IRB #

STUDY00019679

Title

ADJUVANT THERAPY WITH PEMBROLIZUMAB VERSUS PLACEBO IN RESECTED HIGHRISK STAGE II MELANOMA: A RANDOMIZED, DOUBLE-BLIND PHASE 3 STUDY (KEYNOTE 716)

Principal Investigator

Matthew Taylor

Study Purpose

The purpose of the study is to see how well the study drug, pembrolizumab, works compared to placebo in keeping your cancer from coming back or spreading(a placebo looks like the study drug but has no medicine in it), test the safety of the study drug, and see how your body handles the study drug.

Medical Condition(s)

Stage II Melanoma

Eligibility Criteria

1. Men and women 18 years or older
2. Stage II Melanoma
3. Adequate organ function
4. Other criteria apply

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

Your participation in the study will consist of receiving study drug/placebo for 17 cycles (about 1 year) and then being followed to see when your cancer returns. If your cancer returns, you may be able to receive the study drug for an additional 17-35 cycles (1-2 years). We will ask to follow your health through the use of medical record review/follow up phone calls for up to 15 years.

Minors Included

No

Contact

Knight Clinical Trials Information Line
503-494-1080
trials@ohsu.edu

Sponsor

Merck

Recruitment End

07/31/2020

Compensation Provided

No


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