CUE-101 + Keytruda for Head and Neck Squamous Cell Carcinoma
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot have had certain treatments like systemic anti-cancer therapy or radiation therapy within a few weeks before starting the study drug. It's best to discuss your specific medications with the study team.
What data supports the effectiveness of the drug combination CUE-101 and Keytruda for head and neck squamous cell carcinoma?
Research shows that Keytruda (also known as pembrolizumab) is effective in treating head and neck squamous cell carcinoma, especially in patients whose tumors have high levels of PD-L1, a protein that can affect the immune response. This suggests that combining Keytruda with other treatments like CUE-101 might enhance its effectiveness.12345
Is the combination of CUE-101 and Keytruda safe for humans?
Pembrolizumab (Keytruda) has been evaluated for safety in patients with head and neck squamous cell carcinoma, showing some serious side effects like pneumonia and respiratory issues, but its overall safety profile was considered acceptable. There is no specific safety data available for CUE-101 in combination with Keytruda, but pembrolizumab alone has been used safely in various trials.26789
What makes the drug CUE-101 + Keytruda unique for head and neck squamous cell carcinoma?
What is the purpose of this trial?
This is a multi-center, open-label, phase 1 dose escalation and expansion study evaluating the safety, anti-tumor effect, and immunogenicity of CUE-101 as monotherapy treatment in second line or CUE-101 Combination Therapy with Pembrolizumab in first line patients with HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
Research Team
Matteo Levisetti, MD
Principal Investigator
Cue Biopharma
Eligibility Criteria
This trial is for adults over 18 with HPV16+ recurrent or metastatic head and neck squamous cell carcinoma who've had prior systemic therapy. They must have measurable disease, be HLA A*0201 genotype positive, and able to consent to study procedures. Exclusions include HIV/AIDS, hepatitis B/C, other cancers within 2 years, recent major surgery or trauma, significant heart disease, active infections requiring IV treatment, mental incapacity to consent.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
CUE-101 Monotherapy IV infusion Q3W Dose Escalation and Expansion, and CUE-101 Dose Escalation in Combination with Pembrolizumab
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- CUE-101
- Keytruda
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cue Biopharma
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