Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
NCT ID: NCT06029270
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
156 participants
INTERVENTIONAL
2024-07-15
2029-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Arm I (Nivolumab)
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 PET/CT or bone scan as clinically indicated.
Bone Scan
Undergo bone scan
Computed Tomography
Undergo CT or PET/CT
Magnetic Resonance Imaging
Undergo MRI
Nivolumab
Given IV
Positron Emission Tomography
Undergo PET/CT
Arm II (Nivolumab, relatlimab)
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.
Bone Scan
Undergo bone scan
Computed Tomography
Undergo CT or PET/CT
Magnetic Resonance Imaging
Undergo MRI
Nivolumab
Given IV
Positron Emission Tomography
Undergo PET/CT
Relatlimab
Given IV
Induction therapy (Platinum-gemcitabine-nivolumab)
Patients receive nivolumab 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 CT or MRI and blood sample collection during screening and on study.
Biospecimen Collection
Undergo blood sample collection
Carboplatin
Given IV
Cisplatin
Given IV
Computed Tomography
Undergo CT or PET/CT
Gemcitabine
Given IV
Magnetic Resonance Imaging
Undergo MRI
Nivolumab
Given IV
Interventions
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Biospecimen Collection
Undergo blood sample collection
Bone Scan
Undergo bone scan
Carboplatin
Given IV
Cisplatin
Given IV
Computed Tomography
Undergo CT or PET/CT
Gemcitabine
Given IV
Magnetic Resonance Imaging
Undergo MRI
Nivolumab
Given IV
Positron Emission Tomography
Undergo PET/CT
Relatlimab
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pathologically (histologically or cytologically) proven diagnosis of nasopharyngeal carcinoma (NPC) that has recurred locoregionally and/or is present at distant sites. Patients who present with metastatic disease (de novo) at diagnosis are also eligible. For locoregional recurrence, the disease must not be amenable to potentially curative surgery or re-irradiation. Eligible patient must have the following characteristics:
* Tumor showing (histological/cytological) Epstein-Barr encoded ribonucleic acid (EBER)-positivity (e.g., In situ hybridization, immunohistochemistry) or
* A known history of detectable plasma EBV DNA (via a polymerase chain reaction \[PCR\]-based assay) at any time point since the initial diagnosis of NPC.
* Measurable disease as defined by RECIST 1.1 criteria. Lesion(s) that have been irradiated previously can be counted as measurable as long as radiological progression after the prior radiation therapy has been demonstrated.
* Contrast enhanced CT scan of the chest. The contrast enhanced CT component of a whole-body PET-CT is also acceptable. The plain (non-contrast) CT component of a PET-CT is not acceptable.
* CT the abdomen and pelvis, if clinically indicated (diagnostic quality with contrast, unless contraindicated).
* Patients with known locoregional disease must have contrast enhanced MRI or CT of the nasopharynx and neck as this disease site(s) may be assessed as target lesions. For patients without known locoregional disease, imaging of the nasopharynx and neck is optional.
* Symptomatic and active brain metastases and/or leptomeningeal metastasis on CT and/or MRI imaging: Patients who have prior therapies for brain and leptomeningeal metastasis or cord/cauda compression who are clinically stable for \>= 2 months prior to registration and have discontinued systemic steroids therapy (\> 10 mg/day prednisone or equivalent) \> 4 weeks prior to registration are eligible.
* Patients with base of skull involvement by NPC are allowed unless their disease is directly invading the brain parenchyma, associated with clinical symptoms and/or significant vasogenic edema on radiological imaging.
* Age \>= 18 years.
* Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status of 0-2.
* Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal.
* Absolute neutrophil count (ANC) \>= 1500 cells/mm\^3.
* Platelets \>= 100,000 cells/mm\^3.
* Hemoglobin (Hgb) \>= 8.0 g/dL (Transfusion is accepted. Erythropoietin dependency not accepted.).
* Total bilirubin =\< 1.5 × institutional upper limit of normal (ULN) or direct bilirubin =\< ULN for patients with total bilirubin levels \> 1.5 × ULN. Patients with known Gilbert's disease who have serum bilirubin level =\< 3 × ULN may be enrolled.
* Alanine transaminase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 3 × ULN (=\< 5 × ULN for patients with liver metastases).
* Serum creatinine =\< 1.5 × ULN or calculated creatinine clearance (CrCl) based on Cockcroft-Gault equation \>= 30 mL/min for patients with serum creatinine levels \> 1.5 × ULN. Cisplatin or carboplatin may be used at the discretion of the investigator - except for patients with CrCl between 30-50 mL/min, for whom carboplatin should be used instead of cisplatin. CrCl must be \> 50 mL/min for cisplatin to be used.
* Albumin-adjusted calcium level based on corrected calcium equation =\< 1.5 × ULN (patients are allowed to have treatment for hypercalcemia prior to starting treatment).
* No prior systemic treatment for recurrent/metastatic (R/M) NPC including cytotoxic chemotherapy. Prior treatment for non-recurrent and non-metastatic NPC is allowed.
* No prior treatment with a PD-1 inhibitor (except if given as adjuvant or neoadjuvant therapy for NPC), PD-L1 inhibitor, anti-PD-L2 inhibitor, LAG-3 inhibitor, CTLA-4 inhibitor (except if given as adjuvant or neoadjuvant therapy for non-recurrent and non-metastatic NPC), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
* The interval between the last dose of curative-intent treatment for non-recurrent, non-metastatic NPC, including definitive radiotherapy (RT) and/or induction, concurrent, or adjuvant chemotherapy and recurrence must be ˃ 6 months.
