A Phase II Study of Nivolumab With Ipilimumab and Cabozantinib in Patients With Untreated Renal Cell Carcinoma Brain Metastases

Who is this study for? Patients with Brain Metastases, Renal Cell Carcinoma
What treatments are being studied? Nivolumab+Ipilimumab+Cabozantinib
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

A Phase II Study of Nivolumab with Ipilimumab and Cabozantinib in Patients with Untreated Renal Cell Carcinoma Brain Metastases

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Signed Informed Consent Form (ICF)

• Ability and willingness to comply with the requirements of the study protocol

• Age ≥18 years

• Life expectancy \>12 weeks

• Asymptomatic and off steroids for at least 10 days except patients: who have mild symptoms from intracranial disease that do not affect their performance status

• Prior therapies for extracranial metastatic renal cell carcinoma as long as it did not include anti- CTLA-4 or cabozantinib or MET inhibitors

• Patients with histologically confirmed metastatic renal cell carcinoma and at least one measurable intracranial target lesion for which all of the following criteria are met:

• \- Previously untreated or progressive after previous local therapy(limited to SRS and surgery)

⁃ Immediate local therapy clinically not indicated or patient is not a suitable candidate to receive immediate local therapy.

⁃ 5mm to 30mm, as determined by MRI with contrast.

• Adequate hematologic and essential organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment (C1D1)

‣ Absolute neutrophil count (ANC) ≥1500 cells/µL

⁃ White blood cell (WBC) counts \>2500/µ -- Lymphocyte count ≥500/µL

⁃ Platelet count ≥ 100,000/µL;

⁃ Hemoglobin ≥9.0 g/dL

⁃ Serum albumin≥2.8g/dl

⁃ Total bilirubin ≤1.5×upper limit of normal (ULN) with the following exception:

• Patients with known Gilbert disease who have serum bilirubin level ≤3×ULN may be enrolled.

• \- Alanine aminotransferase (ALT) ≤ 3x upper limit of normal (ULN).

⁃ Aspartate aminotransferase (AST) ≤ 3x upper limit of normal (ULN).

⁃ Alkaline phosphatase ≤5×ULN in patients with documented bone metastases.

⁃ Serum creatinine ≤ 1.5x ULN or calculated creatinine clearance ≥ 40mL/min (≥ 0.675mL/sec) using the Cockcroft-Gault equation: Males: (140 - age) x weight (kg)/(serum creatinine \[mg/dL\] × 72)Females: \[(140 - age) x weight (kg)/(serum creatinine \[mg/dL\] × 72)\] × 0.85

⁃ Urine protein/creatinine ratio (UPCR) ≤ 1 mg/mg (≤ 113.2 mg/mmol), or 24-h urine protein ≤ 1 g.

• For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use highly effective form(s) of contraception (i.e., one that results in a low failure rate \[\<1% per year\] when used consistently and correctly) and to continue its use for at least 12 months after the last dose of Cabozantinib and Nivolumab

⁃ Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 (see Appendix 5)

⁃ INR and aPTT ≤1.5×ULN within 7 days prior to study enrollment 12. Recovery to baseline or ≤ Grade 1 CTCAE v5 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.

Locations
United States
Texas
M D Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Jianbo Wang
jwang38@mdanderson.org
(713) 792-3393
Time Frame
Start Date: 2022-09-20
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 20
Treatments
Experimental: Nivolumab
by vein every 3 weeks for 4 doses
Experimental: Ipilimumab
by vein over 30 minutes every 3 weeks for 4 doses
Experimental: Cabozantinib
tablets by mouth 1 time every day.
Related Therapeutic Areas
Sponsors
Leads: M.D. Anderson Cancer Center
Collaborators: Bristol-Myers Squibb, Exelixis

This content was sourced from clinicaltrials.gov

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