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



Status:Recruiting
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:12 - Any
Updated:4/6/2019
Start Date:September 12, 2018
End Date:October 21, 2033
Contact:Toll Free Number
Email:Trialsites@merck.com
Phone:1-888-577-8839

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Adjuvant Therapy With Pembrolizumab Versus Placebo in Resected High-risk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study (KEYNOTE-716)

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 for up to 17
cycles. Participants who receive placebo or who stop treatment after receiving 17 cycles of
pembrolizumab in Part 1, do not experience disease recurrence within 6 months of completing
pembrolizumab in Part 1, and do not stop treatment with pembrolizumab for disease recurrence
or intolerability, may be eligible to receive up to 35 additional cycles of pembrolizumab 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.


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

- Male participants must agree to use contraception during the treatment period and for
at least 120 days after the last dose of study treatment and refrain from donating
sperm during this period

- 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 a woman 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

- Has recovered adequately from major surgery or the toxicity and/or complications from
the intervention prior to starting study treatment

- WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization
or treatment allocation. 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
co-inhibitory 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

- Is pregnant or breastfeeding or expecting to conceive or father children within the
projected duration of the study starting with the screening visit through 120 days
after the last dose of study treatment

- Has had an allogeneic tissue/solid organ transplant
We found this trial at
28
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Germantown, Tennessee 38138
Phone: 901683005561236
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Baltimore, Maryland 21231
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Phone: 410-502-9380
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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1924 Alcoa Highway
Knoxville, Tennessee 37920
Phone: 865-305-7915
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Phone: 585-275-5345
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2200 Santa Monica Blvd
Santa Monica, California 90404
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825 Eastlake Ave E
Seattle, Washington 98109
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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
(404) 851-8000
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Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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1365 Clifton Rd NE
Atlanta, Georgia 30322
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Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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450 Brookline Ave
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
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Chicago, Illinois 60611
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
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La Jolla, California 92093
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600 Highland Ave
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