Nasopharyngeal CarcinomaPhase 1NCT07650266
A Study of Cemiplimab and Fianlimab in People With Nasopharyngeal Carcinoma
A Phase 1 study testing Cemiplimab and Fianlimab in people with Nasopharyngeal Carcinoma and Nasopharyngeal Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharyngeal Carcinoma, Nasopharyngeal Cancer, Nasopharynx Carcinoma
- What is being tested?
- Cemiplimab and Fianlimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesUnited States
- Study dates
- Dec 2026to Jul 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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.
Who cannot join
- 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
Show all 39Show fewer
- 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.
- Received a live vaccine within 30 days of planned start of study medication, during treatment and for 90 days after treatment.
- o Live or live attenuated vaccination with replicating potential. If a patient intends to receive a COVID-19 vaccine before the start of study drug, participation in the study should be delayed at least 1 week after any COVID-19 vaccination. During the treatment period, it is recommended to delay COVID-19vaccination until patients are receiving and tolerating a steady dose of study drug. A vaccine dose should not be less than 48 hours before or after study drug dosing.
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Nancy Lee, MD, 212-639-3341
Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
Commack, New York, 11725
Nancy Lee, MD, 212-639-3341
Memorial Sloan Kettering Westchester (Limited protocol activities)
Harrison, New York, 10604
Nancy Lee, MD, 212-639-3341
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, 07748
Nancy Lee, MD, 212-639-3341
Memorial Sloan Kettering Bergen (Limited Protocol Activities )
Montvale, New Jersey, 07645
Nancy Lee, MD, 212-639-3341
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Nancy Lee, MD, 212-639-3341
Memorial Sloan Kettering at Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
Nancy Lee, MD, 212-639-3341
About this study
Official title: A Pilot Randomized Trial of Induction Cemiplimab With or Without Fianlimab in De-escalated Chemoradiation for Locoregionally Advanced Non-Metastatic Nasopharyngeal Carcinoma
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.
- Conditions
- Nasopharyngeal Carcinoma, Nasopharyngeal Cancer, Nasopharynx Carcinoma, Nasopharynx Cancer
- Being tested
- Cemiplimab, Fianlimab
- Keywords
- Nasopharyngeal Carcinoma, Nasopharyngeal Cancer, Nasopharynx Carcinoma, Nasopharynx Cancer, Locoregionally Advanced Non-Metastatic Nasopharyngeal Carcinoma, Memorial Sloan Kettering Cancer Center, 26-172
- Medical subject headings
- Nasopharyngeal Carcinoma, Nasopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CemiplimabDrug
Also called LIBTAYO
Cemiplimab (LIBTAYO) is a PD-1 blocking antibody
FianlimabDrug
Fianlimab is a fully human monoclonal antibody targeting the immune checkpoint receptor LAG-3 on T cells
| Study group | Role | What they receive |
|---|---|---|
| Induction Therapy: Cemiplimab alone | Experimental | Participant will undergo induction therapy (cemiplimab alone or cemiplimab + fianlimab) after screening and randomization is complete Receives: Drug: Cemiplimab |
| Induction Therapy: Cemiplimab + Fianlimab | Active comparator | Participant will undergo induction therapy (cemiplimab alone or cemiplimab + fianlimab) after screening and randomization is complete Receives: Drug: Cemiplimab; Drug: Fianlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study startDec 2026 (estimated)
- Primary completionJul 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Nancy Lee, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07650266
- Sponsor's protocol ID
- 26-172
- Status last verified
- Aug 2026
- First submitted
- 10 Jun 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Trial of Induction Cemiplimab With or Without Fianlimab in De-escalated Chemoradiation for Locoregionally Advanced Non-Metastatic Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT07650266
- Acronym / sponsor ID
- 26-172
- Conditions
- Nasopharyngeal Carcinoma, Nasopharyngeal Cancer, Nasopharynx Carcinoma, Nasopharynx Cancer
- Keywords
- Nasopharyngeal Carcinoma, Nasopharyngeal Cancer, Nasopharynx Carcinoma, Nasopharynx Cancer, Locoregionally Advanced Non-Metastatic Nasopharyngeal Carcinoma, Memorial Sloan Kettering Cancer Center, 26-172
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Induction Therapy: Cemiplimab alone | Experimental | Drug: CemiplimabParticipant will undergo induction therapy (cemiplimab alone or cemiplimab + fianlimab) after screening and randomization is complete |
| Induction Therapy: Cemiplimab + Fianlimab | Active comparator | Drug: Cemiplimab, Drug: FianlimabParticipant will undergo induction therapy (cemiplimab alone or cemiplimab + fianlimab) after screening and randomization is complete |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (39 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CemiplimabAlso: LIBTAYOCemiplimab (LIBTAYO) is a PD-1 blocking antibody | Drug | Induction Therapy: Cemiplimab + Fianlimab, Induction Therapy: Cemiplimab alone |
| FianlimabFianlimab is a fully human monoclonal antibody targeting the immune checkpoint receptor LAG-3 on T cells | Drug | Induction Therapy: Cemiplimab + Fianlimab |
Primary outcome
Complete response rate
Time frame: 4 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Nasopharyngeal Carcinoma
RecruitingPhase 2
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Metastatic Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Carcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
Not yet recruitingObservational study
Development and Validation of a Biopsy Decision Model for Nasopharyngeal Carcinoma Based on Serological Markers and Endoscopic Features
Nasopharyngeal Carcinoma (NPC)
RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Head and Neck Carcinoma, Adenoid Cystic Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nancy Lee, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cemiplimab and Fianlimab in people with Nasopharyngeal Carcinoma and Nasopharyngeal Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nancy Lee, MD (212-639-3341, leen1@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.