Study of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma (STELLAR-304)

• ClinicalTrials.gov Identifier: NCT05678673
• Recruitment Status: Recruiting
• First Posted: January 10, 2023
• Last Update Posted: January 12, 2024
• Sponsor: Exelixis
• Information provided by (Responsible Party): Exelixis

Tracking Information

• First Submitted Date: December 23, 2022
• First Posted Date: January 10, 2023
• Last Update Posted Date: January 12, 2024
• Actual Study Start Date: January 1, 2023
• Estimated Primary Completion Date: July 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 23, 2022)

• Duration of Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), by Blinded Independent Radiology Committee (BIRC) [ Time Frame: Approximately 27 months after the first subject is randomized ]
  Defined as the time from randomization to the earlier of either radiographic PD per RECIST 1.1 as determined by the BIRC or death from any cause
• Objective response rate (ORR) as assessed by BIRC per RECIST 1.1 [ Time Frame: Up to 24 months after the first subject is randomized ]
  Defined as the proportion of subjects with the best overall response of complete response (CR) or partial response (PR) per RECIST 1.1 as determined by the BIRC that is confirmed at a follow-up assessment ≥ 28 days later

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 23, 2022)

Duration of Overall Survival (OS) [ Time Frame: Approximately 46 months after the first subject is randomized ]

Defined as the time from randomization to death due to any cause

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma
• Official Title: A Randomized Open-Label Phase 3 Study of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Non-Clear Cell Renal Cell Carcinoma

Intervention

• Drug: XL092
  Specified doses on specified days
• Drug: Nivolumab
  Specified doses on specified days
  Other Name: Opdivo®
• Drug: Sunitinib Malate
  Specified doses on specified days
  Other Name: Sutent®

Study Arms

• Experimental: XL092 + Nivolumab
  Subjects with advanced or metastatic nccRCC will receive XL092 + nivolumab
  Interventions:

  • Drug: XL092
  • Drug: Nivolumab
• Active Comparator: Sunitinib Malate
  Subjects with advanced or metastatic nccRCC will receive an active comparator of sunitinib
  Intervention: Drug: Sunitinib Malate

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 23, 2022): 291
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2028
• Estimated Primary Completion Date: July 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Exelixis Clinical Trials; 1-888-EXELIXIS (888-393-5494); druginfo@exelixis.com

Contact: Backup or International; 650-837-7400

• Listed Location Countries: Argentina, Australia, Brazil, Chile, Czechia, Finland, France, Germany, Italy, Korea, Republic of, Malaysia, Netherlands, Poland, Spain, Thailand, United States

Administrative Information

• NCT Number: NCT05678673
• Other Study ID Numbers: XL092-304; EU CTR: 2022-501703-27-0 ( Other Identifier: European Medicines Agency )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Exelixis
• Original Responsible Party: Same as current
• Current Study Sponsor: Exelixis
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Exelixis
• Verification Date: January 2024