Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06308913
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-03-05
Brief Title:
Pembrolizumab INCB081776 and Radiation Therapy for Head and Neck Squamous Cell Carcinoma
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Primary Objective
To evaluate the safety and tolerability of INCB081776 in combination with pembrolizumab and standard palliative radiation therapy in subjects with recurrentmetastatic 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 recurrentmetastatic squamous cell carcinoma of the head and neck The irradiated lesion lesion A will not be included in the analysis
To evaluate the safety and tolerability of INCB081776 in combination with pembrolizumab and standard palliative radiation therapy in subjects with recurrentmetastatic 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 recurrentmetastatic squamous cell carcinoma of the head and neck The irradiated lesion lesion A will not be included in the analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UW23121 | OTHER | None | None |
| A534260 | OTHER | None | None |
| Protocol Version 2152024 | OTHER | None | None |
| P50DE026787 | NIH | None | None |
| P50CA278595-07 | NIH | UW Madison | httpsreporternihgovquickSearchP50CA278595-07 |