drugset
drugset / Trial / NCT04326257

Personalized Immunotherapy in Patients With Recurrent /Metastatic SCCHN That Have Progressed on Prior Immunotherapy

NCT04326257 ↗

Phase 2 Completed 20 enrolled Dan Zandberg Bristol-Myers Squibb · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2020-05-14
Primary completion
2023-08-12
Completion
2024-08-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipilimumab Monoclonal antibody 1 mg/kg Intravenous
Subject Nivolumab Monoclonal antibody 3 mg/kg Intravenous
Subject Nivolumab Monoclonal antibody 480 mg Intravenous
Subject Relatlimab Monoclonal antibody 160 mg Intravenous

Indications

head and neck squamous cell carcinoma