Axitinib Intensification Plus Nivolumab or Nivolumab Alone After Nivolumab Plus Ipilimumab in mRCC Patients

Sponsor
Consorzio Oncotech
Study ID
NCT05817903
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Axitinib — DRUG
    Axitinib will be started at the standard dose of 5 mg BID until progression of disease, unacceptable toxicity, patient' or physician' decision.
  • Nivolumab — DRUG
    Nivolumab will be administered at a flat dose of 480 mg IV every four weeks until progression of disease, unacceptable toxicity, patient' or physician' decision

Study Details

This phase II open label trial randomized patients who completed the induction with nivolumab plus ipilimumab without complete response or progressive disease will be randomized 1:1 to receive axitinib in addition to nivolumab (Arm A) or continue with nivolumab alone (Arm B).Treatment will be continued until progression of disease, unacceptable toxicity, patient's refusal, or physician decision whichever occurred first.

Key Dates

Start date
Apr 18, 2023
Status verified
May 2023
Primary completion
Apr 1, 2026
Completion
Apr 1, 2027

Study Design

Enrollment
118 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ARM A
    Axitinib (starting dose 5 mg BID orally) in addition to nivolumab (lat dose of 480 mg IV every four weeks as per standard clinical practice)
  • Active Comparator: ARM B
    Nivolumab (flat dose of 480 mg IV every four weeks as per standard clinical practice) after nivolumab plus ipilimumab induction as per standard clinical practice

Primary Outcome Measure

Efficacy of axitinib in addition to nivolumab compared to nivolumab alone at the end of the induction with nivolumab plus ipilimumab in mRCC. [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first ]

Central Contacts

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