Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Exelixis
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically confirmed nccRCC that is unresectable, advanced or metastatic. Histologic subtypes including papillary, unclassified, and translocation-associated are allowed. Among the eligible histologic subtypes, sarcomatoid features are allowed.
Measurable disease according to RECIST v1.1 as determined by the Investigator.
Available archival tumor biopsy material.
Recovery to baseline or ≤ Grade 1 per CTCAE v5 from AE(s) related to any prior treatments unless AE(s) are deemed clinically nonsignificant by the Investigator and/or stable on supportive therapy.
Age 18 years or older on the day of consent.
Karnofsky Performance Status (KPS) ≥ 70%.
Adequate organ and marrow function within 14 days prior to randomization.
Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception.
Female subjects of childbearing potential must not be pregnant at screening.
You may not be if
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.
* Note: One prior systemic adjuvant therapy, including immune checkpoint inhibitor therapy and excluding sunitinib, is allowed for completely resected RCC and if recurrence occurred at least 6 months after the last dose of adjuvant therapy.
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.
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.
* Note: If feasible, approved non-live vaccines for SARS-CoV-2 should be administered at least 2 weeks before randomization.
