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

Status
Closed
Cancer Type
Melanoma
Unknown Primary
Trial Phase
Phase III
Eligibility
12 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03553836
Protocol IDs
3475-716 (primary)
NCI-2018-01981
2018-000669-35
MK-3475-716
KEYNOTE 716
Study Sponsor
Merck Sharp & Dohme LLC

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

  1. 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

Treatment Sites in Georgia

Atlanta Cancer Care - Conyers


1498 Klondike Road
Suite 106
Conyers, GA 30094
404-303-3355
www.atlantacancercare.com

Atlanta Cancer Care - Decatur


2545 Lawrenceville Highway
Suite 300
Decatur, GA 30033
404-303-3355
www.atlantacancercare.com

Doctors:

Lijo Simpson MD

Atlanta Cancer Care - Stockbridge


7813 Spivey Station Boulevard
Suite 210
Jonesboro, GA 30236
678 466-2069
www.atlantacancercare.com

Doctors:

Gurinderjit K. Sidhu MD
Lijo Simpson MD

Georgia Cancer Specialists - CenterPointe


1100 Johnson Ferry Road
Suite 600
Sandy Springs, GA 30342
404-256-4777 ext 9242
www.gacancer.com

Doctors:

Rodolfo E. Bordoni MD
Nishan H. Fernando MD
Pradeep C. Jolly MD

Georgia Cancer Specialists - Macon-Coliseum


308 Coliseum Drive
Suite 120
Macon, GA 31217
478-745-6130 x8152
www.gacancer.com

Doctors:

Cheryl F. Jones MD
Premila Malhotra MD
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.