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CDK4/6 Inhibitor

Abemaciclib +/− Atezolizumab for Prostate Cancer

Phase 2

Waitlist Available

Led By Atish Choudhury, MD, PhD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have adequate organ and marrow function as defined below: leukocytes ≥3,000/mcL absolute neutrophil count ≥1,500/mcL hemoglobin ≥9 g/dL (without transfusion or growth factor in prior 28 days) platelets ≥100,000/mcL (without transfusion or growth factor in prior 28 days) total bilirubin ≤1.5 × institutional upper limit of normal, unless the subject has known or suspected Gilbert's syndrome AST(SGOT)/ALT(SGPT) ≤1.5 × institutional upper limit of normal creatinine clearance ≥30 mL/min/1.73 m2 Life expectancy of at least 6 months, as determined by a study Investigator. Ability to swallow oral medications. Ability to understand and willingness to sign an IRB-approved informed consent.

Patients must have metastatic disease by bone scintigraphy or other nodal or visceral lesions on CT or MRI with a bone or soft tissue lesion amenable to image-guided percutaneous biopsy, and the patient must be evaluable for disease response by either Baseline PSA ≥ 2.0 ng/mL OR Measurable disease per RECIST 1.1

Must not have

Prior history of radiation therapy to thorax (including to lungs/pleura, esophagus, intrathoracic lymph nodes, C7-L2 vertebrae, or ribs) for any reason and any duration/dose

Any history of interstitial lung disease, pneumonitis or idiopathic pulmonary fibrosis, regardless of remission or immunosuppression status

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment to end of treatment, up to 2 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial is testing the effectiveness of a molecularly targeted chemotherapy drug and an immunotherapy drug in shrinking or preventing the growth of metastatic prostate cancer.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects include reactions related to immune system activation such as inflammation in various organs, fatigue, digestive issues, blood-related problems, increased risk of infections, and possibly others specific to each drug's profile.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has spread, and it can be measured by a blood test or scans.

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I cannot take taxane due to health reasons.

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I am maintaining low testosterone levels for my treatment.

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I am maintaining low testosterone levels for my treatment.

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I am a man aged 18 or older.

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I can take pills by mouth.

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My cancer has spread, and it can be checked by scans or biopsy.

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My tests show a CDK12 loss in my cancer's genetic material.

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I have advanced prostate cancer that is not responding to hormone therapy.

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I have tried at least one advanced prostate cancer treatment and it didn't work or caused side effects.

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My cancer has grown or spread, confirmed by scans.

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My condition worsened within 12 months after finishing or not tolerating a taxane treatment.

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I cannot receive docetaxel or cabazitaxel chemotherapy.

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I have refused taxane treatment.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had radiation therapy to my chest area before.

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I have a history of lung conditions like interstitial lung disease or pneumonitis.

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I have not had a blood clot in the last 3 months.

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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.

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I have brain metastases that are either known and untreated.

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I haven't had chemotherapy or radiotherapy in the last 4 weeks.

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I have a history of lung cancer, no matter the stage or treatment.

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I have been treated with a CDK4/6 inhibitor before.

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I have not received a live vaccine in the last 30 days.

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I do not have any active infections, including HIV or hepatitis.

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I have been treated for an autoimmune disease with medication in the last 2 years.

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I have another active cancer besides the one being studied.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment to end of treatment, up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment to end of treatment, up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to end of treatment, up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

6-month Progression free survival (PFS) rate

Objective response rate (ORR)

Rate of Adverse Events

+1 more

Secondary study objectives

Clinical benefit rate (CBR)

Duration of response (DOR)

Duration of therapy (DOT)

+2 more

Side effects data

From 2018 Phase 2 trial • 132 Patients • NCT02102490

91%

Diarrhoea

67%

Nausea

48%

Fatigue

45%

Decreased appetite

35%

Vomiting

27%

Anaemia

26%

Abdominal pain

23%

Asthenia

23%

Neutrophil count decreased

21%

Cough

20%

Constipation

20%

Headache

19%

Arthralgia

18%

White blood cell count decreased

18%

Neutropenia

15%

Alopecia

14%

Dry mouth

14%

Platelet count decreased

14%

Weight decreased

14%

Dysgeusia

13%

Dyspnoea

12%

Abdominal pain upper

12%

Back pain

12%

Dizziness

11%

Oedema peripheral

11%

Dyspepsia

11%

Pyrexia

11%

Blood creatinine increased

10%

Pain

Stomatitis

Aspartate aminotransferase increased

Thrombocytopenia

Lacrimation increased

Dehydration

Dry skin

Pruritus

Alanine aminotransferase increased

Flatulence

Upper respiratory tract infection

Urinary tract infection

Hypokalaemia

Chills

Musculoskeletal chest pain

Musculoskeletal pain

Anxiety

Gastrooesophageal reflux disease

Rash

Myalgia

Cellulitis

Pleural effusion

Atypical pneumonia

Gastroenteritis viral

Lung infection

Sepsis

Fall

Hip fracture

Pneumonitis

Pneumothorax

Febrile neutropenia

Respiratory tract infection

Haematotoxicity

Sinus bradycardia

Tachycardia

Large intestinal obstruction

Pancreatic enzyme abnormality

Pancreatitis

Varices oesophageal

Electrocardiogram abnormal

Liver function test abnormal

Renal function test abnormal

Bone pain

Muscular weakness

Acute kidney injury

Pulmonary embolism

Arterial thrombosis

Epilepsy

100%

80%

60%

40%

20%

Study treatment Arm

Abemaciclib

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abemaciclib

FDA approved

Atezolizumab

FDA approved

0 / 28Eligibility criteria met