Clinical Trial: NCT03815058 - My Cancer Genome

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

URL:

https://clinicaltrials.gov/show/NCT03815058

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: GO40558
SECONDARY ID: 2018-001773-24
NCT ID: NCT03815058

Conditions

Advanced Melanoma

Interventions

Drug	Synonyms	Arms
RO7198457		Randomized Period: Arm B: RO7198457 + Pembrolizumab
Pembrolizumab	Keytruda	Randomized Period: Arm A: Pembrolizumab

Purpose

Trial Arms

Name	Type	Description	Interventions
Safety Run-in Period: RO7198457 + Pembrolizumab	Experimental	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.	RO7198457 Pembrolizumab
Randomized Period: Arm A: Pembrolizumab	Active Comparator	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.	Pembrolizumab
Randomized Period: Arm B: RO7198457 + Pembrolizumab	Experimental	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.	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.

Last Updated

August 4, 2021

Clinical Trials /

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