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Pembrolizumab + INCB081776 + Radiation for Head and Neck Cancer

Phase < 1
Recruiting
Led By Deric Wheeler, PhD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

Summary

"This trial will test a new drug called INCB081776 along with pembrolizumab and radiation therapy in patients with advanced head and neck cancer. 12 patients will participate and the study will

Who is the study for?
This trial is for people with metastatic or recurrent head and neck squamous cell carcinoma. Participants will be involved in the study for up to a year. Specific eligibility criteria are not provided, but typically include factors like age, health status, and cancer stage.
What is being tested?
The study tests INCB081776 combined with pembrolizumab (a checkpoint inhibitor) and palliative radiation therapy. The goal is to see how well these treatments work together in patients with advanced head and neck cancer.
What are the potential side effects?
Possible side effects may include immune-related reactions due to pembrolizumab, fatigue from radiation therapy, and any unknown risks associated with INCB081776 since it's being evaluated.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Duration of Adverse Events
Incidence of Adverse Events (AEs)
Severity of Adverse Events
Secondary outcome measures
Disease control rate (DCR)
Duration of response (DoR)
Overall response rate (ORR)

Trial Design

1Treatment groups
Experimental Treatment
Group I: INCB081776/Pembrolizumab and RT for HNSCCExperimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2070
Palliative RT
2007
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,841 Previous Clinical Trials
41,002,877 Total Patients Enrolled
University of Wisconsin, MadisonLead Sponsor
1,210 Previous Clinical Trials
3,157,727 Total Patients Enrolled
National Institute of Dental and Craniofacial Research (NIDCR)NIH
302 Previous Clinical Trials
849,603 Total Patients Enrolled
~8 spots leftby Sep 2026
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