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.

University of Michigan Rogel Cancer Center

Symptoms and General Pathology

Rare Diseases

Recurrence

Oligodendroglioma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Abemaciclib 200mg tablet PO twice daily administered on 28-day cycles Subjects remain on treatment until tumor progression or unacceptable toxicity.

Subjects will be treated with abemaciclib 200mg by mouth once every 12 hours. Dosing will be continuous and administered on a 28-day cycle

Stephen Bagley, MD

This is a phase II, single arm, open label study looking how well a drug called abemaciclib works in patients with recurrent oligodendroglioma

Primary Objective:

• To determine the efficacy of abemaciclib for recurrent oligodendroglioma, as measured by the estimated proportion of patients alive without disease progression at 6 months from study enrollment (PFS-6)

Secondary Objectives:

* To evaluate the safety and tolerability of abemaciclib in recurrent oligodendroglioma
* To estimate the objective radiographic response rate (ORR) associated with abemaciclib in recurrent oligodendroglioma
* To determine the median progression-free survival (PFS) and overall survival (OS) of patients with recurrent oligodendroglioma treated with abemaciclib
* To determine ORR, PFS, and OS in the subgroup of recurrent oligodendroglioma patients with tumor CIC gene mutations

Exploratory Objectives:

* To measure pharmacodynamic markers of abemaciclib activity on oligodendroglial tumor cells
* To identify pre-treatment tumor characteristics that are associated with response to abemaciclib recurrent oligodendroglioma

This is an open-label, single-institution, single-arm phase II study of the efficacy and safety of abemaciclib in patients with recurrent oligodendroglioma.

Abemaciclib in Patients With Oligodendroglioma

A Single-Arm, Open-label, Phase II Study Evaluating the Efficacy and Safety of Abemaciclib in Patients With Recurrent Oligodendroglioma

Assessed as a) Tumor progression (as measured by modified RANO criteria) or death due to disease or toxicity; OR b) alive without tumor progression

Number of participants with treatment-related adverse events as assessed by CTCAE version 5.0

measured by modified Response Assessment in Neuro-Oncology (RANO) criteria.

defined as the time from date of enrollment until the earliest date of disease progression (as determined by modified RANO criteria) or death due to any cause

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Abemaciclib With or Without Atezolizumab in Metastatic Castration Resistant Prostate Cancer	NCT04272645	Prostate Cancer	Abemaciclib 200... Atezolizumab 12... Abemaciclib 150...	18 Years -	University of Michigan Rogel Cancer Center
Abemaciclib in Patients With Oligodendroglioma	NCT03969706	Oligodendroglio...	Abemaciclib 200...	18 Years -	Abramson Cancer Center at Penn Medicine

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