Public trial registry of the CCC-Munich

Trial CheckMate 915: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 915

Trial Trial design Status In-/Exclusion Therapy Participants Documents Permissions Tumorboards

Trial
World
Trial acronym
:
CheckMate 915: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 915
World
Full title
:

A Phase 3, Randomized Study of Adjuvant Immunotherapy with Nivolumab Combined with Ipilimumab Versus Ipilimumab or Nivolumab Monotherapy after Complete Resection of Stage IIIb/c/d or Stage IV Melanoma

World
Description
:

The rationale for this study is to generate efficacy and safety data for the patient population with stage IIIb/c/d or stage IV no evidence of disease (NED) melanoma following complete resection of their lesion(s).

The study will allow for direct comparison of the clinical benefit, as measured by recurrence-free survival and Overall survival, provided by ipilimumab and nivolumab
combination therapy versus ipilimumab and nivolumab monotherapy. It will provide clinical data allowing clinicians to select the appropriate treatment for each patient based on their individual risk-benefit ratio.

World
EudraCT number
:
World
Responsible organization
:
KUM - Klinik und Poliklinik für Dermatologie und Allergologie - Dermato-Onkologie Lmu
Indications
Classification Code Description
ICD-10-GM C43.9 Bösartiges Melanom der Haut, nicht näher bezeichnet
Trial design
World
Trial type
:
Interventional
World
Blinding type
:
Double blinded
World
Phase
:
III
Status
World
Status
:
Recruitment active
Votes
World
Institutional review board - vote
:
Positive
World
PEI - vote
:
Positive
Initiiation & lock
World
Date of lock (planned / actual)
:
Unknown / Unknown
Participants
Function Prename Surname Organization
World Principal Investigator Carola Berking KUM - Klinik und Poliklinik für Dermatologie und Allergologie - Dermato-Onkologie Magnifier
World Responsible contact Carola Berking KUM - Klinik und Poliklinik für Dermatologie und Allergologie, München - Dermato-Onkologie Magnifier
World Sponsor Bristol-Myers Squibb BMS Magnifier