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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03815058
Ethics application status
Date submitted
7/01/2019
Date registered
24/01/2019
Date last updated
13/08/2019

Titles & IDs
Public title
A Study to Evaluate The Efficacy And Safety Of 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
IMCODE001 (GO40558)
Universal Trial Number (UTN)
Trial acronym
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 - RO7198457
Treatment: Drugs - Pembrolizumab

Experimental: Safety Run-in Period: RO7198457 + 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 RO7198457.

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 RO7198457 plus pembrolizumab (Arm B) after confirmed disease progression.

Experimental: Randomized Period: Arm B: RO7198457 + 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 RO7198457.


Other interventions: RO7198457
Participants will receive a recommended dose of RO7198457 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 - The 2-item GHS/HRQoL questionnaire of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) uses a 7-point scale from 1=very poor to 7= excellent. Score range for GHS/HRQoL is 2-14. A negative change from baseline indicates deterioration in GHS.
Timepoint [4] 0 0
From randomization up to approximately 24 months.
Secondary outcome [5] 0 0
Mean Change in Physical Function (PF) Score After Randomization - The 5-item PF questionnaire of the EORTC QLQ C30 uses a 4-point scale from 1=not at all to 4=very much. Score range for PF is 5-20. A negative change from baseline indicates deterioration in PF.
Timepoint [5] 0 0
From randomization up to approximately 24 months.
Secondary outcome [6] 0 0
Mean Change in Role Function (RF) Score After Randomization - The 2-item RF questionnaire of the EORTC QLQ C30 uses a 4-point scale from 1=not at all to 4=very much. Score range for RF is 2-8. A negative change from baseline indicates deterioration in RF.
Timepoint [6] 0 0
From randomization up to approximately 24 months.
Secondary outcome [7] 0 0
Number of Participants With Adverse Events Reported Through the Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Timepoint [7] 0 0
From randomization up to approximately 24 months.
Secondary outcome [8] 0 0
Objective Response Rate (ORR) According to RECISTv.1.1 After Cross Over
Timepoint [8] 0 0
Up to 12 months from the time of cross-over
Secondary outcome [9] 0 0
Percentage of Participants With Adverse Events (AEs)
Timepoint [9] 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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre; Medical Oncology - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee
Country [6] 0 0
United States of America
State/province [6] 0 0
Washington

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 RO7198457 plus pembrolizumab compared with pembrolizumab alone in patients
with previously untreated advanced melanoma.
Trial website
https://clinicaltrials.gov/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
Reference Study ID Number: IMCODE001(GO40558) www.roche.com/about_roche/roche_worldwide.htm
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. and Canada)
Fax 0 0
Email 0 0
global-roche-genentech-trials@gene.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03815058