A Phase II, Open-label Study to Assess the Efficacy, Safety, and Tolerability of AZD4635 in Combination with Durvalumab and in Combination with Cabazitaxel and Durvalumab in Patients Who Have Progressive Metastatic Castrate-Resistant Prostate Cancer (AARDVARC) - AARDVARC

AstraZeneca AB0 sites80 target enrollmentOctober 21, 2020

Overview

No summary available.

Registry

who.int

Start Date

October 21, 2020

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

•1 Participant must be 18 years of age inclusive at the time of signing the informed consent.
•2 Histologically confirmed adenocarcinoma of the prostate.
•3 Known castrate\-resistant disease.
•4 Evidence of disease progression \=6 months.
•5 Body weight \>30 kg at screening.
•6 Willingness to adhere to the study treatment\-specific contraception requirements.
•7 Adequate bone marrow reserve and organ function.
•8 Adequate organ function for Arm A as demonstrated by all of the following laboratory values:
•\- Alanine aminotransferase (ALT) \=2\.5 × upper limit of normal (ULN) if no demonstrable liver metastases or \=5 × ULN in the presence of liver metastases.
•\- Aspartate aminotransferase (AST) \=2\.5 × ULN if no demonstrable liver metastases or \=5 × ULN in the presence of liver metastases

•1 Active brain metastases or leptomeningeal metastases.
•2 There must be no requirement for immunosuppressive doses of systemic corticosteroids for at least 2 weeks prior to study enrollment.
•3 History of pneumonitis, second malignancy that is progressing and/or received active treatment \=3 years before the first dose of study intervention, and hypersensitivity to polysorbate\-80 if allocated to cabazitaxel.
•4 As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases.
•5 Creatinine clearance \<40 mL/min (calculated by Cockcroft\-Gault equation).
•6 Prior exposure to immune\-mediated therapy.
•7 History of allogeneic organ transplantation.\-
•8 Active or prior documented autoimmune or inflammatory disorders
•9 History of active primary immunodeficiency.
•10 Active infection including tuberculosis