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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
nivolumab
DrugEarly discontinuation of nivolumab maintenance therapy in patients with irresectable stage III or metastatic melanoma
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Early discontinuation of nivolumabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Ongoing response
The rate of ongoing response at 12 months in patients with irresectable stage III or metastatic melanoma who are treated with first-line ipilimumab-nivolumab and who early discontinue nivolumab upon achieving a CR or PR according to RECIST v1.1
Time frame
12 months after start of ipilimumab-nivolumab combination therapySecondary outcomes
1
Ongoing response
Ongoing response at 24 months after start of first-line treatment with ipilimumab-nivolumab
Time frame
24 months after start of treatment2
Disease control
Disease control (CR/PR) at different time points
Time frame
5 years after inclusion3
duration of response
Duration of response (CR/PR) measured until progressive/recurrent disease
Time frame
5 years after inclusion4
Melanoma Specific Survival rate
Melanoma specific survival measured from start of first-line treatment with ipilimumab-nivolumab until melanoma related death
Time frame
5 years after inclusionSponsors and contacts
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Source ClinicalTrials.gov