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)
Condition(s) studied
Investigational drug(s) / intervention(s)
Pembrolizumab: 200 or 400 mg IV infusion
Standard of Care (SOC): IV infusion or oral tablets
Lenvatinib: Oral capsules
Olaparib: 300mg or 250mg or 100mg oral tablers
MK-4280: IV Infusion
MK-4280A: 800mg favezelimab + 200mg pembrolizumab IV Infusion
Pembrolizumab (+) Berahyaluronidase alfa: 395 mg or 790 mg SC administration
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.
Eligibility
Primary outcome measure(s)
- Overall Survival (OS) — Up to approximately 10 years
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.
Trial sites (782)
| Facility | City | Region | Status |
|---|---|---|---|
| Arizona Cancer Center at UMC North ( Site 0018) | Tucson | Arizona | Recruiting |
| Comprehensive Blood & Cancer Center [Bakersfield, CA] ( Site 0054) | Bakersfield | California | Recruiting |
| California Cancer Associates for Research & Excellence ( Site 0016) | Fresno | California | Completed |
| Providence Medical Foundation ( Site 0087) | Fullerton | California | Completed |
| The Angeles Clinic and Research Institute ( Site 0005) | Los Angeles | California | Active Not Recruiting |
| UCLA - Hematology/Oncology - Administrative Office ( Site 0009) | Los Angeles | California | Recruiting |
| University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0076) | Orange | California | Completed |
| Stanford Cancer Center ( Site 0086) | Palo Alto | California | Recruiting |
| UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0004) | San Francisco | California | Recruiting |
| Providence Saint John's Health Center ( Site 0059) | Santa Monica | California | Recruiting |
| University of Colorado Cancer Center ( Site 0021) | Aurora | Colorado | Recruiting |
| Yale Cancer Center ( Site 0014) | New Haven | Connecticut | Completed |
| Georgetown University Medical Center ( Site 0023) | Washington D.C. | District of Columbia | Active Not Recruiting |
| Holy Cross Hospital, Michael & Dianne Bienes Comp Cancer Ctr ( Site 0022) | Fort Lauderdale | Florida | Recruiting |
| Baptist MD Anderson Cancer Center ( Site 0083) | Jacksonville | Florida | Completed |
| Mount Sinai Braman Comprehensive Cancer Center ( Site 0031) | Miami Beach | Florida | Recruiting |
| Moffitt Cancer Center ( Site 0011) | Tampa | Florida | Completed |
| Emory School of Medicine ( Site 0013) | Atlanta | Georgia | Completed |
| Augusta University ( Site 0077) | Augusta | Georgia | Active Not Recruiting |
| Northwest Georgia Oncology Centers PC ( Site 0061) | Marietta | Georgia | Recruiting |
| Kaiser Permanente Moanalua Medical Center ( Site 0063) | Honolulu | Hawaii | Completed |
| The University of Chicago ( Site 0020) | Chicago | Illinois | Recruiting |
| University of Iowa Hospital and Clinics ( Site 0026) | Iowa City | Iowa | Recruiting |
| James Graham Brown Cancer Center ( Site 0058) | Louisville | Kentucky | Recruiting |
| Mercy Health-Paducah Cancer Center ( Site 0084) | Paducah | Kentucky | Recruiting |
| Women's Cancer Care ( Site 0088) | Covington | Louisiana | Recruiting |
| MedStar Franklin Square Medical Center ( Site 0046) | Baltimore | Maryland | Recruiting |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 0056) | Baltimore | Maryland | Recruiting |
| Maryland Oncology Hematology (MOH) ( Site 8000) | Columbia | Maryland | Recruiting |
| Massachusetts General Hospital ( Site 0041) | Boston | Massachusetts | Active Not Recruiting |
| Dana-Farber Cancer Institute ( Site 0006) | Boston | Massachusetts | Active Not Recruiting |
| Karmanos Cancer Institute ( Site 0047) | Detroit | Michigan | Recruiting |
| Mayo Clinic in Rochester, Minnesota ( Site 0002) | Rochester | Minnesota | Active Not Recruiting |
| Comprehensive Cancer Centers of Nevada ( Site 0043) | Las Vegas | Nevada | Recruiting |
| John Theurer Cancer Center at Hackensack University Medical Center ( Site 0038) | Hackensack | New Jersey | Active Not Recruiting |
| Cancer Institute of New Jersey ( Site 0025) | New Brunswick | New Jersey | Recruiting |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0032) | New York | New York | Recruiting |
| Memorial Sloan Kettering Cancer Center ( Site 0012) | New York | New York | Completed |
| White Plains Hospital-Center for Cancer Care ( Site 0069) | White Plains | New York | Recruiting |
| WakeMed Cancer Care - Waverly Hematology & Medical Oncology ( Site 0074) | Cary | North Carolina | Active Not Recruiting |
+ 742 more sites — see the full list on the official registry below.
On this site
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03486873 on ClinicalTrials.gov ↗ ← All trials in Italy