Phase 3: testing Pembrolizumab for Solid Tumors
This study wants to measure the long-term safety and how well it works 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.
Official registry: https://clinicaltrials.gov/study/NCT03486873 · Merck Sharp & Dohme LLC · enrollment listed as 3,500
What this phase means
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Pembrolizumab, Standard of Care (SOC), or Lenvatinib. The registry lists allocation as randomized. This study wants to measure the long-term safety and how well it works of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study.
They plan to enroll about 3,500 people at 782 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.
Official title (unrewritten)
A Multicenter, Open-label, Phase 3 Study to Evaluate the Long-term Safety and Efficacy in Participants Who Are Currently on Treatment or in Follow-up in Studies That Include Pembrolizumab
Interventions: Pembrolizumab, Standard of Care (SOC), Lenvatinib, Olaparib, MK-4280, MK-4280A, Pembrolizumab (+) Berahyaluronidase alfa
Primary outcome (registry wording): Overall Survival (OS)
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- Treated on the parent pembrolizumab studies established by the Sponsor as MK-3475-587 ready
- Currently receiving pembrolizumab, pembrolizumab based combinations or lenvatinib from parent studies or in a follow-up phase
- Additional eligibility criteria for participants who enter Second Course Phase once they are enrolled on MK-3475-587:
- Has not received any anticancer systemic treatment since the last dose of pembrolizumab or a pembrolizumab-based combination in First Course Phase
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Demonstrates adequate organ function
- Additional eligibility criteria for participants who enter dosing with Lenvatinib:
Who the registry excludes
- People the protocol lists as excluded — the study team must confirm.
Public study contact (from the registry)
Toll Free Number
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
782 listed- 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)
+ 717 sites outside the US on the same record
FAQ about this NCT record
Is NCT03486873 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT03486873?
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT03486873?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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