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A Study to Evaluate The Efficacy And Safety Of RO7198457 In Combination With Pembrolizumab Versus Pembrolizumab Alone In Participants With Previously Untreated Advanced Melanoma. (IMCODE001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03815058
Recruitment Status : Recruiting
First Posted : January 24, 2019
Last Update Posted : March 10, 2020
Sponsor:
Collaborator:
Biontech SE
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE January 7, 2019
First Posted Date  ICMJE January 24, 2019
Last Update Posted Date March 10, 2020
Actual Study Start Date  ICMJE January 7, 2019
Estimated Primary Completion Date September 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECISTv.1.1) After Randomization [ Time Frame: The time from randomization to disease progression/death (up to approximately 24 months) ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 23, 2019)
  • Progression-free Survival (PFS) in RO7198457 + pembrolizumab treated participants compared with pembrolizumab-only participants [ Time Frame: The time from randomization to disease progression/death (up to approximately 24 months) ]
    According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
  • Objective Response Rate (ORR) in RO7198457 + pembrolizumab treated participants compared with pembrolizumab-only participants [ Time Frame: Proportion of participants with Complete Response (CR) or Partial Response (PR) (up to approximately 24 months) ]
    According to RECIST v1.1
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
  • Objective Response Rate (ORR) According to RECISTv.1.1 After Randomization [ Time Frame: Up to approximately 24 months ]
  • Overall Survival (OS) After Randomization [ Time Frame: The time from randomization to death from any cause (up to approximately 24 months). ]
  • Duration of Response (DOR) According to RECISTv.1.1 After Randomization [ Time Frame: The time from randomization up to approximately 24 months. ]
  • Mean Change in Global Health Status (GHS)/Health-related Quality of Life (HRQoL) Score After Randomization [ Time Frame: From randomization up to approximately 24 months. ]
    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.
  • Mean Change in Physical Function (PF) Score After Randomization [ Time Frame: From randomization up to approximately 24 months. ]
    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.
  • Mean Change in Role Function (RF) Score After Randomization [ Time Frame: From randomization up to approximately 24 months. ]
    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.
  • Number of Participants With Adverse Events Reported Through the Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) [ Time Frame: From randomization up to approximately 24 months. ]
  • Objective Response Rate (ORR) According to RECISTv.1.1 After Cross Over [ Time Frame: Up to 12 months from the time of cross-over ]
  • Percentage of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to 90 days after the final dose of study drug (up to approximately 27 months) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2019)
  • Overall Survival (OS) in RO7198457 + pembrolizumab treated participants compared with pembrolizumab-only participants [ Time Frame: The time from randomization to death from any cause (up to approximately 24 months). ]
    Survival follow-up will be collected approximately every 3 months until death, loss to follow-up, withdrawal of consent, whichever occurs first.
  • Duration of Response (DOR) in RO7198457 + pembrolizumab treated participants compared with pembrolizumab-only participants [ Time Frame: The time from randomization up to approximately 24 months. ]
    Determined by the Investigator according to RECIST v1.1
  • Mean change in health-related quality of life (HRQoL) scores in RO7198457 + pembrolizumab treated participants compared with pembrolizumab-only participants [ Time Frame: The time from randomization up to approximately 24 months. ]
  • Percentage of Participants with Objective Response of CR or PR following cross-over from pembrolizumab monotherapy to combination therapy [ Time Frame: Up to 12 months from the time of cross-over ]
    According to RECIST v1.1
  • Incidence and Severity of Adverse Events (AEs) [ Time Frame: Baseline Up to 90 days after the final dose of study drug ]
    According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate The Efficacy And Safety Of RO7198457 In Combination With Pembrolizumab Versus Pembrolizumab Alone In Participants With Previously Untreated Advanced Melanoma.
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Melanoma
Intervention  ICMJE
  • Biological: RO7198457
    Participants will receive a recommended dose of RO7198457 administered by IV infusion at protocol-defined intervals.
  • Drug: Pembrolizumab
    Participants will receive 200 mg pembrolizumab administered by IV infusion Q3W.
    Other Name: Keytruda
Study Arms  ICMJE
  • 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.
    Interventions:
    • Biological: RO7198457
    • Drug: Pembrolizumab
  • 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.
    Intervention: Drug: Pembrolizumab
  • 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.
    Interventions:
    • Biological: RO7198457
    • Drug: Pembrolizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 23, 2019)
132
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2022
Estimated Primary Completion Date September 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Reference Study ID Number: IMCODE001(GO40558) www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com
Listed Location Countries  ICMJE Australia,   Belgium,   Germany,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03815058
Other Study ID Numbers  ICMJE GO40558
2018-001773-24 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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).
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Biontech SE
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Genentech, Inc.
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP