At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Pembrolizumab (drug), Standard of Care (SOC) (drug), Lenvatinib (drug), Olaparib (drug)
- How long the study runs
- Study runs about 300 months (dates as stated)
- About the drug or intervention
- Pembrolizumab — drug: 200 or 400 mg IV infusion · Standard of Care (SOC) — drug: IV infusion or oral tablets · Lenvatinib — drug: Oral capsules · Olaparib — drug: 300mg or 250mg or 100mg oral tablers · MK-4280 — drug: IV Infusion · MK-4280A — biological: 800mg favezelimab + 200mg pembrolizumab IV Infusion · Pembrolizumab (+) Berahyaluronidase alfa — biological: 395 mg or 790 mg SC administration
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 3,500
- Started
- 2018-08-21
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for solid tumors
- • Phase3 - 3,500 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with solid tumors
Where?
- • Aberdeen - Aberdeen Royal Infirmary-Department of Oncology ( Site 0521)
- • Cambridge - Addenbrookes Hospital ( Site 0522)
- • Edinburgh - Western General Hospital ( Site 0502)
- • Manchester - The Christie ( Site 0516)
- • +15 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ recovered from the toxicity and/or complications of the intervention
What the study is looking for
- ✓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...
- ✓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...
- ✓Has an activity scale (ECOG) performance status of 0 or 1.
Who cannot take part
- ✗There are no exclusion criteria to participate in MK-3475-587.
- ✗Participants are excluded from entering Second Course trial treatment once they are enrolled on MK-3475-587 if any...
- ✗Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients.
- ✗Has received a live vaccine within 30 days prior to the first dose of Second Course Phase trial treatment.
- ✗Has known active central nervous system metastases and/or carcinomatous meningitis.
See the full criteria
Where Is This Study? (19 UK sites)
Aberdeen Royal Infirmary-Department of Oncology ( Site 0521)
Aberdeen AB25 2ZN, United Kingdom
Addenbrookes Hospital ( Site 0522)
Cambridge CB2 2QQ, United Kingdom
Western General Hospital ( Site 0502)
Edinburgh EH4 2XU, United Kingdom
The Christie ( Site 0516)
Manchester M20 4BX, United Kingdom
Weston Park Hospital ( Site 0519)
Sheffield S10 2SJ, United Kingdom
Mid Essex Hospitals Service Trust. Broomfield Hospital ( Site 0503)
Broomfield CM1 7ET, United Kingdom
The Beatson West of Scotland Cancer Centre ( Site 0506)
Glasgow G12 0YN, United Kingdom
Royal Preston Hospital ( Site 0518)
Preston PR2 9HT, United Kingdom
Barts Health NHS Trust ( Site 0512)
London EC1A 7BE, United Kingdom
University College London Hospital-Cancer Clinical Trials Unit ( Site 0520)
London NW1 2PG, United Kingdom
Royal Free Hospital ( Site 0507)
London NW3 2QG, United Kingdom
Royal Marsden Hospital ( Site 0505)
London SW3 6JJ, United Kingdom
Sarah Cannon Research UK ( Site 0504)
London W1G 6AD, United Kingdom
Belfast City Hospital ( Site 0508)
Belfast BT9 7AB, United Kingdom
Nottingham University Hospitals NHS Trust ( Site 0510)
Nottingham NG5 1PB, United Kingdom
University Hospital Coventry & Warwickshire ( Site 0524)
Coventry CV2 2DX, United Kingdom
St James University Hospital ( Site 0509)
Leeds LS9 7TF, United Kingdom
The Royal Marsden NHS Foundation Trust. ( Site 0513)
Sutton SM2 5PT, United Kingdom
New Cross Hospital-Department of Oncology ( Site 0517)
Wolverhampton WV10 0QP, United Kingdom
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