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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months after the first subject is randomized
Awards & highlights
STELLAR-304 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.Check my eligibility
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.See study design
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.
STELLAR-304 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My kidney cancer cannot be surgically removed and has spread.
Select...
I am mostly able to care for myself.
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I am not pregnant and can become pregnant.
STELLAR-304 Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Duration of Overall Survival (OS)
STELLAR-304 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
~4750
Find a Location
Who is running the clinical trial?
ExelixisLead Sponsor
117 Previous Clinical Trials
19,260 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- There is a stored sample of your tumor from a past biopsy.I am 18 years old or older.My kidney cancer cannot be surgically removed and has spread.I am on blood thinners but can switch to LMWH; I am not on platelet inhibitors.I have not had major surgery in the last 8 weeks, laparoscopic nephrectomy in the last 4 weeks, or minor surgery in the last 10 days.I am mostly able to care for myself.I am not pregnant and can become pregnant.Your heart's electrical activity (measured by ECG) shows a prolonged QT interval.I have not received a live vaccine in the last 30 days.My brain metastases have been treated and stable for over 4 weeks.I have had treatment for advanced kidney cancer that cannot be surgically removed.My organs and bone marrow are working well.My kidney cancer is of a specific type (Chromophobe, renal medullary carcinoma, or collecting duct).My last tumor biopsy was over a week ago and I've had no complications from it.The doctor can measure your disease using a specific method called RECIST v1.1.I haven't had radiation for bone metastases in the last 2 weeks or any other radiation in the last 4 weeks.My side effects from previous treatments are mild or gone.
Research Study Groups:
This trial has the following groups:- Group 1: XL092 + Nivolumab
- Group 2: Sunitinib Malate
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the combination of XL092 and Nivolumab sanctioned by regulatory authorities?
"There is a substantial amount of preliminary research that supports the safety profile of XL092 + Nivolumab, therefore it has been assigned an agreeable score of 3."
Answered by AI
Is enrollment still ongoing for this clinical trial?
"Confirmed, the clinical trial is actively recruiting patients. The information was initially posted on January 1st 2023 and was recently updated on January 13th of the same year. This study requires 291 individuals to be enrolled from a single site."
Answered by AI
How many individuals are included in the sample population of this research?
"Affirmative, the information hosted on clinicaltrials.gov attests to this trial's active recruitment of patients which began in January 1st 2023 and has since been updated as recent as January 13th 2023. This project needs 291 participants from a single medical centre."
Answered by AI
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