Prostate CancerPhase 2NCT04751929
Abemaciclib With or Without Atezolizumab for mCRPC
A Phase 2 study testing Abemaciclib and Atezolizumab in people with Prostate Cancer and Metastatic Castration-resistant Prostate Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Metastatic Castration-resistant Prostate Cancer
- What is being tested?
- Abemaciclib and Atezolizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2021to 6 Nov 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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), with progressive disease at the time of study entry by either
- Sequence of at least 2 rising PSA values at a minimum of 1-week intervals
- Radiographic progression per RECIST1.1 for soft tissue and/or per PCWG3 for bone, with or without PSA progression
- Adult males 18 years of age or older.
- ECOG performance status of 0 or 1
- 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
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- Baseline PSA ≥ 2.0 ng/mL OR
- Measurable disease per RECIST 1.1
- 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.
- 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.
- 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.
- Additional Inclusion Criteria (Arm C patients)
- Must have 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.
- Patients whose tumors have not previously undergone NGS are not eligible for Arm C but are eligible for the randomized unselected cohorts.
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 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.
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- Prior treatment with an inhibitor of PD-1, PD-L1, or PD-L2.
- 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.
- 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).
- 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.
- Any history of lung cancer, regardless of stage or treatment
- Any of the following abnormalities on pre-treatment pulmonary function testing:
- FEV1/FVC < lower limit of normal (LLN) and FEV1 < 75% predicted OR
- FVC < 70% of predicted, regardless of FEV1/FVC ratio OR
- DLCO (corrected for hemoglobin) < 70% of predicted
- 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
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: A Phase II Multi-Center Trial of Abemaciclib With or Without Atezolizumab in Metastatic Castration Resistant Prostate Cancer
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.
Read the detailed description
This is a multi-center, open label Phase II study of patients with metastatic castration resistant prostate cancer (mCRPC) who will be treated with abemaciclib and atezolizumab alone or in combination.
The U.S. Food and Drug Administration (FDA) has not approved abemaciclib or atezolizumab alone or in combination for use in prostate cancer. Abemaciclib is an orally administered molecularly targeted chemotherapy drug called a cyclin-dependent kinase inhibitor, which acts to block the ability of cancer cells to divide and thus prevents tumors from growing. In the laboratory setting, this drug is effective in prostate cancer models that have become resistant to standard hormonal treatments, and this drug is currently being studied for its effectiveness in prostate cancer in other clinical trials. Atezolizumab is an intravenously administered drug called an immune checkpoint inhibitor, which acts to activate the immune system to kill cancer cells. Atezolizumab is ineffective on its own in most patients with prostate cancer, but is being tested in combination with other drugs for prostate cancer in other clinical trials. Multiple research groups have demonstrated in laboratory model systems that abemaciclib can may make immune checkpoint inhibitors more effective.
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
The study design divides study participants into two separate cohorts. The first cohort is a set of subjects whose tumors are not known to have mutations in the CDK12 gene (the "biomarker unselected cohort") - either because tumor tissue never underwent genetic profiling, or because genetic profiling was performed but did not demonstrate a mutation in the CDK12 gene. In this "biomarker unselected cohort," this study will be testing whether abemaciclib alone or in combination with atezolizumab is an effective treatment strategy.
The second cohort of participants is a set of subjects whose tumors are known to have mutations in the CDK12 gene based on genetic profiling of the tumor that occurred prior to enrollment on this study. Prior studies suggest that cancers with mutations in the CDK12 gene can shrink in response to immune checkpoint inhibitors. This study will be testing in study participants whose tumors are known to have mutations in CDK12 whether atezolizumab alone or in combination with abemaciclib is an effective treatment strategy.
In addition, the trial is testing the safety of the combination of the two drugs in both cohorts.
Participants will receive study treatment for as long as they do not have serious side effects and their disease does not get worse. Participants will be followed after completion of study treatment for up to 24 months
It is expected that about 75 people will take part in this research study.
Eli Lilly and Company is supporting this research study by providing funding for research and the study drug abemaciclib. Genentech, Inc. is supporting the study by providing the study drug atezolizumab.
