IRB #

STUDY00019943

Title

A PHASE II, OPEN-LABEL, MULTICENTER,
RANDOMIZED STUDY OF THE EFFICACY AND SAFETY OF RO7198457 IN COMBINATION WITH PEMBROLIZUMAB VERSUS PEMBROLIZUMAB IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED MELANOMA

Principal Investigator

Matthew Taylor

Study Purpose

The purpose of the study is to compare the effects, good or bad, of RO7198457, a personalized cancer vaccine (hereafter referred to as the study drug) plus pembrolizumab versus pembrolizumab alone in participants with melanoma. We are hoping to find out if the combination of the study drug and pembrolizumab is a safe and effective way to treat melanoma compared to pembrolizumab alone.

Medical Condition(s)

untreated unresectable locally advanced or metastatic melanoma

Eligibility Criteria

Male and Female participants of 18 years of age and older.
unresectable locally advanced (Stages IIIC and IIID) and metastatic (recurrent or de novo Stage IV) melanoma.

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

If you are determined to be eligible for the study, you will receive the study drugs for up to 2 years or until your disease worsens, you experience unacceptable side effects, or you withdraw your consent to participate in the study.

After you finish the study intervention, the investigator will continue to watch you for side effects and follow your condition every 3 months for indefinitely through a telephone phone call or a clinic visit.

Minors Included

No

Contact

Knight Clinical Trials Information Line
503-494-1080

Sponsor

Genentech Inc.

Recruitment End

11/01/2021

Compensation Provided

No


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