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Monoclonal Antibodies

Arm II (Nivolumab, relatlimab) 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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free survival (PFS)

Secondary outcome measures

Distant metastasis

Incidence of adverse events

Locoregional failure

+5 more

Other outcome measures

Post-induction EBV DNA as a predictive biomarker

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, 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. Cycles repeat every 28 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

Carboplatin

2014

Completed Phase 3

~6670

Computed Tomography

2017

Completed Phase 2

~2720

Cisplatin

2013

Completed Phase 3

~1940

Biospecimen Collection

2004

Completed Phase 2

~1700

Gemcitabine

2017

Completed Phase 3

~2070

Relatlimab

2018

Completed Phase 2

~1120

Positron Emission Tomography

2008

Completed Phase 2

~2240

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Nivolumab

2014

Completed Phase 3

~4750

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,667 Previous Clinical Trials

40,926,010 Total Patients Enrolled

Brigette B MaPrincipal InvestigatorNRG Oncology

2 Previous Clinical Trials

60 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available for patients to participate in this trial?

"Indeed, as per the details provided on clinicaltrials.gov, this study is actively seeking eligible patients. The trial was initially posted on October 4th, 2024 and recently updated on January 24th, 2024. A total of 156 participants are sought from three designated sites."

Answered by AI

How large is the participant pool for this clinical trial in its entirety?

"Indeed, the information available on clinicaltrials.gov indicates that this trial is actively seeking participants. The initial posting date was October 4th, 2024, and it has been recently updated as of January 24th, 2024. The study aims to recruit a total of 156 patients across three distinct locations."

Answered by AI

What are the risks associated with Arm II (comprising Nivolumab and relatlimab) when administered to patients?

"Based on our evaluation, the safety rating for Arm II (Nivolumab, relatlimab) is 2. This assessment stems from it being a Phase 2 trial where there exists limited data affirming its safety but no evidence supporting efficacy yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06029270.

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