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Monoclonal Antibodies

pepinemab + pembrolizumab for Head and Neck Squamous Cell Carcinoma (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
Subjects must be ≥18 years of age
Subjects must have adequate renal function based on Serum creatinine ≤1.5 × ULN or Calculated creatinine clearance of >30 mL/min
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

KEYNOTE-B84 Trial 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.

KEYNOTE-B84 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My kidney function is within the normal range.
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I am HIV positive, on treatment, and my HIV is well-controlled.
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My cancer is a type of squamous cell carcinoma located in my head or neck.
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My cancer is advanced and cannot be cured with surgery or radiation.
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My liver function tests are within the required range.
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My cancer can be measured by scans and has grown in previously treated areas.
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I am fully active or restricted in physically strenuous activity but can do light work.

KEYNOTE-B84 Trial 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)

KEYNOTE-B84 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.

Find a Location

Who is running the clinical trial?

Vaccinex Inc.Lead Sponsor
11 Previous Clinical Trials
688 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,488 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being sought for this research study?

"In order to reach statistical significance, this clinical trial requires 65 patients that match the inclusion criteria. The sponsor, Vaccinex Inc., has chosen Siteman Cancer Center - Washington University Medical Campus and Virginia Cancer Specialists - Fairfax as two of their many study locations."

Answered by AI

What other similar drugs have been studied in coordination with pepinemab and pembrolizumab?

"As of now, 1005 different clinical trials are investigating pepinemab + pembrolizumab. Furthermore, 122 of these studies have reached Phase 3. Many of the active trials for this combination therapy are running out of in Houston, Texas; however, there are 36068 locations total running studies for pepinemab + pembrolizumab."

Answered by AI

Is this research project still looking for participants?

"The trial you are inquiring about, as per the most recent information available on clinicaltrials.gov, is still recruiting patients. This particular study was first posted on 8/9/2021 and was last edited on 6/13/2022."

Answered by AI

Are there any restrictions for who can participate in this research?

"Researchers are looking for 65 individuals that have been diagnosed with hnscc. The age bracket for this study is 18-100 years old. Candidates must also meet the following prerequisites: RECIST 1.1, life expectancy of 12 weeks, ECOG PS 0 or 1, and more as specified in the original answer."

Answered by AI

Is this clinical trial only accepting people who are over 60 years old?

"The age range for this particular trial is 18 to 100 years old. Out of the 4703 total clinical trials, 263 are for patients that fall below the age of eighteen and 4440 are for people aged 65 or older."

Answered by AI

What are the goals of this medical experiment?

"The primary focus of this long-term study is to establish the Recommended Phase 2 Dose (RP2D) of the medication. Additionally, researchers will be measuring secondary objectives like the Extent of Disease, Overall Survival rates, and Duration of Response in order to collect a more comprehensive data set."

Answered by AI

In how many distinct places is this research being conducted?

"Washington University Medical Campus in Saint Louis, Missouri; Virginia Cancer Specialists - Fairfax in Fairfax, Virginia; Hematology/Oncology Clinic-Baton Rouge in Baton Rouge, Louisiana are all Siteman Cancer Center locations where patients can be enrolled for this study. There are 17 other potential sites as well."

Answered by AI

For what type of condition is pepinemab + pembrolizumab commonly prescribed?

"pepinemab + pembrolizumab is a cancer medication, however it can also be used to treat other conditions like unresectable melanoma and microsatellite instability high."

Answered by AI
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~13 spots leftby Dec 2024