A Study to evaluate the Efficacy and Safety of RO7198457 in Combination With Pembrolizumab Versus Pembrolizumab in Patients with Previously Untreated Advanced Melanoma

Phase 1

• Conditions: Advanced Melanoma; MedDRA version: 21.1Level: PTClassification code: 10025671Term: Malignant melanoma stage IV Class: 100000004864; MedDRA version: 21.1Level: PTClassification code: 10025670Term: Malignant melanoma stage III Class: 100000004864; MedDRA version: 20.0Level: PTClassification code: 10066600Term: Melanoma recurrent Class: 100000004864; MedDRA version: 21.1Level: PTClassification code: 10025650Term: Malignant melanoma Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code: 10027481Term: Metastatic melanoma Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-507389-15-00
• Lead Sponsor: Genentech Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-26
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Histologically confirmed metastatic (recurrent or de novo Stage IV) or unresectable locally advanced (Stage IIIC or IIID) cutaneous, acral, or mucosal melanoma, as defined by the AJCC v8.0, ECOG Performance Status of 0 or 1, Life expectancy = 12 weeks, Adequate hematologic and end-organ function, Measurable disease per RECIST v1.1, Naive to prior systemic anti-cancer therapy for advanced melanoma, with the exceptions as specified in the protocol

Exclusion Criteria

Ocular/uveal melanoma, Known clinically significant liver disease, Previous splenectomy, Any anti-cancer therapy with the exceptions as specified in the protocol, History of autoimmune disease, Positive test for HIV infection

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: To evaluate the efficacy of RO7198457 plus pembrolizumab compared with pembrolizumab alone on the basis of Objective Response Rate (ORR), Overall Survival (OS), Duration of Response (DOR), mean change from baseline in Health-Related Quality of Life (HRQoL) scores, To evaluate the safety of RO7198457 plus pembrolizumab compared with pembrolizumab alone on the basis of incidence and severity of adverse events and change from baseline in targeted vital signs and clinical laboratory test results;Primary end point(s): 1. Progression Free Survival;Main Objective: To evaluate the efficacy of RO7198457 plus pembrolizumab compared with pembrolizumab alone on the basis of progression free survival

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):1. Objective Response Rate;Secondary end point(s):2. Overall Survival;Secondary end point(s):3. Duration of Response;Secondary end point(s):4. Mean change from baseline in Health-Related Quality of Life (HRQoL) scores as assessed through use of the two-item Global Health Status (GHS)/HRQoL subscale (Questions 29 and 30) of the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 (EORTC QLQ-C30) at specified timepoints;Secondary end point(s):5. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0);Secondary end point(s):6. Change from baseline in targeted vital signs;Secondary end point(s):7. Change from baseline in targeted clinical laboratory test results