Purpose

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.

Condition

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: Autogene Cevumeran + 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 autogene cevumeran.
  • Biological: Autogene cevumeran
    Participants will receive a recommended dose of autogene cevumeran administered by IV infusion at protocol-defined intervals.
    Other names:
    • RO7198457
  • 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 autogene cevumeran 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: Autogene Cevumeran + 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 autogene cevumeran.
  • Biological: Autogene cevumeran
    Participants will receive a recommended dose of autogene cevumeran administered by IV infusion at protocol-defined intervals.
    Other names:
    • RO7198457
  • Drug: Pembrolizumab
    Participants will receive 200 mg pembrolizumab administered by IV infusion Q3W.
    Other names:
    • Keytruda

More Details

Status
Active, not recruiting
Sponsor
Genentech, Inc.

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.