Combination treatment for advanced non-clear cell kidney cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 trial evaluates the efficacy of XL092 combined with nivolumab compared to sunitinib in patients with unresectable, locally advanced or metastatic non-clear cell renal cell carcinoma (nccRCC) who have not previously received systemic anticancer therapy. The study is multicenter and randomized, with a 2:1 allocation ratio. Participants will be assessed for measurable disease and must meet specific eligibility criteria, including adequate organ function and performance status.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

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.

  * 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.
* 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.

  * Note: Fresh tumor biopsies should be performed at least 7 days before randomization. Subjects with clinically relevant ongoing complications from prior surgical procedures, including biopsies, are not eligible.
* 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.

Where it's running

• Exelixis Clinical Site #1
  Duarte, California, United States Recruiting
• Exelixis Clinical Site #164
  Newport Beach, California, United States Recruiting
• Exelixis Clinical Site #162
  San Francisco, California, United States Recruiting
• Exelixis Clinical Site #163
  Aurora, Colorado, United States Recruiting
• Exelixis Clinical Site #55
  Jacksonville, Florida, United States Recruiting
• Exelixis Clinical Site #161
  Buffalo, New York, United States Recruiting

+114 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Exelixis Clinical Trials
• Email: druginfo@exelixis.com
• Phone: 1-888-EXELIXIS (888-393-5494)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.