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.

Part of paid clinical trials in Duarte, California.

Sponsor
Genentech, Inc.
Study ID
NCT03815058
Phase
PHASE2
Status
Completed

Conditions

  • Advanced Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Autogene cevumeran — BIOLOGICAL
    Participants will receive a recommended dose of autogene cevumeran administered by IV infusion at protocol-defined intervals.
  • Pembrolizumab — DRUG
    Participants will receive 200 mg pembrolizumab administered by IV infusion Q3W.

Study Details

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.

Key Dates

Start date
Dec 21, 2018
Status verified
Jan 2026
Primary completion
Jan 21, 2025
Completion
Jan 21, 2025

Study Design

Enrollment
131 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v.1.1) After Randomization [ Time Frame: From randomization to PD or death (up to approximately 60 months) ]

Locations (17)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
University of California San Diego Moores Cancer CenterLa JollaCalifornia92037-
UCSF Comprehensive Cancer CtrSan FranciscoCalifornia94115-
University of ColoradoDenverColorado80262-
Cancer SpecialistsJacksonvilleFlorida32256-
Moffitt McKinley Outpatient CenterTampaFlorida33612-
Atlanta Cancer CareAlpharettaGeorgia30005-
Northwestern UniversityChicagoIllinois60611-
Massachusetts General Hospital.BostonMassachusetts02114-
Washington UniversitySt LouisMissouri63110-
Case Western Research UniversityClevelandOhio44106-5067-
Oregon Health and Science UniversityPortlandOregon97239-
Sarah Cannon Research Institute / Tennessee OncologyNashvilleTennessee37203-
Intermountain Surgical OncologyMurrayUtah84107-
Huntsman Cancer InstituteSalt Lake CityUtah84112-
University of VirginiaCharlottesvilleVirginia22906-
Seattle Cancer Care AllianceSeattleWashington98109-

Related coverage on Hipa.ai

Find similar trials in Duarte, CA

By research site
City of Hope Comprehensive Cancer Center· Duarte, CAUniversity of California San Diego Moores Cancer Center· La Jolla, CAUCSF Comprehensive Cancer Ctr· San Francisco, CAUniversity of Colorado· Denver, COCancer Specialists· Jacksonville, FLMoffitt McKinley Outpatient Center· Tampa, FL

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