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Checkpoint Inhibitor

Nivolumab + Ipilimumab With/Without Camu Camu for Kidney Cancer

Phase 1

Recruiting

Led By Sumanta K Pal

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

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

Must have

Advanced or metastatic RCC (AJCC 8 stage IV)

Intermediate or poor risk disease by International Metastatic Renal Cell Carcinoma Database Consortium Criteria (IMDC) classification

Must not have

Prior treatment with specific antibodies or drugs targeting T-cell co-stimulation or checkpoint pathways

Condition requiring systemic treatment with corticosteroids or other immunosuppressive medications within 14 days prior to first dose of study drug

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 12 weeks for up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a combo of drugs & camu camu to treat kidney cancer spread to other parts of body. It may help immune system fight cancer & stop growth of tumor cells.

Who is the study for?

This trial is for adults with advanced kidney cancer that has spread. Participants must have adequate kidney and liver function, no prior treatments targeting PD-1 or PD-L1, and not be on immunosuppressants. They should not have favorable risk disease by IMDC classification, active autoimmune diseases, severe lung issues, recent heart problems, untreated brain metastases or be pregnant.

What is being tested?

The trial tests the safety and optimal dose of camu camu combined with nivolumab and ipilimumab in metastatic renal cell carcinoma. It explores whether this prebiotic supplement can enhance the effectiveness of these monoclonal antibodies which boost the immune system's response to cancer.

What are the potential side effects?

Potential side effects include immune-related reactions affecting organs (like inflammation), infusion reactions from antibody treatment, fatigue, possible changes in blood counts leading to increased infection risk. The impact of camu camu as a new intervention will also be closely monitored.

Eligibility Criteria

Inclusion Criteria

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

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My kidney cancer has spread to other parts of my body.

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My kidney cancer is classified as intermediate or poor risk.

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My liver is functioning well according to recent tests.

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My kidney function is within the required range.

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My kidney cancer has been confirmed to be of a specific type.

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I can do all my daily activities without help.

Exclusion Criteria

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

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I have been treated with drugs that target the immune system.

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I haven't taken steroids or immunosuppressants in the last 14 days.

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I am not pregnant or breastfeeding.

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My kidney function is reduced, with low creatinine clearance or high serum creatinine.

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I have or had lung inflammation treated with steroids.

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I have brain metastases that have not been treated.

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I have an autoimmune disease or have been on steroids/immunosuppressants.

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My adrenal glands are not working properly and it's not under control.

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I have recovered from side effects of previous treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 12 weeks for up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 12 weeks for up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 12 weeks for up to 3 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

Abundance of ruminococcus in the stool

Secondary study objectives

Best overall response

Incidence of adverse events

Progression-free survival (PFS)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 2 (nivolumab, ipilimumab, camu camu)Experimental Treatment7 Interventions

Patients receive nivolumab IV over 30 minutes on day, ipilimumab IV over 30 minutes on day 1, and camu camu PO QD continuously with each cycle. Cycles repeat every 3 weeks for cycles 1-4. Beginning cycle 5, patients receive nivolumab over 30 minutes on day 1, and camu camu PO QD of each cycle. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood and stool sample collection and undergo CT and/or bone scan and/or MRI on trial.

Group II: Arm 1 (nivolumab and ipilimumab)Active Control6 Interventions

Patients receive nivolumab IV over 30 minutes on day 1 and ipilimumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 3 weeks for cycles 1-4. Beginning cycle 5, patients receive nivolumab over 30 minutes on day 1 of each cycle. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood and stool sample collection and undergo CT and/or bone scan and/or MRI on trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ipilimumab

2015

Completed Phase 3

~3420

Bone Scan

2015

Completed Phase 2

~50