Bavituximab + Pembrolizumab for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Maryland, Baltimore

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase II single arm study is being done to determine if bavituximab could potentially synergize with PD-1 inhibitor therapy to generate an effective anti-tumor immune response in patients with recurrent/metastatic squamous cell head and neck cancer (HNSCC) who progressed on a PD-1 inhibitor.

Eligibility Criteria

This trial is for adults over 18 with recurrent/metastatic squamous cell head and neck cancer who've seen their cancer progress after platinum therapy and PD-1 inhibitor treatment. They must have measurable disease, provide a recent tumor tissue sample, have good performance status (0 or 1), adequate organ function, agree to use contraception, and not be pregnant.

Inclusion Criteria

Have measurable disease based on RECIST 1.1

My head and neck cancer has worsened after treatment with drugs like nivolumab or pembrolizumab.

My cancer got worse after platinum therapy or within 6 months of cisplatin and radiation treatment.

+8 more

Exclusion Criteria

I have a history of active tuberculosis.

I am currently being treated for an infection.

Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator

+17 more

Participant Groups

The study tests if bavituximab can enhance the immune response when combined with pembrolizumab in patients whose cancers progressed on prior PD-1 inhibitors. It's a phase II single-arm trial where all participants receive both drugs.

1Treatment groups

Experimental Treatment

Group I: Pembrolizumab + BavituximabExperimental Treatment2 Interventions

Pembro and Bavituximab for progressive recurrent/metastatic squamous cell carcinoma of head and neck