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Monoclonal Antibodies

Relatlimab + Immunotherapy for Nasopharyngeal Cancer

Phase 2

Recruiting

Led By Brigette B Ma

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status of 0-2.

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called BMS-986016 (relatlimab) in combination with standard immunotherapy for patients with nasopharyngeal cancer. Nasopharyngeal

Who is the study for?

This trial is for adults with recurrent or metastatic nasopharyngeal cancer, positive for Epstein-Barr virus. They must have measurable disease and be stable if they've had brain metastases treated. Good performance status (able to carry out daily activities) is required, and women of childbearing potential need a negative pregnancy test.

What is being tested?

The trial tests adding Relatlimab to standard immunotherapy after initial chemotherapy for nasopharyngeal cancer. It compares the usual treatment (chemo with Cisplatin or Carboplatin plus Gemcitabine, followed by Nivolumab) against this regimen plus Relatlimab to see if it better controls tumor growth.

What are the potential side effects?

Possible side effects include reactions related to the immune system attacking normal organs, infusion-related reactions from monoclonal antibodies like Relatlimab and Nivolumab, as well as typical chemo side effects such as fatigue, nausea, blood cell count changes leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to get out of my bed or chair and move around.

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My tumor is positive for Epstein-Barr virus, or I have had detectable EBV DNA in my blood.

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I have had a CT scan with contrast of my chest, or as part of a whole-body PET-CT.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival (PFS)

Secondary study objectives

Distant metastasis

Incidence of adverse events

Locoregional failure

+5 more

Other study objectives

Post-induction EBV DNA as a predictive biomarker

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Induction therapy (Platinum-gemcitabine-nivolumab)Experimental Treatment7 Interventions

Patients receive nivolumab IV over 30 minutes on day 1 of each cycle, cisplatin IV or carboplatin IV over 30-60 minutes on day 1 of each cycle and gemcitabine IV over 30 minutes on days 1 and 8 of each cycle. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI and blood sample collection during screening and on study.

Group II: Arm II (Nivolumab, relatlimab)Experimental Treatment7 Interventions

Patients receive nivolumab IV over 30 minutes and relatlimab IV over 30-90 minutes. Cycles repeat every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI on study. Patients also undergo PET/CT or bone scan as clinically indicated.

Group III: Arm I (Nivolumab)Active Control6 Interventions

Patients receive nivolumab IV over 30 minutes. Cycles repeat every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI on study. Patients also undergo PET/CT or bone scan as clinically indicated.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2014

Completed Phase 3

~5220

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160