RecruitingNot ApplicableNCT05652673

Safe Stop Ipilimumab-nivolumab (IPI-NIVO) Trial

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

Sponsor

Erasmus Medical Center

Enrollment

80 participants

Start Date

Feb 1, 2023

Study Type

INTERVENTIONAL

Conditions

Immunotherapy Melanoma Stage IV Melanoma Stage III Toxicity, Drug

Summary

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether patients with advanced melanoma who are doing well on combination immunotherapy (ipilimumab + nivolumab) can safely stop the ipilimumab component earlier than usual and continue on nivolumab alone — potentially reducing side effects while maintaining cancer control. **You may be eligible if...** - You are 18 or older with stage III unresectable or metastatic (stage IV) melanoma - You have received at least one dose of the ipilimumab-nivolumab combination as first-line treatment - You and your doctor are considering maintenance therapy **You may NOT be eligible if...** - Your melanoma has not responded to the initial treatment - You have active serious side effects from your current immunotherapy - You have certain autoimmune conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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