Combination Nivolumab and Ipilimumab With and Without Camu Camu in First Line Treatment of Metastatic Renal Cell Carcinoma

Plain English Summary

Nivolumab and Ipilimumab With and Without Camu Camu for the Treatment of Patients With Metastatic Renal Cell Carcinoma is a Phase 1 clinical trial sponsored by City of Hope Medical Center studying Clear Cell Renal Cell Carcinoma, Sarcomatoid Renal Cell Carcinoma, Stage III Renal Cell Cancer AJCC v8, Stage IV Renal Cell Cancer AJCC v8. This trial is testing a combination of existing kidney cancer drugs (nivolumab and ipilimumab) with camu camu, a natural supplement, to see if it's safe and effective. It is for patients with advanced or metastatic kidney cancer (clear cell or sarcomatoid type) who have not received prior systemic therapy. Participation involves receiving the study drugs and camu camu, along with regular medical check-ups, scans, and sample collections. Alternative treatments include other standard chemotherapy, targeted therapy, or immunotherapy regimens for advanced kidney cancer. The trial aims to enroll 30 participants.

Official Summary

This phase I trial tests the safety, side effects, and best dose of camu camu when used in combination with nivolumab and ipilimumab in treating patients with kidney cancer that has spread to other places in the body. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Camu camu is a prebiotic that may have a beneficial effect on the immune system. Giving camu camu in combination with nivolumab and ipilimumab may kill more tumor cells than nivolumab and ipilimumab alone in patients with metastatic kidney cancer.

Who Can Participate

Here is what you need to know about eligibility for this trial. Patients with clear cell or sarcomatoid kidney cancer that has spread and is not curable by surgery or radiation can join. Patients must be at least 18 years old and have good general health, with no prior treatment for advanced kidney cancer (with some exceptions). Patients with untreated brain tumors or certain autoimmune conditions are not eligible. Patients must have adequate kidney and liver function, and specific blood cell counts. This trial is studying Clear Cell Renal Cell Carcinoma, Sarcomatoid Renal Cell Carcinoma, Stage III Renal Cell Cancer AJCC v8, Stage IV Renal Cell Cancer AJCC v8, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures the change in a specific type of gut bacteria (Ruminococcus) in stool samples, which may indicate how the treatment affects the gut microbiome and potentially influences c The specific primary outcome measures are: Abundance of ruminococcus in the stool (From baseline to week 12 of therapy). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.

Why This Trial Matters

This trial aims to explore if adding camu camu, a prebiotic, to standard immunotherapy can improve treatment outcomes for patients with advanced kidney cancer, addressing a need for more effective the This research targets Clear Cell Renal Cell Carcinoma, Sarcomatoid Renal Cell Carcinoma, Stage III Renal Cell Cancer AJCC v8, Stage IV Renal Cell Cancer AJCC v8, where improved treatment options are needed.

Investor Insight

This Phase 1 trial, though suspended, signals interest in exploring novel combinations for a significant cancer market; success could lead to further development, but the suspension indicates early-st Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor about the potential benefits and risks of camu camu, especially if you are taking other supplements. Be prepared for regular clinic visits for drug administration, blood tests, scans, and sample collection. Report any new or worsening symptoms, especially those related to your digestive system or immune response, to your care team immediately. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 30 participants

Interventions

• PROCEDURE: Biospecimen Collection — Undergo blood and stool sample collection
• PROCEDURE: Bone Scan — Undergo bone scan
• PROCEDURE: Computed Tomography — Undergo CT
• BIOLOGICAL: Ipilimumab — Given IV
• PROCEDURE: Magnetic Resonance Imaging — Undergo MRI

Primary Outcomes

• Abundance of ruminococcus in the stool (From baseline to week 12 of therapy)

Secondary Outcomes

• Best overall response (Every 12 weeks for up to 3 years)
• Progression-free survival (PFS) (Time from enrollment to progression date or date of death, whichever occurs first (Each cycle is 4 weeks))
• Incidence of adverse events (Up to 30 days post-last dose of protocol therapy)

Full Eligibility Criteria

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)

Trial Locations

• City of Hope Medical Center, Duarte, California, United States

Frequently Asked Questions

Related Conditions

• Kidney Cancer
• Renal Cell Carcinoma
• Metastatic Cancer
• Clear Cell Renal Cell Carcinoma
• Sarcomatoid Renal Cell Carcinoma
• Stage III Cancer
• Stage IV Cancer
• Immunotherapy
• Oncology
• Gastrointestinal Health

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