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Double immunotherapy may keep nasopharyngeal cancer at bay

NCT ID NCT06029270

Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 04, 2026 · Updated 14 times

Summary

This phase II trial tests whether adding the immunotherapy drug relatlimab to standard nivolumab maintenance therapy can extend the time before cancer grows or spreads in patients with recurrent or metastatic nasopharyngeal cancer linked to Epstein-Barr virus. Participants first receive chemotherapy (cisplatin or carboplatin plus gemcitabine) with nivolumab, then are randomly assigned to continue nivolumab alone or with relatlimab. The study aims to enroll 156 patients and will compare progression-free survival between the two groups.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nivolumab and relatlimab (immunotherapy drugs)
What this could lead to
If successful, this could lead to a new maintenance treatment option that delays cancer progression in patients with recurrent or metastatic nasopharyngeal cancer.
What could go wrong
This is a phase II trial with only 156 participants, so results are preliminary. Adding relatlimab may increase side effects without improving outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 156 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * PRIOR TO STEP 1 REGISTRATION: * 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 of palliative intent for recurrent/metastatic (R/M) NPC including cytotoxic chemotherapy. Prior treatment for non-recurrent and non-metastatic NPC is allowed. Systemic therapy given prior to curative intent re-irradiation or surgery is allowed for potentially curable locoregional recurrence. * 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 unless the irradiated site(s) are not the target lesions. The irradiated site(s) also 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.

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Conditions

The condition(s) this trial relates to.

nasopharyngeal carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic nasopharyngeal carcinoma Recurrent nasopharyngeal carcinoma Stage IV nasopharyngeal carcinoma ajcc V8

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    86 sites in 5 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Benefis Sletten Cancer Institute

