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

ConditionMetastatic Renal Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorConsorzio Oncotech

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically or cytologically confirmed advanced RCC with predominantly clear-cell subtype and candidate to receive nivolumab after nivolumab plus ipilimumab induction as per standard clinical practice.

Completion of the induction of nivolumab and ipilimumab without toxicity ≥ G2 and no complete response or progressive disease.

Male or female subjects aged ≥ 18 years

Available tumor tissue sample.

Disqualifiers

Prior treatment with systemic therapy for advanced RCC with the exclusion of the induction of nivolumab and ipilimumab.

Prior adjuvant or neoadjuvant therapy

Active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis

Diagnosis of any non-RCC malignancy occurring within 2 years prior to the date of the start of treatment except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix or low-grade prostate cancer with no plans for treatment intervention.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

118 Participants
are divided into 2 treatment groups
Group A: ARM AExperimental treatment 2 interventions
Group B: ARM BActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Efficacy of axitinib in addition to nivolumab compared to nivolumab alone at the end of the induction with nivolumab plus ipilimumab in mRCC.

The response rate will be evaluated as the number of patients with complete or partial response in each arm. Response rate will be evaluated using RECIST 1.1 criteria.

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first

Secondary outcomes

1

Progression free survival (PFS)

The PFS is defined as the time interval from the date of randomization to the date of radiological or clinical progression or death due to any cause. PFS will be reported as the median value and estimated by Kaplan-Meier method, difference between the two arms will be assessed by log-rank test.

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first
2

Overall survival (OS)

The OS is defined as the time interval from the date of randomization to the date of death due to any cause. OS will be reported as the median value and estimated by Kaplan-Meier method, difference between the two arms will be assessed by log-rank test.

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first
3

Depth of response.

The depth of response is defined as the number of patients who achieved different grades of tumor reduction between the two arms. Difference in the depth of response between will be reported as absolute number and percentage and difference between the two groups will be analyzed.

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first
4

Duration of response (DOR).

The DOR is the length of time that a tumor continues to respond to treatment without the cancer growing or spreading. DOR will be reported as the median value and estimated by Kaplan-Meier method, difference between the two arms will be assessed by log-rank test.

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first

Other outcomes

1

expression of PD-L1, PBRM1, CD31 on tumor cells ad CD8+ on lymphocytes

Patients enrolled will be evaluated for the expression in an archival paraffin embedded tumour tissue block for the immunohistochemistry expression of PBRM1, PD-L1, CD31 and immune infiltration CD8+. The expression of these proteins will be related to the main outcomes investigated in the study. Tumor samples will be collected and analyzed at the end of the trial. The analysis will be performed by two expert pathologists in GU tumors at Fondazione Policlinico Universitario Agostino Gemelli IRCCS in Rome, Italy.

Time frame
24 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Consorzio Oncotech

Lead sponsor

Pfizer

Collaborator

Source ClinicalTrials.gov
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