Ignite Creation Date:
2024-05-06 @ 9:39 AM
Last Modification Date:
2024-10-26 @ 12:17 PM
Study NCT ID:
NCT03036488
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2017-01-27
Brief Title:
Study of Pembrolizumab MK-3475 Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy in Participants With Triple Negative Breast Cancer TNBC MK-3475-522KEYNOTE-522
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase III Randomized Double-blind Study to Evaluate Pembrolizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple Negative Breast Cancer TNBC
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 evaluate the efficacy and safety of pembrolizumab MK-3475 plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy and pembrolizumab vs placebo as adjuvant therapy in participants who have triple negative breast cancer TNBC
After a screening phase of approximately 28 days each participant will receive neoadjuvant study treatment Pembrolizumab Chemotherapy OR Placebo Chemotherapy based on the randomization schedule for approximately 24 weeks 8 cycles Each participant will then undergo definitive surgery 3-6 weeks after conclusion of the last cycle of the neoadjuvant study treatment After definitive surgery each participant will receive adjuvant study treatment Pembrolizumab OR Placebo for approximately 27 weeks 9 cycles Following adjuvant study treatment each participant will be monitored for safety survival and disease recurrence
The primary study hypothesis is that pembrolizumab is superior to placebo in combination with chemotherapy as measured by the rate of Pathological Complete Response pCR andor Event-free Survival EFS in participants with locally advanced TNBC
After a screening phase of approximately 28 days each participant will receive neoadjuvant study treatment Pembrolizumab Chemotherapy OR Placebo Chemotherapy based on the randomization schedule for approximately 24 weeks 8 cycles Each participant will then undergo definitive surgery 3-6 weeks after conclusion of the last cycle of the neoadjuvant study treatment After definitive surgery each participant will receive adjuvant study treatment Pembrolizumab OR Placebo for approximately 27 weeks 9 cycles Following adjuvant study treatment each participant will be monitored for safety survival and disease recurrence
The primary study hypothesis is that pembrolizumab is superior to placebo in combination with chemotherapy as measured by the rate of Pathological Complete Response pCR andor Event-free Survival EFS in participants with locally advanced TNBC
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 |
|---|---|---|---|
| 2016-004740-11 | EUDRACT_NUMBER | Merck | None |
| 173567 | REGISTRY | None | None |
| MK-3475-522 | OTHER | None | None |
| KEYNOTE-522 | OTHER | None | None |