Illinois, United States

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

Northwestern Medicine Orland Park

Orland Park, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States

Heartland Oncology and Hematology LLP

Council Bluffs, Iowa, United States

Methodist Jennie Edmundson Hospital

Council Bluffs, Iowa, United States

Nebraska Cancer Specialists/Oncology Hematology West PC - MEJ

Council Bluffs, Iowa, United States

Mercy Hospital South

St Louis, Missouri, United States

Mercy Hospital Saint Louis

St Louis, Missouri, United States

Community Hospital of Anaconda

Anaconda, Montana, United States

Billings Clinic Cancer Center

Billings, Montana, United States

Bozeman Health Deaconess Hospital

Bozeman, Montana, United States

Benefis Sletten Cancer Institute

Great Falls, Montana, United States

Logan Health Medical Center

Kalispell, Montana, United States

Community Medical Center

Missoula, Montana, United States

Nebraska Cancer Specialists/Oncology Hematology West PC - MECC

Omaha, Nebraska, United States

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Oncology Associates PC

Omaha, Nebraska, United States

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, United States

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Oklahoma Cancer Specialists and Research Institute-Tulsa

Tulsa, Oklahoma, United States

Saint Alphonsus Cancer Care Center-Ontario

Ontario, Oregon, United States

Providence Portland Medical Center

Portland, Oregon, United States

Providence Saint Vincent Medical Center

Portland, Oregon, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Swedish Medical Center-First Hill

Seattle, Washington, United States

ProHealth D N Greenwald Center

Mukwonago, Wisconsin, United States

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, United States

ProHealth Waukesha Memorial Hospital

Waukesha, Wisconsin, United States

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, United States

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

University Health Network-Princess Margaret Hospital

Toronto, Ontario, Canada

Chinese University of Hong Kong-Prince of Wales Hospital

Shatin, Hong Kong

National University Hospital Singapore

Singapore, Singapore

National Cancer Centre Singapore

Singapore, Singapore

View Full Details on ClinicalTrials.gov

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NCT06029270


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