Clinical trial Recruiting at 472 sites Phase 3 Interventional Ages 18 and up

Long-term evaluation of pembrolizumab for patients with advanced tumors

Official title: 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

Run by Merck Sharp & Dohme LLC · NCT03486873 · Data updated 2026-11-12

This study is testing how well pembrolizumab works and how safe it is for people with advanced tumors who have already been part of previous studies.

More Solid Tumors trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment3500 (estimated)
SponsorMerck Sharp & Dohme LLC
Industry-sponsored
Drugs / interventionspembrolizumab, lenvatinib, radiation, prednisone
Locations782 sites (Tucson, Arizona and 781 other locations)
StatusRecruiting
StartedAugust 21, 2018
Main results expectedAugust 4, 2043
Study endsAugust 4, 2043
Registry record updatedNovember 10, 2026
Trial IDNCT03486873 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals who have previously participated in Merck's pembrolizumab studies and are currently receiving treatment or in follow-up.

Probably not a fit

Patients who have not been treated with pembrolizumab or related therapies in the parent studies may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the long-term safety and efficacy of pembrolizumab (MK-3475) in patients with advanced tumors who have previously participated in Merck's pembrolizumab studies. Participants will transition into one of three phases based on their prior treatment status, receiving up to 35 doses of pembrolizumab or a combination therapy. The study will monitor the effects of the treatment over an extended period to gather data on its long-term outcomes.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness and safety of pembrolizumab for patients with advanced tumors.

How similar studies have gone: Other studies involving pembrolizumab have shown promising results, indicating that this approach is built on previously established efficacy.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • Arizona Cancer Center at UMC North ( Site 0018)
    Tucson, Arizona, United States
    Recruiting
  • Comprehensive Blood & Cancer Center [Bakersfield, CA] ( Site 0054)
    Bakersfield, California, United States
    Recruiting
  • UCLA - Hematology/Oncology - Administrative Office ( Site 0009)
    Los Angeles, California, United States
    Recruiting
  • Stanford Cancer Center ( Site 0086)
    Palo Alto, California, United States
    Recruiting
  • UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0004)
    San Francisco, California, United States
    Recruiting
  • Providence Saint John's Health Center ( Site 0059)
    Santa Monica, California, United States
    Recruiting
Show 44 more locations
  • University of Colorado Cancer Center ( Site 0021)
    Aurora, Colorado, United States
    Recruiting
  • Holy Cross Hospital, Michael & Dianne Bienes Comp Cancer Ctr ( Site 0022)
    Fort Lauderdale, Florida, United States
    Recruiting
  • Mount Sinai Braman Comprehensive Cancer Center ( Site 0031)
    Miami Beach, Florida, United States
    Recruiting
  • Northwest Georgia Oncology Centers PC ( Site 0061)
    Marietta, Georgia, United States
    Recruiting
  • The University of Chicago ( Site 0020)
    Chicago, Illinois, United States
    Recruiting
  • University of Iowa Hospital and Clinics ( Site 0026)
    Iowa City, Iowa, United States
    Recruiting
  • James Graham Brown Cancer Center ( Site 0058)
    Louisville, Kentucky, United States
    Recruiting
  • Mercy Health-Paducah Cancer Center ( Site 0084)
    Paducah, Kentucky, United States
    Recruiting
  • Women's Cancer Care ( Site 0088)
    Covington, Louisiana, United States
    Recruiting
  • MedStar Franklin Square Medical Center ( Site 0046)
    Baltimore, Maryland, United States
    Recruiting
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 0056)
    Baltimore, Maryland, United States
    Recruiting
  • Maryland Oncology Hematology (MOH) ( Site 8000)
    Columbia, Maryland, United States
    Recruiting
  • Karmanos Cancer Institute ( Site 0047)
    Detroit, Michigan, United States
    Recruiting
  • Comprehensive Cancer Centers of Nevada ( Site 0043)
    Las Vegas, Nevada, United States
    Recruiting
  • Cancer Institute of New Jersey ( Site 0025)
    New Brunswick, New Jersey, United States
    Recruiting
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0032)
    New York, New York, United States
    Recruiting
  • White Plains Hospital-Center for Cancer Care ( Site 0069)
    White Plains, New York, United States
    Recruiting
  • University of North Carolina at Chapel Hill ( Site 0040)
    Chapel Hill, North Carolina, United States
    Recruiting
  • Duke Cancer Center ( Site 0028)
    Durham, North Carolina, United States
    Recruiting
  • Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0082)
    Tulsa, Oklahoma, United States
    Recruiting
  • University of Pennsylvania ( Site 0010)
    Philadelphia, Pennsylvania, United States
    Recruiting
  • Fox Chase Cancer Center ( Site 0042)
    Philadelphia, Pennsylvania, United States
    Recruiting
  • UPMC Hillman Cancer Center ( Site 0008)
    Pittsburgh, Pennsylvania, United States
    Recruiting
  • Vanderbilt Health One Hundred Oaks Diagnostic ( Site 0060)
    Nashville, Tennessee, United States
    Recruiting
  • Vanderbilt University Medical Center-Vanderbilt-Ingram Cancer Center ( Site 0015)
    Nashville, Tennessee, United States
    Recruiting
  • Texas Oncology - Central/South Texas ( Site 8001)
    Austin, Texas, United States
    Recruiting
  • Texas Oncology-Baylor Sammons Cancer Center ( Site 0062)
    Dallas, Texas, United States
    Recruiting
  • University of Texas MD Anderson Cancer Center ( Site 0007)
    Houston, Texas, United States
    Recruiting
  • South Texas Accelerated Research Therapeutics, LLC (START) ( Site 0001)
    San Antonio, Texas, United States
    Recruiting
  • University of Virginia Health System ( Site 0035)
    Charlottesville, Virginia, United States
    Recruiting
  • VCU Health Adult Outpatient Pavillion ( Site 0080)
    Richmond, Virginia, United States
    Recruiting
  • Blue Ridge Cancer Care ( Site 0067)
    Roanoke, Virginia, United States
    Recruiting
  • Fred Hutchinson Cancer Center ( Site 0024)
    Bellevue, Washington, United States
    Recruiting
  • Derma Internacional SA ( Site 1372)
    Caba, Buenos Aires, Argentina
    Recruiting
  • Instituto Alexander Fleming ( Site 1364)
    Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
    Recruiting
  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 1363)
    Mar del Plata, Buenos Aires, Argentina
    Recruiting
  • Instituto Médico Río Cuarto ( Site 1375)
    Río Cuarto, Córdoba Province, Argentina
    Recruiting
  • Sanatorio Parque ( Site 1355)
    Rosario, Santa Fe Province, Argentina
    Recruiting
  • Instituto de Oncologia de Rosario ( Site 1350)
    Rosario, Santa Fe Province, Argentina
    Recruiting
  • Clínica Universitaria Reina Fabiola ( Site 1376)
    Córdoba, Argentina
    Recruiting
  • Centro Medico Privado CEMAIC ( Site 1371)
    Córdoba, Argentina
    Recruiting
  • Fundación CORI para la Investigación y Prevención del Cáncer ( Site 1358)
    La Rioja, Argentina
    Recruiting
  • Liverpool Hospital-Medical Oncology ( Site 3021)
    Liverpool, New South Wales, Australia
    Recruiting
  • Macquarie University ( Site 3010)
    Macquarie University, New South Wales, Australia
    Recruiting

+732 more sites. See ClinicalTrials.gov for the full list.

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.