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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 12 weeks for up to 3 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Abundance of ruminococcus in the stool
Secondary outcome measures
Best overall response
Incidence of adverse events
Progression-free survival (PFS)
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
Biospecimen Collection
2004
Completed Phase 2
~1700
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2620
Computed Tomography
2017
Completed Phase 2
~2720
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
567 Previous Clinical Trials
1,922,630 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,411 Total Patients Enrolled
Sumanta K PalPrincipal InvestigatorCity of Hope Medical Center
9 Previous Clinical Trials
323 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment available for this clinical trial at present?
"The latest information from clinicaltrials.gov reveals that this medical trial is actively recruiting participants, with the initial posting on September 25th 2023 and an update made on September 19th 2023."
Answered by AI
What is the scope of participants being observed in this research project?
"Affirmative. According to clinicaltrials.gov, this medical trial is currently looking for 30 participants from one research centre and was initially posted on September 25th 2023 with the most recent edit occurring on September 19th 2023."
Answered by AI
Has the Arm 2 combination of nivolumab, ipilimumab, and camu camu been given clearance by the FDA?
"Our team at Power has ranked the safety of Arm 2 (nivolumab, ipilimumab, camu camu) with a score of 1. This is due to the fact that this Phase 1 trial only contains limited data regarding both efficiency and protection."
Answered by AI
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