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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.

NCT03815058

Description:

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.

Related Conditions:
  • Acral Lentiginous Melanoma
  • Cutaneous Melanoma
  • Mucosal Melanoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief 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.
  • 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

Clinical Trial IDs

  • ORG STUDY ID: IMCODE001 (GO40558)
  • SECONDARY ID: 2018-001773-24
  • NCT ID: NCT03815058

Conditions

  • Advanced Melanoma

Interventions

DrugSynonymsArms
RO7198457Safety Run-in Period: RO7198457 + Pembrolizumab
PembrolizumabKeytrudaSafety Run-in Period: RO7198457 + Pembrolizumab

Purpose

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 Arms

NameTypeDescriptionInterventions
Safety Run-in Period: RO7198457 + PembrolizumabExperimentalParticipants 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.
  • RO7198457
  • Pembrolizumab
Randomized Period: Arm A: PembrolizumabActive ComparatorParticipants 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.
  • Pembrolizumab
Randomized Period: Arm B: RO7198457 + PembrolizumabExperimentalParticipants 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.
  • RO7198457
  • Pembrolizumab

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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)
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Objective Response Rate (ORR) According to RECISTv.1.1 After Randomization
Time Frame:Up to approximately 24 months
Safety Issue:
Description:
Measure:Overall Survival (OS) After Randomization
Time Frame:The time from randomization to death from any cause (up to approximately 24 months).
Safety Issue:
Description:
Measure:Duration of Response (DOR) According to RECISTv.1.1 After Randomization
Time Frame:The time from randomization up to approximately 24 months.
Safety Issue:
Description:
Measure: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.
Safety Issue:
Description: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.
Measure:Mean Change in Physical Function (PF) Score After Randomization
Time Frame:From randomization up to approximately 24 months.
Safety Issue:
Description: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.
Measure:Mean Change in Role Function (RF) Score After Randomization
Time Frame:From randomization up to approximately 24 months.
Safety Issue:
Description: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.
Measure: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.
Safety Issue:
Description:
Measure:Objective Response Rate (ORR) According to RECISTv.1.1 After Cross Over
Time Frame:Up to 12 months from the time of cross-over
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Genentech, Inc.

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