Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Start Date
7/15/2024
Completion Date
4/30/2029
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.
Detailed Description
PRIMARY OBJECTIVE: I. To determine if adding BMS-986016 (relatlimab) to nivolumab maintenance therapy shows a signal of improved progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 in patients who do not progress following treatment with platinum-gemcitabine-nivolumab combination in the first-line treatment of recurrent and/or metastatic nasopharyngeal carcinoma (R/M NPC). SECONDARY OBJECTIVES: I. To determine if adding BMS-986016 (relatlimab) to nivolumab maintenance improves overall survival (OS) compared to nivolumab maintenance alone. II. To compare patterns of failure (local-regional relapse and distant metastasis) between treatment arms. III. To determine if adding BMS-986016 (relatlimab) to nivolumab maintenance improves objective response, duration of response, and disease control rate compared to nivolumab maintenance alone. IV. To evaluate the tolerability of nivolumab-BMS-986016 (relatlimab) maintenance and assess and compare toxicity between arms based on the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) criteria. V. To evaluate baseline plasma Epstein-Barr virus (EBV) DNA (\< 2000 copies/mL versus \[vs.\] \>= 2000 copies/mL) as a prognostic biomarker. VI. To validate post-induction plasma EBV DNA (detectable \[\>= 1 copies/mL\] vs. undetectable \[0 copies/mL\]) as a prognostic biomarker. EXPLORATORY OBJECTIVES: I. To collect blood and tissue specimens for future translational science studies. II. To assess post-induction plasma EBV DNA (detectable \[\>= 1 copies/mL\] vs. undetectable \[0 copies/mL\]) as a predictive biomarker. OUTLINE: INDUCTION THERAPY: Patients receive nivolumab intravenously (IV) over 30 minutes on day 1 of each cycle, cisplatin IV or carboplatin IV over 30-60 minutes on day 1 of each cycle and gemcitabine IV over 30 minutes on days 1 and 8 of each cycle. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) or magnetic resonance imaging (MRI) and blood sample collection during screening and on study. MAINTENANCE THERAPY: Patients who do not progress radiologically are randomized to 1 of 2 arms. ARM I: Patients receive nivolumab IV over 30 minutes. Cycles repeat every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI on study. Patients also undergo positron emission tomography (PET)/CT or bone scan as clinically indicated. ARM II: Patients receive nivolumab IV over 30 minutes and relatlimab IV over 30-90 minutes. Cycles repeat every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI on study. Patients also undergo PET/CT or bone scan as clinically indicated. After completion of study treatment, patients are followed up every 4 months for 2 years, every 6 months in years 3-5, and then annually.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Biospecimen Collection
Bone Scan
Carboplatin
Cisplatin
Computed Tomography
Gemcitabine
Magnetic Resonance Imaging
Nivolumab
Positron Emission Tomography
Relatlimab
Conditions
Locations
Kaiser Permanente Dublin
Dublin, California 94568
United States
Kaiser Permanente-Fremont
Fremont, California 94538
United States
Kaiser Permanente Fresno Orchard Plaza
Fresno, California 93720
United States
Kaiser Permanente-Fresno
Fresno, California 93720
United States
Keck Medicine of USC Koreatown
Los Angeles, California 90020
United States
Los Angeles General Medical Center
Los Angeles, California 90033
United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Kaiser Permanente- Modesto MOB II
Modesto, California 95356
United States
Kaiser Permanente-Modesto
Modesto, California 95356
United States
USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California 92663
United States
Kaiser Permanente-Oakland
Oakland, California 94611
United States
Stanford Cancer Institute Palo Alto
Palo Alto, California 94304
United States
Kaiser Permanente-Roseville
Roseville, California 95661
United States
Kaiser Permanente Downtown Commons
Sacramento, California 95814
United States
University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
United States
Kaiser Permanente-South Sacramento
Sacramento, California 95823
United States
Kaiser Permanente-San Francisco
San Francisco, California 94115
United States
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California 95119
United States
Kaiser Permanente San Leandro
San Leandro, California 94577
United States
Kaiser San Rafael-Gallinas
San Rafael, California 94903
United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California 95051
United States
Kaiser Permanente-Santa Rosa
Santa Rosa, California 95403
United States
Kaiser Permanente-South San Francisco
South San Francisco, California 94080
United States
Kaiser Permanente-Vallejo
Vallejo, California 94589
United States
Kaiser Permanente-Walnut Creek
Walnut Creek, California 94596
United States
Emory University Hospital Midtown
Atlanta, Georgia 30308
United States
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii 96819
United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho 83706
United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho 83605
United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho 83814
United States
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho 83687
United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho 83854
United States
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho 83864
United States
Northwestern University
Chicago, Illinois 60611
United States
University of Illinois
Chicago, Illinois 60612
United States
Carle at The Riverfront
Danville, Illinois 61832
United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois 60115
United States
Carle Physician Group-Effingham
Effingham, Illinois 62401
United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois 60134
United States
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois 60026
United States
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois 60030
United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois 60045
United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
United States
Northwestern Medicine Orland Park
Orland Park, Illinois 60462
United States
Carle Cancer Center
Urbana, Illinois 61801
United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois 60555
United States
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa 50023
United States
Saint Anthony Regional Hospital
Carroll, Iowa 51401
United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa 50325
United States
Heartland Oncology and Hematology LLP
Council Bluffs, Iowa 51503
United States
Methodist Jennie Edmundson Hospital
Council Bluffs, Iowa 51503
United States
Nebraska Cancer Specialists/Oncology Hematology West PC - MEJ
Council Bluffs, Iowa 51503
United States
Iowa Methodist Medical Center
Des Moines, Iowa 50309
United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa 50309
United States
Broadlawns Medical Center
Des Moines, Iowa 50314
United States
Mercy Medical Center - Des Moines
Des Moines, Iowa 50314
United States
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa 50314
United States
UI Healthcare Mission Cancer and Blood - Fort Dodge
Fort Dodge, Iowa 50501
United States
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa 50263
United States
Mercy Hospital South
St Louis, Missouri 63128
United States
Mercy Hospital Saint Louis
St Louis, Missouri 63141
United States
Community Hospital of Anaconda
Anaconda, Montana 59711
United States
Billings Clinic Cancer Center
Billings, Montana 59101
United States
Bozeman Health Deaconess Hospital
Bozeman, Montana 59715
United States
Benefis Sletten Cancer Institute
Great Falls, Montana 59405
United States
Logan Health Medical Center
Kalispell, Montana 59901
United States
Community Medical Center
Missoula, Montana 59804
United States
Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
Omaha, Nebraska 68114
United States
Nebraska Methodist Hospital
Omaha, Nebraska 68114
United States
Oncology Associates PC
Omaha, Nebraska 68114
United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio 45219
United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio 45069
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma 74146
United States
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon 97914
United States
Providence Portland Medical Center
Portland, Oregon 97213
United States
Providence Saint Vincent Medical Center
Portland, Oregon 97225
United States
Medical University of South Carolina
Charleston, South Carolina 29425
United States
Swedish Medical Center-First Hill
Seattle, Washington 98122
United States
ProHealth D N Greenwald Center
Mukwonago, Wisconsin 53149
United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin 53066
United States
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin 53188
United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin 53188
United States
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
Australia
University Health Network-Princess Margaret Hospital
Toronto, Ontario M5G 2M9
Canada
Chinese University of Hong Kong-Prince of Wales Hospital
Shatin,
Hong Kong
National University Hospital Singapore
Singapore, 119074
Singapore
National Cancer Centre Singapore
Singapore, 168583
Singapore