NCT06029270

Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer

A Randomized Phase II Study of Nivolumab Versus Nivolumab and BMS-986016 (Relatlimab) as Maintenance Treatment After First-Line Treatment With Platinum-Gemcitabine-Nivolumab for Patients With Epstein-Barr Virus-Associated Recurrent/Metastatic Nasopharyngeal Carcinoma (REMAIN)
National Cancer Institute (NCI)·Phase 2·ClinicalTrials.gov·procedureNot yet recruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Nasopharyngeal Carcinoma
Drug/Device/Intervention
Biospecimen Collection
Study type
Interventional
Intervention type
procedure
Sponsor & location
Primary sponsor
National Cancer Institute (NCI)
Timeline & enrollment
Phase
Phase 2
Start date
Dec 14, 2023
End date
Apr 30, 2029
Enrollment
156 participants
Primary outcome

Progression-free survival (PFS)

Summary

This phase II trial tests the addition of BMS-986016 (relatlimab) to the usual immunotherapy
 after initial treatment for nasopharyngeal cancer that has come back after a period of
 improvement (recurrent) or that has spread from where it first started (primary site) to
 other places in the body (metastatic). Relatlimab is a monoclonal antibody that may interfere
 with the ability of tumor cells to grow and spread. The usual approach of treatment is
 initial treatment with chemotherapy such as the combination of cisplatin (or carboplatin) and
 gemcitabine, along with immunotherapy such as nivolumab. After the initial treatment is
 finished, patients may continue to receive additional immunotherapy. Carboplatin is in a
 class of medications known as platinum-containing compounds. It works in a way similar to the
 anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by
 killing, stopping or slowing the growth of tumor cells. Immunotherapy with monoclonal
 antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may
 interfere with the ability of tumor cells to grow and spread. Gemcitabine is a chemotherapy
 drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells.
 Giving BMS-986016 in addition to the usual immunotherapy after initial treatment may extend
 the time without the tumor cells grow or spread longer than the usual approach in patients
 with recurrent or metastatic nasopharyngeal cancer.

ICD-10 classifications
Malignant neoplasm of nasopharynxMalignant neoplasm: Nasopharynx, unspecifiedMalignant neoplasm: Overlapping lesion of nasopharynxBenign neoplasm: NasopharynxMalignant neoplasm: Posterior wall of nasopharynx
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06029270
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06029270 through Pure Global AI's free database. This Phase 2 trial is sponsored by National Cancer Institute (NCI) and is currently Not yet recruiting. The study focuses on Nasopharyngeal Carcinoma. Target enrollment is 156 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.