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Clinical Trials in the UK / NCT05678673
Active, not recruiting Phase 3

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

NCT05678673 · tracked via the Priya Life Science UK tracker
Sponsor
Exelixis
Phase
Phase 3
Started
2023-01-01
Last updated
2026-07-29

Condition(s) studied

Non-Clear Cell Renal Cell Carcinoma

Investigational drug(s) / intervention(s)

XL092NivolumabSunitinib Malate

XL092: Specified doses on specified days

Nivolumab: Specified doses on specified days

Sunitinib Malate: Specified doses on specified days

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (163)

FacilityCityRegionStatus
Exelixis Clinical Site #1 Duarte California
Exelixis Clinical Site #164 Newport Beach California
Exelixis Clinical Site #162 San Francisco California
Exelixis Clinical Site #163 Aurora Colorado
Exelixis Clinical Site #55 Jacksonville Florida
Exelixis Clinical Site #161 Buffalo New York
Exelixis Clinical Site #58 New York New York
Exelixis Clinical Site #15 New York New York
Exelixis Clinical Site #42 Cleveland Ohio
Exelixis Clinical Site #31 Dallas Texas
Exelixis Clinical Site #88 Pilar Buenos Aires
Exelixis Clinical Site #89 Viedma Río Negro Province
Exelixis Clinical Site #44 Buenos Aires Argentina
Exelixis Clinical Site #35 CABA Argentina
Exelixis Clinical Site #90 Córdoba Argentina
Exelixis Clinical Site #51 Santa Fe Argentina
Exelixis Clinical Site #94 Albury New South Wales
Exelixis Clinical Site #97 Camperdown New South Wales
Exelixis Clinical Site #98 Liverpool New South Wales
Exelixis Clinical Site #95 Macquarie New South Wales
Exelixis Clinical Site #92 Sydney New South Wales
Exelixis Clinical Site #93 Waratah New South Wales
Exelixis Clinical Site #99 Douglas Queensland
Exelixis Clinical Site #100 Elizabeth Vale South Australia
Exelixis Clinical Site #91 Box Hill Victoria
Exelixis Clinical Site #96 St Albans Victoria
Exelixis Clinical Site #14 Chermside Australia
Exelixis Clinical Site #29 South Brisbane Australia
Exelixis Clinical Site #102 Porto Alegre Rio Grande do Sul
Exelixis Clinical Site #68 Barretos Brazil
Exelixis Clinical Site #39 Itajaí Brazil
Exelixis Clinical Site #69 Passo Fundo Brazil
Exelixis Clinical Site #70 Porto Alegre Brazil
Exelixis Clinical Site #78 Porto Alegre Brazil
Exelixis Clinical Site #87 Santo André Brazil
Exelixis Clinical Site #50 São José do Rio Preto Brazil
Exelixis Clinical Site #101 São Paulo Brazil
Exelixis Clinical Site #81 São Paulo Brazil
Exelixis Clinical Site #85 São Paulo Brazil
Exelixis Clinical Site #43 São Paulo Brazil

+ 123 more sites — see the full list on the official registry below.

On this site

📄 Opdivo (nivolumab) drug profile →

More Exelixis trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05678673 on ClinicalTrials.gov ↗ ← All trials in the UK