RecruitingEarly Phase 1NCT06308913

Pembrolizumab, INCB081776, and Radiation Therapy for Head and Neck Squamous Cell Carcinoma

Pilot Study of INCB081776 Together With Palliative Radiation and Anti-PD-1 Checkpoint Blockade With Pembrolizumab in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)


Sponsor

University of Wisconsin, Madison

Enrollment

12 participants

Start Date

Sep 18, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is evaluating INCB081776 when given in combination with the checkpoint inhibitor pembrolizumab and palliative radiation therapy in patients with metastatic or recurrent metastatic or recurrent head and neck squamous cell carcinoma (HNSCC). 12 participants will be enrolled and can expect to be on study for up to 12 months.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a three-drug combination — pembrolizumab (an immunotherapy), INCB081776 (a drug that helps the immune system attack cancer more effectively), and targeted radiation therapy — in patients with head and neck squamous cell carcinoma (a type of cancer affecting the mouth, throat, or voice box) that has spread or returned and cannot be cured. **You may be eligible if...** - You have been diagnosed with head and neck squamous cell carcinoma that has spread or returned after prior treatment - Your cancer cannot be treated with surgery or other curative approaches - You have at least one measurable tumor - Prior cancer treatments were completed at least 14 days ago (or 28 days for antibody therapies) **You may NOT be eligible if...** - You have active autoimmune disease requiring systemic treatment - You are on long-term steroids or other immune-suppressing drugs - You have active infections such as HIV or hepatitis B/C that are not controlled - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGINCB081776

INCB081776 will be given orally on a daily basis. The highest safe/tolerable dose and schedule will be established by the ongoing phase 1 clinical trial of INCB081776 plus INCBMGA00012 (NCT03522142), which is 120 mg daily.

DRUGPembrolizumab

Immune checkpoint blockade with anti-PD-1 (Pembrolizumab) will be given as 200 mg IV on cycle 1 day 15 and cycle 1 day 36. Starting from cycle 2, pembrolizumab will be given on day 1 on each subsequent cycle.

RADIATIONPalliative RT

Palliative RT will be given as either 24 Gy in 3 fractions (8 Gy per fraction) or 20 Gy in 5 fractions (4 Gy per fraction). The palliative radiation therapy dose will be determined based on the clinical judgment of the treating radiation oncology physician. Palliative RT must be completed between cycle 1 day 29 to cycle 1 day 33. After completion of palliative radiation therapy, patients will continue with additional cycles of INCB081776 and pembrolizumab until disease progression, intolerance to the combination regimen, or patient withdrawal.


Locations(1)

UW Carbone Cancer Center

Madison, Wisconsin, United States

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NCT06308913


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