Pepinemab + Pembrolizumab for Head and Neck Cancer

(KEYNOTE-B84 Trial)

Recruiting at 14 trial locations

Overseen By Carla Kipple

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Vaccinex Inc.

Must be taking: Antiretrovirals

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Nasopharynx SCC, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 27

49 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to evaluate the safety and tolerability of pepinemab in combination with pembrolizumab as first-line treatment and determine a recommended Phase 2 dose (RP2D) in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).

Eligibility Criteria

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.

Inclusion Criteria

My kidney function is within the normal range.

Subjects or their legal representative must be able to provide written informed consent to participate in the trial prior to the performance of any study-specific procedures

I am HIV positive, on treatment, and my HIV is well-controlled.

Exclusion Criteria

Subjects with prior allogenic transplants

I had radiotherapy less than 2 weeks before starting the study treatment.

Subjects with any intercurrent medical condition where the known risks of participation in the trial outweigh any potential benefits

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Run-in

Evaluate the safety and tolerability of pepinemab in combination with pembrolizumab and determine a recommended Phase 2 dose (RP2D)

9 weeks

Baseline, week 9

Dose Expansion

Evaluate objective response rate (ORR) of the combination of pepinemab/pembrolizumab in immunotherapy naïve patients

1 year

Every 6 weeks through year 1

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Every 12 weeks after safety follow-up

Treatment Details

Interventions

• Pembrolizumab
• Pepinemab

Trial Overview 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.

Participant Groups

Group I: pepinemab + pembrolizumab Experimental Treatment 1 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.

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

Approved in United States as KEYTRUDA for:

• Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
• Melanoma
• Non-small cell lung cancer (NSCLC)
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Hepatocellular carcinoma
• Renal cell carcinoma
• Cervical cancer
• Endometrial carcinoma

Approved in European Union as KEYTRUDA for:

• Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
• Melanoma
• Non-small cell lung cancer (NSCLC)
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Hepatocellular carcinoma
• Renal cell carcinoma
• Cervical cancer
• Endometrial carcinoma

Approved in United Kingdom as KEYTRUDA for:

• Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1

Who Is Running the Clinical Trial?

Vaccinex Inc.

Lead Sponsor

Trials

12

Recruited

740+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University