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NCT03486873 · ClinicalTrials.gov registry record · Phase 3
Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587)
A Phase 3 study of Solid Tumors and Hematologic Malignancies, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 3,500
- Enrollment target
- 20
- Study locations
NCT03486873: Recruiting Phase 3 study of Solid Tumors and Hematologic Malignancies, sponsored by Merck Sharp & Dohme.
NCT03486873 is a Phase 3 study of Solid Tumors and Hematologic Malignancies that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 3,500 participants, above the 257-participant average among 125 other Solid Tumors trials with a reported enrollment target (1262% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03486873, a Phase 3 study of Solid Tumors and Hematologic Malignancies, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 3,500 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study. This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment with pembrolizumab or lenvatinib in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination or lenvatinib according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment. Any participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated.
Primary Outcome
OS is defined as the time from randomization or start of study treatment for non-randomized participants (on the parent study) to death due to any cause. Participants without documented death at the time of analysis will be censored at the date of the last known to be alive.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Olaparib
- DRUG Lenvatinib
- DRUG Standard of Care (SOC)
- DRUG MK-4280
Study Locations (20)
California
- Comprehensive Blood & Cancer Center [Bakersfield, CA] ( Site 0054) - Bakersfield
- California Cancer Associates for Research & Excellence ( Site 0016) - Fresno
- Providence Medical Foundation ( Site 0087) - Fullerton
- The Angeles Clinic and Research Institute ( Site 0005) - Los Angeles
- UCLA Hematology/Oncology - Westwood (Building 100) ( Site 0009) - Los Angeles
- University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0076) - Orange
- Stanford Cancer Center ( Site 0086) - Palo Alto
- UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0004) - San Francisco
- Providence Saint John's Health Center ( Site 0059) - Santa Monica
Florida
- Holy Cross Hospital, Michael & Dianne Bienes Comp Cancer Ctr ( Site 0022) - Fort Lauderdale
- Baptist MD Anderson Cancer Center ( Site 0083) - Jacksonville
- Mount Sinai Medical Center Comprehensive Cancer Center ( Site 0031) - Miami Beach
- Moffitt Cancer Center ( Site 0011) - Tampa
Georgia
- Emory School of Medicine ( Site 0013) - Atlanta
- Augusta University ( Site 0077) - Augusta
- Northwest Georgia Oncology Centers PC ( Site 0061) - Marietta
Arizona
- Arizona Cancer Center at UMC North ( Site 0018) - Tucson
Colorado
- University of Colorado Cancer Center ( Site 0021) - Aurora
Connecticut
- Yale Cancer Center ( Site 0014) - New Haven
District of Columbia
- Georgetown University Medical Center ( Site 0023) - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,500 participants |
| Start Date | 2018-08-21 |
| Est. Completion | 2043-08-04 |
| Phase | Phase 3 |
What NCT03486873 shows while recruiting
NCT03486873 is an interventional study that assigns participants to a tested intervention. Its 3,500 participants enrollment target places it among the larger protocols in the corpus, above the 257-participant average among 125 other Solid Tumors trials with a reported enrollment target (1262% higher).
The record links to 2 conditions, with Solid Tumors appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT03486873 names 20 study sites across 7 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT03486873 about?
NCT03486873 is a clinical study titled "Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587)". The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study. This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-u...
What is the current status of trial NCT03486873?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 3,500 participants. The study started on 2018-08-21. Estimated completion is 2043-08-04.
What conditions does trial NCT03486873 study?
This clinical trial studies the following conditions: Solid Tumors, Hematologic Malignancies.
What interventions are being tested in trial NCT03486873?
The interventions under investigation include: Pembrolizumab (DRUG), Olaparib (DRUG), Lenvatinib (DRUG), Standard of Care (SOC) (DRUG), MK-4280 (DRUG).
Who is sponsoring clinical trial NCT03486873?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03486873 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Solid Tumors
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03486873's enrollment target sits among peer trials
3,500 2nd of 125 the highest of 125 other Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Solid Tumors 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.
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