Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06504394
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
A Study to Evaluate the Safety and Efficacy of Pembrolizumab MK-3475 Coformulated With Hyaluronidase MK-3475A in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma rrcHL or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma rrPMBCLMK-3475A-F65
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Study to Evaluate the Pharmacokinetics Efficacy and Safety of Subcutaneous Pembrolizumab Coformulated With Hyaluronidase MK-3475A in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma rrcHL or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma rrPMBCL
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:
The primary purpose of the study is to assess the pharmacokinetics PK profile of pembrolizumab MK-3475 following subcutaneous SC injection of pembrolizumab coformulated with hyaluronidase MK-3475A and to evaluate the objective response rate ORR of MK-3475A SC in adult participants with Relapsed or Refractory Classical Hodgkin Lymphoma rrcHL or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma rrPMBCL There is no formal hypothesis to be tested for this study
Detailed Description:
None
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