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Checkpoint Inhibitor

Nivolumab + Ipilimumab for Kidney Cancer

Phase 3

Waitlist Available

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No prior systemic therapy for RCC

Advanced (not amenable to curative surgery or radiation therapy) renal cell carcinoma (RCC) or metastatic RCC (mRCC)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

Study Summary

This trial will test a new combination therapy for kidney cancer that has spread. The goal is to see if it is more effective and safe than a monotherapy treatment.

Who is the study for?

This trial is for adults with advanced kidney cancer that can't be removed by surgery or treated with radiation. They should not have had any previous systemic treatments for their cancer, must show measurable signs of the disease on scans, and be classified as having an intermediate or poor prognosis.Check my eligibility

What is being tested?

The study is comparing the effectiveness of two approaches: one group will receive Nivolumab combined with Ipilimumab (both are immunotherapy drugs), while another group gets Nivolumab alone. The goal is to see which treatment works better for new kidney cancer patients.See study design

What are the potential side effects?

Nivolumab and Ipilimumab may cause immune-related side effects such as inflammation in various organs, skin rash, hormone gland problems like thyroiditis, digestive issues like colitis, liver inflammation called hepatitis, and potential lung issues known as pneumonitis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have not had any drug treatments for kidney cancer.

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My kidney cancer cannot be cured with surgery or radiation.

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My cancer can be measured on scans according to specific criteria.

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My kidney cancer is classified as intermediate or poor risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective response rate (ORR) by BICR

Progression free survival (PFS) by blinded independent central review (BICR)

Secondary outcome measures

Disease control rate (DCR) by BICR

Disease control rate (DCR) by investigator

Duration of response (DoR) by BICR

+21 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Nivolumab + ipilimumab placeboExperimental Treatment1 Intervention

Group II: Nivolumab + ipilimumabExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ipilimumab

2014

Completed Phase 3

~2620

Nivolumab

2014

Completed Phase 3

~4750

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,638 Previous Clinical Trials

4,128,077 Total Patients Enrolled

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03873402 — Phase 3

Kidney Cancer Research Study Groups: Nivolumab + ipilimumab, Nivolumab + ipilimumab placebo

Kidney Cancer Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT03873402 — Phase 3

Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03873402 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Ipilimumab received FDA approval in the United States?

"Ipilimumab is a Phase 3 clinical trial drug, meaning that while there is data supporting its efficacy, there is also extensive data affirming its safety. Therefore, our team rates Ipilimumab as a 3 on our safety scale."

Answered by AI

Is Ipilimumab a new drug being trialed?

"As of now, there are 800 clinical trials researching Ipilimumab with 87 trials in Phase 3. While most of the studies for Ipilimumab are located in Pittsburgh, Pennsylvania, there are 43480 locations operating clinical trials for Ipilimumab."

Answered by AI

Could you provide an estimate of the total patient population for this research?

"As of right now, this particular trial has completed recruitment for participants. The trial was first posted on 6/21/2019, with the most recent update being on 2/9/2022. There are 2655 trials for carcinoma and 800 trials for Ipilimumab that are still admitting patients if you are interested."

Answered by AI

Can you tell me if this research project is still enrolling participants?

"According to the website clinicaltrials.gov, this particular clinical trial is not looking for new participants at the moment. This study was first posted on June 21st, 2019 and was last updated on February 9th, 2022. Although this study isn't currently recruiting, there are 3455 other studies that are."

Answered by AI

What is the primary use for Ipilimumab?

"Ipilimumab is not only effective at treating previous anti-angiogenic therapy, but also malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer

2019. "A Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03873402.

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