CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Nivolumab+Relatlimab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04326257
NCT04326257Phase 2Completed

A Phase II Trial of Personalized Immunotherapy in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck That Have Progressed on Prior Immunotherapy

Dan Zandberg·interventional·Posted Mar 30, 2020·Updated Jan 8, 2026

In Brief

A Phase 2 clinical trial evaluating Nivolumab+Relatlimab and Nivolumab+Ipilimumab for Squamous Cell Carcinoma of the Head and Neck. Completed, enrolled 20 participants across 1 site.

Detailed Summary

In this Phase II trial of personalized immunotherapy in R/M HNSCC, gene expression of LAG3 and CTLA4 by RNA seq will be determined to select the appropriate agent (Ipilimumab or Relatlimab) to add to Nivolumab in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M HNSCC) who have failed prior immunotherapy with anti-PD-1 or PD-L1 mAb therapy. The agent, either Ipilimumab or Relatlimab will be chosen based on the highest relevant immune gene expression (CTLA4 or LAG-3) as long as the minimum difference required is met.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedMar 30, 2020
Enrollment StartMay 14, 2020
Primary CompletionAug 12, 2023
Study CompletionAug 12, 2024
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 6.3 years ago

Interventions

Nivolumab+Relatlimabdrug

IV administration of both Nivolumab and Relatlimab

Nivolumab+Ipilimumabdrug

IV administration of both Nivolumab and Ipilimumab