Durvalumab + Cetuximab for Head and Neck Squamous Cell Carcinoma

Recruiting in Palo Alto (17 mi)

Overseen byTrisha Wise, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Shuchi Gulati

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this research study is to test the combination of the anti-cancer drugs durvalumab, the study drug, and cetuximab as a treatment for metastatic or recurrent head and neck cancer. Participants will receive both durvalumab and cetuximab.

Eligibility Criteria

This trial is for adults over 30 kg with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who aren't eligible for curative treatments like surgery. They must have had disease progression after platinum-based therapy and be in a relatively stable condition (ECOG 0-2). Those with nasopharyngeal/salivary gland tumors or previous treatment with both immunotherapy drugs and Cetuximab can't participate.

Inclusion Criteria

My cancer has worsened after treatment with platinum-based drugs.

I am not eligible for surgery or radiation to cure my condition.

My body weight is over 30 kg.

+2 more

Exclusion Criteria

I have been treated with both immunotherapy and Cetuximab.

My cancer is in the nasopharynx or salivary glands.

Participant Groups

The study is testing the effectiveness of combining two anti-cancer drugs, durvalumab (the study drug) and cetuximab, as a treatment option for patients with metastatic or recurrent head and neck cancer. Participants will receive both medications during the trial.

1Treatment groups

Experimental Treatment

Group I: Durvalumab and CetuximabExperimental Treatment2 Interventions

Durvalumab 500mg as a 120-minute intravenous infusion every two weeks. Cetuximab 400mg/m2 IV loading dose followed by weekly Cetuximab 250mg/m2 IV Treatment with Durvalumab continues until progression and Cetuximab may continue as maintenance

Cetuximab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Erbitux for:

Locally or regionally advanced squamous cell carcinoma of the head and neck
Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck
K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer
BRAF V600E mutation-positive metastatic colorectal cancer

🇪🇺 Approved in European Union as Erbitux for: