About this trial

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 growing or spreading longer than the usual approach in patients with recurrent or metastatic nasopharyngeal cancer.

Eligibility criteria

Qualifiers

Tumor showing (histological/cytological) Epstein-Barr encoded ribonucleic acid (EBER)-positivity (e.g., In situ hybridization, immunohistochemistry) or

A known history of detectable plasma EBV DNA (via a polymerase chain reaction [PCR]-based assay) at any time point since the initial diagnosis of NPC.

Measurable disease as defined by RECIST 1.1 criteria. Lesion(s) that have been irradiated previously can be counted as measurable as long as radiological progression after the prior radiation therapy has been demonstrated.

Contrast enhanced CT scan of the chest. The contrast enhanced CT component of a whole-body PET-CT is also acceptable. The plain (non-contrast) CT component of a PET-CT is not acceptable.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Bone Scan
  • Carboplatin
  • Cisplatin
  • Computed Tomography
  • Gemcitabine
  • Magnetic Resonance Imaging
  • Nivolumab
  • Positron Emission Tomography
  • Relatlimab

Treatment groups

156 Participants
are divided into 3 treatment groups

Locations

88
Australia
Peter MacCallum Cancer Centre3000, MelbourneVictoria, Australia
Canada
University Health Network-Princess Margaret HospitalM5G 2M9, TorontoOntario, Canada
Hong Kong
Chinese University of Hong Kong-Prince of Wales Hospital Shatin Hong Kong
Singapore
National Cancer Centre Singapore168583, Singapore Singapore

Sponsors and collaborators

National Cancer Institute (NCI)

Lead sponsor