Adjuvant Therapy with Pembrolizumab versus Placebo in Resected Highrisk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study (KEYNOTE 716)

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 sites954 target enrollmentAugust 21, 2018

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Enrollment: 954
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 21, 2018

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Eligibility Criteria

Inclusion Criteria

•1\. Male/female participants who are \=12 years of age on the day of providing documented informed consent/assent \[unless local regulations and/or institutional policies do not allow for participants \<18 years of age to participate; for those sites, the eligible population is \=18 years of age] with surgically resected and histologically/pathologically confirmed new diagnosis of Stage IIB or IIC cutaneous melanoma per AJCC 8th edition guidelines.
•2\. Participants must not have been previously treated for melanoma beyond complete surgical resection.
•3\. No more than 12 weeks may elapse between final surgical resection and randomization. Treatment should start only after complete wound healing from the surgery. If there is a delay of 1 to 7 days exceeding 12 weeks due to unforeseen circumstances, the eligibility should be discussed with the Sponsor and the decision documented. A delay of 1 to 7 days for screening imaging requirements will be allowed if sponsor has allowed 1 week extension between surgical resection and randomization.
•4\. Have no evidence of metastatic disease on imaging as determined by investigator assessment. All suspicious lesions amenable to biopsy should be confirmed negative for malignancy
•5\. Have a performance status of 0 or 1 on the ECOG Performance Scale at the time of enrollment, LPS score \=50 (for participants \=16 years old.), or a KPS score \=50 (for participants \>16 and \<18 years old)
•6\. Participant must have recovered adequately from toxicity and/or complications from surgery prior to starting study treatment
•7\. Removed
•8\. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
•? Is not a woman of childbearing potential (WOCBP)
•Is a WOCBP and using a contraceptive method that is highly effective with a failure rate of \<1% per year) or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) as described in Appendix 3 during the intervention period and for at least 120 days after the last dose of study intervention.

Exclusion Criteria

•1\. Has a known additional malignancy that is progressing or has required active antineoplastic therapy (including hormonal) within the past 5 years.
•2\. 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 the first dose of study drug
•3\. If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment
•4\. A 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
•5\. Has received prior therapy with an anti\-PD\-1, anti\-PD\-L1, or anti\-PD\-L2 agent or with an agent directed to another stimulatory or co\-inhibitory T\-cell receptor (eg, CTLA\-4, OX\-40, CD137\)
•6\. Has received prior systemic anticancer therapy for melanoma including investigational agents
•7\. Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette–Guérin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed
•8\. 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
•9\. Has severe hypersensitivity (\=Grade 3\) to any pembrolizumab excipients
•10\. Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed