Study on Abemaciclib With or Without Atezolizumab for Advanced Prostate Cancer

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04751929

Provider View

This clinical trial is exploring whether the drugs abemaciclib and atezolizumab, used alone or together, can help shrink or stop the growth of advanced prostate cancer. The study also aims to determine the safety of using these drugs in combination.

Patient Parameters

Program Overview

This study is testing two drugs, abemaciclib and atezolizumab, to see if they can help treat advanced prostate cancer that has spread and is resistant to standard hormone treatments. Abemaciclib is a chemotherapy drug taken by mouth that stops cancer cells from dividing. Atezolizumab is an immunotherapy drug given through an IV that helps the immune system attack cancer cells. The study will see if these drugs work better together and if they are safe to use in combination. Participants will be divided into two groups based on their tumor's genetic makeup to see which treatment works best for them.

Description

This trial involves patients with advanced prostate cancer that has spread and is resistant to hormone therapy. The study will test the effectiveness and safety of two drugs, abemaciclib and atezolizumab, used alone or together. Abemaciclib is a chemotherapy drug that blocks cancer cell division, while atezolizumab is an immunotherapy drug that boosts the immune system to fight cancer. The study will include two groups of participants: one group whose tumors do not have a specific genetic mutation (CDK12) and another group whose tumors do have this mutation. The study will test different combinations of the drugs in these groups to see which is most effective. Participants will continue treatment as long as it is safe and effective, with follow-up for up to 24 months. About 75 people are expected to participate. The study is supported by Eli Lilly and Company and Genentech, Inc., who provide the study drugs.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 or older with advanced prostate cancer that has spread and is resistant to hormone therapy.
  • Cancer must be progressing, shown by rising PSA levels or scans.
  • Must have had previous treatment with hormone therapy drugs like abiraterone or enzalutamide.
  • Not suitable for certain chemotherapy drugs like docetaxel due to previous intolerance or other reasons.
  • Must maintain low testosterone levels through surgery or medication.
  • Must have good organ function and be able to swallow pills.
  • Must agree to sign informed consent and understand the study.
  • For certain participants, must have a specific genetic mutation (CDK12) in their tumor.

Exclusion Criteria

  • Cancer that has spread to the brain and is untreated.
  • Another active cancer, except for certain skin cancers or cancers in remission.
  • Recent chemotherapy or radiation therapy.
  • Previous treatment with similar drugs to abemaciclib or atezolizumab.
  • Taking certain medications that affect how the study drugs work.
  • Active autoimmune disease needing treatment in the last 2 years.
  • Recent live vaccine.
  • Significant smoking history or lung issues.
  • Active infections like HIV or hepatitis.
  • Recent blood clots or serious medical conditions that could affect participation.

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