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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03815058




Registration number
NCT03815058
Ethics application status
Date submitted
7/01/2019
Date registered
24/01/2019
Date last updated
26/04/2024

Titles & IDs
Public title
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.
Scientific 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
Secondary ID [1] 0 0
2018-001773-24
Secondary ID [2] 0 0
GO40558
Universal Trial Number (UTN)
Trial acronym
IMCODE001
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Autogene cevumeran
Treatment: Drugs - Pembrolizumab

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.


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

Treatment: Drugs: Pembrolizumab
Participants will receive 200 mg pembrolizumab administered by IV infusion Q3W.
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECISTv.1.1) After Randomization
Timepoint [1] 0 0
The time from randomization to disease progression/death (up to approximately 24 months)
Secondary outcome [1] 0 0
Objective Response Rate (ORR) According to RECISTv.1.1 After Randomization
Timepoint [1] 0 0
Up to approximately 24 months
Secondary outcome [2] 0 0
Overall Survival (OS) After Randomization
Timepoint [2] 0 0
The time from randomization to death from any cause (up to approximately 24 months).
Secondary outcome [3] 0 0
Duration of Response (DOR) According to RECISTv.1.1 After Randomization
Timepoint [3] 0 0
The time from randomization up to approximately 24 months.
Secondary outcome [4] 0 0
Mean Change in Global Health Status (GHS)/Health-related Quality of Life (HRQoL) Score After Randomization
Timepoint [4] 0 0
From randomization up to approximately 24 months.
Secondary outcome [5] 0 0
Objective Response Rate (ORR) According to RECISTv.1.1 After Cross Over
Timepoint [5] 0 0
Up to 12 months from the time of cross-over
Secondary outcome [6] 0 0
Percentage of Participants With Adverse Events (AEs)
Timepoint [6] 0 0
Baseline up to 90 days after the final dose of study drug (up to approximately 27 months)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/01/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/10/2025
Actual
Sample size
Target
Accrual to date
Final
131
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
The Queen Elizabeth Hospital; Haematology/Oncology - Woodville South
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Centre; Medical Oncology - Melbourne
Recruitment hospital [4] 0 0
Alfred Hospital; Medical Oncology - Melbourne
Recruitment hospital [5] 0 0
St. John of God - Subiaco Hospital - Subiaco
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
5011 - Woodville South
Recruitment postcode(s) [3] 0 0
3000 - Melbourne
Recruitment postcode(s) [4] 0 0
3181 - Melbourne
Recruitment postcode(s) [5] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Connecticut
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Massachusetts
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United States of America
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Missouri
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United States of America
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Ohio
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United States of America
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Oregon
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United States of America
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Tennessee
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United States of America
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Utah
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United States of America
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Virginia
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United States of America
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Washington
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Belgium
State/province [17] 0 0
Bruxelles
Country [18] 0 0
Belgium
State/province [18] 0 0
Edegem
Country [19] 0 0
Belgium
State/province [19] 0 0
Kortrijk
Country [20] 0 0
Belgium
State/province [20] 0 0
Liège
Country [21] 0 0
Belgium
State/province [21] 0 0
Wilrijk
Country [22] 0 0
Germany
State/province [22] 0 0
Buxtehude
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Germany
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Erlangen
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Germany
State/province [24] 0 0
Hamburg
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Germany
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Hannover
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Germany
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Heidelberg
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Germany
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Koeln
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Germany
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Lübeck
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Germany
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Mainz
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Germany
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Mannheim
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Germany
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Muenster
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Germany
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Tübingen
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Spain
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Navarra
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Sevilla
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Spain
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Valencia
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United Kingdom
State/province [38] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Genentech, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
BioNTech SE
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03815058
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries