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Not recruiting
Phase 3

XL092 & Nivolumab

Sponsor:

Exelixis

Code:

NCT05678673

Conditions

Non-Clear Cell Renal Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

XL092

Nivolumab

Sunitinib Malate

Study Details

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.

Conditions

Non-Clear Cell Renal Cell Carcinoma

Study ID

NCT05678673

Start date

Jan 1, 2023

Status verified date

Dec, 2024

Completion date

Jun, 2028

Anticipated

Primary completion date

Jul, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

291 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: XL092 + Nivolumab

Subjects with advanced or metastatic nccRCC will receive XL092 + nivolumab

active comparator: Sunitinib Malate

Subjects with advanced or metastatic nccRCC will receive an active comparator of sunitinib

Interventions

XL092

Specified doses on specified days

Nivolumab

Specified doses on specified days

Sunitinib Malate

Specified doses on specified days

Primary outcome measure

  • 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 ]
  • Objective response rate (ORR) as assessed by BIRC per RECIST 1.1 [ Time Frame: Up to 24 months after the first subject is randomized ]

Central Contacts and Locations

Central contacts

Exelixis Clinical Trials

1-888-EXELIXIS (888-393-5494)druginfo@exelixis.com

Backup or International

650-837-7400

Locations

Exelixis Clinical Site #1

Recruiting

Duarte, California, United States, 91010

Exelixis Clinical Site #164

Recruiting

Newport Beach, California, United States, 92663

Exelixis Clinical Site #162

Recruiting

San Francisco, California, United States, 94115

Exelixis Clinical Site #163

Recruiting

Aurora, Colorado, United States, 80045

Exelixis Clinical Site #55

Recruiting

Jacksonville, Florida, United States, 32209

Exelixis Clinical Site #161

Recruiting

Buffalo, New York, United States, 14263

Exelixis Clinical Site #58

Recruiting

New York, New York, United States, 10029

Exelixis Clinical Site #15

Recruiting

New York, New York, United States, 10065

Exelixis Clinical Site #42

Recruiting

Cleveland, Ohio, United States, 44106

Exelixis Clinical Site #31

Recruiting

Dallas, Texas, United States, 75246

More Information

Sponsor

Exelixis

Last update posted

Dec 17, 2024

Last verified

Dec, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-20. This information was provided to ClinicalTrials.gov by Exelixis on 2024-12-17.