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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03815058
Ethics application status
Date submitted
7/01/2019
Date registered
24/01/2019

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
Treatment: Other - 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.


Treatment: Other: 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
Treatment: Other
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
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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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Massachusetts
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Missouri
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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
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Belgium
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Edegem
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Belgium
State/province [19] 0 0
Kortrijk
Country [20] 0 0
Belgium
State/province [20] 0 0
Liège
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Belgium
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Wilrijk
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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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03815058