malignant and not otherwise specified skin neoplasms MedDRA version: 20.0 Level: HLGT Classification code 10040900 Term: Skin neoplasms malignant and unspecified System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Opdivo
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: NIVOLUMAB
Other descriptive name: NIVOLUMAB
Trade Name: Keytruda
Pharmaceutical Form: Powder for con
Sponsors
Erasmus Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - advanced or metastatic melanoma - current treatment with first-line nivolumab or pembrolizumab for advanced or metastatic melanoma - having confirmed complete remission (CR) or partial response (PR) according to RECIST v.1.1 - planned to discontinue nivolumab or pembrolizumab within 4 weeks after confirmation of CR or PR before the full period of 2 years therapy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Concomitant systemic therapies with other anti-cancer agents, e.g. BRAF-inhibitor, anti-CTLA4 (e.g. ipilimumab), or other PD-1 blockade than nivolumab or pembrolizumab
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate ongoing responses in patients with advanced and metastatic melanoma who discontinue first-line monotherapy with nivolumab or pembrolizumab upon achieving CR or PR according to RECIST v1.1;Secondary Objective: The secondary endpoints include: 1a. Total duration of response after first documented CR or PR followed by treatment interruption 1b. Duration of response (CR and PR) after discontinuation of nivolumab or pembrolizumab 2. Progression-free survival (PFS) from start of nivolumab/pembrolizumab (PFS1) 3a. Rate of reintroduction of nivolumab/pembrolizumab upon first PD 3b. Failure rate of reintroducing nivolumab/pembrolizumab and the need for other salvage therapy at first PD 4. Best response on rechallenge with nivolumab/pembrolizumab 5. PFS after reintroduction of nivolumab/pembrolizumab (PFS2) 6a. Total PFS (including period after discontinuation and reintroduction of nivolumab/pembrolizumab) 6b. Overall survival (OS) 7a. Rate of grade 3-4 adverse events (AEs) after discontinuation of nivolumab/pembrolizumab 7b. Rate of grade 3-4 adverse events (AEs) after reintroduction of nivolumab/pembrolizumab ;Primary end point(s): Rate of ongoing responses (CR and PR) according to RECIST v1.1 at 24 months after first start of nivolumab or pembrolizumab;Timepoint(s) of evaluation of this end point: 24 months after last patient included | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1a. Totale responsduur vanaf de eerst gedocumenteerde CR of PR voor het staken van de behandeling 1b. Responsduur na het staken van nivolumab of pembrolizumab 2. Progressie vrije overleving (PFS) vanaf het starten van nivolumab/pembrolizumab (PFS1) 3a. Mate van herstart nivolumab/pembrolizumab bij eerst gedocumenteerde progressieve ziekte (PD) 3b. Mate van falen na herstart nivolumab/pembrolizumab en de noodzaak voor een andere behandeling bij eerste PD 4. Beste respons na herstart van nivolumab/pembrolizumab 5. PFS na herstart van nivolumab/pembrolizumab (PFS2) 6a. Totale PFS (inclusief periode na staken en bij herstart van nivolumab/pembrolizumab) 6b. Totale overleving (OS) 7a. Mate van graad 3-4 bijwerkingen na staken nivolumab/pembrolizumab 7b. Mate van graad 3-4 bijwerkingen na herstart nivolumab/pembrolizumab;Timepoint(s) of evaluation of this end point: 60 months after last patient has started treatment | — |
Countries
Netherlands
Contacts
Public ContactDr. A.A.M. van der Veldt
Erasmus Medical Center
Outcome results
None listed