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.
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
Interventions
Drug | Synonyms | Arms |
---|
RO7198457 | | Randomized Period: Arm B: RO7198457 + Pembrolizumab |
Pembrolizumab | Keytruda | Randomized Period: Arm A: 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
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. | |
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. | |
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. | |
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