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Clinical Trials in the UK / NCT03553836
Active, not recruiting Phase 3

Safety and Efficacy of Pembrolizumab Compared to Placebo in Resected High-risk Stage II Melanoma (MK-3475-716/KEYNOTE-716)

NCT03553836 · tracked via the Priya Life Science UK tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 3
Started
2018-09-12
Last updated
2024-11-29

Condition(s) studied

Melanoma

Investigational drug(s) / intervention(s)

PembrolizumabPlacebo

Pembrolizumab: Administered as an intravenous (IV) infusion every 3 weeks (Q3W)

Placebo: Administered as an IV infusion every 3 weeks (Q3W)

Study summary

This 2-part study will evaluate the safety and efficacy of pembrolizumab (MK-3475) compared to placebo in participants with surgically resected high-risk Stage II melanoma. Participants in Part 1 will receive either pembrolizumab or placebo in a double-blind design every 3 weeks (Q3W) for up to 17 cycles/\~1 year (each cycle = 21 days). Participants who complete the initial treatment of 17 cycles of pembrolizumab in Part 1 and experience disease recurrence may be eligible for re-challenge with pembrolizumab at the same dose and schedule of 200 mg Q3W (21-day cycles) for up to 35 cycles (up to \~2 years) in Part 2 in an open label design. Participants who complete the initial treatment of placebo and experience disease recurrence may be eligible to switch over to pembrolizumab 200 mg Q3W (21-day cycles) for up to 35 cycles (up to \~2 years) in Part 2 in an open label design. The primary hypothesis of this study is that pembrolizumab increases recurrence-free survival (RFS) compared to placebo.

Per protocol, response/ progression or adverse events (AEs) during re-challenge/switch-over in Part 2 will not be counted towards the RFS outcome measure or safety outcome measures respectively.

Eligibility

Sex
ALL
Min age
12 Years
Max age
Healthy volunteers
No
Inclusion: * Has surgically resected and histologically/pathologically confirmed new diagnosis of Stage IIB or IIC cutaneous melanoma per American Joint Committee on Cancer (AJCC) 8th edition guidelines * Has not been previously treated for melanoma beyond complete surgical resection * Has ≤12 weeks between final surgical resection and randomization * Has no evidence of metastatic disease on imaging as determined by investigator * Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale or Lansky Play-Performance Scale (LPS) score ≥50 for participants ≤16 years old, or a Karnofsky Performance Scale (KPS) score ≥50 for participants \>16 and \<18 years old * Has recovered adequately from toxicity and/or complications from surgery prior to study start * Female participants must not be pregnant or breastfeeding, and must agree to use contraception during the treatment period and for at least 120 days after the last dose of study treatment if they are women of childbearing potential (WOCBP) Exclusion: * Has a known additional malignancy that is progressing or has required active antineoplastic therapy (including hormonal) within the past 5 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment * WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required * Has received prior therapy with an anti-Programmed Cell Death Receptor 1 (PD-1), anti-Programmed Cell Death Receptor Ligand 1 (PD-L1) or anti-Programmed Cell Death Receptor Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], OX-40, CD137) * Has received prior systemic anti-cancer therapy for melanoma including investigational agents * Has received a live vaccine within 30 days prior to the first dose of study treatment * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment * Has severe hypersensitivity (≥Grade 3) to any excipients of pembrolizumab * Has an active autoimmune disease that has required systemic treatment in the past 2 years * Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis * Has an active infection requiring systemic therapy * Has a known history of human immunodeficiency virus (HIV) infection * Has a known history of hepatitis B (defined as hepatitis B surface antigen reactive) or known active hepatitis C virus (defined as hepatitis C virus ribonucleic acid \[RNA\] \[qualitative\] is detected) infection * Has a history of active tuberculosis (Bacillus tuberculosis) * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator * Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study * Has had an allogeneic tissue/solid organ transplant

Primary outcome measure(s)

Trial sites (159)

FacilityCityRegionStatus
University of Arizona Cancer Center ( Site 0121) Tucson Arizona
UCSD Moores Cancer Center ( Site 0133) La Jolla California
The Angeles Clinic and Research Institute ( Site 0029) Los Angeles California
UCLA Hematology & Oncology ( Site 0130) Los Angeles California
John Wayne Cancer Institute ( Site 0026) Santa Monica California
University of Colorado Cancer Center ( Site 0027) Aurora Colorado
Yale University ( Site 0035) New Haven Connecticut
Mayo Clinic Florida ( Site 0024) Jacksonville Florida
Moffitt McKinley Outpatient Center ( Site 0131) Tampa Florida
Winship Cancer Institute of Emory University ( Site 0046) Atlanta Georgia
Northside Hospital ( Site 0115) Atlanta Georgia
Northwestern Medical Group ( Site 0135) Chicago Illinois
The University of Chicago Medical Center ( Site 0007) Chicago Illinois
Advocate Medical Group-Park Ridge ( Site 0025) Park Ridge Illinois
University of Iowa Hospital and Clinics ( Site 0001) Iowa City Iowa
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 0047) Baltimore Maryland
Massachusetts General Hospital ( Site 0126) Boston Massachusetts
Beth Israel Deaconess Medical Center ( Site 0141) Boston Massachusetts
Dana Farber Cancer Institute ( Site 0124) Boston Massachusetts
Karmanos Cancer Institute ( Site 0111) Detroit Michigan
Mayo Clinic [Rochester, MN] ( Site 0016) Rochester Minnesota
Siteman Cancer Center ( Site 0143) St Louis Missouri
Memorial Sloan Kettering ( Site 0006) Harrison New York
Laura and Isaac Perlmutter Cancer Center ( Site 0137) New York New York
Memorial Sloan Kettering Cancer Center ( Site 0142) New York New York
Mount Sinai Medical Center ( Site 0038) New York New York
University of Rochester ( Site 0019) Rochester New York
The Lindner Center for Research and Education at The Christ Hospital ( Site 0004) Cincinnati Ohio
Stephenson Cancer Center ( Site 0042) Oklahoma City Oklahoma
Oregon Health & Science University ( Site 0032) Portland Oregon
Children's Hospital of Pittsburgh UPMC ( Site 0144) Pittsburgh Pennsylvania
UPMC Hillman Cancer Centers ( Site 0043) Pittsburgh Pennsylvania
West Cancer Center - East Campus ( Site 0022) Germantown Tennessee
University of Tennessee Medical Center Knoxville ( Site 0116) Knoxville Tennessee
University of Texas-MD Anderson Cancer Center ( Site 0134) Houston Texas
Inova Schar Cancer Institute ( Site 0014) Fairfax Virginia
VCU Massey Cancer Center ( Site 0008) Richmond Virginia
Seattle Cancer Care Alliance ( Site 0044) Seattle Washington
University of Wisconsin Hospital and Clinics ( Site 0030) Madison Wisconsin
Melanoma Institute Australia ( Site 0856) North Sydney New South Wales

+ 119 more sites — see the full list on the official registry below.

On this site

📄 Keytruda (pembrolizumab) drug profile →

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Official registry record

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 NCT03553836 on ClinicalTrials.gov ↗ ← All trials in the UK