Safe Stop Ipilimumab-nivolumab (IPI-NIVO) Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorErasmus Medical Center
About this 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
Eligibility criteria
Qualifiers
18 years of age or older
Irresectable stage III or metastatic melanoma
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.
Disqualifiers
Patients with SD/PD according to RECIST v1.1
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.
prior to first-line treatment with ipilimumab-nivolumab, or;
when defined as new or progressive brain metastases at the time of study entry;
Trial design
Treatments tested in this trial
- nivolumab
Treatment groups
80 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov