Pepinemab + Pembrolizumab for Head and Neck Cancer
(KEYNOTE-B84 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment pairing for individuals with recurrent or metastatic head and neck cancer. Researchers aim to determine if combining pepinemab (an experimental treatment) with pembrolizumab (an immunotherapy drug) is safe and tolerable as a first-line treatment. Potential participants include those with head and neck cancer not treatable with local therapies and diagnosed with squamous cell carcinoma that recurs or has spread. As a Phase 1, Phase 2 trial, this research seeks to understand the treatment's effects and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking cancer treatment advancements.
Do I have to stop taking my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you require immunosuppressive therapy or have received certain treatments recently. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that combining pepinemab and pembrolizumab is promising in terms of safety for patients with head and neck cancer. Studies have found this combination to be safe and well-tolerated as an initial treatment for those with advanced or metastatic head and neck squamous cell carcinoma.
Patients receiving this treatment have not reported any unexpected severe side effects, indicating that it is generally manageable, though some may require dose adjustments. The results so far are encouraging and suggest this could be a viable option for patients seeking new treatments.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of pepinemab and pembrolizumab for head and neck cancer because it offers a novel approach compared to existing treatments like surgery, radiation, and chemotherapy. While pembrolizumab is already known as an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells, pepinemab brings in a unique mechanism by blocking a protein called SEMA4D, potentially enhancing the immune response further. This combination aims to create a more robust immune attack on cancer cells, which could lead to improved outcomes for patients.
What evidence suggests that this trial's treatments could be effective for head and neck cancer?
Research has shown that combining pepinemab and pembrolizumab might effectively treat head and neck cancer. In this trial, participants will receive this combination, as studies indicate that pepinemab enhances the effects of pembrolizumab, an immune therapy, by strengthening the body's immune response against tumors. This combination has proven safe and well-tolerated in patients with advanced head and neck cancer. Early findings suggest that pepinemab helps create structures in tumors that support a stronger immune attack. These initial results are promising for those considering this treatment option.13467
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Safety Run-in
Evaluate the safety and tolerability of pepinemab in combination with pembrolizumab and determine a recommended Phase 2 dose (RP2D)
Dose Expansion
Evaluate objective response rate (ORR) of the combination of pepinemab/pembrolizumab in immunotherapy naïve patients
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Pembrolizumab
- Pepinemab
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
- 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
- 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
- Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vaccinex Inc.
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
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