Overview
Sponsor-declared trial summary
Melanoma
Demonstrate that an adequate steady-state level is reached by showing that the mean trough level measured after 3 reduced doses of nivolumab 240 mg 4 weekly is not lower than the mean trough level 4 weeks after treatment start (i.e. 4 weeks after the dose of 6 mg/kg or 480 mg)
Key facts
- Sponsor
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2024-08-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Mrace Efficiency Grant 2020
External identifiers
- EU CT number
- 2024-516718-39-00
- EudraCT number
- 2021-001707-32
- ClinicalTrials.gov
- NCT06116461
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
Demonstrate that an adequate steady-state level is reached by showing that the mean trough level measured after 3 reduced doses of nivolumab 240 mg 4 weekly is not lower than the mean trough level 4 weeks after treatment start (i.e. 4 weeks after the dose of 6 mg/kg or 480 mg)
Secondary objectives 5
- Explore PD1 receptor occupancy in PBMCs
- Safety of reduced nivolumab doses
- Efficacy of reduced nivolumab doses
- Pharmacokinetic profile of nivolumab
- Cost effectiveness
Conditions and MedDRA coding
Melanoma
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Age ≥ 18 years
- Advanced or metastatic melanoma or RCC
- Current treatment with nivolumab in a 6 mg/kg or 480 mg, 4 weekly scheme
- Documented confirmed and ongoing CR, PR or SD according to RECIST v1.1
- On treatment for at least 6 months
Exclusion criteria 2
- Unable to draw blood for study purposes
- Patients willing to participate or already included in the SAFE-STOP trial
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Difference between the mean trough level 4 weeks after the 3rd nivolumab dose of 240 mg and the mean trough level 4 weeks after treatment start (i.e. 4 weeks after the first 6 mg/kg or 480 mg dose)
Secondary endpoints 5
- PD-1 receptor occupancy in PBMCs, measured 4 weeks after 3 reduced nivolumab doses
- Grade ≥3 adverse events during reduced doses
- Number of patients with new PD during 3 reduced doses
- Pharmacokinetic profile of nivolumab
- Cost effectiveness
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP8265340 · ATC
- Active substance
- Nivolumab
- Substance synonyms
- BMS936558, ABP 206
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 240 mg milligram(s)
- Max total dose
- 720 mg milligram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF01 — NIVOLUMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Sponsor organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Address
- Dr. Molewaterplein 40
- City
- Rotterdam
- Postcode
- 3015 GD
- Country
- Netherlands
Scientific contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- Michiel Zietse
Public contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- Michiel Zietse
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 34 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol EU_CT number 2024-516718-39-00 - NIVOPTIMIZE | 4 |
| Recruitment arrangements (for publication) | Statement EU_CT number 2024-516718-39-00 - NIVOPTIMIZE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Erasmus MC EU_CT 2024-516718-39-00 | 5 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Nivolumab | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-30 | Netherlands | Acceptable with conditions 2024-08-15
|
2024-08-15 |