ACTIVE_NOT_RECRUITING

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

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Conditions

Non-Clear Cell Renal Cell Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-01-01
Study Completion:2028-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05678673

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Measurable disease according to RECIST v1.1 as determined by the Investigator.
  3. * Available archival tumor biopsy material.
  4. * 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.
  5. * Age 18 years or older on the day of consent.
  6. * Karnofsky Performance Status (KPS) ≥ 70%.
  7. * Adequate organ and marrow function within 14 days prior to randomization.
  8. * Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception.
  9. * Female subjects of childbearing potential must not be pregnant at screening.
  1. * Chromophobe, renal medullary carcinoma, and pure collecting duct histologic subtypes of nccRCC.
  2. * Prior systemic anticancer therapy for unresectable locally advanced or metastatic nccRCC including investigational agents.
  3. * 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.
  4. * Radiation therapy for bone metastases within 2 weeks, any other radiation therapy within 4 weeks prior to randomization.
  5. * 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.
  6. * 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.
  7. * 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.
  8. * 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.
  9. * Corrected QT interval calculated by the Fridericia formula (QTcF) \> 480 ms per electrocardiogram (ECG) within 14 days before randomization.
  10. * Pregnant or lactating females.
  11. * Administration of a live, attenuated vaccine within 30 days before randomization.
  12. * Note: If feasible, approved non-live vaccines for SARS-CoV-2 should be administered at least 2 weeks before randomization.

Contacts and Locations

Study Locations (Sites)

Exelixis Clinical Site #1
Duarte, California, 91010
United States
Exelixis Clinical Site #164
Newport Beach, California, 92663
United States
Exelixis Clinical Site #162
San Francisco, California, 94115
United States
Exelixis Clinical Site #163
Aurora, Colorado, 80045
United States
Exelixis Clinical Site #55
Jacksonville, Florida, 32209
United States
Exelixis Clinical Site #161
Buffalo, New York, 14263
United States
Exelixis Clinical Site #58
New York, New York, 10029
United States
Exelixis Clinical Site #15
New York, New York, 10065
United States
Exelixis Clinical Site #42
Cleveland, Ohio, 44106
United States
Exelixis Clinical Site #31
Dallas, Texas, 75246
United States

Collaborators and Investigators

Sponsor: Exelixis

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-01
Study Completion Date2028-06

Study Record Updates

Study Start Date2023-01-01
Study Completion Date2028-06

Terms related to this study

Additional Relevant MeSH Terms

  • Non-Clear Cell Renal Cell Carcinoma