Immunotherapy With Nivolumab or Nivolumab Plus Ipilimumab vs. Double Placebo for Stage IV Melanom… (NCT02523313) | Clinical Trial Compass
CompletedPhase 2
Immunotherapy With Nivolumab or Nivolumab Plus Ipilimumab vs. Double Placebo for Stage IV Melanoma w. NED
Germany167 participantsStarted 2015-09-02
Plain-language summary
This is a prospective, double-blind placebo-controlled, multicenter, randomized phase II trial testing the adjuvant immunotherapy with Nivolumab plus Ipilimumab Placebo or Nivolumab plus Ipilimumab versus Double Placebo Control as a post-surgical/post-radiation treatment for stage IV melanoma with no evidence of disease (NED).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Stage IV melanoma arising from a primary cutaneous site or metastatic from an unknown primary site with no evidence of disease (NED) after surgery or radiation therapy (conducted within 8 weeks before enrolment)
* Signed written informed consent
* Known BRAF status
* Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study
* Minimum life expectancy of five years excluding their melanoma diagnosis
* ECOG performance status of 0 or 1
* Tumor tissue from the resected site of disease must be provided for biomarker analyses. In order to be randomized a subject must have a PD-L 1 expression classification (positive (≥ 5% tumor cells expressing PD-L1) or negative (\< 5% tumor cells expressing PD-L1)). If an insufficient amount of tumor tissue from the resected site is provided for analysis, acquisition of additional archived tumor tissue (block and/or slides) for the biomarker analyses is required.
* Prior radiotherapy must have been completed at least 2 weeks prior to study drug administration
* Required laboratory values
* Negative pregnancy test for female subjects and effective contraception (Pearl-Index \<1) for both male and female subjects if the risk of conception exists
Exclusion Criteria:
* History of primary uveal or mucosal melanoma
* Prior therapy with CTLA4 or PD1 antibodies
* The patient has psychiatric or addictive disorders that may compromise his/her abili…
What they're measuring
1
Efficacy of adjuvant immunotherapy with Nivolumab alone or in combination with Ipilimumab (Recurrence-free survival)
Timeframe: 24 months after the last patient ended treatment