Actively Recruiting
Safe Stop Ipilimumab-nivolumab (IPI-NIVO) Trial
Led by Erasmus Medical Center · Updated on 2025-02-28
80
Participants Needed
1
Research Sites
356 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Safe Stop IPI-NIVO Trial: Early discontinuation of nivolumab upon achieving a (confirmed) complete or partial response in patients with irresectable stage III or metastatic melanoma treated with first-line ipilimumab-nivolumab
CONDITIONS
Official Title
Safe Stop Ipilimumab-nivolumab (IPI-NIVO) Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Diagnosed with irresectable stage III or metastatic melanoma
- Treated with at least one dose of first-line ipilimumab-nivolumab and considered candidate for nivolumab maintenance
- Previous systemic treatment including immune-checkpoint inhibitors in (neo)adjuvant setting allowed
- Response evaluation with diagnostic CT every 12 (-2/+6) weeks from start of ipilimumab-nivolumab
- For complete response, a low-dose CT is allowed at baseline
- For partial response, low-dose CT allowed if sufficient measurable target lesions
- Intracerebral tumor response confirmed by MRI if brain metastases present before treatment
- Inclusion no later than 5 weeks after first confirmed complete or partial response
- Planned to discontinue nivolumab within 4(+1) weeks after inclusion
- Inclusion no later than 9 months after start of ipilimumab-nivolumab
- MRI of brain available for screening brain metastases
- Patients with asymptomatic brain metastases may participate if criteria met
- Signed and dated informed consent form
You will not qualify if you...
- Patients with stable disease or progressive disease according to RECIST v1.1
- Malignant disease other than melanoma being treated in this study, except curatively treated malignancies without recurrence in last 2 years and certain resected skin cancers
- Presence of symptomatic brain metastases prior to first-line treatment or as new/progressive at study entry
- Brain metastases needing steroid treatment within last 8 weeks prior to study entry
- Presence of leptomeningeal metastases
- Systemic chronic steroid therapy (>10mg prednisone or equivalent) at inclusion
- Need or history of second-line immunosuppressive therapy for immune adverse events
- Psychological, familial, sociological, or geographical conditions that could hinder compliance with study protocol or follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Erasmus MC
Rotterdam, Netherlands, 3015GD
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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