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Checkpoint Inhibitor

XL092 + Nivolumab vs Sunitinib for Kidney Cancer (STELLAR-304 Trial)

Phase 3
Recruiting
Research Sponsored by Exelixis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years or older on the day of consent.
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.
Must not have
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.
Prior systemic anticancer therapy for unresectable locally advanced or metastatic nccRCC including investigational agents.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months after the first subject is randomized
Awards & highlights

Summary

This trial tests a new drug combo vs. an existing one for people with advanced kidney cancer who haven't had treatment.

Who is the study for?
Adults with advanced or metastatic non-clear cell renal cell carcinoma (nccRCC) that hasn't been treated before can join. They need a certain level of fitness, measurable disease, and proper organ function. Pregnant women, those with specific nccRCC subtypes, recent surgery patients, or individuals who've had certain treatments for this cancer are excluded.
What is being tested?
The trial is testing XL092 in combination with Nivolumab against Sunitinib alone in people with nccRCC. It's a Phase 3 study where participants are randomly assigned to either the test combo or the standard treatment in a 2:1 ratio without hiding which treatment they receive.
What are the potential side effects?
Possible side effects include typical reactions to cancer medications such as fatigue, nausea, skin issues and potential immune-related complications like inflammation of organs due to Nivolumab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My kidney cancer cannot be surgically removed and has spread.
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I am mostly able to care for myself.
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I am not pregnant and can become pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am on blood thinners but can switch to LMWH; I am not on platelet inhibitors.
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I have had treatment for advanced kidney cancer that cannot be surgically removed.
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My kidney cancer is of a specific type (Chromophobe, renal medullary carcinoma, or collecting duct).
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My last tumor biopsy was over a week ago and I've had no complications from it.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months after the first subject is randomized
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months after the first subject is randomized for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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)
Objective response rate (ORR) as assessed by BIRC per RECIST 1.1
Secondary study objectives
Duration of Overall Survival (OS)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: XL092 + NivolumabExperimental Treatment2 Interventions
Subjects with advanced or metastatic nccRCC will receive XL092 + nivolumab
Group II: Sunitinib MalateActive Control1 Intervention
Subjects with advanced or metastatic nccRCC will receive an active comparator of sunitinib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~5220

Find a Location

Who is running the clinical trial?

ExelixisLead Sponsor
119 Previous Clinical Trials
19,628 Total Patients Enrolled

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05678673 — Phase 3
Renal Cell Carcinoma Research Study Groups: XL092 + Nivolumab, Sunitinib Malate
Renal Cell Carcinoma Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT05678673 — Phase 3
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05678673 — Phase 3
~87 spots leftby Jul 2025
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