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Looking for participantsPhase3

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)

Sponsor: Merck Sharp & Dohme LLC

NCT ID: NCT03486873

View on ClinicalTrials.gov ↗

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.

Solid TumorsHematologic Malignancies

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What we know so far

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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

or is positive

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
Inclusion Criteria: * 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. * Have resolution of any toxic effect(s) of First Course Phase trial treatment with pembrolizumab or a pembrolizumab-based combination to Grade 1 or less (except alopecia) before trial treatment in Second Course Phase is started. If participant received major surgery or radiation therapy of \>30 Gray (Gy), they must have recovered from the toxicity and/or complications of the intervention. * A female participant is eligible to enroll if she is not pregnant, not breastfeeding, and ≥1 of the following conditions applies: A woman of childbearing potential (WOCBP) who agrees to use contraception during the study treatment period and for ≥120 days (corresponding to time needed to eliminate any study combination treatment(s) plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity. Additional eligibility criteria for participants who enter dosing with Lenvatinib: * Adequately controlled blood pressure (BP) to \<150/90 mmHg, with or without antihypertensive medications. * For male agrees to be abstinent from penile-vaginal intercourse OR agrees to use a highly effective contraceptive method while receiving study drug and for 7 days after the last dose of lenvatinib. * Is female and not pregnant/breastfeeding and at least one of the following applies during the study and for ≥4 days after: is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method) or is a WOCBP who is abstinent from heterosexual intercourse. Exclusion Criteria: -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 of the following criteria applies: * 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 a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the Cycle 1 Day 1 of Second Course Phase. * Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early stage cancers (carcinoma in situ or Stage 1) treated with curative intent, melanoma (non-ulcerated, thin primary), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy. * Has known active central nervous system metastases and/or carcinomatous meningitis. * Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. * Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Note: Participants that experienced pneumonitis during First Course that did not meet the criteria for permanent discontinuation are eligible. * Non-small cell lung cancer (NSCLC) participants only: Has interstitial lung disease. * Has an active infection requiring systemic therapy. * Has a known history of human immunodeficiency virus (HIV) infection. * Has a known history of or is positive for hepatitis B or hepatitis C. For parent studies where inclusion of participants with hepatitis was permitted, MK-3475-587 will follow the parent study eligibility criteria for hepatitis. * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Second Course Phase eligibility Visit through 120 days after the last dose of study treatment. * Has severe cardiovascular disease, i.e., arrhythmias, requiring chronic treatment, congestive heart failure (New York Heart Association Class III or IV) or symptomatic ischemic heart disease. * Has hepatic decompensation (Child-Pugh score \>6 \[class B and C\]). * Has uncontrolled thyroid dysfunction. * Has uncontrolled diabetes mellitus. * Has had an allogeneic tissue/solid organ transplant. * Has a known history of active tuberculosis (TB; Bacillus tuberculosis). Additional exclusion criteria for participants who enter dosing with Lenvatinib: * Has had major surgery within 3 weeks prior to first dose of study intervention(s). * Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula. * Has urine protein ≥1 g/24 hours. * Has LVEF below the institutional (or local laboratory) normal range, as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO). * Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation. * Prolongation of QT intervals corrected for heart rate using Fridericia's (cube root) correction (QTcF) interval to \>480 ms. * Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability. * Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib. * Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug. * Has a history of any contraindication or has a severe hypersensitivity to any components of lenvatinib.

Where Is This Study? (19 UK sites)

Aberdeen Royal Infirmary-Department of Oncology ( Site 0521)

Aberdeen AB25 2ZN, United Kingdom

ACTIVE_NOT_RECRUITING

Addenbrookes Hospital ( Site 0522)

Cambridge CB2 2QQ, United Kingdom

ACTIVE_NOT_RECRUITING

Western General Hospital ( Site 0502)

Edinburgh EH4 2XU, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441315371000

The Christie ( Site 0516)

Manchester M20 4BX, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator01614463000

Weston Park Hospital ( Site 0519)

Sheffield S10 2SJ, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator0114 2265000

Mid Essex Hospitals Service Trust. Broomfield Hospital ( Site 0503)

Broomfield CM1 7ET, United Kingdom

COMPLETED
Hospital R&D contact (matched)

Dr Sam Hayton

mse.researchenquiries@nhs.net---

The Beatson West of Scotland Cancer Centre ( Site 0506)

Glasgow G12 0YN, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441413017073

Royal Preston Hospital ( Site 0518)

Preston PR2 9HT, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator01772 524656

Barts Health NHS Trust ( Site 0512)

London EC1A 7BE, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+442034657108

University College London Hospital-Cancer Clinical Trials Unit ( Site 0520)

London NW1 2PG, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator07943 094 762

Royal Free Hospital ( Site 0507)

London NW3 2QG, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Natasha Ajraam

rf-tr.randd@nhs.net020 375 82150

Royal Marsden Hospital ( Site 0505)

London SW3 6JJ, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+442078082132

Sarah Cannon Research UK ( Site 0504)

London W1G 6AD, United Kingdom

COMPLETED

Belfast City Hospital ( Site 0508)

Belfast BT9 7AB, United Kingdom

COMPLETED

Nottingham University Hospitals NHS Trust ( Site 0510)

Nottingham NG5 1PB, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Alison Lloyd

nuhnt.researchsponsor@nhs.net0115 9249924

University Hospital Coventry & Warwickshire ( Site 0524)

Coventry CV2 2DX, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Josie Goodby

research@uhcw.nhs.uk02476 965244

St James University Hospital ( Site 0509)

Leeds LS9 7TF, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441132068320

The Royal Marsden NHS Foundation Trust. ( Site 0513)

Sutton SM2 5PT, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+4402073528171

New Cross Hospital-Department of Oncology ( Site 0517)

Wolverhampton WV10 0QP, United Kingdom

ACTIVE_NOT_RECRUITING

How to Get in Touch

Toll Free Number

Sponsor contact

CONTACT

1-888-577-8839 Trialsites@msd.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10