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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 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 1,174 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03036488
The ClinicalTrials.gov registry entry for NCT03036488 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,174 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT03036488 reports 0 study locations.
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.
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