Pepinemab + Pembrolizumab for Head and Neck Cancer (KEYNOTE-B84 Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Vaccinex Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if the combination of two immunotherapy drugs is safe and tolerable for people with R/M HNSCC.

Who is the study for?

Adults with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) who have not been cured by existing treatments. Participants must be over 18, have a life expectancy of at least 12 weeks, and show measurable disease progression. They need proper liver, blood, and kidney function; HIV-positive patients must meet specific criteria. Pregnant women can't join, and those able to conceive must use effective contraception.

What is being tested?

The trial is testing the combination of two drugs: pepinemab and pembrolizumab as a first-line treatment for R/M HNSCC. The goal is to assess safety, tolerability, and determine the optimal dose for Phase 2 trials.

What are the potential side effects?

Potential side effects include immune-related reactions that could affect various organs, infusion-related responses such as fever or chills, fatigue from treatment burden on the body's resources, digestive disturbances like nausea or diarrhea due to gastrointestinal tract involvement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Efficacy Endpoint

Evaluation of RP2D

Number of Subjects with Treatment Emergent Adverse Events (TEAE's).

Secondary study objectives

Duration of Response (DoR)

Extent of Disease (EOD)

Immunogenicity Endpoint

+4 more

Other study objectives

On-Treatment Tumor Biopsies

Serum and CSF Levels of Neuroinflammatory Cytokines

T- and B-Cell Quantitation by Flow Cytometry (TBNK)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: pepinemab + pembrolizumabExperimental Treatment1 Intervention

Pepinemab will be administered at 20 mg/kg (with possible dose modifications to 15 mg/kg or 10 mg/kg, if the initial 20 mg/kg dose of pepinemab is determined not to be well tolerated) in combination with a fixed dose of 200 mg pembrolizumab, administered in separate IV infusions, Q3W.

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