Actively Recruiting
Study of Cabozantinib and Nivolumab in Metastatic Castration Resistant Prostate Cancer
Led by Rana McKay, MD · Updated on 2026-01-23
47
Participants Needed
4
Research Sites
218 weeks
Total Duration
On this page
Sponsors
R
Rana McKay, MD
Lead Sponsor
E
Exelixis
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multicenter, single-arm, two-stage open-label phase 2 study of the combination of cabozantinib + nivolumab in subjects with advanced castration-resistant prostate cancer (CRPC).
CONDITIONS
Official Title
Study of Cabozantinib and Nivolumab in Metastatic Castration Resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males 18 years of age and older
- Histological or cytological proof of prostate adenocarcinoma or mixed adenocarcinoma/neuroendocrine tumors (pure small cell prostate cancer not allowed)
- ECOG performance status of 2 or less
- Progressive metastatic castration-resistant prostate cancer with castrate serum testosterone levels and disease progression by PSA or imaging
- Measurable or non-measurable disease allowed; enrollment with only bone metastases capped at 50%
- Prior exposure to one taxane chemotherapy (or taxane ineligible/refusal) and one androgen receptor-targeting agent
- Recovery to baseline or Grade 1 or less from prior treatment toxicities
- Normal organ function with specified laboratory values within 14 days before treatment
- Agreement to use medically acceptable birth control
- HIV-positive patients with negative viral loads and CD4 count above 350 on stable antiretroviral therapy
You will not qualify if you...
- Disease progression during prior checkpoint inhibitor therapy
- Prior treatment with cabozantinib
- Use of kinase inhibitors within 2 weeks prior to study treatment
- Use of cytotoxic, biologic, or investigational anti-cancer agents within 4 weeks prior
- Recent treatment with certain prostate cancer therapies within 2 to 4 weeks
- More than one prior chemotherapy line (first-generation anti-androgens not counted)
- Live attenuated vaccine within 30 days before study treatment
- Active autoimmune disease or requiring prednisone over 10 mg daily
- Imminent or established spinal cord compression
- Radiation therapy within 1 week before treatment start
- Untreated or unstable brain metastases
- History or evidence of pneumonitis or lung inflammation
- Malabsorption syndrome or dialysis requirement
- History of organ or stem cell transplant
- Active hepatitis B/C or tuberculosis needing treatment
- Use of certain anticoagulants unless stable and without bleeding complications
- Significant uncontrolled cardiovascular or gastrointestinal diseases
- Recent major or minor surgery without complete healing
- QTc interval over 500 ms on ECG
- Other active malignancies requiring treatment within 3 years except certain skin or superficial bladder cancers
- Known allergy to study drugs
- Inability to swallow tablets
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
University of California San Diego
La Jolla, California, United States, 92093
Actively Recruiting
2
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
3
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
4
University of Wisconsin
Madison, Wisconsin, United States, 53705
Actively Recruiting
Research Team
R
Rana R. McKay, MD
CONTACT
L
LeaEtta Hyer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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