Phase II study of axitinib intensification plus standard of care (SOC) compared to SOC alone after induction with nivolumab plus ipilimumab in mRCC patients without previous complete response (AxIn study).

You likely can't join if

• 1. Prior treatment with systemic therapy for advanced RCC with the exclusion of the induction of nivolumab and ipilimumab. 2. Prior adjuvant or neoadjuvant therapy 3. Active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis 4. 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. 5. Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before the start of treatment. Systemic treatment with radionuclides within 6 weeks before the start of treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible. 6. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 3 months before the start of treatment. 7. Concomitant anticoagulation at therapeutic doses with oral anticoagulants (e.g., warfarin, direct thrombin and Factor Xa inhibitors) or platelet inhibitors (e.g., clopidogrel). These are not allowed in case of randomization in the experimental arm, enrollment is allowed if clinician and patient agree to switch to low-molecular-weight heparin (LMWH) in case of randomization to axitinib + SOC arm. No restrictions to anticoagulants is applied for patients randomized in the SOC arm alone.8. In past 6 months: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack. 9. Chronic treatment with corticosteroids or other immunosuppressive agents (with the exception of inhaled or topical corticosteroids or corticosteroids with a daily dosage equivalent = 10 mg prednisone if given for disorders other than renal cell cancer). Subjects with brain metastases requiring systemic corticosteroid are not eligible. 10. The subject has uncontrolled, significant intercurrent or recent illness i 11. Major surgery (e.g., GI surgery, removal or biopsy of brain metastasis) within 3 months before the start of treatment. Complete wound healing from major surgery must have occurred 1 month before the start of treatment and from minor surgery (e.g., simple excision, tooth extraction) at least 10 days before the start of treatment. Subjects with clinically relevant ongoing complications from prior surgery are not eligible. 12. Corrected QT interval calculated by the Fridericia formula (QTcF) > 500 msec within 1 month before the start of treatment . 13. Vaccination within 4 weeks of the first dose of axitinib and while on trials is prohibited except for administration of inactivated vaccines. 14. Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible. 15. Current use of immunosuppressive medication, 16. Has a history of substance abuse or medical, psychological, or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results. 17. Has illness or medical conditions that are unstable or could jeopardize the safety of the patient and his or her compliance in the study. 18. Pregnant or lactating females. 19. Inability to swallow tablets or capsules. 20. Previously identified allergy or hypersensitivity to components of the study treatment formulations. 21. Rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.