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Monoclonal Antibodies

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

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy Endpoint
Evaluation of RP2D
Number of Subjects with Treatment Emergent Adverse Events (TEAE's).
Secondary outcome measures
Duration of Response (DoR)
Extent of Disease (EOD)
Immunogenicity Endpoint
+4 more
Other outcome measures
On-Treatment Tumor Biopsies
Serum and CSF Levels of Neuroinflammatory Cytokines
T- and B-Cell Quantitation by Flow Cytometry (TBNK)

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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Who is running the clinical trial?

Vaccinex Inc.Lead Sponsor
11 Previous Clinical Trials
688 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,919 Previous Clinical Trials
5,068,198 Total Patients Enrolled
~8 spots leftby Dec 2024
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