* Clinically significant toxicities from any prior systemic therapy or radiotherapy must have resolved to grade 0 or 1 as per National Cancer Institute (NCI) CTCAE v 5.0 - except alopecia, dry mouth, dysgeusia, dysphagia, and fatigue. Patients with a history of grade 3-4 cisplatin related neuropathy must have recovered to grade 0-2 prior to registration. Patients with a history of hearing impairment, or ototoxicity from prior cisplatin, of any grade are allowed.
* No prior palliative RT within 30 days prior to registration. This includes RT given with palliative intent to recurrent/metastatic sites. The irradiated sites must not be the only sites of measurable recurrent disease.
* No major surgical procedures within 30 days prior to registration.
* No history of unstable angina requiring hospitalization within the last 6 months.
* No history of myocardial infarction within the last 6 months.
* New York Heart Association Functional Classification II or better (New York Heart Association \[NYHA\] Functional Classification III/IV are not eligible). Patients with symptomatic coronary artery disease, congestive heart failure or a known history of having a left ventricular ejection fraction \< 50% must be stably controlled with medication in the opinion of the treating physician, in consultation with a cardiologist if appropriate.
* No prior history of myocarditis.
* No active infection requiring IV antibiotics, IV antiviral, or IV antifungal treatments at the time of study registration.
* No history of (non-infectious) pneumonitis that required steroids or current pneumonitis requiring steroids and/or immunosuppressive therapy, idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans), or idiopathic pneumonitis.
* No history of multi-drug resistant mycobacterium tuberculosis (TB) or active TB, as defined by systemic treatment received =\< 2 years prior to registration. Note: Patients who had a history of treated TB ˃ 2 years prior to registration are allowed.
* No prior solid organ transplant or bone marrow transplant.
* No conditions requiring systemic treatment with either immunosuppressive doses of corticosteroids (\> 10 mg daily prednisone or equivalents) or other immunosuppressive medications within 14 days of registration. Inhaled or topical steroids and adrenal replacement doses \< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Steroid premedication for the prophylaxis of CT contrast-related allergies is allowed. The use of dexamethasone as an anti-emetic premedication prior to chemotherapy is also allowed.
* No active autoimmune disease requiring systemic treatment (i.e., disease modifying agents, corticosteroids, or immunosuppressive drugs) within the past 2 years. These may include (but not limited to) patients with a history of immune-related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), rheumatoid arthritis, connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's disease, ulcerative colitis, autoimmune hepatitis, glomerulonephritis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome.
* Note: Patients are permitted to enroll if they have vitiligo; type I diabetes mellitus; hypothyroidism, pituitary or adrenal insufficiency requiring only hormone replacement; alopecia; and/or psoriasis not requiring systemic treatment. Conditions not expected to recur in the absence of an external trigger are permitted to enroll.
* No prior live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist \[registered trademark\]) are live attenuated vaccines and are not allowed. Coronavirus disease 2019 (COVID-19) vaccines that are approved by the local drug regulatory authority of the participating region are allowed.
* No known history of grade 3-4 allergic reaction or hypersensitivity reaction to cisplatin, carboplatin, or gemcitabine.
* No known history of grade 4 hypersensitivity (or infusion) reaction to any monoclonal antibody. Patients who had prior grade 3 hypersensitivity (or infusion) reaction but could tolerate resumption of the antibody treatment after appropriate pre-medication are eligible.
* PRIOR TO STEP 2 REGISTRATION:
* Collection of plasma EBV DNA at baseline is mandatory for all patients prior to Step 2 registration and induction treatment.
* Note: Submission of the baseline sample will be batch shipped.
* PRIOR TO STEP 3 REGISTRATION/RANDOMIZATION: PATIENTS WITHOUT PROGRESSIVE DISEASE (PD) ONLY:
* All patients must have received minimum of 3 cycles, and up to a maximum of 6 cycles of induction treatment within 20 weeks from cycle 1, day 1 of induction treatment (i.e., patients must have completed all induction treatment within 20 weeks from cycle 1 day 1, including the treatment breaks). Patients must have completed 6 cycles of induction treatment, except in the following circumstances:
* Significant dose delays as a result of treatment-related toxicities.
* Intercurrent illness(s), that rendered the patient unable to continue induction treatment.
* Note: If a patient received \< 6 cycles of induction treatment for reasons other than the above circumstances, they will not be eligible for randomization.
* A CT scan within 30 days prior to Step 3 registration/randomization is required. If the most recent scan performed is not within this time frame, a repeat scan is required to assess response.
* Did not meet any criteria that result in permanent discontinuation of study treatment during induction treatment phase.
* Must meet the criteria for starting/resuming a new cycle of maintenance treatment.
* Did not experience any nivolumab-related autoimmune toxicities that would result in permanent discontinuation of nivolumab during the induction treatment phase.
* Collection of the plasma EBV DNA post-induction treatment is mandatory.
* Note: Submission of the post-induction sample will be batch shipped.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Brigette B Ma
Role: PRINCIPAL_INVESTIGATOR
NRG Oncology
Locations
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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
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
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
Countries
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Facility Contacts
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Other Identifiers
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NCI-2023-06678
Identifier Type: REGISTRY
Identifier Source: secondary_id
NRG-HN011
Identifier Type: OTHER
Identifier Source: secondary_id
NRG-HN011
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2023-06678
Identifier Type: -
Identifier Source: org_study_id