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Checkpoint Inhibitor

Nivolumab + Ipilimumab for Kidney Cancer

Phase 2

Waitlist Available

Led By Nizar M Tannir

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Patients with locally advanced or metastatic RMC histologically confirmed by expert pathology review and loss of SMARCB1 staining by immunohistochemistry

Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Must not have

Patients who have organ allografts

Patients must not have any other malignancies within the past 2 years except for in situ carcinoma of any site, or adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is studying nivolumab and ipilimumab to see how well they work in treating patients with kidney cancer.

Who is the study for?

This trial is for patients with kidney cancer, specifically Renal Medullary Carcinoma. Participants can be new to treatment or have had previous therapies, must not be HIV positive or pregnant, and should not have other severe medical conditions. They need a good performance status (able to carry out daily activities) and acceptable blood test results.

What is being tested?

The trial is testing the combination of two immunotherapy drugs: Nivolumab and Ipilimumab. These drugs are designed to help the immune system recognize and fight cancer cells in patients with advanced kidney cancer.

What are the potential side effects?

Potential side effects include immune-related reactions that can affect organs like the liver, intestines, skin, hormone glands; fatigue; infusion reactions; possible worsening of pre-existing autoimmune diseases; and an increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is advanced or has spread, and tests show a specific protein is missing.

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I can take care of myself and am up and about more than half of the day.

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I am willing to provide a fresh biopsy of my tumor.

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My kidney function, measured by creatinine, is within normal limits.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received an organ transplant from another person.

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I haven't had any cancer except for specific skin cancers or treated cervical cancer in the last 2 years.

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I am taking high dose steroids or strong immune-suppressing drugs.

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I am not currently on cancer treatment and haven't been for the last 2 weeks.

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I am not on any other treatments for kidney cancer.

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I am not pregnant, breastfeeding, and if capable of having children, I am using effective birth control.

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My cancer has spread to my brain or its coverings and is not under control.

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I have an autoimmune disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective response rate (ORR) defined as completion response or partial response assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria

Progression-free survival (PFS) assessed by RECIST criteria

Secondary study objectives

Incidence of adverse events

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (nivolumab, ipilimumab)Experimental Treatment2 Interventions

Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab IV over 60 minutes on day 1. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ipilimumab

FDA approved

Nivolumab

FDA approved

0 / 12Eligibility criteria met