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

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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Non-Clear Cell Renal Cell Carcinoma Drug: XL092 Drug: Nivolumab Drug: Sunitinib Malate Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 291 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 1, 2023
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : June 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: XL092 + Nivolumab
Subjects with advanced or metastatic nccRCC will receive XL092 + nivolumab
 Drug: XL092
Specified doses on specified days

Drug: Nivolumab
Specified doses on specified days
Other Name: Opdivo®
Active Comparator: Sunitinib Malate
Subjects with advanced or metastatic nccRCC will receive an active comparator of sunitinib
 Drug: Sunitinib Malate
Specified doses on specified days
Other Name: Sutent®


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05678673


Contacts
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Contact: Exelixis Clinical Trials 1-888-EXELIXIS (888-393-5494) druginfo@exelixis.com
Contact: Backup or International 650-837-7400

Locations
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Sponsors and Collaborators
Exelixis
More Information
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Responsible Party: Exelixis
ClinicalTrials.gov Identifier: NCT05678673    
Other Study ID Numbers: XL092-304
EU CTR: 2022-501703-27-0 ( Other Identifier: European Medicines Agency )
First Posted: January 10, 2023    Key Record Dates
Last Update Posted: January 12, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Kidney Diseases
Urologic Diseases
 Male Urogenital Diseases
Nivolumab
Sunitinib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors