Nivolumab and Ipilimumab With and Without Camu Camu for the Treatment of Patients With Metastatic Renal Cell Carcinoma
NCT ID: NCT06049576
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE1
30 participants
INTERVENTIONAL
2023-10-06
2026-03-14
Brief Summary
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Detailed Description
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I. To determine the effect of camu camu in combination with nivolumab/ipilimumab on Ruminococcus abundance in stool samples of patients with metastatic renal cell carcinoma (mRCC).
SECONDARY OBJECTIVES:
I. To evaluate the effect of camu camu on the clinical efficacy of the nivolumab/ipilimumab combination.
II. To determine the effect of camu camu on systemic immunodulation of the nivolumab/ipilimumab combination in patients with mRCC.
III. To describe the toxicity and safety profile of the use of camu camu in combination with nivolumab/ipilimumab.
IV. To determine the effect of camu camu on gut microbiome diversity and function.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients receive nivolumab intravenously (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 computed tomography (CT) and/or bone scan and/or magnetic resonance imaging (MRI) on trial.
ARM 2: Patients receive nivolumab IV over 30 minutes on day, ipilimumab IV over 30 minutes on day 1, and camu camu orally (PO) once a day (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.
After completion of study treatment, patients are followed up every 12 weeks until time of death or formal withdrawal from the study, whichever comes first.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1 (nivolumab and ipilimumab)
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.
Biospecimen Collection
Undergo blood and stool sample collection
Bone Scan
Undergo bone scan
Computed Tomography
Undergo CT
Ipilimumab
Given IV
Magnetic Resonance Imaging
Undergo MRI
Nivolumab
Given IV
Arm 2 (nivolumab, ipilimumab, camu camu)
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.
Biospecimen Collection
Undergo blood and stool sample collection
Bone Scan
Undergo bone scan
Computed Tomography
Undergo CT
Ipilimumab
Given IV
Magnetic Resonance Imaging
Undergo MRI
Myrciaria dubia Prebiotic Supplement
Given PO
Nivolumab
Given IV
Interventions
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Biospecimen Collection
Undergo blood and stool sample collection
Bone Scan
Undergo bone scan
Computed Tomography
Undergo CT
Ipilimumab
Given IV
Magnetic Resonance Imaging
Undergo MRI
Myrciaria dubia Prebiotic Supplement
Given PO
Nivolumab
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histological confirmation of renal cell carcinoma (RCC) with a clear-cell or sarcomatoid component
* Advanced (not amenable to curative surgery or radiation therapy) or metastatic (American Joint Committee on Cancer \[AJCC\] 8 stage IV) RCC
* Intermediate or poor risk disease by International Metastatic Renal Cell Carcinoma Database Consortium Criteria (IMDC) classification
* No prior systemic therapy for RCC with the following exception:
* One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such therapy did not include an agent that targets PD-1 or PD-L1 and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy
* Eastern Cooperative Oncology Group (ECOG) performance status \< 2
* Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
* Males and females, ages \>= 18
* Any ethnicity or race
* Adequate renal function defined as calculated creatinine clearance \>= 30 milliliters per minute (mL/min) per the Cockcroft and Gault formula or Serum creatinine \< 1.5 x upper limit of normal (ULN)
* Adequate liver function defined by aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 3 x ULN (\< 5 x ULN if liver metastases are present), and total bilirubin \< 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin up to 3.0 mg/dL)
* White blood cells (WBC) \> 2,000/mm\^3
* Neutrophils \> 1,500/mm\^3
* Platelets \> 100,000/mm\^3
Exclusion Criteria
* Favorable risk disease by IMDC classification
* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
* Any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (\> 10 mg daily prednisone equivalent) or immunosuppressive medications except for syndromes which would not be expected to recur in the absence of an external trigger. Subjects with vitiligo or type I diabetes mellitus or residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement are permitted to enroll
* Active interstitial lung disease (ILD)/pneumonitis or history of ILD/pneumonitis requiring treatment with systemic steroids
* Baseline pulse oximetry less than 92% "on room air"
* Current use, or intent to use probiotics, prebiotics, yogurt, bacterial fortified foods and other natural supplements =\< 2 week prior to treatment initiation and during the period of treatment
* Any condition requiring systemic treatment with corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to first dose of study drug. Inhaled steroids and adrenal replacement steroid doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
* Uncontrolled adrenal insufficiency
* Known medical condition (e.g., a condition associated with diarrhea or acute diverticulitis) that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results
* Not recovered to =\< Grade 1 toxicities related to any prior therapy before administration of study drug
* Women who are pregnant or breastfeeding
* History of myocarditis or congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), as well as unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction 6 months prior to study entry
* WBC \< 2,000/mm\^3
* Neutrophils \< 1,500/mm\^3
* Platelets \< 100,000/mm\^3
* AST or ALT \> 3 x ULN (\> 5 x ULN if liver metastases are present)
* Total bilirubin \> 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin 3.0 mg/dL)
* Calculated creatinine clearance \<30 millimeters per minute (mL/min) per the Cockcroft and Gault formula or serum creatinine \> 1.5 x upper limit of normal (ULN)
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Sumanta K Pal
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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Other Identifiers
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NCI-2023-06703
Identifier Type: REGISTRY
Identifier Source: secondary_id
22457
Identifier Type: OTHER
Identifier Source: secondary_id
22457
Identifier Type: -
Identifier Source: org_study_id