A Study to Evaluate The Efficacy And Safety Of RO7198457 In Combination With Pembrolizumab Versus Pembrolizumab Alone In Participants With Previously Untreated Advanced Melanoma.

A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran (RO7198457) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Participants With Previously Untreated Advanced Melanoma.

Cancer
Skin Cancer
Melanoma
Advanced Melanoma

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Basic Details

Sponsor Genentech, Inc.

Phase Phase 2

Trial Identifier NCT03815058, GO40558, 2018-001773-24,2023-507389-15-00

Condition Advanced Melanoma

Official 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

Study Summary

This study will evaluate the efficacy, safety, pharmacokinetics, and patient-reported outcomes (PROs) of autogene cevumeran (RO7198457) plus pembrolizumab compared with pembrolizumab alone in patients with previously untreated advanced melanoma.

Eligibility Criteria

Gender

All

Age

≥18 Years

Healthy Volunteers

Inclusion Criteria

Histologically confirmed metastatic (recurrent or de novo Stage IV) or unresectable locally advanced (Stage IIIC or IIID) cutaneous, acral, or mucosal melanoma;
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
Life expectancy >/= 12 weeks;
Adequate hematologic and end-organ function;
Naive to prior systemic anti-cancer therapy for advanced melanoma with some exceptions;
Tumor specimen availability;
Measurable disease per RECIST v1.1.

Exclusion Criteria

Ocular/uveal melanoma;
Any anti-cancer therapy with the exceptions as specified in the protocol;
Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases;
Previous splenectomy;
History of autoimmune disease;
Prior allogeneic bone marrow transplantation or prior solid organ transplantation;
Positive test for Human Immunodeficiency Virus (HIV) infection;
Active hepatitis B or C or tuberculosis;
Significant cardiovascular disease;
Known clinically significant liver disease.

The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

Results Disclaimer

What is Clinical Research?

In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.

A Study to Evaluate The Efficacy And Safety Of RO7198457 In Combination With Pembrolizumab Versus Pembrolizumab Alone In Participants With Previously Untreated Advanced Melanoma.

Basic Details

Study Summary

Eligibility Criteria

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com

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A Study to Evaluate The Efficacy And Safety Of RO7198457 In Combination With Pembrolizumab Versus Pembrolizumab Alone In Participants With Previously Untreated Advanced Melanoma.

For the latest version of this information please go to www.forpatients.roche.com