Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06525220
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab Vs Pembrolizumab in First-line Treatment of Head and Neck Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 3 Randomized Open-label Study to Evaluate the Efficacy and Safety of Petosemtamab Plus Pembrolizumab Vs Pembrolizumab in First-line Treatment of Recurrent or Metastatic PD-L1 Head and Neck Squamous Cell Carcinoma
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is Phase 3 randomized open-label study to evaluate the efficacy and safety of petosemtamab plus pembrolizumab vs pembrolizumab in first-line treatment of recurrent or metastatic PD-L1 head and neck squamous cell carcinoma
Detailed Description:
This is a Phase 3 randomized open-label study to evaluate the efficacy and safety of petosemtamab plus pembrolizumab vs pembrolizumab in first-line treatment of recurrent or metastatic PD-L1 HNSCC HNSCC patients should not have had previous systemic therapy administered in the recurrent or metastatic setting although previous systemic therapy as part of multimodal treatment for locally advanced disease is allowed if PD was 6 months after the last platinum-containing therapy dose Previous treatments with anti PD-L1 or anti-EGFR therapies are not allowed In the case of cetuximab patients who have received cetuximab with radiotherapy as a local treatment and PD was 1 year after the last dose of cetuximab are eligible
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None