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)
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) — 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 — 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
Trial sites (163)
Facility
City
Region
Status
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.
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.
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