Stopping nivolumab early in melanoma patients who respond to ipilimumab-nivolumab

Trial details

Who runs it

Erasmus Medical Center

Trial code

NCT05652673

Record updated

28 February 2025

Original description

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-nivolumabRead full original descriptionShow less

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

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

Inclusion: 18 years of age or older; Irresectable stage III or metastatic melanoma; Treated with at least one dose of first-line ipilimumab-nivolumab and considered to be a candidate for maintenance treatment with nivolumab:; previous systemic treatment, including immune-checkpoint inhibitors, in (neo)adjuvant setting for resectable melanoma is allowed; in this protocol, nivolumab maintenance is interchangeable with pembrolizumab maintenance therapy; Response evaluation according to RECIST v1.1 30 using a diagnostic CT documenting target lesions every 12 (-2/+6) weeks from the start of ipilimumab-nivolumab:; for patients with CR on a diagnostic CT at response evaluation, a low-dose CT (which is usually part of 18FDG-PET/CT) is allowed at baseline; for patients with PR on a diagnostic CT at response evaluation, a low-dose CT (which is usually part of 18FDG-PET/CT) is allowed if sufficient target lesions are measurable for response evaluation according to RECIST v1.1 criteria 30; in case of asymptomatic brain metastases prior to start of first-line ipilimumab-nivolumab, intracerebral tumor response should be confirmed using an MRI for response evaluation prior to inclusion in this study; Patients should be included after first CR/PR or first confirmed CR/PR according to RECIST v1.1 30:; inclusion should take place no later than 5 weeks after first confirmed CR/PR; in case of SD at first response evaluation, confirmed CR/PR is required for inclusion; planned and willing to discontinue nivolumab within 4(+1) weeks after inclusion, i.e. first CR/PR or first confirmed CR/PR; no later than 9 months after start of treatment with ipilimumab-nivolumab; Presence of MRI brain for the screening of brain metastases (prior to discontinuation of ipilimumab-nivolumab); Participants with previously locally treated brain metastases may participate in case they meet the following criteria:; completely asymptomatic brain metastases at inclusion; MRI of brain at baseline and for response evaluation during treatment; Signed and dated informed consent form.

Exclusion: Malignant disease other than being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to start of study treatment; completely resected basal cell and squamous cell skin cancers and any completely resected carcinoma in situ; Presence of symptomatic brain metastases:; prior to first-line treatment with ipilimumab-nivolumab, or; when defined as new or progressive brain metastases at the time of study entry; brain metastases with need for steroid treatment in the last 8 weeks prior to study entry Note: An incidental epileptic seizure caused by a brain lesion is not considered an exclusion criterion; (provided that the other in- and exclusion criteria are met); Systemic chronic steroid therapy (>10mg/day prednisone or equivalent) at inclusion or patients who need or needed any other second-line immunosuppressive therapy (e.g. infliximab, mycophenolate mofetil) for the treatment of immune related adverse events (irAEs). Note: local steroids such as topical, inhaled, nasal and ophthalmic steroids are allowed; Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial; Patients with SD/PD according to RECIST v1.1; Presence of leptomeningeal metastases.

ClinicalTrials.gov NCT05652673