Actively Recruiting
Phase II Trial of Alternative Cabozantinib Dosing Schedule in Metastatic Renal Cell Carcinoma and Neuroendocrine Tumors
Led by Fox Chase Cancer Center · Updated on 2026-05-22
111
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
F
Fox Chase Cancer Center
Lead Sponsor
E
Exelixis
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a phase II trial to study an alternative dosing schedule of cabozantinib in patients with metastatic renal cell carcinoma (mRCC) and neuroendocrine tumors (NETs). The trial includes patients with different risk levels of mRCC who have not previously been treated with cabozantinib, as well as patients with pancreatic or extra-pancreatic NETs. The study aims to assess cabozantinib's dosing effects alone or combined with nivolumab, focusing on safety, dosing, and patient outcomes. The trial is divided into three cohorts. Cohorts A and C will receive cabozantinib alone with a flexible dosing schedule starting at 40 mg daily, with adjustments made in smaller increments using alternate day dosing to fine-tune the dose between 20 mg every other day and 60 mg daily. Cohort B will receive cabozantinib alongside monthly fixed-dose nivolumab infusions. Each treatment cycle lasts 28 days, with weekly follow-ups during the first cycle, bi-weekly during the second, and monthly thereafter to monitor and adjust dosing as needed. Participants will undergo regular assessments including weekly and bi-weekly visits initially, then monthly check-ins to monitor dose adjustments and side effects. Researchers will evaluate the average daily dose patients can tolerate, progression-free survival, adverse events, response rates by RECIST criteria, and overall survival. The study will last up to two years for outcome measurement and safety monitoring, with ongoing dose adjustments based on patient tolerance and protocol criteria throughout the treatment period.
CONDITIONS
Brief Title
Trial of an Alternative Cabozantinib Dosing Schedule in Metastatic Renal Cell Carcinoma and Neuroendocrine Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed advanced renal cell carcinoma with clear cell or non-clear cell components for Cohorts A and B
- Any number of prior therapies allowed for Cohort A; Cohort B patients must be treatment-naive in metastatic setting
- Prior adjuvant immunotherapy allowed if completed over 12 months ago for Cohort B
- Well-differentiated neuroendocrine tumors grades 1-3 with progression in prior 12 months for Cohort C
- Stable dose of somatostatin analogue for at least 2 months allowed
- At least one measurable lesion by RECIST 1.1
- No uncontrolled hypertension; blood pressure must be controlled
- Age 18 years or older
- ECOG performance status 0 to 2
- Normal organ and marrow function as defined by specific blood counts and lab values
- Ability to understand and sign informed consent
- Agree to use medically accepted contraception during and 4 months after study treatment
You will not qualify if you...
- Systemic anti-cancer therapy or radiotherapy within 14 days or five half-lives before study start
- Radiation therapy for bone metastases within 2 weeks or other radiation within 4 weeks before study
- Prior therapy with cabozantinib
- Prior systemic therapy for advanced RCC not allowed for Cohort B
- Active or suspected autoimmune disease for Cohort B except specific allowed conditions
- Systemic corticosteroids or immunosuppressive medication use within 14 days before study drug for Cohort B
- Use of other investigational agents
- Allergic reactions to similar compounds
- Use of strong CYP3A4 inhibitors or inducers (except topical)
- Certain anticoagulant medications not permitted; some low-dose or stable anticoagulants allowed
- Uncontrolled infections, heart failure, unstable angina, arrhythmias, or psychiatric/social conditions limiting compliance
- Specific cardiovascular conditions including severe heart failure and prolonged QTc
- Uncontrolled hypertension despite treatment
- Recent stroke, myocardial infarction, or thromboembolic events within 6 months
- Gastrointestinal disorders with high risk of perforation or fistula
- Recent abdominal fistula, GI perforation, bowel obstruction, or abscess within 6 months
- Cavitating pulmonary lesions or disease in airway
- Tumor lesions invading or encasing major blood vessels except certain intrahepatic vessels
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive cabozantinib starting at 40 mg daily with possible dose escalation or de-escalation based on pre-specified criteria. Cohort B participants also receive monthly nivolumab infusions. Treatment cycles are 28 days with weekly visits during the first cycle, bi-weekly visits during the second cycle, and monthly visits thereafter for dose adjustments and monitoring.
Weekly visits for cycle 1, bi-weekly visits for cycle 2, then monthly visits
Trial Site Locations
Total: 1 location
1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
Research Team
R
Ryan Romasko, MBA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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