Abemaciclib +/− Atezolizumab for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen byAtish D. Choudhury

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing whether a molecularly targeted chemotherapy drug called abemaciclib and an immunotherapy drug called atezolizumab, alone or in combination, are effective in shrinking or preventing the growth of metastatic prostate cancer. The trial is also testing the safety of the combination of abemaciclib with atezolizumab.

Research Team

Atish D. Choudhury

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for adult males with metastatic castration-resistant prostate cancer (mCRPC) who have progressive disease and are not candidates for certain chemotherapies. They must have tried at least one antiandrogen therapy, maintain low testosterone levels, and be in good enough health to participate. Men with untreated brain metastases or active autoimmune diseases treated recently are excluded.

Inclusion Criteria

creatinine clearance ≥30 mL/min/1.73 m2

My tumor has not been tested with NGS; I can join the unselected study groups.

My doctor thinks taxane treatment isn't right for me.

See 37 more

Exclusion Criteria

Any of the following abnormalities on pre-treatment pulmonary function testing:

I have had radiation therapy to my chest area before.

Active smoking or a history of smoking greater than 20 pack-years (i.e. # packs of cigarettes smoked per day × # of years patient has smoked > 20)

See 19 more

Treatment Details

Interventions

Abemaciclib (CDK4/6 Inhibitor)
Atezolizumab (PD-L1 Inhibitor)

Trial OverviewThe trial examines the effectiveness of abemaciclib alone or combined with atezolizumab in treating mCRPC. It also assesses the safety of this combination therapy. Participants will receive molecularly targeted chemotherapy and immunotherapy drugs to see if they can shrink or halt tumor growth.

Participant Groups

4Treatment groups

Experimental Treatment

Group I: CDK12 Mutation Atezolizumab Monotherapy (Non-Randomized)Experimental Treatment1 Intervention

Participants in the CDK12 Mutation Cohort defined as those whose tumors are known to have mutations in the CDK12 gene are not randomized but are assigned to receive either Atezolizumab monotherapy or in combination with Abemaciclib based on how many participants in this cohort previously received study treatment. Atezolizumab monotherapy will be given to participants 1-5, these participants will receive Atezolizumab intravenously Day 1 of each 21-Day cycle

Group II: CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized)Experimental Treatment2 Interventions

Participants in the CDK12 Mutation Cohort defined as those whose tumors are known to have mutations in the CDK12 gene are not randomized but are assigned to receive either Atezolizumab monotherapy or in combination with Abemaciclib based on how many participants in this cohort previously received study treatment. Combination Therapy will be given to participants 6-21, these participants will receive Abemaciclib orally 2x daily and Atezolizumab intravenously Day 1 of each 21-Day cycle

Group III: Biomarker-Unselected Abemaciclib Monotherapy (Randomized)Experimental Treatment1 Intervention

Participants in the Biomarker-Unselected Cohort, defined as those whose tumors are not known to have mutations in the CDK12 gene will be randomized to either receive Abemaciclib as monotherapy or in combination with Atezolizumab * Monotherapy : Participants will receive Abemaciclib orally 2x daily

Group IV: Biomarker-Unselected Abemaciclib + Atezolizumab (Randomized)Experimental Treatment2 Interventions

Participants in the Biomarker-Unselected Cohort, defined as those whose tumors are not known to have mutations in the CDK12 gene will be randomized to either receive Abemaciclib as monotherapy or in combination with Atezolizumab * Combination Therapy: Participants will receive Abemaciclib orally 2x daily and Atezolizumab intravenously Day 1 of each 21-Day cycle