Clinical trial • Phase IV • Oncology

Nivolumab for Melanoma | Renal cell carcinoma

Phase IV trial of Nivolumab for Melanoma | Renal cell carcinoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Melanoma | Renal cell carcinoma
Trial Stage
Phase IV
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
30-07-2024
First CTIS Authorization Date
15-08-2024

Trial design

Comparator: standard nivolumab dosing of 6 mg/kg or 480 mg every 4 weeks versus reduced nivolumab dosing of 240 mg every 4 weeks.-controlled Phase IV trial across 2 sites in Netherlands.

Comparator
Comparator: standard nivolumab dosing of 6 mg/kg or 480 mg every 4 weeks versus reduced nivolumab dosing of 240 mg every 4 weeks.
Target Sample Size
34

Eligibility

Recruits 34 No vulnerable population selected; trial includes adults only (Age ≥ 18 years)..

Vulnerable Population
No vulnerable population selected; trial includes adults only (Age ≥ 18 years).

Inclusion criteria

  • {"criterion_text":"- Age ≥ 18 years"}
  • {"criterion_text":"- Advanced or metastatic melanoma or RCC"}
  • {"criterion_text":"- Current treatment with nivolumab in a 6 mg/kg or 480 mg, 4 weekly scheme"}
  • {"criterion_text":"- Documented confirmed and ongoing CR, PR or SD according to RECIST v1.1"}
  • {"criterion_text":"- On treatment for at least 6 months"}

Exclusion criteria

  • {"criterion_text":"- Unable to draw blood for study purposes"}
  • {"criterion_text":"- Patients willing to participate or already included in the SAFE-STOP trial"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 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)","definition_or_measurement_approach":"Compare mean trough nivolumab serum concentrations: mean trough level measured 4 weeks after the 3rd reduced dose of 240 mg (given 4-weekly) versus mean trough level 4 weeks after treatment start (4 weeks after first 6 mg/kg or 480 mg dose)."}

Secondary endpoints

  • {"endpoint_text":"- PD-1 receptor occupancy in PBMCs, measured 4 weeks after 3 reduced nivolumab doses","definition_or_measurement_approach":"Measure PD-1 receptor occupancy in peripheral blood mononuclear cells (PBMCs) 4 weeks after 3 reduced nivolumab doses."}
  • {"endpoint_text":"- Grade ≥3 adverse events during reduced doses","definition_or_measurement_approach":"Assessment of safety by recording adverse events of grade ≥3 occurring during the reduced-dose period."}
  • {"endpoint_text":"- Number of patients with new PD during 3 reduced doses","definition_or_measurement_approach":"Count of patients with new progressive disease (PD) during the period of 3 reduced nivolumab doses."}
  • {"endpoint_text":"- Pharmacokinetic profile of nivolumab","definition_or_measurement_approach":"Characterisation of nivolumab pharmacokinetics (trough levels and PK profile) under the reduced dosing regimen."}
  • {"endpoint_text":"- Cost effectiveness","definition_or_measurement_approach":"Health economic assessment comparing costs and outcomes of the reduced dosing regimen versus standard dosing."}

Recruitment

Planned Sample Size
34
Recruitment Window Months
50
Consent Approach
Informed consent obtained from participants; participants are adults (Age ≥ 18 years). Subject information and informed consent form document is listed (L1_SIS and ICF Erasmus MC), but no further details on assent, age-specific documents or languages are available in the provided data.

Geography

Total Number Of Sites
2
Total Number Of Participants
34

Netherlands

Earliest CTIS Part Ii Submission Date
14-08-2024
Latest Decision Or Authorization Date
15-08-2024
Processing Time Days
1
Number Of Sites
2
Number Of Participants
34

Sites

Site Name
Isala Klinieken Stichting
Department Name
Medical Oncology
Contact Person Name
Elianne de Boer
Contact Person Email
E.c.s.de.Boer@isala.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Medical Oncology
Contact Person Name
Stijn Koolen
Contact Person Email
s.koolen@erasmusmc.nl

Sponsor

Primary sponsor

Full Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
NIVOLUMAB
Active Substance
Nivolumab
Modality
Monoclonal antibody
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
Authorised
Starting Dose
240 mg (reduced regimen); comparator: 6 mg/kg or 480 mg (standard)
Dose Levels
240 mg every 4 weeks; comparator 6 mg/kg or 480 mg every 4 weeks
Frequency
Every 4 weeks
Maximum Dose
720 mg

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