Nivolumab dose optimization in patients with a complete, partial or stable response (NIVOPTIMIZE-trial)

Nivolumab dose optimization in patients with a complete, partial or stable response (NIVOPTIMIZE-trial) - NIVOPTIMIZE-trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001707-32-NL

Enrollment

Registered

2021-04-22

Start date

2021-07-08

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with advanced or metastatic melanoma or renal cell carcinoma treated with nivolumab monotherapy in a 480mg or 6 mg/kg 4 weekly scheme (either from start or after combination therapy with ipilimumab), have a confirmed CR, PR or SD, are at least 6 months on treatment and are willing to receive 3 reduced doses of 240 mg

Interventions

Trade Name: Opdivo Pharmaceutical Form: Solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age = 18 years 2. Advanced or metastatic melanoma or renal cell carcinoma 3. Current treatment with nivolumab in a 480 mg or 6mg/kg, 4 weekly scheme 4. Documented confirmed and ongoing CR, PR or SD according to RECIST v1.1 5. On treatment for at least 6 months 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 31 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: - Unable to draw blood for study purposes - Patients willing to participate or already included in the SAFE-STOP trial

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to demonstrate that the nivolumab steady-state level after 3 cycles with a reduced nivolumab dosage (240 mg every 4 weeks) is not lower than the nivolumab concentration 4 weeks after the first 480 mg or 6mg/kg dose. ;Secondary Objective: -Explore PD1 receptor occupancy in PBMCs -Safety of reduced nivolumab doses -Efficacy of reduced nivolumab doses -Pharmacokinetic profile of nivolumab -Cost effectiveness ;Primary end point(s): 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 480 mg or 6mg/kg dose);Timepoint(s) of evaluation of this end point: 4 weeks after the 3rd reduced dose of 240 mg and 4 weeks after the 1st dose of 480 mg or 6mg/kg	—

Measure

Time frame

Main Objective: The primary objective is to demonstrate that the nivolumab steady-state level after 3 cycles with a reduced nivolumab dosage (240 mg every 4 weeks) is not lower than the nivolumab concentration 4 weeks after the first 480 mg or 6mg/kg dose. ;Secondary Objective: -Explore PD1 receptor occupancy in PBMCs -Safety of reduced nivolumab doses -Efficacy of reduced nivolumab doses -Pharmacokinetic profile of nivolumab -Cost effectiveness ;Primary end point(s): 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 480 mg or 6mg/kg dose);Timepoint(s) of evaluation of this end point: 4 weeks after the 3rd reduced dose of 240 mg and 4 weeks after the 1st dose of 480 mg or 6mg/kg

—

Secondary

Measure	Time frame
Secondary end point(s): - 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 ;Timepoint(s) of evaluation of this end point: 4 weeks after the 3rd reduced dose of 240 mg	—

Countries

Netherlands

Contacts

Public ContactE.A. Basak

Erasmus Medical Center Rotterdam

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026