Triple Drug Combo for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

+102 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Incyte Biosciences International Sàrl

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new combination of drugs to treat a specific type of head and neck cancer. The treatment includes retifanlimab, which helps the immune system attack cancer, combined with other experimental drugs to enhance this effect. It targets patients whose cancer has come back or spread and who haven't received other treatments yet. Retifanlimab is an immunotherapy drug that helps the immune system attack cancer cells.

Research Team

Matthias Bartenstein, MD

Principal Investigator

Incyte Corporation

Eligibility Criteria

This trial is for adults with PD-L1-positive recurrent or metastatic squamous cell carcinoma of the head and neck, who haven't had systemic therapy before. They should have a performance status indicating they can care for themselves and not be expected to need curative treatment. Participants must avoid pregnancy, have measurable tumors per specific criteria, provide tissue samples, and not have certain health conditions that could affect their participation.

Inclusion Criteria

My cancer is in my throat, mouth, or voice box.

I am fully active or can carry out light work.

My head or neck cancer can't be treated with the intent to cure, and I haven't refused surgery that could potentially cure a recurrence.

Exclusion Criteria

My tumor is invading major blood vessels and causing active bleeding.

I do not have active brain metastases or have had brain radiation in the last 4 weeks.

Less than 3-month life expectancy.

Treatment Details

Interventions

• INCAGN02385 (PD-L1 Inhibitor)
• INCAGN02390 (PD-L1 Inhibitor)
• Placebo (Other)
• Retifanlimab (PD-L1 Inhibitor)

Trial Overview The study tests retifanlimab combined with INCAGN02385 and possibly INCAGN02390 against retifanlimab alone in first-line treatment. It aims to find out how safe this combination is and how well it works compared to just using retifanlimab by itself in patients who are new to systemic therapy.

Participant Groups

Group I: Treatment Group 3: Retifanlimab + INCAGN02385 + INCAGN02390 Experimental Treatment 3 Interventions

Retifanlimab plus INCAGN02385 and INCAGN02390 will be administered intravenously. Retifanlimab will be administered intravenously every 4 weeks. INCAGN02385 and INCAGN02390 will be administered every 2 weeks.

Group II: Treatment Group 2: Retifanlimab + INCAGN02385 Experimental Treatment 3 Interventions

Retifanlimab will be administered intravenously every 4 weeks. INCAGN02385 and Placebo for INCAGN02390 will be administered intravenously every 2 weeks.

Group III: Treatment Group 1: Retifanlimab Monotherapy Experimental Treatment 2 Interventions

Retifanlimab will be administered intravenously every 4 weeks. Placebos for INCAGN02385 and INCAGN02390 will be administered intravenously every 2 weeks.

Who Is Running the Clinical Trial?

Incyte Biosciences International Sàrl

Lead Sponsor

Trials

16

Recruited

810+