Ignite Creation Date:
2024-05-06 @ 2:06 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04210115
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2019-12-20
Brief Title:
Study of Pembrolizumab MK-3475 Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy MK-3475-975KEYNOTE-975
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Phase 3 Trial of Pembrolizumab MK-3475 Versus Placebo in Participants With Esophageal Carcinoma Receiving Concurrent Definitive Chemoradiotherapy KEYNOTE 975
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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 assess the efficacy and safety of treatment with definitive chemoradiotherapy dCRT pembrolizumab MK-3475 compared to treatment with dCRT placebo with respect to Event-free Survival EFS and Overall Survival OS in
participants whose tumors express Programmed Death-Ligand 1 PD-L1 Combined Positive Score CPS 10
participants whose tumors express PD-L1 CPS 1
all participants
The primary study hypotheses are that dCRT pembrolizumab is better than dCRT placebo with respect to
EFS in participants whose tumors express PD-L1 CPS 10
EFS in participants whose tumors express PD-L1 CPS 1
EFS in all participants
OS in participants whose tumors express PD-L1 CPS 10
OS in participants whose tumors express PD-L1 CPS 1
OS in all participants
participants whose tumors express Programmed Death-Ligand 1 PD-L1 Combined Positive Score CPS 10
participants whose tumors express PD-L1 CPS 1
all participants
The primary study hypotheses are that dCRT pembrolizumab is better than dCRT placebo with respect to
EFS in participants whose tumors express PD-L1 CPS 10
EFS in participants whose tumors express PD-L1 CPS 1
EFS in all participants
OS in participants whose tumors express PD-L1 CPS 10
OS in participants whose tumors express PD-L1 CPS 1
OS in all participants
Detailed Description:
Participants receive pembrolizumab or placebo PLUS one of two chemotherapy regimens PLUS radiation therapy for up to approximately one year The chemotherapy regimens are either
FP 5-fluorouracil 5-FU cisplatin or
FOLFOX 5-FU oxaliplatin leucovorin or levoleucovorin
FP 5-fluorouracil 5-FU cisplatin or
FOLFOX 5-FU oxaliplatin leucovorin or levoleucovorin
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 |
|---|---|---|---|
| 2022-501531-16 | REGISTRY | Japic-CTI | None |
| MK-3475-975 | OTHER | None | None |
| KEYNOTE-975 | OTHER | None | None |
| PHRR200210-002490 | REGISTRY | None | None |
| 205261 | REGISTRY | None | None |
| 2019-002006-51 | EUDRACT_NUMBER | None | None |