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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

No Placebo-Only Group

Pivotal Trial

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months after the first subject is randomized

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)