Immunotherapy for HPV-Positive Throat Cancer

Recruiting in Palo Alto (17 mi)

+816 other locations

Overseen byNabil F Saba

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing whether adding the drug nivolumab can help patients with a specific type of throat cancer live longer and prevent the cancer from coming back. Nivolumab boosts the immune system to better fight the cancer. The study focuses on patients whose cancer has spread to nearby areas.

Research Team

Nabil F Saba

Principal Investigator

ECOG-ACRIN Cancer Research Group

Eligibility Criteria

Adults with intermediate-risk HPV-positive oropharyngeal cancer that has spread locally but not to distant sites. Participants must have adequate organ function, no prior treatments for this cancer, and cannot be pregnant or breastfeeding. They should not have a history of severe allergic reactions to chemotherapy agents like cisplatin or immune conditions that require steroids.

Inclusion Criteria

I had hepatitis C but am cured, or I'm being treated with no detectable virus.

STEP 2: Hgb >= 8.0 g/dL (must be obtained =< 2 weeks prior to registration)

Patients of childbearing potential must use an accepted and effective method of contraception or abstain from sexual intercourse for at least one week prior to the start of treatment, and continue for 5 months after the last dose of protocol treatment. Patients must also not donate ova during this same time period

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Treatment Details

Interventions

Cisplatin (Chemotherapy Agent)
Intensity-Modulated Radiation Therapy (Radiation Therapy)
Nivolumab (Checkpoint Inhibitor)

Trial OverviewThe trial is testing if adding maintenance immunotherapy (nivolumab) after standard treatment with radiation and chemotherapy (cisplatin) improves survival in patients compared to just the standard treatment alone. It's looking at overall survival and progression-free survival as key outcomes.

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm C (nivolumab)Experimental Treatment6 Interventions

Patients receive nivolumab IV over 30 minutes every 4 weeks for 12 months in the absence of disease progression or unacceptable toxicity. Patients undergo CT or FDG PET/CT scans throughout the trial. Patients may undergo ECHO as clinically indicated. Additionally, patients undergo blood sample collection during screening.

Group II: Arm A (cisplatin, IMRT, nivolumab)Experimental Treatment8 Interventions

Patients receive cisplatin IV over 60 minutes weekly and IMRT 5 days a week for 7 weeks for a total of 35 fractions. Within 4 weeks after completion of concurrent therapy, patients receive nivolumab IV once weekly over 30 minutes every 4 weeks for 12 months in the absence of disease progression or unacceptable toxicity. Patients undergo CT or FDG PET/CT scans throughout the trial. Patients may undergo ECHO as clinically indicated. Additionally, patients undergo blood sample collection during screening.

Group III: Arm B (cisplatin, IMRT, observation)Active Control8 Interventions

Patients receive cisplatin IV over 60 minutes weekly and IMRT 5 days a week for 7 weeks for a total of 35 fractions, and then go on observation. Patients will be offered the option to cross-over to Arm C if they have clearly documented progression within 12 months from the end of cisplatin/radiation therapy. Patients undergo CT or FDG PET/CT scans throughout the trial. Patients may undergo ECHO as clinically indicated. Additionally, patients undergo blood sample collection during screening.

Cisplatin is already approved in Canada, Japan for the following indications: