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Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer - Trial NCT06029270

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.

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NCT06029270
Phase 2
Not yet recruiting
procedure
Trial Details
ClinicalTrials.gov โ€ข NCT06029270
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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)

Study Focus

Nasopharyngeal Carcinoma

Biospecimen Collection

Interventional

procedure

Sponsor & Location

National Cancer Institute (NCI)

Timeline & Enrollment

Phase 2

Dec 14, 2023

Apr 30, 2029

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 nasopharynx
Malignant neoplasm: Nasopharynx, unspecified
Malignant neoplasm: Overlapping lesion of nasopharynx
Benign neoplasm: Nasopharynx
Malignant neoplasm: Posterior wall of nasopharynx

Data Source

ClinicalTrials.gov

NCT06029270

Non-Device Trial