Ignite Creation Date:
2024-05-06 @ 10:20 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03221426
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2017-07-17
Brief Title:
Study of Pembrolizumab MK-3475 Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction GEJ Adenocarcinoma MK-3475-585KEYNOTE-585
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase III Randomized Double-Blind Clinical Trial of Pembrolizumab MK-3475 Plus Chemotherapy XP or FP Versus Placebo Plus Chemotherapy XP or FP as NeoadjuvantAdjuvant Treatment for Subjects With Gastric and Gastroesophageal Junction GEJ Adenocarcinoma KEYNOTE-585
Status:
ACTIVE_NOT_RECRUITING
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:
The purpose of this study is to evaluate the efficacy of pembrolizumab MK-3745 in the neoadjuvant prior to surgery or adjuvant after surgery treatment of previously untreated adults with gastric and gastroesophageal junction GEJ adenocarcinoma
The primary study hypotheses are that
Neoadjuvant and adjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab is superior to neoadjuvant and adjuvant placebo plus chemotherapy followed by adjuvant placebo in terms of Event-free Survival EFS based on Response Evaluation Criteria in Solid Tumors Version 11 RECIST 11 and
Neoadjuvant pembrolizumab plus chemotherapy is superior to neoadjuvant placebo plus chemotherapy in terms of rate of Pathological Complete Response pathCR at the time of surgery
With Amendment 10 upon study completion participants will be discontinued and may be enrolled in an extension study
The primary study hypotheses are that
Neoadjuvant and adjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab is superior to neoadjuvant and adjuvant placebo plus chemotherapy followed by adjuvant placebo in terms of Event-free Survival EFS based on Response Evaluation Criteria in Solid Tumors Version 11 RECIST 11 and
Neoadjuvant pembrolizumab plus chemotherapy is superior to neoadjuvant placebo plus chemotherapy in terms of rate of Pathological Complete Response pathCR at the time of surgery
With Amendment 10 upon study completion participants will be discontinued and may be enrolled in an extension study
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-004408-76 | EUDRACT_NUMBER | PHRR Research Registration | None |
| MK-3475-585 | OTHER | None | None |
| 173786 | REGISTRY | None | None |
| KEYNOTE-585 | OTHER | None | None |
| PHRR200226-002534 | REGISTRY | None | None |