A Study of Cemiplimab and Fianlimab for Nasopharyngeal Carcinoma
This study is looking into whether cemiplimab and fianlimab, alone or together, can effectively treat advanced nasopharyngeal carcinoma (NPC), a type of head and neck cancer. These drugs are given along with standard chemotherapy (gemcitabine and cisplatin) before standard radiation and chemotherapy. You may be able to join if you are at least 18 years old and have a confirmed diagnosis of non-keratinizing nasopharynx carcinoma, with your Epstein-Barr virus (EBV) status confirmed in a biopsy. The researchers will measure success by looking at the complete response rate (how many people have their cancer disappear) after 4 months. The current status of this study is unclear.
- Study design
- This is an interventional study planning to enroll 60 participants. The phase of the study is not specified.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured at 4 months, but the full follow-up duration is not specified.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07650266
A Study of Cemiplimab and Fianlimab in People With Nasopharyngeal Carcinoma
Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatmentMemorial Sloan Kettering Cancer CenterInvestigator-initiated
~60 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:CemiplimabFianlimab
At a glance
Recruiting sites
0 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete response rate
Measured over 4 months
Conditions
NCT07650266
Where you'd take part
This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Memorial Sloan Kettering at Nassau (Limited Protocol Activities)
Uniondale, New Yorkstudy coordinator listed
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jerseystudy coordinator listed
Memorial Sloan Kettering Bergen (Limited Protocol Activities )
Montvale, New Jerseystudy coordinator listed
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New Yorkstudy coordinator listed
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jerseystudy coordinator listed
Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
Commack, New Yorkstudy coordinator listed
Memorial Sloan Kettering Westchester (Limited protocol activities)
Harrison, New Yorkstudy coordinator listed
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Nancy Lee, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center
Who to contact
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Eligibility criteria
Inclusion
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.
Exclusion
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
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:
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.
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.
Received a live vaccine within 30 days of planned start of study medication, during treatment and for 90 days after treatment.
Woman of child bearing potential (WOCBP)\* must have a negative serum (beta-hCG) within 14 days prior to registration.
\*WOCBP are defined as women who are fertile following menarche until becoming postmenopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.
Pregnancy testing and contraception are not required for women who are post-menopausal or permanently sterile.
A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high FSH level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient to determine the occurrence of a postmenopausal state. The above definitions are according to the CTFG guidance. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation
Male study participants with WOCBP partners are required to use condoms during the study and until 6 months after the last dose of study treatment unless they are vasectomized or practice sexual abstinence†
Vasectomized partner or vasectomized study participant must have received medical assessment of the surgical success.
Periodic abstinence‡, withdrawal (coitus interruptus), spermicides only, and LAM are not acceptable methods of contraception. Female condom and male condom should not be used together.
WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the entire trial and until 6 months after last treatment
All men must agree not to donate sperm during the trial and for 6 months after receiving the last therapy dose
Pregnant or breastfeeding women. o WOCBP who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose. Highly effective contraceptive measures include: i. stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening; ii. intrauterine device; intrauterine hormone-releasing system; iii. bilateral tubal occlusion/ligation; iv. vasectomized partner (provided that the male vasectomized partner is the sole sexual partner of the WOCBP study participant and that the vasectomized partner has obtained medical assessment of surgical success for the procedure); and/or v. sexual abstinence† ‡
Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drugs. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient.
Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and LAM are not acceptable methods of contraception. Female condom and male condom should not be used together.
What this trial measures
- Complete response rate4 months
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