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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 : October 26, 2020
Sponsor:
Collaborator:
BioNTech SE
Information provided by (Responsible Party):
Genentech, Inc.

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.

Condition or disease Intervention/treatment Phase
Advanced Melanoma Biological: RO7198457 Drug: Pembrolizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 8, 2019
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arm Intervention/treatment
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.
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

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.
Drug: Pembrolizumab
Participants will receive 200 mg pembrolizumab administered by IV infusion Q3W.
Other Name: Keytruda

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.
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




Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) According to RECISTv.1.1 After Randomization [ Time Frame: Up to approximately 24 months ]
  2. Overall Survival (OS) After Randomization [ Time Frame: The time from randomization to death from any cause (up to approximately 24 months). ]
  3. Duration of Response (DOR) According to RECISTv.1.1 After Randomization [ Time Frame: The time from randomization up to approximately 24 months. ]
  4. 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.

  5. 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.

  6. 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.

  7. 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. ]
  8. Objective Response Rate (ORR) According to RECISTv.1.1 After Cross Over [ Time Frame: Up to 12 months from the time of cross-over ]
  9. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03815058


Contacts
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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

Locations
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Sponsors and Collaborators
Genentech, Inc.
BioNTech SE
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT03815058    
Other Study ID Numbers: GO40558
2018-001773-24 ( EudraCT Number )
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: October 26, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
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).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents