Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04761198
Status:
COMPLETED
Last Update Posted:
2024-02-22
First Post:
2021-02-12
Brief Title:
A Study of Etigilimab and Nivolumab in Subjects with Locally Advanced or Metastatic Tumors
Sponsor:
Mereo BioPharma
Organization:
Mereo BioPharma
Study Overview
Official Title:
A Phase 1b2 Open-Label Study of the Efficacy and Safety of Etigilimab MPH313 Administered in Combination with Nivolumab to Subjects with Locally Advanced or Metastatic Solid Tumors ACTIVATE
Status:
COMPLETED
Status Verified Date:
2024-10
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 is an open-label phase 1b2 multicenter study designed to evaluate the efficacy safety tolerability PK and pharmacodynamics of etigilimab in combination with nivolumab in subjects with locally advanced or metastatic solid tumors Subjects will be assigned to receive etigilimab every 2 weeks in combination with nivolumab 240 mg every 2 weeks
Detailed Description:
This is an open-label phase 1b2 multicenter study designed to evaluate the efficacy safety tolerability PK and pharmacodynamics of etigilimab in combination with nivolumab in subjects with locally advanced or metastatic solid tumors Subjects will be assigned to receive etigilimab every 2 weeks in combination with nivolumab 240 mg every 2 weeks and will continue until either unacceptable toxicity or disease progression Subjects may continue to receive treatment beyond documented RECIST 11 or disease progression Subjects who are both CPI checkpoint inhibitor naïve as well as subjects who have received or progressed following a CPI will be eligible and include the following tumor types head and neck squamous cell carcinoma HNSCC cervical carcinoma gastric or gastroesophageal carcinoma endometrial carcinoma tumor mutation burden high TMB-H select rare tumors and ovarian carcinoma
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 |
|---|---|---|---|
| 2020-004222-37 | EUDRACT_NUMBER | None | None |