Spots Global Cancer Trial Database for Immunotherapy With Nivolumab or Nivolumab Plus Ipilimumab vs. Double Placebo for Stage IV Melanoma w. NED
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Trial Identification
Brief Title: Immunotherapy With Nivolumab or Nivolumab Plus Ipilimumab vs. Double Placebo for Stage IV Melanoma w. NED
Official Title: A Phase II Randomized, Double-Blind Trial of Immunotherapy With Nivolumab or Nivolumab Plus Ipilimumab Versus Double-Placebo Control as a Post-Surgical/Post-Radiation Treatment for Stage IV Melanoma With No Evidence of Disease
Study ID: NCT02523313
Conditions
Study Description
Brief 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).
Detailed Description: This study will allow for direct comparison of the clinical benefit provided by Nivolumab monotherapy or Nivolumab combined with Ipilimumab versus double placebo control. Furthermore, it will also allow for direct comparison of the respective safety profiles of Nivolumab monotherapy or Nivolumab combined with Ipilimumab. Nivolumab monotherapy was chosen as one of the experimental arms because of a favourable risk-benefit ratio assessed in the large Phase 1 study (MDX1106-03/CA209-003). The combination of Nivolumab and Ipilimumab was chosen as an experimental arm because of the preliminary evidence from the Phase 1 study CA209-004 suggesting synergy between Nivolumab and Ipilimumab resulting in a higher frequency of patients with increased tumour burden reduction. Evaluating both Nivolumab monotherapy and the combination of Nivolumab and Ipilimumab will provide clinical data allowing clinicians to select the appropriate treatment for each patient based on their individual risk-benefit ratio.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Charité Berlin, Berlin, , Germany
Elbe Klinikum Buxtehude, Buxtehude, , Germany
Universitätsklinikum Dresden, Dresden, , Germany
HELIOS Klinikum Erfurt, Erfurt, , Germany
Studienzentrum Hautklinik Universitätsklinikum Essen (AöR) Klinik für Dermatologie, Essen, , Germany
SRH Wald-Klinikum Gera GmbH, Gera, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Universitätrsklinikum Heidelberg Dermatologie / NCT, Heidelberg, , Germany
SLK Kliniken Heilbronn GmbH, Heilbronn, , Germany
Universitäts-Hautklinik Kiel Klinik f. Dermatologie, Venerologie u. Allergologie, Kiel, , Germany
Universitätsklinikum Leipzig Klinik u. Poliklinik f. Dermatologie, Venerologie u. Allergologie, Leipzig, , Germany
Klinikum der Stadt Ludwigshafen, Ludwigshafen, , Germany
UKSH Campus Lübeck, Lübeck, , Germany
Universitätsklinikum Mainz Hautklinik und Polklinik, Mainz, , Germany
Klinik für Dermatologie, Venerologie und Allergologie UMM - Universitätsmedizin Mannheim, Mannheim, , Germany
Johannes Wesling Klinikum Minden Hautklinik, Minden, , Germany
Universitätsklinikum München (LMU), München, , Germany
Fachklinik Hornheide, Münster, , Germany
Universitätsklinikum Regensburg, Regensburg, , Germany
Universitätshautklinik Tübingen, Tübingen, , Germany
Contact Details
Name: Dirk Schadendorf, Prof. Dr.
Affiliation: Studienzentrum Hautklinik Universitätsklinikum Essen Klinik f. Dermatologie
Role: PRINCIPAL_INVESTIGATOR
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