Combination of targeted radiation and immunotherapy for HPV-related throat cancer
Neoadjuvant Radiation and Evorpacept (ALX148) in Combination With Pembrolizumab In Patients With Previously Untreated Locally Advanced, Resectable, HPVOPC (Human Papilloma Virus Oropharynx Cancer)
PHASE2 · University of California, San Diego · NCT05787639
This study is testing a new treatment that combines targeted radiation with immunotherapy to see if it helps people with early-stage HPV-related throat cancer do better before surgery.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 29 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Diego (other) |
| Drugs / interventions | Pembrolizumab, radiation, immunotherapy |
| Locations | 3 sites (La Jolla, California and 2 other locations) |
| Trial ID | NCT05787639 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of neoadjuvant immunoradiotherapy using evorpacept and pembrolizumab in patients with stage I HPV-related oropharynx cancer. The study employs a multi-center, open-label design and aims to enhance the immune response against tumors by combining targeted radiation with immunotherapy before surgical intervention. By focusing on tumor-targeted radiation while sparing lymphatics, the trial seeks to improve patient outcomes compared to standard treatment protocols.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically confirmed stage I T1-2N1M0 HPV oropharynx cancer who are eligible for surgical resection.
Not a fit: Patients with solitary lymph nodes less than 3 cm may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment responses and outcomes for patients with HPV-related oropharynx cancer.
How similar studies have performed: Other studies have shown promise in combining targeted radiation with immunotherapy, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: • Patients with solitary lymph nodes less than 3 cm
Where this trial is running
La Jolla, California and 2 other locations
- UC San Diego Moores Cancer Center — La Jolla, California, United States (RECRUITING)
- Providence Health & Services — Portland, Oregon, United States (RECRUITING)
- Oregon Health and Science University — Portland, Oregon, United States (RECRUITING)
Study contacts
- Principal investigator: Jospeh A Califano, MD — University of California, San Diego
- Study coordinator: Joseph A Califano, MD
- Email: jcalifano@health.ucsd.edu
- Phone: 858-822-6197
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Oropharynx Cancer