Actively Recruiting
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
156
Participants Needed
79
Research Sites
250 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of nasopharyngeal carcinoma (NPC) that is recurrent or metastatic, confirmed by pathology
- Tumor must be Epstein-Barr encoded RNA positive or have a history of detectable plasma Epstein-Barr virus DNA
- Measurable disease by RECIST 1.1 criteria, including lesions previously irradiated if progression is shown
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Negative pregnancy test for persons of childbearing potential within 14 days prior to registration
- Adequate blood counts: neutrophils >= 1500 cells/mm3, platelets >= 100,000 cells/mm3, hemoglobin >= 8.0 g/dL
- Liver and kidney function within specified limits including bilirubin, ALT, creatinine levels
- No prior systemic treatment for palliative intent of recurrent/metastatic NPC
- No prior treatment with PD-1, PD-L1, LAG-3, CTLA-4 inhibitors except as adjuvant/neoadjuvant for non-recurrent, non-metastatic NPC
- At least 6 months since last curative-intent treatment and recurrence
- Clinically stable with resolved toxicities from prior treatments except certain mild conditions
- No recent palliative radiotherapy or major surgery within 30 days prior to registration
- No recent unstable angina or myocardial infarction within 6 months
- Heart function NYHA class II or better
- No prior myocarditis
- No active infection requiring IV antimicrobial treatment
- No history of pneumonitis requiring steroids or current pneumonitis
- No active or recent multi-drug resistant tuberculosis
- No prior solid organ or bone marrow transplant
- No recent systemic immunosuppressive treatment within 14 days
- No active autoimmune disease requiring systemic treatment within past 2 years except certain permitted conditions
- No prior live vaccines within 30 days prior to registration
- No history of severe allergic reactions to study drugs
- Required plasma Epstein-Barr virus DNA samples collected prior to treatment and randomization
- Completion of 3 to 6 cycles of induction treatment within 20 weeks without disease progression or unacceptable toxicity
- Appropriate imaging within 30 days prior to randomization
You will not qualify if you...
- Disease amenable to potentially curative surgery or re-irradiation for locoregional recurrence
- Disease directly invading brain parenchyma with symptoms or significant brain swelling
- ECOG performance status worse than 2
- Positive pregnancy test or potential for pregnancy without adequate contraception
- Inability to meet blood count or organ function criteria
- Prior systemic treatment of palliative intent for recurrent/metastatic NPC
- Prior use of immune checkpoint inhibitors except as allowed for non-recurrent NPC
- Recent major surgery or radiotherapy within specified time frames
- Unstable cardiovascular conditions or recent serious heart events
- History of myocarditis
- Active infections requiring IV antimicrobial treatment
- History or presence of pneumonitis requiring steroids
- Active tuberculosis or recent treatment within 2 years
- Prior organ or bone marrow transplant
- Use of systemic immunosuppressive medications within 14 days
- Active autoimmune diseases needing systemic treatment within 2 years except specified exceptions
- Receipt of live vaccines within 30 days before registration
- History of severe allergic reaction to study drugs or monoclonal antibodies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 79 locations
1
Kaiser Permanente Dublin
Dublin, California, United States, 94568
Actively Recruiting
2
Kaiser Permanente-Fremont
Fremont, California, United States, 94538
Actively Recruiting
3
Kaiser Permanente Fresno Orchard Plaza
Fresno, California, United States, 93720
Actively Recruiting
4
Kaiser Permanente-Fresno
Fresno, California, United States, 93720
Actively Recruiting
5
Keck Medicine of USC Koreatown
Los Angeles, California, United States, 90020
Actively Recruiting
6
Los Angeles General Medical Center
Los Angeles, California, United States, 90033
Actively Recruiting
7
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
8
Kaiser Permanente- Modesto MOB II
Modesto, California, United States, 95356
Actively Recruiting
9
Kaiser Permanente-Modesto
Modesto, California, United States, 95356
Actively Recruiting
10
USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California, United States, 92663
Actively Recruiting
11
Kaiser Permanente-Oakland
Oakland, California, United States, 94611
Actively Recruiting
12
Stanford Cancer Institute Palo Alto
Palo Alto, California, United States, 94304
Actively Recruiting
13
Kaiser Permanente-Roseville
Roseville, California, United States, 95661
Actively Recruiting
14
Kaiser Permanente Downtown Commons
Sacramento, California, United States, 95814
Actively Recruiting
15
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
16
Kaiser Permanente-South Sacramento
Sacramento, California, United States, 95823
Actively Recruiting
17
Kaiser Permanente-San Francisco
San Francisco, California, United States, 94115
Actively Recruiting
18
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, United States, 95119
Actively Recruiting
19
Kaiser Permanente San Leandro
San Leandro, California, United States, 94577
Actively Recruiting
20
Kaiser San Rafael-Gallinas
San Rafael, California, United States, 94903
