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

Purpose

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

Condition

  • Advanced Melanoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Safety Run-in Period: RO7198457 + Pembrolizumab
Participants will receive at least one cycle of 200 mg pembrolizumab monotherapy by intravenous (IV) infusion followed by 200 mg pembrolizumab IV infusion every 3 weeks (Q3W) plus a recommended dose of RO7198457.
  • Biological: RO7198457
    Participants will receive a recommended dose of RO7198457 administered by IV infusion at protocol-defined intervals.
  • Drug: Pembrolizumab
    Participants will receive 200 mg pembrolizumab administered by IV infusion Q3W.
    Other names:
    • Keytruda
Active Comparator
Randomized Period: Arm A: Pembrolizumab
Participants will receive 200 mg pembrolizumab administered by IV infusion Q3W. Participants in Arm A have the option to cross over to combination treatment with RO7198457 plus pembrolizumab (Arm B) after confirmed disease progression.
  • Drug: Pembrolizumab
    Participants will receive 200 mg pembrolizumab administered by IV infusion Q3W.
    Other names:
    • Keytruda
Experimental
Randomized Period: Arm B: RO7198457 + Pembrolizumab
Participants will receive at least one cycle of 200 mg pembrolizumab monotherapy by IV infusion followed by 200 mg pembrolizumab IV infusion Q3W plus a recommended dose of RO7198457.
  • Biological: RO7198457
    Participants will receive a recommended dose of RO7198457 administered by IV infusion at protocol-defined intervals.
  • Drug: Pembrolizumab
    Participants will receive 200 mg pembrolizumab administered by IV infusion Q3W.
    Other names:
    • Keytruda

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232

More Details

Status
Recruiting
Sponsor
Genentech, Inc.

Study Contact

Reference Study ID Number: IMCODE001(GO40558) https://forpatients.roche.com/
888-662-6728 (U.S. and Canada)
global-roche-genentech-trials@gene.com