Cabozantinib and Atezolizumab for the Treatment of Metastatic Castration-Resistant Prostate Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Utah

About this trial

This phase II trial tests whether cabozantinib and atezolizumab work to shrink tumors in patients with castrate-resistant prostate cancer that had spread to other places in the body (metastatic). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib and atezolizumab may kill more tumor cells in patients with metastatic castrate-resistant prostate cancer.

Eligibility criteria

Qualifiers

Male subject aged >= 18 years

Histologically or cytologically confirmed prostatic adenocarcinoma without small cell histology

Metastatic disease progression after continuous androgen deprivation therapy for hormone sensitive state

Patient must have non-measurable disease outside the pelvis (above aortic bifurcation) per RECIST 1.1 criteria. Non-measurable disease can be bone lesions and/or extraskeletal disease

Disqualifiers

Prior chemotherapy in the metastatic castration refractory prostate cancer setting is not allowed (taxane-based in metastatic castration-sensitive disease is allowed)

Prior treatment with cabozantinib, CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-a, anti-PD1 and anti-PD-L1 therapeutic antibodies

Prior treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment

Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment

Trial design

Treatments tested in this trial

  • Atezolizumab
  • Cabozantinib S-malate

Treatment groups

33 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of Utah

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Huntsman Cancer Institute

Collaborator