A Study of Cemiplimab and Fianlimab in People With Nasopharyngeal Carcinoma

Starting soon · Phase 1

Conditions studied: Nasopharyngeal Carcinoma, Nasopharyngeal Cancer, Nasopharynx Carcinoma, Nasopharynx Cancer

In brief

The purpose of this study is to find out whether cemiplimab, with or without fianlimab, is an effective treatment for advanced nasopharyngeal carcinoma (NPC), when given with standard chemotherapy drugs gemcitabine and cisplatin before standard chemoradiation.

Key facts

Study ID: NCT07650266
Run by: Memorial Sloan Kettering Cancer Center
People needed: 60
Starts: 2026-07-01
Expected to finish: 2030-07-01
Last updated by the study team: 2026-06-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age ≥ 18
Pathologically (histologically or cytologically) proven (from primary lesion and/or lymph node) diagnosis of non-keratinizing nasopharynx carcinoma
Pathologic confirmation of EBV status in biopsy sample. EBER (Epstein-Barr virus-encoded RNA) detection via immunohistochemistry or in situ hybridization or polymerase chain reaction, collected as routine clinical standard to determine EBV status.
Patient must be seen by head and neck surgery, radiation oncology, medical oncology, as standard of care which includes standard nasopharyngoscopy. All three disciplines need to agree that the patient is eligible. Note: Nasopharyngoscopy does not need to be repeated by all three disciplines. This test is often only performed by head and neck surgery and/or radiation oncology.
AJCC 8th edition: T1N1, T2N0-1, T1-T2N2 nasopharynx carcinoma
ECOG performance status 0-1
Adequate organ and bone marrow function documented by:
Hemoglobin > 9.0 g/dL
Absolute neutrophil count (ANC) >1.5 x 109 /L
Platelet count >100 x 109 /L
Adequate renal function: Serum creatinine <1.5 mg/dL or creatinine clearance ≥ 50 ml/min determined by 24-hour urine collection or estimated by Cockcroft-Gault formula
Adequate hepatic function: - T bili <1.5x ULN, AST or ALT < 1.5 ULN, Alkaline phosphatase <1.5 x ULN). Note: for patients with Gilbert Syndrome, total Bilirubin <3x ULN.
Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential
Signed informed consent form by the participant.

You may not qualify if…

Evidence of distant metastatic disease by radiographic imaging. Equivocal findings are subject to P.I. and Co-PI approval
Prior head and neck radiation (Exceptions can be made if the overlap regions are minimal and must be approved by PI/Co-PI)
Grade ≥2 hearing loss
Grade ≥2 peripheral sensory neuropathy
Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 3 years or if cure rate from treatment at 5 years is 90% or greater
o Note: Exceptions can be made for patients with prior or concurrent invasive malignancy if determined by the PI/Co-PI, then the patient can proceed with protocol activities
Prior systemic chemotherapy for the study cancer o Note: prior chemotherapy for a different cancer is allowable, must check with PI/Co-PI
Severe, active co-morbidity defined as follows:
o Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
Transmural myocardial infarction within the last 6 months
Acute bacterial or fungal infection requiring intravenous antibiotics treatment within 2 weeks prior to the first dose of trial medication
Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization within 30 days of registration
Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
Lack of ability to understand and willingness to sign a written informed consent and complete questionnaires.
Participants with a history of myocarditis.
TnT or troponin I TnI > 2x institutional ULN at baseline. Patients with TnT or TnI levels between > 1 to 2x ULN are permitted if repeat levels within 24 hours are ≤ 1x ULN. If TnT or TnI levels are > 1 to 2x ULN within 24 hours, the patient may undergo a cardiac evaluation and be considered for treatment by the investigator based on the medical judgement in the patient's best interest.
History or current evidence of significant (CTCAE grade ≥2) local or systemic infection (eg, cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 2 weeks prior to the first dose of trial medication.
Uncontrolled infection with HIV, HBV, or HCV infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection.
o Patients with known HIV who have controlled infection (undetectable viral load and CD4 count above 350 either spontaneously or on a stable antiviral regimen) are permitted. For patients with controlled HIV infection, monitoring will be performed per local standards.
Patients with known hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA per local standards and must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study drug.
Patients who are known hepatitis C virus antibody positive (HCV Ab+) who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted.
Patients with HIV or hepatitis must be reviewed by a qualified specialist (e.g., infectious disease or hepatologist) managing this disease prior to commencing and regularly throughout the duration of their participation in the trial
Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents. The following are non-exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment.
Known hypersensitivity to the active substances or to any of the excipients.
Patients using immunosuppressive doses (≥10 mg per day of prednisone or equivalent) of systemic corticosteroids other than for corticosteroid replacement will not be eligible for the study.

Where it is running

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Limited protocol activities) — Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities ) — Montvale, New Jersey, United States
Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities) — Commack, New York, United States
Memorial Sloan Kettering Westchester (Limited protocol activities) — Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States
Memorial Sloan Kettering at Nassau (Limited Protocol Activities) — Uniondale, New York, United States

Full record on ClinicalTrials.gov

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