Study Summary
This trial will test different combinations of immunotherapy drugs to see if they are effective and safe in treating people with resectable Stage III melanoma or Stage IV melanoma. The study is designed to be flexible, so that new treatment arms can be added as new treatments become available, and existing treatment arms can be closed if they don't work well or have unacceptable side effects.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 16 Secondary · Reporting Duration: Randomization up to approximately 5 years
Year 5
Percentage of Participants With Adverse Events for Cohort 1
Percentage of Participants With Adverse Events for Cohort 2
Baseline to Week 12
Percentage of Participants With Immune-Related Adverse Events for Cohort 1
Year 5
Objective Response Rate (ORR) for Cohort 2
Year 5
Duration of Response (DOR) for Cohort 2
Week 6
Objective Response Rate (ORR) for Cohort 1
Year 5
Overall Survival (OS) for Cohort 1
Year 5
Event-Free Survival (EFS) for Cohort 1
Year 5
Disease Control for Cohort 2
Year 5
Overall Survival (OS) for Cohort 2
Year 5
Overall Survival (OS) at Specific Timepoints for Cohort 2
Year 5
Progression-Free Survival (PFS) for Cohort 2
Year 5
Relapse-Free Survival (RFS) for Cohort 1
Week 7
Pathologic Response Rate (pRR) for Cohort 1 as Determined by Independent Pathologic Review
pRR for Cohort 1 as Determined by Local Pathologic Assessment
Month 6
Surgical Complication Rates for Cohort 1
Week 9
Duration of Delayed Surgery Due to Treatment-Related Adverse Events for Cohort 1
Rate of Delayed Surgery Due to Treatment-Related Adverse Events for Cohort 1
Trial Safety
Safety Progress
Trial Design
5 Treatment Groups
Cohort 1: Nivolumab + Ipilimumab
1 of 5
Cohort 1: RO7247669
1 of 5
Cohort 1: + Atezolizumab + Tiragolumab
1 of 5
Cohort 1: RO7247669 + Tiragolumab
1 of 5
Cohort 2: RO7247669 + Tiragolumab
1 of 5
Active Control
Experimental Treatment
191 Total Participants · 5 Treatment Groups
Primary Treatment: RO7247669 · No Placebo Group · Phase 1 & 2
Cohort 1: RO7247669
Drug
Experimental Group · 1 Intervention: RO7247669 · Intervention Types: DrugCohort 1: + Atezolizumab + TiragolumabExperimental Group · 2 Interventions: Tiragolumab, Atezolizumab · Intervention Types: Drug, Drug
Cohort 1: RO7247669 + TiragolumabExperimental Group · 2 Interventions: Tiragolumab, RO7247669 · Intervention Types: Drug, Drug
Cohort 2: RO7247669 + TiragolumabExperimental Group · 2 Interventions: Tiragolumab, RO7247669 · Intervention Types: Drug, Drug
Cohort 1: Nivolumab + IpilimumabActiveComparator Group · 2 Interventions: Ipilimumab, Nivolumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: randomization up to approximately 5 years
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,362 Previous Clinical Trials
1,067,955 Total Patients Enrolled
46 Trials studying Melanoma
58,244 Patients Enrolled for Melanoma
Clinical TrialsStudy DirectorHoffmann-La Roche
2,149 Previous Clinical Trials
876,045 Total Patients Enrolled
50 Trials studying Melanoma
42,782 Patients Enrolled for Melanoma
Eligibility Criteria
Age 18+ · All Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have resectable Stage III melanoma and no history of in-transit metastases within the last 6 months.
You have not had a positive HIV test, negative HBsAb, and negative HBcAb, and negative HCV at screening.
You are receiving therapeutic anticoagulation.
Who else is applying?
How old are they?
| 18 - 65 | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
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Conditions
Cancer Related
Treatments