Health Trials

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

Qualifiers

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

Treatments tested in this trial

  • Cemiplimab
  • Fianlimab

Treatment groups

60 Participants
are divided into 2 treatment groups

Locations

7
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)07920, Basking RidgeNew Jersey, United States
Memorial Sloan Kettering Monmouth (Limited protocol activities)07748, MiddletownNew Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities )07645, MontvaleNew Jersey, United States
Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)11725, CommackNew York, United States

Sponsors and collaborators

Memorial Sloan Kettering Cancer Center

Lead sponsor

Regeneron Pharmaceuticals

Collaborator

Source ClinicalTrials.gov