Actively Recruiting
21
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States, 95051
Actively Recruiting
22
Kaiser Permanente-Santa Rosa
Santa Rosa, California, United States, 95403
Actively Recruiting
23
Kaiser Permanente-South San Francisco
South San Francisco, California, United States, 94080
Actively Recruiting
24
Kaiser Permanente-Vallejo
Vallejo, California, United States, 94589
Actively Recruiting
25
Kaiser Permanente-Walnut Creek
Walnut Creek, California, United States, 94596
Actively Recruiting
26
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
27
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, United States, 96819
Actively Recruiting
28
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States, 83706
Suspended
29
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, United States, 83605
Suspended
30
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, United States, 83814
Actively Recruiting
31
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, United States, 83687
Suspended
32
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, United States, 83854
Actively Recruiting
33
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, United States, 83864
Actively Recruiting
34
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
35
University of Illinois
Chicago, Illinois, United States, 60612
Actively Recruiting
36
Carle at The Riverfront
Danville, Illinois, United States, 61832
Actively Recruiting
37
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, United States, 60115
Actively Recruiting
38
Carle Physician Group-Effingham
Effingham, Illinois, United States, 62401
Actively Recruiting
39
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, United States, 60134
Actively Recruiting
40
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, United States, 60026
Actively Recruiting
41
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, United States, 60030
Actively Recruiting
42
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, United States, 60045
Actively Recruiting
43
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States, 61938
Actively Recruiting
44
Northwestern Medicine Orland Park
Orland Park, Illinois, United States, 60462
Actively Recruiting
45
Carle Cancer Center
Urbana, Illinois, United States, 61801
Actively Recruiting
46
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States, 60555
Actively Recruiting
47
Heartland Oncology and Hematology LLP
Council Bluffs, Iowa, United States, 51503
Suspended
48
Methodist Jennie Edmundson Hospital
Council Bluffs, Iowa, United States, 51503
Actively Recruiting
49
Nebraska Cancer Specialists/Oncology Hematology West PC - MEJ
Council Bluffs, Iowa, United States, 51503
Actively Recruiting
50
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Actively Recruiting
51
Mercy Hospital South
St Louis, Missouri, United States, 63128
Actively Recruiting
52
Mercy Hospital Saint Louis
St Louis, Missouri, United States, 63141
Actively Recruiting
53
Community Hospital of Anaconda
Anaconda, Montana, United States, 59711
Actively Recruiting
54
Billings Clinic Cancer Center
Billings, Montana, United States, 59101
Actively Recruiting
55
Bozeman Health Deaconess Hospital
Bozeman, Montana, United States, 59715
Actively Recruiting
56
Benefis Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Actively Recruiting
57
Logan Health Medical Center
Kalispell, Montana, United States, 59901
Actively Recruiting
58
Community Medical Center
Missoula, Montana, United States, 59804
Actively Recruiting
59
Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
Omaha, Nebraska, United States, 68114
Actively Recruiting
60
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
Actively Recruiting
61
Oncology Associates PC
Omaha, Nebraska, United States, 68114
Suspended
62
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States, 45219
Active, Not Recruiting
63
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, United States, 45069
Active, Not Recruiting
64
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
65
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, United States, 74146
Suspended
66
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon, United States, 97914
Suspended
67
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Actively Recruiting
68
Providence Saint Vincent Medical Center
Portland, Oregon, United States, 97225
Actively Recruiting
69
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
70
Swedish Medical Center-First Hill
Seattle, Washington, United States, 98122
Actively Recruiting
71
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, United States, 53149
Actively Recruiting
72
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States, 53066
Actively Recruiting
73
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, United States, 53188
Actively Recruiting
74
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, United States, 53188
Actively Recruiting
75
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
76
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
77
Chinese University of Hong Kong-Prince of Wales Hospital
Shatin, Hong Kong
Suspended
78
National University Hospital Singapore
Singapore, Singapore, 119074
Actively Recruiting
79
National Cancer Centre Singapore
Singapore, Singapore, 168583
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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