Cetuximab + Nivolumab for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byChristine H. Chung, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this study is to find out if the combination of two established anti-cancer therapies are beneficial in participants with Head and Neck Squamous Cell Carcinoma (HNSCC). Specifically, investigators want to determine if the combination of Cetuximab and nivolumab can help people with advanced cases of HNSCC. Both cetuximab and nivolumab have been used separately to treat HNSCC and are Food and Drug Administration (FDA) approved in this type of cancer.

Eligibility Criteria

Adults with advanced Head and Neck Squamous Cell Carcinoma (HNSCC) who have already tried at least one treatment like chemotherapy or radiation. They must be in good enough health to participate, not pregnant, and using effective contraception if sexually active. People can't join if they've had certain recent treatments, uncontrolled illnesses, severe allergies to similar drugs, or specific heart conditions.

Inclusion Criteria

Participants must have a life expectancy of greater than 3 months

My cancer is confirmed as squamous cell carcinoma in the specified areas.

Participants, if sexually active, must meet contraceptive requirements

+7 more

Exclusion Criteria

I had severe skin reactions from previous EGFR therapy.

My cancer is p16 negative and started in the lymph nodes of my neck.

I had a severe reaction to previous anti-PD1 therapy.

+9 more

Participant Groups

The trial is testing the effectiveness of combining two FDA-approved cancer drugs—Cetuximab and Nivolumab—in treating HNSCC. Researchers want to see if this drug duo works better together for patients whose cancer has returned or spread and cannot be cured with surgery or radiation alone.

4Treatment groups

Experimental Treatment

Group I: Phase II - Moffitt Site OnlyExperimental Treatment2 Interventions

Nivolumab and Cetuximab at recommended Phase II dose (RP2D).

Group II: Phase II - Affiliate Sites OnlyExperimental Treatment2 Interventions

Nivolumab and Cetuximab at recommended Phase II dose (RP2D).

Group III: Phase I - Moffitt Site OnlyExperimental Treatment2 Interventions

Nivolumab and dose escalation of Cetuximab. Dose Level 1: Lead-in Day -14 before Cycle 1 only: Cetuximab 500 mg/m\^2; Nivolumab - none. Cycle 1 Day 1 and all subsequent doses every 2 weeks (Q2W): Cetuximab 500 mg/m\^2; Nivolumab 240 mg. Dose Level -1: Lead-in Day -14 before Cycle 1 only: Cetuximab 500 mg/m\^2; Nivolumab - none. Cycle 1 Day 1 and all subsequent doses every 2 weeks (Q2W): Cetuximab 250 mg/m\^2; Nivolumab 240 mg.

Group IV: Phase I - Affiliate Sites OnlyExperimental Treatment2 Interventions

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: