A Study of AZD4635 With Durvalumab and With Cabazitaxel and Durvalumab in Patients With mCRPC.

Conditions

• Progressive Metastatic Castrate-Resistant Prostate Cancer

Eligibility Criteria

Sex

MALE

Age

18 Years - 150 Years

Healthy Volunteers

Not accepted

Interventions

• AZD4635 — DRUG
  Subjects will receive AZD4635 orally daily
• Durvalumab — DRUG
  Subjects will receive intravenous durvalumab every 4 weeks for Arm A and every 3 weeks for Arm B.
• Cabazitaxel — DRUG
  Subjects will receive intravenous cabazitaxel every 3 weeks

Study Details

This is a Phase II, international, open-label, two-arm, non-randomised study of AZD4635 in participants with metastatic castration-resistant prostate cancer (mCRPC).

Key Dates

Start date

Aug 4, 2020

Status verified

Jul 2023

Primary completion

Nov 1, 2021

Completion

Aug 8, 2022

Study Design

Enrollment

30 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: AZD4635 + durvalumab
  AZD4635 plus durvalumab (Arm A) will consist of participants with mCRPC previously treated with one or more approved NHAs (eg, abiraterone acetate, enzalutamide, apalutamide and/or darolutamide), and one or more taxanes, or participants who are taxane ineligible.
• Experimental: Arm B: AZD4635 + durvalumab + cabazitaxel
  AZD4635 plus durvalumab plus cabazitaxel (Arm B) will consist of participants with mCRPC previously treated with docetaxel and one prior NHA (either abiraterone acetate or enzalutamide but not both (prior apalutamide is not allowed in Arm B).

Primary Outcome Measure

Radiographic Progression Free Survival (rPFS) in Each Arm Separately to Determine the Efficacy of AZD4635 Plus Durvalumab and of AZD4635 Plus Durvalumab Plus Cabazitaxel in Patients With Metastatic Castrate-resistant Prostate Cancer (mCRPC) [ Time Frame: From first dose to first documented progression or death from any cause (whichever comes first) (approximately 1 year) ]

Locations (5)

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