A Study of Cemiplimab and Fianlimab in People With Nasopharyngeal Carcinoma
A Pilot Randomized Trial of Induction Cemiplimab With or Without Fianlimab in De-escalated Chemoradiation for Locoregionally Advanced Non-Metastatic Nasopharyngeal Carcinoma
1 other identifier
interventional
60
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2026
Longer than P75 for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2026
CompletedFirst Posted
Study publicly available on registry
June 16, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2030
June 16, 2026
June 1, 2026
4 years
June 10, 2026
June 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete response rate
To determine the post-induction complete response rate in participants treated with induction gemcitabine/cisplatin/cemiplimab with or without fianlimab prior to personalized chemoradiation for locoregionally advanced non-metastatic NPC
4 months
Study Arms (2)
Induction Therapy: Cemiplimab alone
EXPERIMENTALParticipant will undergo induction therapy (cemiplimab alone or cemiplimab + fianlimab) after screening and randomization is complete
Induction Therapy: Cemiplimab + Fianlimab
ACTIVE COMPARATORParticipant will undergo induction therapy (cemiplimab alone or cemiplimab + fianlimab) after screening and randomization is complete
Interventions
Cemiplimab (LIBTAYO) is a PD-1 blocking antibody
Fianlimab is a fully human monoclonal antibody targeting the immune checkpoint receptor LAG-3 on T cells
Eligibility Criteria
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.
- +23 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centerlead
- Regeneron Pharmaceuticalscollaborator
Study Sites (7)
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities )
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Limited protocol activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Memorial Sloan Kettering at Nassau (Limited Protocol Activities)
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nancy Lee, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2026
First Posted
June 16, 2026
Study Start
July 1, 2026
Primary Completion (Estimated)
July 1, 2030
Study Completion (Estimated)
July 1, 2030
Last Updated
June 16, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.