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Advanced MelanomaPhase 2IMCODE001NCT03815058

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.

A Phase 2 study testing Autogene cevumeran and Pembrolizumab in people with Advanced Melanoma, run by Genentech, Inc. at 41 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Melanoma
What is being tested?
Autogene cevumeran and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
131 participants
Where
41 sitesin 6 countries
Study dates
21 Dec 2018to 21 Jan 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 10Show fewer
  • Positive test for Human Immunodeficiency Virus (HIV) infection;
  • Active hepatitis B or C or tuberculosis;
  • Significant cardiovascular disease;
  • Known clinically significant liver disease.

Trial locations and contacts

41 sites in 6 countries.

41 sites in 6 countries

United States17 sites

  • Atlanta Cancer Care

    Alpharetta, Georgia, 30005

  • Massachusetts General Hospital.

    Boston, Massachusetts, 02114

  • University of Virginia

    Charlottesville, Virginia, 22906

  • Northwestern University

    Chicago, Illinois, 60611

  • Case Western Research University

    Cleveland, Ohio, 44106-5067

  • University of Colorado

    Denver, Colorado, 80262

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Cancer Specialists

    Jacksonville, Florida, 32256

  • University of California San Diego Moores Cancer Center

    La Jolla, California, 92037

  • Intermountain Surgical Oncology

    Murray, Utah, 84107

  • Sarah Cannon Research Institute / Tennessee Oncology

    Nashville, Tennessee, 37203

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • UCSF Comprehensive Cancer Ctr

    San Francisco, California, 94115

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Washington University

    St Louis, Missouri, 63110

  • Moffitt McKinley Outpatient Center

    Tampa, Florida, 33612

Other trials in United States

Germany9 sites

  • Elbe Kliniken Stade-Buxtehude GmbH

    Buxtehude, 21614

  • Universitätsklinikum Koeln

    Cologne, 50937

  • Universitatsklinikum Eppendorf

    Hamburg, 20246

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Uni Schleswig-Holstein

    Lübeck, 23562

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR, Hautklinik und Poliklinik

    Mainz, 55131

  • Med. Fakultat Mannheim der Universitat Heidelberg

    Mannheim, 68167

  • Fachklinik Hornheide

    Münster, 48157

  • Universitätshautk. Tübingen

    Tübingen, 72076

Other trials in Germany

Spain7 sites

  • Instituto Oncológico Dr. Rosell

    Barcelona, 08028

  • Vall d?Hebron Institute of Oncology (VHIO), Barcelona

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Hospital Universitario La Paz

    Madrid, 280146

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008

  • Hospital Universitario Virgen Macarena

    Seville, 41009

Other trials in Spain

Australia5 sites

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

  • Alfred Hospital

    Melbourne, Victoria, 3181

  • St. John of God - Subiaco Hospital

    Subiaco, Western Australia, 6008

  • The Queen Elizabeth Hospital

    Woodville South, South Australia, 5011

Other trials in Australia

Belgium2 sites

  • Antwerp University Hospital

    Edegem, 2650

  • ZAS Sint Augustinus Wilrijk

    Wilrijk, 2610

Other trials in Belgium

United Kingdom1 site

  • Barts and The London

    London, EC1M 6BQ

Other trials in United Kingdom

About this study

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

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.

Being tested
Autogene cevumeran, Pembrolizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autogene cevumeranBiological

    Also called RO7198457

    Participants will receive a recommended dose of autogene cevumeran administered by IV infusion at protocol-defined intervals.

  • PembrolizumabDrug

    Also called Keytruda

    Participants will receive 200 mg pembrolizumab administered by IV infusion Q3W.

Study groups in NCT03815058
Study groupRoleWhat they receive
Safety Run-in Period: Autogene Cevumeran + PembrolizumabExperimentalParticipants 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.
Receives: Biological: Autogene cevumeran; Drug: Pembrolizumab
Randomized Period: Arm A: PembrolizumabActive comparatorParticipants 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.
Receives: Drug: Pembrolizumab
Randomized Period: Arm B: Autogene Cevumeran + PembrolizumabExperimentalParticipants 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.
Receives: Biological: Autogene cevumeran; Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v.1.1) After Randomization

    PFS was defined as the time from randomization to the first documented PD as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Kaplan-Meier (KM) method was used to estimate median PFS.

    Measured: From randomization to PD or death (up to approximately 60 months)

Secondary outcomes (6)

  1. Objective Response Rate (ORR) According to RECIST V.1.1 After Randomization

    ORR was defined as the percentage of participants with a complete response (CR) or a partial response (PR) on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions or any pathological lymph nodes must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off to the nearest whole number.

    Measured: Up to approximately 60 months

  2. Overall Survival (OS) After Randomization

    OS was defined as the time from randomization to death from any cause. KM method was used to estimate the median OS.

    Measured: From randomization to death (up to approximately 63 months)

  3. Duration of Response (DOR) According to RECIST V.1.1 After Randomization

    DOR was defined as the time from the first occurrence of a documented objective response (OR) to PD or death from any cause, whichever occurred first, as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions or any pathological lymph nodes must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. DOR was estimated using the KM methodology.

    Measured: Up to approximately 60 months

  4. Change From Baseline in Global Health Status (GHS)/Health-related Quality of Life (HRQoL) Score Assessed by European Organisation for Research and Treatment of Cancer 30-Item Quality of Life Questionnaire (EORTC QLQ-C30)

    EORTC QLQ-C30 consists of 30 questions that assess participant functioning (physical, emotional, role, cognitive, and social), symptom scales (fatigue, nausea and vomiting, pain), GHS/QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Change in HRQoL was assessed using participant responses to questions regarding GHS (Question 29: GHS; "How would you rate your overall health during the past week?") and QoL (Question 30: QoL; "How would you rate your overall quality of life during the past week?") and were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores were standardized. Scores range from 0-100. A higher score indicates a better QoL.

    Measured: Baseline, Day 1 of Cycles 1 to 34, time of first PD, time to last dose, treatment discontinuation and study drug completion (up to approximately 29 months) (1 cycle = 21 days)

  5. ORR According to RECIST V.1.1 After Crossover

    ORR was defined as the percentage of participants with a CR or PR on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1. CR was defined as disappearance of all target lesions or any pathological lymph nodes must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.

    Measured: Up to 54.7 months

  6. Number of Participants With Adverse Events (AEs)

    An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.

    Measured: Baseline up to 90 days after the final dose of study drug (Safety run-in and randomized stage: up to 32 months; Cross-over stage: up to 24 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2019
  2. Study start21 Dec 2018
  3. Primary completion21 Jan 2025
  4. Study completion21 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
131 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03815058
Sponsor's protocol ID
GO40558
Other IDs
2018-001773-24, 2023-507389-15-00, 2023, 2018
Acronym
IMCODE001
Status last verified
Jan 2026
First submitted
7 Jan 2019
Last updated
30 Jan 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Autogene cevumeran and Pembrolizumab in people with Advanced Melanoma, run by Genentech, Inc. at 41 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States, Germany, Spain, Australia, Belgium and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03815058.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.

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