Neoplasms

All Conditions

Symptoms and General Pathology

Carcinoma

Carcinoma, Squamous Cell

Recurrence

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Cycle 1 of this clinical trial is 56 days in duration to allow for the systematic addition of each agent to the combination regimen. For cycle 2 and all subsequent cycles, the treatment cycle will be 21 days in length.

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.

INCB081776

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.

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.

Palliative RT

Cancer Connect

Justine Bruce, MD

Deric Wheeler, PhD

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.

Primary Objective

• To evaluate the safety and tolerability of INCB081776 in combination with pembrolizumab and standard palliative radiation therapy in subjects with recurrent/metastatic squamous cell carcinoma of the head and neck.

Secondary Objectives

• To determine the preliminary efficacy of INCB081776 in combination with pembrolizumab plus palliative radiation therapy in subjects with recurrent/metastatic squamous cell carcinoma of the head and neck. The irradiated lesion (lesion A) will not be included in the analysis.

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)

Frequency of AEs through physical examinations, by evaluating changes in vital signs, through clinical laboratory blood sample evaluations.

Duration of AEs through physical examinations, by evaluating changes in vital signs, through clinical laboratory blood sample evaluations.

Severity of AEs through physical examinations, by evaluating changes in vital signs, through clinical laboratory blood sample evaluations. Severity will be reported by Grade between 1 (mild) and 5 (death).

Defined as the percentage of participants having CR or PR per RECIST 1.1. The irradiated lesion (lesion A) will not be included in the analysis.

Defined as the percentage of participants having complete response (CR), partial response (PR), or stable disease (SD) per RECIST 1.1.

Defined as the time from earliest date of response until the earliest date of disease progression or death per RECIST 1.1 due to any cause, if occurring sooner than progression.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pembrolizumab, INCB081776, and Radiation Therapy for Head and Neck Squamous Cell Carcinoma	NCT06308913	Head and Neck S...	INCB081776 Pembrolizumab Palliative RT	18 Years -	University of Wisconsin, Madison
Pembrolizumab, INCB081776, and Radiation Therapy for Head and Neck Squamous Cell Carcinoma	NCT06308913	Head and Neck S...	INCB081776 Pembrolizumab Palliative RT	18 Years -	University of Wisconsin, Madison

Spots Global Cancer Trial Database for incb081776

Every month we try and update this database with for incb081776 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for incb081776

Every month we try and update this database with for incb081776 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for incb081776 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.