A Randomized Open-Label Phase 3 Study of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma
A Randomized Open-Label Phase 3 Study of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma
This is a multicenter, randomized (2:1), open-label, controlled Phase 3 trial of XL092 in combination with nivolumab versus sunitinib in subjects with unresectable, locally advanced or metastatic nccRCC who have not received prior systemic anticancer therapy.
Inclusion Criteria:
Exclusion Criteria:
Chromophobe, renal medullary carcinoma, and pure collecting duct histologic subtypes of nccRCC.
Prior systemic anticancer therapy for unresectable locally advanced or metastatic nccRCC including investigational agents.
Radiation therapy for bone metastases within 2 weeks, any other radiation therapy within 4 weeks prior to randomization.
Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy (including radiosurgery) or surgically removed and stable for at least 4 weeks before randomization.
Concomitant anticoagulation with oral anticoagulants and platelet inhibitors. Subjects who are receiving oral anticoagulants at the time of screening must be transitioned to LMWH prior to randomization. Subjects who require treatment with platelet inhibitors are not eligible.
Major surgery (eg, GI surgery, removal or biopsy of brain metastasis) within 8 weeks prior to randomization. Prior laparoscopic nephrectomy within 4 weeks prior to randomization. Minor surgery (eg, simple excision, tooth extraction) within 10 days before randomization. Complete wound healing from major or minor surgery must have occurred at least prior to randomization.
Corrected QT interval calculated by the Fridericia formula (QTcF) > 480 ms per electrocardiogram (ECG) within 14 days before randomization.
Pregnant or lactating females.
Administration of a live, attenuated vaccine within 30 days before randomization.
CABA, C1419GEP, Argentina
Macquarie, New South Wales 2109, Australia