Could a tropical berry boost immunotherapy for kidney cancer?
NCT ID NCT06049576
First seen Jun 26, 2026 · Last updated Jul 23, 2026 · Updated 3 times
Summary
This early-phase trial tests whether adding camu camu, a prebiotic fruit, to standard immunotherapy (nivolumab and ipilimumab) is safe and can improve treatment for advanced kidney cancer. About 31 people with metastatic clear-cell or sarcomatoid kidney cancer will receive the combination. The study looks at changes in gut bacteria and tumor response, aiming to see if the prebiotic helps the immune system fight cancer better.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- camu camu (a prebiotic fruit extract) combined with nivolumab and ipilimumab (immunotherapy drugs)
- What this could lead to
- If it works, adding camu camu could boost the immune system's ability to fight kidney cancer, potentially improving how well standard immunotherapy works.
- What could go wrong
- This is a very early phase 1 trial with only 31 people, so it is mainly checking safety and dosing. It is too soon to know if camu camu truly helps, and it may not lead to better outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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31 people
The number who actually took part.
- Started
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Oct 2023
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Be willing and able to provide informed consent for the trial * 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: * Presence of untreated brain metastases. Patients with treated brain metastases must be stable for 4 weeks after completion of treatment and have documented stability on pre-study imaging. Patients must have no clinical symptoms from brain metastases and have no requirement for systemic corticosteroids amounting to \> 10 mg/day of prednisone or its equivalent for at least 2 weeks prior to first dose of study drug. Patients with known leptomeningeal metastases are excluded, even if treated * 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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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City of Hope Medical Center
Duarte, California, 91010, United States
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Other studies related to the condition(s) this trial covers.
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