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NCT03036488 · ClinicalTrials.gov registry record · Phase 3
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-3475-522/KEYNOTE-522)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,174
- Enrollment target
NCT03036488: Completed Phase 3 study, sponsored by Merck Sharp & Dohme.
NCT03036488 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 1,174 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03036488, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,174 participants
- Enrollment target
Study 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) and/or Event-free Survival (EFS), in participants with locally advanced TNBC.
Primary Outcome
pCR rate (ypT0/Tis ypN0) is defined as the percentage of participants without residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by current American Joint Committee on Cancer (AJCC) staging criteria assessed by the local pathologist at the time of definitive surgery.
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Carboplatin
- DRUG Doxorubicin
- DRUG Paclitaxel
- DRUG Epirubicin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,174 participants |
| Start Date | 2017-03-07 |
| Est. Completion | 2025-10-14 |
| Phase | Phase 3 |
What the finished NCT03036488 record still lists
NCT03036488 is an interventional study that assigns participants to a tested intervention. Its 1,174 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% higher).
The record links to 0 conditions, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT03036488 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03036488 about?
NCT03036488 is a clinical study titled "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-3475-522/KEYNOTE-522)". 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 o...
What is the current status of trial NCT03036488?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,174 participants. The study started on 2017-03-07. Estimated completion is 2025-10-14.
What interventions are being tested in trial NCT03036488?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Carboplatin (DRUG), Doxorubicin (DRUG), Paclitaxel (DRUG), Epirubicin (DRUG).
Who is sponsoring clinical trial NCT03036488?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03036488's enrollment target sits among peer trials
1,174 235th of 2000 higher than 1,766 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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