Ignite Creation Date:
2024-05-06 @ 3:25 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04624113
Status:
TERMINATED
Last Update Posted:
2024-02-21
First Post:
2020-11-09
Brief Title:
Tazemetostat and Pembrolizumab in Patients With Pembrolizumab- or Nivolumab-Resistant Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Tazemetostat and Pembrolizumab in Patients With Pembrolizumab- or Nivolumab-Resistant Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma A Phase 1-2 Trial
Status:
TERMINATED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Ipsen bought out Epizyme
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary aim of the phase 1 portion of the trial is to establish the recommended phase 2 dose RP2D of tazemetostat in combination with a fixed dose of pembrolizumab in patients with recurrent or metastatic RM head and neck cancer
The primary aim of the phase 2 portion of the trial is to establish the proportion of patients with pembrolizumab- or nivolumab-resistant PD-L1 positive RM head and neck squamous-cell carcinoma HNSCC who achieve an objective tumor response to tazemetostat and pembrolizumab
The primary aim of the phase 2 portion of the trial is to establish the proportion of patients with pembrolizumab- or nivolumab-resistant PD-L1 positive RM head and neck squamous-cell carcinoma HNSCC who achieve an objective tumor response to tazemetostat and pembrolizumab
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None