RecruitingPhase 2NCT05787639

Neoadjuvant Immunoradiotherapy With Evorpacept and Pembrolizumab in HPVOPC (Human Papilloma Virus Oropharynx Cancer)

Neoadjuvant Radiation and Evorpacept (ALX148) in Combination With Pembrolizumab In Patients With Previously Untreated Locally Advanced, Resectable, HPVOPC (Human Papilloma Virus Oropharynx Cancer)

Sponsor

University of California, San Diego

Enrollment

29 participants

Start Date

Feb 20, 2024

Study Type

INTERVENTIONAL

Conditions

Oropharynx Cancer

Summary

The majority of head and neck cancer patients do not respond to immunotherapies, and clinical responses are often not durable. However, targeting tumors with stereotactic radiation in combination with immunotherapy while sparing draining lymphatics enhances anticancer immunity, resulting in dramatic response in HPV (Human Papilloma Virus) virus related cancers of the throat. This trial will leverage targeted tumor radiation and immunotherapy in advance of standard surgical therapy to improve the response of HPV (Human Papilloma Virus) throat cancer to radiation and immunotherapy.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination treatment before surgery for a type of throat cancer called HPV-positive oropharyngeal cancer (cancer of the tonsils or back of the throat caused by the human papillomavirus). The pre-surgery treatment combines two immunotherapy drugs — evorpacept and pembrolizumab — with radiation, hoping to shrink the tumor before it is surgically removed. **You may be eligible if...** - You have been diagnosed with HPV-positive oropharyngeal cancer, Stage I (T1-2, N1, M0) - Your tumor is eligible for surgical removal - You are healthy enough to safely receive radiation and both immunotherapy drugs **You may NOT be eligible if...** - You have only a single involved lymph node that is smaller than 3 cm 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

DRUGEvorpacept

After stereotactic radiation to primary tumor and neck on week 1 of study, Evorpacept 45 mg/kg is administered by IV infusion every three weeks starting on Week 2, Day 1 of study for a total two 21-day cycles (6 weeks)