NCT04326257

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Dan Zandberg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In this Phase II non-randomized trial, n=40 eligible patients will have tumor tissue (core or excisional/incisional) for gene expression of LAG3 and CTLA4 via RNA seq per OmniSeq Immune Report Card to determine which drug (either Relatlimab or Ipilimumab) will be added to Nivolumab for treatment. The patient will then receive the prescribed therapy continuously for up to 24 cycles (1 cycle = 28 days). The drug to be added to Nivolumab will be based on which relevant gene has the highest expression as long as the minimum difference required is met. If the minimum difference is not met than a patient will be randomized to either Nivolumab plus Relatlimab or Nivolumab plus Ipilimumab. The patient will then receive the prescribed therapy continuously for up to 24 cycles (1 cycle = 28 days) with repeat imaging prior to every 3rd cycle until progression of disease. Response, evaluated by RECIST 1.1, with modifications to allow for continued therapy until progressive disease is confirmed if the patient is clinically stable, will be used in the trial. If the patient has confirmed progression the patient may be eligible to undergo a second biopsy and second treatment on trial. If these criteria are met the patient will then be treated with this new combination with repeat imaging prior to every 3rd cycle as per initial treatment, until progression of disease.

Conditions

• Squamous Cell Carcinoma of the Head and Neck

Interventions

Type	Name	Description
DRUG	Nivolumab+Relatlimab	IV administration of both Nivolumab and Relatlimab
DRUG	Nivolumab+Ipilimumab	IV administration of both Nivolumab and Ipilimumab

Timeline

• Start date: 2020-05-14
• Primary completion: 2023-08-12
• Completion: 2024-08-12
• First posted: 2020-03-30
• Last updated: 2026-01-08
• Results posted: 2026-01-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study