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Monoclonal Antibodies

Pembrolizumab + Cetuximab for Head and Neck Cancer

Phase 2

Waitlist Available

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1

Histologically or cytologically proven squamous cell carcinoma of the head and neck (lip, oral cavity, oropharynx, larynx, hypopharynx, non-EBV related nasopharynx, sinonasal, cutaneous), not amenable to curative intent therapy

Must not have

Patient has had major surgery or insufficient recovery from surgical-related trauma or wound healing within 14 days of Study Day 1

Patient has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 9 weeks from first on-treatment scan until disease progression or patient withdrawal from study or date of death from any cause, whichever came first, assessed up to 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a combination of two drugs, pembrolizumab and cetuximab, for patients with head and neck cancer that has returned or spread. Pembrolizumab helps the immune system fight cancer, and cetuximab attacks the cancer cells directly. Both drugs are used in treating head and neck squamous cell carcinoma.

Who is the study for?

This trial is for adults with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) that can't be treated with surgery or radiation. Participants must have good organ function, performance status of 0 or 1, and not be pregnant or planning to become pregnant. They should agree to use contraception and have not received certain treatments before the study.

What is being tested?

The trial tests a combination therapy using Pembrolizumab and Cetuximab in four different patient groups based on their previous treatments. It's an open-label phase II study across multiple centers aiming to enroll a total of 83 patients who will receive this combined treatment.

What are the potential side effects?

Potential side effects include allergic reactions, fatigue, skin rash, diarrhea, low blood counts increasing infection risk, liver inflammation, kidney issues, lung problems like pneumonitis (lung tissue swelling), as well as other immune-related adverse events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My cancer in the head or neck area cannot be cured with surgery or radiation.

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My condition did not improve with platinum-based treatment or I cannot receive it.

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I have at least one tumor that can be measured.

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I agree to follow strict birth control measures or abstain from sex during and 120 days after the study.

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My cancer progressed after initially responding to PD-1/PD-L1 inhibitor therapy.

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My skin cancer cannot be treated with surgery or radiation.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had major surgery or fully recovered from surgery within the last 14 days.

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I have an autoimmune disease treated with medication in the last 2 years.

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I had a severe reaction to previous immunotherapy.

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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.

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I have a long-term lung condition affecting the tissue and space around the air sacs.

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I am currently being treated for an infection.

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I have active Hepatitis B or C, or I am an HIV carrier.

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My cancer originates in my salivary gland.

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I have never received PD-1 or PD-L1 inhibitor immunotherapy.

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I have a history of or currently have non-infectious lung inflammation.

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I have cancer that has spread to my brain or spinal cord.

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I have an active tuberculosis infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 9 weeks from first on-treatment scan until disease progression or patient withdrawal from study or date of death from any cause, whichever came first, assessed up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 9 weeks from first on-treatment scan until disease progression or patient withdrawal from study or date of death from any cause, whichever came first, assessed up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 9 weeks from first on-treatment scan until disease progression or patient withdrawal from study or date of death from any cause, whichever came first, assessed up to 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response Rate

Secondary study objectives

Correlative analyses

Duration of Response

Number of patients with grade 3 through grade 5 adverse events that are related to pembrolizumab and cetuximab, graded according to NCI CTCAE v4.03

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort 4Experimental Treatment1 Intervention

cutaneous HNSCC Pembrolizumab (Keytruda®): Pembrolizumab is administered on an outpatient basis. 200 mg pembrolizumab will be administered as a 30 minute (-5 min/+10 min) intravenous (IV) infusion every 3 weeks. Cetuximab (Erbitux®): The initial cetuximab dose of 400mg/m2 is administered on Cycle 1, Day 1 as a 120-minute IV infusion (maximum infusion rate 10mg/min).1 Subsequent weekly cetuximab doses of 250mg/m2 are administered as 60-minute IV infusions (maximum infusion rate 10mg/min).

Group II: Cohort 3Experimental Treatment1 Intervention

PD-1/PD-L1 inhibitor-refractory, cetuximab-refractory Pembrolizumab (Keytruda®): Pembrolizumab is administered on an outpatient basis. 200 mg pembrolizumab will be administered as a 30 minute (-5 min/+10 min) intravenous (IV) infusion every 3 weeks. Cetuximab (Erbitux®): The initial cetuximab dose of 400mg/m2 is administered on Cycle 1, Day 1 as a 120-minute IV infusion (maximum infusion rate 10mg/min).1 Subsequent weekly cetuximab doses of 250mg/m2 are administered as 60-minute IV infusions (maximum infusion rate 10mg/min).

Group III: Cohort 2Experimental Treatment1 Intervention

PD-1/PD-L1 inhibitor-refractory, cetuximab-naïve Pembrolizumab (Keytruda®): Pembrolizumab is administered on an outpatient basis. 200 mg pembrolizumab will be administered as a 30 minute (-5 min/+10 min) intravenous (IV) infusion every 3 weeks. Cetuximab (Erbitux®): The initial cetuximab dose of 400mg/m2 is administered on Cycle 1, Day 1 as a 120-minute IV infusion (maximum infusion rate 10mg/min).1 Subsequent weekly cetuximab doses of 250mg/m2 are administered as 60-minute IV infusions (maximum infusion rate 10mg/min).

Group IV: Cohort 1Experimental Treatment1 Intervention

PD-1/PD-L1 inhibitor-naïve, cetuximab-naïve Pembrolizumab (Keytruda®): Pembrolizumab is administered on an outpatient basis. 200 mg pembrolizumab will be administered as a 30 minute (-5 min/+10 min) intravenous (IV) infusion every 3 weeks. Cetuximab (Erbitux®): The initial cetuximab dose of 400mg/m2 is administered on Cycle 1, Day 1 as a 120-minute IV infusion (maximum infusion rate 10mg/min).1 Subsequent weekly cetuximab doses of 250mg/m2 are administered as 60-minute IV infusions (maximum infusion rate 10mg/min).

0 / 20Eligibility criteria met