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Prostate CancerPhase 2NCT04272645

Abemaciclib With or Without Atezolizumab in Metastatic Castration Resistant Prostate Cancer

A Phase 2 study testing Abemaciclib 200 MG, Atezolizumab 1200 MG in 20 ML Injection and Abemaciclib 150 MG in people with Prostate Cancer, run by University of Michigan Rogel Cancer Center at 4 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Abemaciclib 200 MG, Atezolizumab 1200 MG in 20 ML Injection and Abemaciclib 150 MG
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
4 sitesUnited States
Study dates
Oct 2020to Oct 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of metastatic castration resistant prostate cancer (mCRPC), with histologic confirmation of adenocarcinoma of the prostate, without evidence of small cell carcinoma.
  • ECOG performance status of 0 or 1.
  • Evaluable for response based on: baseline PSA ≥ 2 ng/mL OR measurable disease per RECIST 1.1 criteria.
  • Past progression or intolerance to at least one novel antiandrogen therapy (abiraterone, enzalutamide, galeterone, apalutamide, darolutamide, orteronel, seviteronel or equivalent) in either the hormone-sensitive or castration-resistant disease setting.
  • Not a candidate for docetaxel or cabazitaxel chemotherapy due to: progression within 12 months of completion or intolerance to prior taxane OR refusal of taxane OR contraindication to, or lack of fitness for taxane OR Investigator assessment that taxane is not clinically indicated or preferred.
  • Maintenance of castration status, defined as serum testosterone level of less than 50 ng/dL. Patients must be surgically castrate or maintained on LHRH agonist or antagonist therapy for the duration of the study period.
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  • Must have recovered from any treatment-related toxicities to ≤ CTCAE grade 1. Patients with ≤ CTCAE grade 2 anorexia, alopecia, neuropathy, and/or fatigue however, are also permitted to enroll.
  • Adequate bone marrow, renal, and liver function with no lab abnormalities > CTCAE grade 1. Platelet count of ≥100 x 109 /L.
  • 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.
  • For inclusion specifically in Arm C, documentation (via CLIA approved, CAP certified next generation sequencing [NGS] assay report) of genomic aberration resulting in CDK12 loss of function in metastatic tumor tissue.

Who cannot join

  • Clinical evidence of, or known and untreated metastatic CNS disease.
  • Concurrent active malignancy. Patients with non-melanomatous skin cancer, cancer not needing active therapy for at least 2 years, cancer for which the treating investigator deems the subject to be in remission, or any prior malignancy that was treated with curative intent (no evidence of disease for at least 3 years) are also permitted to enroll.
  • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to planned cycle 1 day 1 of study treatment.
  • Patients who have received oral anti-neoplastic intervention such as an oral hormonal agent, PARP inhibitor, AR targeted therapy, or oral experimental agent within 14 days prior to planned cycle 1 day 1 of study treatment.
  • Prior treatment with an inhibitor of CDK4 and/or 6.
  • Prior treatment with an inhibitor of PD-1, PD-L1, or PD-L2.
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  • Patients on concurrent therapy with a moderate or strong CYP3A4 inducer or inhibitor which cannot be safely stopped at least five half-lives prior to initiation of therapy with abemaciclib.
  • Evidence of an active autoimmune disease that has required systemic treatment within the last 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Patients with conditions requiring replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) are permitted to enroll.
  • Live vaccine within 30 days of registration.
  • Evidence of active, non-infectious pneumonitis. Patients with a history of asymptomatic radiation pneumonitis with no signs of active process are permitted to enroll.
  • Active bacterial or fungal infection, or known detectable viral infection (e.g., Human Immunodeficiency Virus [HIV] or viral hepatitis).
  • Arterial or venous thromboembolic event within the last 3 months.
  • Significant infection, medical condition, or social situation which, in the opinion of the investigator, would preclude participation or limit the patient's ability to comply with study requirements.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Washington University - St. Louis

    St Louis, Missouri, 63130

Other trials in United States

About this study

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

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.

Conditions
Prostate Cancer
Being tested
Abemaciclib 200 MG, Atezolizumab 1200 MG in 20 ML Injection, Abemaciclib 150 MG
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abemaciclib 200 MGDrug

    200 MG orally BID Days 1-21

  • Atezolizumab 1200 MG in 20 ML InjectionDrug

    1200 mg IV on Day 1 of 21-day cycle

  • Abemaciclib 150 MGDrug

    150 MG orally BID Days 1-21

Study groups in NCT04272645
Study groupRoleWhat they receive
Arm A - Abemaciclib 200 mgExperimentalAbemaciclib twice daily. 1 cycle of treatment is 21 days in length.
Receives: Drug: Abemaciclib 200 MG
Arm B - Abemaciclib 150 mg + atezolizumabExperimentalAtezolizumab on the first day of each 21-day cycle in combination with abemaciclib twice daily.
Receives: Drug: Atezolizumab 1200 MG in 20 ML Injection; Drug: Abemaciclib 150 MG
Experimental: Arm C - Patients with CDK12 lossExperimentalGroup 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.
Receives: Drug: Atezolizumab 1200 MG in 20 ML Injection; Drug: Abemaciclib 150 MG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival (PFS) (Arms A and B)

    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.

    Measured: 6 months after start of treatment

  2. Incidence of dose limiting toxicities (DLTs) of combination therapy with abemaciclib and atezolizumab

    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.

    Measured: From start of treatment to end of cycle 1; up to 21 days

Secondary outcomes (8)

  1. Objective response rate (ORR) (Arms A and B)

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

    Measured: Up to 2 years after end of treatment or until study closes, whichever is earliest

  2. Clinical benefit rate (CBR) (Arms A and B)

    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.

    Measured: Up to 2 years after end of treatment or until study closes, whichever is earliest

  3. Duration of response (DOR) (Arms A and B)

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

    Measured: Up to 2 years after end of treatment or until study closes, whichever is earliest

  4. Duration of therapy (DOT) (Arms A and B)

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

    Measured: Up to 2 years after end of treatment or until study closes, whichever is earliest

  5. Time to progression (TTP) (Arms A and B)

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

    Measured: Up to 2 years after end of treatment or until study closes, whichever is earliest

  6. Number and severity of Adverse Events of Special Interest (AESI) (all arms)

    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).

    Measured: Up to 2 years after end of treatment or until study closes, whichever is earliest

  7. Overall survival among all patients (Arms A and B)

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

    Measured: Up to 2 years after end of treatment or until study closes, whichever is earliest

  8. Overall survival among patients who respond to treatment (Arms A and B)

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

    Measured: Up to 2 years after end of treatment or until study closes, whichever is earliest

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2020
  2. Study startOct 2020 (estimated)
  3. Primary completionOct 2022 (estimated)
  4. Study completionOct 2022 (estimated)

Why it stopped: Coordinating site change

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04272645
Sponsor's protocol ID
UMCC 2019.124
Other IDs
HUM00171336
Status last verified
Jul 2020
First submitted
13 Feb 2020
Last updated
15 Jul 2020
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abemaciclib 200 MG, Atezolizumab 1200 MG in 20 ML Injection and Abemaciclib 150 MG in people with Prostate Cancer, run by University of Michigan Rogel Cancer Center at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (PFS) (Arms A and B) (time frame: 6 months after start of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04272645.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2020.

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