RecruitingPhase 1Phase 2NCT06007092

Therapeutic Vaccine in Patients With Human Papillomavirus HPV-positive Oropharyngeal Cancer

Multicentric Randomized Phase I/IIa Trial of the Safety and Immunogenicity of a Therapeutic Anti-HPV DC Targeting Vaccine in Patients With Human Papillomavirus (HPV)-Positive Oropharyngeal Cancer

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Enrollment

24 participants

Start Date

Jul 31, 2023

Study Type

INTERVENTIONAL

Conditions

Head and Neck Carcinoma Adult Disease

Summary

This study is a multicentric double-blind placebo-controlled dose escalation trial of a CD40HVac vaccine (humanized anti-CD40 mAb fused to HPV16 E6/E7 oncoproteins) adjuvanted with poly-ICLC (Hiltonol) in patients with HPV16 oropharyngeal carcinoma with no evidence of residual or recurrent disease after surgery and/or radiochemotherapy. The primary objective is to determine the recommended phase 2 dose (RP2D) of a poly-ICLC(Hiltonol)-adjuvanted CD40HVac vaccine according to the safety and the capacity to elicit immune responses of different doses Two dose levels of poly-ICLC-adjuvanted CD40.HVac will be explored * 1st dose level: CD40.HVac 1.0 mg, with 1.0 mg poly-ICLC * 2nd dose level: CD40.HVac 3.0 mg, with 1.0 mg poly-ICLC The safety data will be reviewed by an IDSMB that will give recommendations.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a therapeutic cancer vaccine (targeting HPV16) in patients who have been treated and are disease-free from HPV-positive oropharyngeal (throat) cancer — to see if the vaccine can help prevent the cancer from coming back. **You may be eligible if:** - You are 18 or older - You were diagnosed with HPV16-positive oropharyngeal squamous cell carcinoma - You completed your full cancer treatment at least 16 weeks ago - There is no sign of remaining or returning cancer on your recent scans - Your blood counts and organ function are within normal ranges **You may NOT be eligible if:** - You have active or recurrent cancer - Your treatment was completed less than 16 weeks ago - You have a significant immune system condition - You are pregnant or nursing Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALHPVDC injection level dose 1

patient receive 3 injections of vaccine at the same level dose

BIOLOGICALplacebo injection level dose 1

patient receive 3 injections of vaccine at the same level dose

BIOLOGICALHPVDC injection level dose 2

patient receive 3 injections of vaccine at the same level dose

BIOLOGICALplacebo injection level dose 2

patient receive 3 injections of vaccine at the same level dose

Locations(1)

Gustave Roussy

Villejuif, France

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NCT06007092

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