CUE-101 + Keytruda for Head and Neck Squamous Cell Carcinoma

Recruiting at16 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Cue Biopharma

No Placebo Group

Breakthrough Therapy

Trial Summary

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

Results from medical tests show certain abnormalities or conditions.

You have advanced head and neck cancer that has worsened after receiving at least one type of treatment. You must have already received platinum-based chemotherapy and/or pembrolizumab as a first-line treatment.

You fully understand the study and have agreed to participate. You are also willing to follow the study procedures and provide the necessary research samples.

Exclusion Criteria

Known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome

Known history of hepatitis B or hepatitis C infection or known positive test for hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C polymerase chain reaction

Second primary invasive malignancy that has not been in remission for >2 years

Treatment Details

Interventions

• CUE-101 (CAR T-cell Therapy)
• Keytruda (PD-1/PD-L1 Inhibitor)

Trial Overview The trial is testing CUE-101 alone as a second-line treatment or in combination with Pembrolizumab (KEYTRUDA®) as a first-line treatment. It's an open-label phase 1 study focusing on safety and effectiveness against HPV16+ head and neck cancer.

Participant Groups

Group I: Pembrolizumab and CUE-101 Experimental Treatment 2 Interventions

Part C\&D: CUE-101 Dose Escalation in Combination with KEYTRUDA® (pembrolizumab) for injection, for IV use 200 mg Q3W (Part C). Expansion of pembrolizumab plus CUE-101 at the combination RP2D (Part D)

Group II: CUE-101 dose escalation and expansion Experimental Treatment 1 Intervention

Part A\&B: CUE-101 Monotherapy IV infusion Q3W Dose Escalation (Part A) and Expansion (Part B)

Who Is Running the Clinical Trial?

Cue Biopharma

Lead Sponsor

Trials

3

Recruited

160+

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