    RECRUITING

    Great Falls, Montana, 59405, United States

    Contact Email: •••••@•••••

  • Billings Clinic Cancer Center

    RECRUITING

    Billings, Montana, 59101, United States

    Contact Email: •••••@•••••

  • Bozeman Health Deaconess Hospital

    RECRUITING

    Bozeman, Montana, 59715, United States

    Contact Email: •••••@•••••

  • Broadlawns Medical Center

    RECRUITING

    Des Moines, Iowa, 50314, United States

  • Carle Cancer Center

    RECRUITING

    Urbana, Illinois, 61801, United States

    Contact Email: •••••@•••••

  • Carle Physician Group-Effingham

    RECRUITING

    Effingham, Illinois, 62401, United States

    Contact Email: •••••@•••••

  • Carle Physician Group-Mattoon/Charleston

    RECRUITING

    Mattoon, Illinois, 61938, United States

    Contact Email: •••••@•••••

  • Carle at The Riverfront

    RECRUITING

    Danville, Illinois, 61832, United States

    Contact Email: •••••@•••••

  • Chinese University of Hong Kong-Prince of Wales Hospital

    RECRUITING

    Shatin, Hong Kong

  • Community Hospital of Anaconda

    RECRUITING

    Anaconda, Montana, 59711, United States

    Contact Email: •••••@•••••

  • Community Medical Center

    RECRUITING

    Missoula, Montana, 59804, United States

    Contact Email: •••••@•••••

  • Emory University Hospital Midtown

    RECRUITING

    Atlanta, Georgia, 30308, United States

  • Heartland Oncology and Hematology LLP

    SUSPENDED

    Council Bluffs, Iowa, 51503, United States

  • Iowa Methodist Medical Center

    RECRUITING

    Des Moines, Iowa, 50309, United States

  • Kaiser Permanente Downtown Commons

    RECRUITING

    Sacramento, California, 95814, United States

  • Kaiser Permanente Dublin

    RECRUITING

    Dublin, California, 94568, United States

  • Kaiser Permanente Fresno Orchard Plaza

    RECRUITING

    Fresno, California, 93720, United States

  • Kaiser Permanente Medical Center - Santa Clara

    RECRUITING

    Santa Clara, California, 95051, United States

  • Kaiser Permanente Moanalua Medical Center

    RECRUITING

    Honolulu, Hawaii, 96819, United States

  • Kaiser Permanente San Leandro

    RECRUITING

    San Leandro, California, 94577, United States

  • Kaiser Permanente- Modesto MOB II

    RECRUITING

    Modesto, California, 95356, United States

  • Kaiser Permanente-Fremont

    RECRUITING

    Fremont, California, 94538, United States

  • Kaiser Permanente-Fresno

    RECRUITING

    Fresno, California, 93720, United States

  • Kaiser Permanente-Modesto

    RECRUITING

    Modesto, California, 95356, United States

  • Kaiser Permanente-Oakland

    RECRUITING

    Oakland, California, 94611, United States

  • Kaiser Permanente-Roseville

    RECRUITING

    Roseville, California, 95661, United States

  • Kaiser Permanente-San Francisco

    RECRUITING

    San Francisco, California, 94115, United States

  • Kaiser Permanente-Santa Rosa

    RECRUITING

    Santa Rosa, California, 95403, United States

  • Kaiser Permanente-Santa Teresa-San Jose

    RECRUITING

    San Jose, California, 95119, United States

  • Kaiser Permanente-South Sacramento

    RECRUITING

    Sacramento, California, 95823, United States

  • Kaiser Permanente-South San Francisco

    RECRUITING

    South San Francisco, California, 94080, United States

  • Kaiser Permanente-Vallejo

    RECRUITING

    Vallejo, California, 94589, United States

  • Kaiser Permanente-Walnut Creek

    RECRUITING

    Walnut Creek, California, 94596, United States

  • Kaiser San Rafael-Gallinas

    RECRUITING

    San Rafael, California, 94903, United States

  • Keck Medicine of USC Koreatown

    RECRUITING

    Los Angeles, California, 90020, United States

  • Kootenai Clinic Cancer Services - Post Falls

    RECRUITING

    Post Falls, Idaho, 83854, United States

    Contact Email: •••••@•••••

  • Kootenai Clinic Cancer Services - Sandpoint

    RECRUITING

    Sandpoint, Idaho, 83864, United States

    Contact Email: •••••@•••••

  • Kootenai Health - Coeur d'Alene

    RECRUITING

    Coeur d'Alene, Idaho, 83814, United States

    Contact Email: •••••@•••••

  • Logan Health Medical Center

    RECRUITING

    Kalispell, Montana, 59901, United States

    Contact Email: •••••@•••••

  • Los Angeles General Medical Center

    RECRUITING

    Los Angeles, California, 90033, United States

    Contact Email: •••••@•••••

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Mercy Hospital Saint Louis

    RECRUITING

    St Louis, Missouri, 63141, United States

  • Mercy Hospital South

    RECRUITING

    St Louis, Missouri, 63128, United States

  • Mercy Medical Center - Des Moines

    RECRUITING

    Des Moines, Iowa, 50314, United States

  • Methodist Jennie Edmundson Hospital

    RECRUITING

    Council Bluffs, Iowa, 51503, United States

  • National Cancer Centre Singapore

    RECRUITING

    Singapore, 168583, Singapore

    Contact Email: •••••@•••••

  • National University Hospital Singapore

    RECRUITING

    Singapore, 119074, Singapore

  • Nebraska Cancer Specialists/Oncology Hematology West PC - MECC

    SUSPENDED

    Omaha, Nebraska, 68114, United States

  • Nebraska Cancer Specialists/Oncology Hematology West PC - MEJ

    RECRUITING

    Council Bluffs, Iowa, 51503, United States

  • Nebraska Methodist Hospital

    RECRUITING

    Omaha, Nebraska, 68114, United States

  • Northwestern Medicine Cancer Center Delnor

    RECRUITING

    Geneva, Illinois, 60134, United States

  • Northwestern Medicine Cancer Center Kishwaukee

    RECRUITING

    DeKalb, Illinois, 60115, United States

  • Northwestern Medicine Cancer Center Warrenville

    RECRUITING

    Warrenville, Illinois, 60555, United States

  • Northwestern Medicine Glenview Outpatient Center

    RECRUITING

    Glenview, Illinois, 60026, United States

  • Northwestern Medicine Grayslake Outpatient Center

    RECRUITING

    Grayslake, Illinois, 60030, United States

  • Northwestern Medicine Lake Forest Hospital

    RECRUITING

    Lake Forest, Illinois, 60045, United States

    Contact Email: •••••@•••••

  • Northwestern Medicine Orland Park

    RECRUITING

    Orland Park, Illinois, 60462, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

