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

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

Inclusion Criteria3

  • Histologically confirmed diagnosis of Stage I T1-2N1M0 HPVOPC (Human Papilloma Virus Oropharynx Cancer)
  • Amenable to surgical resection
  • Are able to safely receive neoadjuvant radiation and Evorpacept/Pembrolizumab

Exclusion Criteria1

  • • Patients with solitary lymph nodes less than 3 cm

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)


Locations(3)

UC San Diego Moores Cancer Center

La Jolla, California, United States

Providence Health & Services

Portland, Oregon, United States

Oregon Health and Science University

Portland, Oregon, United States

View Full Details on ClinicalTrials.gov

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NCT05787639


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