Oncology / Haematology

A Phase 3, Randomized, Open-Label, Controlled Study of Cabozantinib (XL184) in Combination with Atezolizumab vs. Second Novel Hormonal Therapy (NHT) in Patients with High Risk, Metastatic Castration-Resistant Prostate Cancer

Trial Name: CONTACT-02

PI: Dr Emma Beardsley

Who can take part:

• Patients with histologically or cytologically confirmed adenocarcinoma of the prostate.
• Prior treatment with one, and only one, NHT (eg, abiraterone, apalutamide, darolutamide, or enzalutamide) for castration-sensitive locally advanced (T3 or T4) or metastatic castration-sensitive prostate cancer, M0 CRPC, or mCRPC.
• Bilateral orchiectomy or ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist/antagonist (surgical or medical castration), with serum testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at screening.
• Patients with measurable (extrapelvic soft tissue) metastatic disease

 

Exclusion criteria:

• Patients with only evidence of metastasis is adenopathy below the aortic bifurcation, non-measurable soft tissue (visceral or adenopathic) disease per RECIST 1.1, or bone-only disease.
• Any prior nonhormonal therapy initiated for the treatment of mCRPC.
• Receipt of abiraterone within 1 week; cyproterone within 10 days; or receipt of flutamide, nilutamide, bicalutamide, enzalutamide, or other androgen-receptor inhibitors within 2 weeks before randomization

For further information please contact Sean Chinnathumby – 03 9784 8152

Trial Phase

Non-drug Phase 1 Phase 2 Phase 3 Phase 4