    Contact Email: •••••@•••••

  • Oklahoma Cancer Specialists and Research Institute-Tulsa

    SUSPENDED

    Tulsa, Oklahoma, 74146, United States

  • Oncology Associates PC

    SUSPENDED

    Omaha, Nebraska, 68114, United States

  • Peter MacCallum Cancer Centre

    RECRUITING

    Melbourne, Victoria, 3000, Australia

  • ProHealth D N Greenwald Center

    RECRUITING

    Mukwonago, Wisconsin, 53149, United States

  • ProHealth Oconomowoc Memorial Hospital

    RECRUITING

    Oconomowoc, Wisconsin, 53066, United States

  • ProHealth Waukesha Memorial Hospital

    RECRUITING

    Waukesha, Wisconsin, 53188, United States

  • Providence Portland Medical Center

    RECRUITING

    Portland, Oregon, 97213, United States

    Contact Email: •••••@•••••

  • Providence Saint Vincent Medical Center

    RECRUITING

    Portland, Oregon, 97225, United States

    Contact Email: •••••@•••••

  • Saint Alphonsus Cancer Care Center-Boise

    SUSPENDED

    Boise, Idaho, 83706, United States

  • Saint Alphonsus Cancer Care Center-Caldwell

    SUSPENDED

    Caldwell, Idaho, 83605, United States

  • Saint Alphonsus Cancer Care Center-Nampa

    SUSPENDED

    Nampa, Idaho, 83687, United States

  • Saint Alphonsus Cancer Care Center-Ontario

    SUSPENDED

    Ontario, Oregon, 97914, United States

  • Saint Anthony Regional Hospital

    RECRUITING

    Carroll, Iowa, 51401, United States

  • Stanford Cancer Institute Palo Alto

    RECRUITING

    Palo Alto, California, 94304, United States

    Contact Email: •••••@•••••

  • Swedish Medical Center-First Hill

    RECRUITING

    Seattle, Washington, 98122, United States

  • UI Health Care Mission Cancer and Blood - Ankeny Clinic

    RECRUITING

    Ankeny, Iowa, 50023, United States

  • UI Health Care Mission Cancer and Blood - Des Moines Clinic

    RECRUITING

    Des Moines, Iowa, 50309, United States

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    RECRUITING

    Des Moines, Iowa, 50314, United States

  • UI Health Care Mission Cancer and Blood - Waukee Clinic

    RECRUITING

    Waukee, Iowa, 50263, United States

  • UI Health Care Mission Cancer and Blood - West Des Moines Clinic

    RECRUITING

    Clive, Iowa, 50325, United States

  • UI Healthcare Mission Cancer and Blood - Fort Dodge

    RECRUITING

    Fort Dodge, Iowa, 50501, United States

    Contact Email: •••••@•••••

  • USC / Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90033, United States

  • USC Norris Oncology/Hematology-Newport Beach

    RECRUITING

    Newport Beach, California, 92663, United States

  • UW Cancer Center at ProHealth Care

    RECRUITING

    Waukesha, Wisconsin, 53188, United States

  • University Health Network-Princess Margaret Hospital

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

    Contact Email: •••••@•••••

  • University of California Davis Comprehensive Cancer Center

    RECRUITING

    Sacramento, California, 95817, United States

  • University of Cincinnati Cancer Center-UC Medical Center

    ACTIVE_NOT_RECRUITING

    Cincinnati, Ohio, 45219, United States

  • University of Cincinnati Cancer Center-West Chester

    ACTIVE_NOT_RECRUITING

    West Chester, Ohio, 45069, United States

  • University of Illinois

    RECRUITING

    Chicago, Illinois, 60612, United States

  • University of Oklahoma Health Sciences Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

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