A Study of Cemiplimab and Fianlimab in People With Nasopharyngeal Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Cemiplimab
DrugCemiplimab (LIBTAYO) is a PD-1 blocking antibody
Fianlimab
DrugFianlimab is a fully human monoclonal antibody targeting the immune checkpoint receptor LAG-3 on T cells
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Induction Therapy: Cemiplimab aloneExperimental treatment 1 intervention
Group B: Induction Therapy: Cemiplimab + FianlimabActive comparator 2 interventions
Trial outcomes
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
Time frame
4 monthsSponsors and contacts
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Memorial Sloan Kettering Cancer Center
Lead sponsor
Regeneron Pharmaceuticals
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: