Immunoradiotherapy for Head and Neck Cancer
Recruiting in Palo Alto (17 mi)
RL
Overseen byRom Leidner, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Waitlist Available
Sponsor: Providence Health & Services
Stay on Your Current Meds
No Placebo Group
Breakthrough Therapy
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?
The purpose of this study is to test the safety of neoadjuvant immunoradiotherapy as a safe means of down-staging Head and Neck Squamous Cell Carcinoma (HNSCC) prior to surgical resection.
Research Team
RL
Rom Leidner, MD
Principal Investigator
Providence Health and Services
Eligibility Criteria
Adults with head and neck squamous cell carcinoma scheduled for surgery can join. They must have certain blood counts, be HPV status known, able to consent, and have an acceptable performance status. Pregnant women or those not using contraception are excluded, as well as individuals on high-dose steroids or with active autoimmune diseases.Inclusion Criteria
My cancer's HPV status has been checked.
Patients with history of psychiatric illness judged by the investigator as able to understand the investigational nature and risks associated with the therapy
Laboratory values within specified ranges
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Exclusion Criteria
I take 20mg or more of prednisone or its equivalent daily.
History of or current active autoimmune disease posing an active and significant morbidity risk
Clinical factors such as bleeding, active infection, or psychiatric factors that would preclude safe participation and compliance with study procedures
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Treatment Details
Interventions
- Nivolumab (Checkpoint Inhibitor)
- Radiation (3 days) (Radiation)
- Radiation (5 days) (Radiation)
- Surgical Resection (Procedure)
Trial OverviewThe trial is testing if giving Nivolumab (an immunotherapy drug) combined with a short course of radiation before surgery can safely shrink tumors in patients with head and neck cancer. The study will separate participants into groups based on their HPV status.
Participant Groups
4Treatment groups
Experimental Treatment
Group I: Treatment Cohort 4Experimental Treatment3 Interventions
Nivolumab administration (3 doses) and radiation (3 days) therapy prior to restaging and surgical resection followed by additional administration of nivolumab (3 doses).
Group II: Treatment Cohort 3Experimental Treatment3 Interventions
Radiation (3 days) therapy prior to restaging and surgical resection followed by additional administration of nivolumab (3 doses).
Group III: Treatment Cohort 2Experimental Treatment3 Interventions
Nivolumab administration (3 doses) and radiation (3 days) therapy prior to restaging and surgical resection followed by additional administration of nivolumab (3 doses).
Group IV: Treatment Cohort 1Experimental Treatment3 Interventions
Nivolumab administration (3 doses) and radiation (5 days) therapy prior to restaging and surgical resection followed by additional administration of nivolumab (3 doses).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Providence Health & Services
Lead Sponsor
Trials
131
Recruited
827,000+
Dr. Laurel Soot
Providence Health & Services
Chief Medical Officer since 2024
MD, FACS
Erik Wexler
Providence Health & Services
Chief Executive Officer
Bachelor's degree in Business Administration from the University of Massachusetts Amherst
Providence Cancer Center, Earle A. Chiles Research Institute
Collaborator
Trials
21
Recruited
500+