Advanced melanoma MedDRA version: 20.0 Level: PT Classification code 10066600 Term: Melanoma recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10027481 Term: Metastatic melanoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10025671 Term: Malignant melanoma stage IV System Organ Cl
Conditions
Interventions
Product Code: RO7198457/F01
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: n/a
CAS Number: 7365-45-9
Current Sponsor code: RO7198457
Other descriptive name: PCV
Conce
Sponsors
Genentech Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age >=18 years at time of signing the Informed Consent Form - Able to comply with the study protocol, in the investigator's judgment - Histologically confirmed metastatic (recurrent or de novo Stage IV) or unresectable locally advanced (Stage IIIC or IIID) cutaneous, acral, or mucosal melanoma, as defined by the AJCC v8.0 - ECOG Performance Status of 0 or 1 - Life expectancy >= 12 weeks - Adequate hematologic and end-organ function - Measurable disease per RECIST v1.1 - Naive to prior systemic anti-cancer therapy for advanced melanoma, with the exceptions as specified in the protocol - Tumor specimen availability. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 79 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 53
Exclusion criteria
Exclusion criteria: - Ocular/uveal melanoma - Significant cardiovascular disease - Known clinically significant liver disease - Previous splenectomy - Any anti-cancer therapy with the exceptions as specified in the protocol - History of autoimmune disease - Positive test for HIV infection - Active hepatitis B or C - Known active or latent tuberculosis infection - Prior allogeneic bone marrow transplantation or prior solid organ transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of RO7198457 plus pembrolizumab compared with pembrolizumab alone on the basis of progression free survival.;Secondary Objective: • To evaluate the efficacy of RO7198457 plus pembrolizumab compared with pembrolizumab alone on the basis of Objective Response Rate (ORR), Overall Survival (OS), Duration of Response (DOR), mean change from baseline in Health-Related Quality of Life (HRQoL) scores. • To evaluate the safety of RO7198457 plus pembrolizumab compared with pembrolizumab alone on the basis of incidence and severity of adverse events and change from baseline in targeted vital signs and clinical laboratory test results. ;Primary end point(s): Progression Free Survival;Timepoint(s) of evaluation of this end point: Up to 45 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Objective Response Rate 2. Overall Survival 3. Duration of Response 4. Mean change from baseline in Health-Related Quality of Life (HRQoL) scores as assessed through use of the two-item Global Health Status (GHS)/HRQoL subscale (Questions 29 and 30) of the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 (EORTC QLQ-C30) at specified timepoints 5. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) 6. Change from baseline in targeted vital signs 7. Change from baseline in targeted clinical laboratory test results.;Timepoint(s) of evaluation of this end point: 1-7. Up to 45 months | — |
Countries
Australia, Belgium, Germany, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
Genentech Inc. c/o F. Hoffmann-La Roche Ltd
Outcome results
None listed