Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Atezolizumab

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Abemaciclib twice daily. 1 cycle of treatment is 21 days in length.

Atezolizumab on the first day of each 21-day cycle in combination with abemaciclib twice daily.

Group 1 - Atezolizumab: Patients with CDK12 loss will receive atezolizumab monotherapy on the first day of each 21-day cycle

Group 2 - Abemaciclib 150 mg + atezolizumab: Patients with CDK12 loss will receive atezolizumab on the first day of each 21-day cycle in combination with abemaciclib twice daily.

Abemaciclib 200 MG

Atezolizumab 1200 MG in 20 ML Injection

Abemaciclib 150 MG

Ajjai Alva, MD

This research is studying two experimental drugs, abemaciclib and atezolizumab, alone and in combination with each other, to learn about the safety and effectiveness of these treatments and their side effects. This is an investigational study treatment for adult men with metastatic castrate resistant prostate cancer (mCRPC) who have progressive disease despite previous treatment with androgen deprivation therapy (ADT). One group of men (men without a genetic mutation called "CDK12 loss") will receive abemaciclib therapy alone. Two other groups of men (men with CDK12 loss in one group and men without CDK12 loss in the other) will receive the combination of abemaciclib and atezolizumab. Another group of men with CDK12 loss will receive atezolizumab therapy alone.

Abemaciclib With or Without Atezolizumab in Metastatic Castration Resistant Prostate Cancer

A Phase II Multi-Center Trial of Abemaciclib With or Without Atezolizumab in Metastatic Castration Resistant Prostate Cancer

Percentage of patients without disease progression at 6 months after start of treatment. Disease progression as defined by Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria.

Dose safety for the combination of abemaciclib and atezolizumab is the DLT incidence in Arm B and the combination-therapy cohort of Arm C. DLT is defined in the protocol.

The percentage of patients with at least 50% decline in PSA from pretreatment baseline per PCWG3 criteria

CBR as estimated by proportion of evaluable patients who had complete response (CR), partial response (PR) or stable disease (SD) as their best response to treatment by PCWG3 criteria.

DOR among responders by PCWG3 criteria will be reported by treatment arm using Kaplan-Meier methods.

DOT among responders by PCWG3 criteria will be reported by treatment arm using Kaplan-Meier methods.

TTP among responders by PCWG3 criteria will be reported by treatment arm using Kaplan-Meier methods.

Assessed by Common Terminology Criteria for Adverse Events (CTCAE) 5.0. Results will be submitted in tabular format, showing the number of each AESI by grade (names of AESI in rows; grades 1 - 5 in columns). AESIs are protocol-specific (as defined in the protocol).

Number of patients (in arms A and B) alive at 2 years after the end of their treatment.

Number of patients who responded to treatment (per PCWG3 criteria) alive at 2 years after the end of their treatment.

Spots Global Cancer Trial Database for abemaciclib 150 mg