Safe Stop Ipilimumab-nivolumab (IPI-NIVO) Trial

Sponsor
Erasmus Medical Center
Study ID
NCT05652673
Status
Recruiting
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Conditions

  • Immunotherapy
  • Melanoma Stage III
  • Melanoma Stage IV
  • Toxicity, Drug

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • nivolumab — DRUG
    Early discontinuation of nivolumab maintenance therapy in patients with irresectable stage III or metastatic melanoma

Study Details

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

Key Dates

Start date
Feb 1, 2023
Status verified
Feb 2025
Primary completion
Dec 1, 2025
Completion
Dec 1, 2029

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Early discontinuation of nivolumab

Primary Outcome Measure

Ongoing response [ Time Frame: 12 months after start of ipilimumab-nivolumab combination therapy ]

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