Actively Recruiting
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 Epstein-Barr Virus-Associated Recurrent/Metastatic Nasopharyngeal Carcinoma
Led by National Cancer Institute (NCI) · Updated on 2026-06-03
156
Participants Needed
88
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the addition of BMS-986016 (relatlimab), a monoclonal antibody, to the usual immunotherapy after initial treatment for nasopharyngeal cancer that has returned or spread to other parts of the body. This phase II study focuses on patients with recurrent or metastatic nasopharyngeal carcinoma treated first with chemotherapy and immunotherapy, aiming to see if adding relatlimab can extend the time the cancer does not grow or spread. The usual initial treatment includes drugs like cisplatin or carboplatin, gemcitabine, and the immunotherapy drug nivolumab. The study involves an induction therapy phase where patients receive nivolumab, cisplatin or carboplatin, and gemcitabine intravenously in cycles every 21 days for up to 6 cycles, unless the disease progresses or side effects become unacceptable. After this, patients without disease progression are randomly assigned to one of two maintenance therapy groups: one receiving nivolumab alone every 4 weeks for up to 2 years, and the other receiving both nivolumab and relatlimab on the same schedule and duration. Imaging tests like CT, MRI, PET/CT, or bone scans are performed as part of the treatment monitoring. Participants will undergo regular scans and blood sample collections during screening, treatment, and follow-up. After completing study treatment, follow-up visits occur every 4 months for 2 years, then every 6 months for years 3 to 5, and annually afterward. Researchers will measure progression-free survival, overall survival, tumor response, side effects, and biomarkers related to Epstein-Barr virus DNA. Blood and tissue samples will also be collected for future research. Safety and treatment effects will be monitored for up to 6 years.
CONDITIONS
Brief 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...
- Pathologically proven diagnosis of nasopharyngeal carcinoma that is recurrent or metastatic
- Tumor positive for Epstein-Barr virus RNA or history of detectable plasma EBV DNA
- Measurable disease by RECIST 1.1 criteria
- Age 18 years or older
- ECOG performance status of 0-2
- Negative pregnancy test for persons of childbearing potential
- Adequate blood counts and organ function as specified
- No prior systemic treatment for recurrent/metastatic nasopharyngeal carcinoma
- No prior treatment with PD-1, PD-L1, LAG-3, CTLA-4 inhibitors for recurrent/metastatic disease except certain adjuvant/neoadjuvant therapies
- Interval of at least 6 months since last definitive treatment for non-metastatic disease
- Clinically stable brain metastases or leptomeningeal metastases if previously treated
- No active infection requiring IV antibiotics, antivirals, or antifungals
- No active autoimmune disease requiring systemic treatment in past 2 years
- No prior live vaccine within 30 days before registration
- Ability to complete induction therapy and meet criteria for maintenance therapy
You will not qualify if you...
- Disease amenable to curative surgery or re-irradiation for locoregional recurrence
- Direct brain parenchyma invasion causing symptoms or significant edema
- Prior palliative radiotherapy within 30 days to target lesions
- Major surgery within 30 days prior to registration
- History of unstable angina or myocardial infarction within last 6 months
- NYHA Functional Classification III or IV heart failure
- History of myocarditis
- Pneumonitis requiring steroids or immunosuppressive therapy
- Multi-drug resistant or active tuberculosis within last 2 years
- Prior solid organ or bone marrow transplant
- Use of systemic immunosuppressive doses of corticosteroids or other immunosuppressive drugs within 14 days
- Known grade 3-4 allergic reactions to cisplatin, carboplatin, gemcitabine, or monoclonal antibodies
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 weeks
Participants receive nivolumab, cisplatin or carboplatin, and gemcitabine intravenously in cycles repeated every 21 days for up to 6 cycles if no disease progression or unacceptable toxicity occurs. Imaging and blood sample collections occur during this period.
Up to 6 cycles every 3 weeks with multiple IV infusions and imaging assessments
Duration - Up to 2 years
Participants who do not experience disease progression are randomized to receive either nivolumab alone or nivolumab combined with relatlimab intravenously every 4 weeks for up to 2 years. Imaging assessments occur during this period, and additional imaging scans are done as clinically indicated.
Monthly IV infusions with imaging assessments; additional scans as needed
Duration - Up to 5 years
After completion of study treatment, participants are monitored regularly to assess their health and disease status.
Visits every 4 months for 2 years, every 6 months for years 3 to 5, then annually
Trial Site Locations
Total: 88 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
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, United States, 50023
Actively Recruiting
48
Saint Anthony Regional Hospital
Carroll, Iowa, United States, 51401
Actively Recruiting
49
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, United States, 50325
Actively Recruiting
50
Heartland Oncology and Hematology LLP
Council Bluffs, Iowa, United States, 51503
Suspended
51
Methodist Jennie Edmundson Hospital
Council Bluffs, Iowa, United States, 51503
Actively Recruiting
52
Nebraska Cancer Specialists/Oncology Hematology West PC - MEJ
Council Bluffs, Iowa, United States, 51503
Actively Recruiting
53
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Actively Recruiting
54
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, United States, 50309
Actively Recruiting
55
Broadlawns Medical Center
Des Moines, Iowa, United States, 50314
Actively Recruiting
56
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Actively Recruiting
57
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, United States, 50314
Actively Recruiting
58
UI Healthcare Mission Cancer and Blood - Fort Dodge
Fort Dodge, Iowa, United States, 50501
Actively Recruiting
59
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, United States, 50263
Actively Recruiting
60
Mercy Hospital South
St Louis, Missouri, United States, 63128
Actively Recruiting
61
Mercy Hospital Saint Louis
St Louis, Missouri, United States, 63141
Actively Recruiting
62
Community Hospital of Anaconda
Anaconda, Montana, United States, 59711
Actively Recruiting
63
Billings Clinic Cancer Center
Billings, Montana, United States, 59101
Actively Recruiting
64
Bozeman Health Deaconess Hospital
Bozeman, Montana, United States, 59715
Actively Recruiting
65
Benefis Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Actively Recruiting
66
Logan Health Medical Center
Kalispell, Montana, United States, 59901
Actively Recruiting
67
Community Medical Center
Missoula, Montana, United States, 59804
Actively Recruiting
68
Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
Omaha, Nebraska, United States, 68114
Actively Recruiting
69
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
Actively Recruiting
70
Oncology Associates PC
Omaha, Nebraska, United States, 68114
Suspended
71
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States, 45219
Active, Not Recruiting
72
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, United States, 45069
Active, Not Recruiting
73
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
74
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, United States, 74146
Suspended
75
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon, United States, 97914
Suspended
76
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Actively Recruiting
77
Providence Saint Vincent Medical Center
Portland, Oregon, United States, 97225
Actively Recruiting
78
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
79
Swedish Medical Center-First Hill
Seattle, Washington, United States, 98122
Actively Recruiting
80
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, United States, 53149
Actively Recruiting
81
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States, 53066
Actively Recruiting
82
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, United States, 53188
Actively Recruiting
83
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, United States, 53188
Actively Recruiting
84
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
85
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
86
Chinese University of Hong Kong-Prince of Wales Hospital
Shatin, Hong Kong
Suspended
87
National University Hospital Singapore
Singapore, Singapore, 119074
Suspended
88
National Cancer Centre Singapore
Singapore, Singapore, 168583
Suspended
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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