- Being tested
- Abemaciclib, Atezolizumab
- Keywords
- Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Abemaciclib, Atezolizumab, CDK4/6, Immunotherapy, PD-L1
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbemaciclibDrug
Also called Verzenio
Taken orally 2x daily
AtezolizumabDrug
Also called Tecentriq
Intravenously Day 1 of 21 day cycle
| Study group | Role | What they receive |
|---|---|---|
| Biomarker-Unselected Abemaciclib Monotherapy (Randomized) | Experimental | 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 Receives: Drug: Abemaciclib |
| Biomarker-Unselected Abemaciclib + Atezolizumab (Randomized) | Experimental | 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 Receives: Drug: Abemaciclib; Drug: Atezolizumab |
| CDK12 Mutation Atezolizumab Monotherapy (Non-Randomized) | Experimental | 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 Receives: Drug: Atezolizumab |
| CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) | Experimental | 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 Receives: Drug: Abemaciclib; Drug: Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month Progression Free Survival (PFS) Rate
The percentage of participants alive and progression-free at 6 months, as assessed by RECIST 1.1 and PCWG3.
Measured: 6 months
Objective Response Rate (ORR)
The percentage of evaluable patients who had radiographic response (complete response or partial response) by RECIST 1.1 criteria OR 50% decline in PSA from pretreatment baseline per PCWG3 criteria.
Measured: 6 months
Number of Participants Experiencing Dose Limiting Toxicity (DLT) in Biomarker-Unselected Abemaciclib + Atezolizumab (Randomized) and CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) Arms
DLT was assessed by Bayesian Continuous Toxicity Monitoring in Biomarker-Unselected Abemaciclib + Atezolizumab (Randomized) and CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arms.
Measured: DLTs were collected while participants on treatment. Treatment duration up to 18 months.
Secondary outcomes (6)
Clinical Benefit Rate (CBR)
Proportion of evaluable patients who had complete response (CR), partial response (PR) or stable disease (SD) as their best response to treatment in arms biomarker-unselected abemaciclib monotherapy (randomized), biomarker-unselected abemaciclib + atezolizumab (randomized), and CDK12 mutation abemaciclib + atezolizumab (non-randomized)
Measured: From treatment initiation to end of treatment, with follow-up for up to 2 years after treatment discontinuation
Duration of Response (DOR)
The time from the first documented complete response (CR) or partial response (PR) to the earliest date of disease progression or death, whichever occurs first, as determined by PCWG3 criteria.
Measured: From the date of first documented CR or PR until disease progression or death, or up to 2 years
Duration of Therapy (DOT)
The length of time from the first administration of study treatment to the date of treatment discontinuation for any reason
Measured: From treatment initiation until treatment discontinuation for any reason
Time to Progression (TTP)
The duration of time from the first administration of study treatment to the date of first documented disease progression, as determined by Prostate Cancer Working Group 3 (PCWG3) criteria. Patients without documented progression are censored at the last tumor assessment date.
Measured: From treatment initiation until documented disease progression, or assessed up to 2 years
12-month Overall Survival (OS)
The percentage of participants who are alive 12 months after the start of treatment
Measured: 12 months
Number of Participants With Maximum Grade Adverse Events by CTCAE v5.0
Number of participants experiencing adverse events, categorized by the maximum grade according to CTCAE v5.0.
Measured: From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start20 Aug 2021
- Primary completion17 Jun 2024
- Study completion6 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, Genentech, Inc.
- Responsible party
- Principal investigator, Atish Choudhury, MD, Dana-Farber Cancer Institute
- Investigators
- Atish Choudhury, MD, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751929
- Sponsor's protocol ID
- 20-701
- Status last verified
- May 2026
- First submitted
- 4 Feb 2021
- Last updated
- 17 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Multi-Center Trial of Abemaciclib With or Without Atezolizumab in Metastatic Castration Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT04751929
- Acronym / sponsor ID
- 20-701
- Keywords
- Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Abemaciclib, Atezolizumab, CDK4/6, Immunotherapy, PD-L1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Eli Lilly and Company, Genentech, Inc.
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 17 Jun 2024 (actual)
- Study completion
- 6 Nov 2025 (actual)
- First posted
- 12 Feb 2021 (actual)
- Results
- Posted 2 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multi-center, open label Phase II study of patients with metastatic castration resistant prostate cancer (mCRPC) who will be treated with abemaciclib and atezolizumab alone or in combination.
The U.S. Food and Drug Administration (FDA) has not approved abemaciclib or atezolizumab alone or in combination for use in prostate cancer. Abemaciclib is an orally administered molecularly targeted chemotherapy drug called a cyclin-dependent kinase inhibitor, which acts to block the ability of cancer cells to divide and thus prevents tumors from growing. In the laboratory setting, this drug is effective in prostate cancer models that have become resistant to standard hormonal treatments, and this drug is currently being studied for its effectiveness in prostate cancer in other clinical trials. Atezolizumab is an intravenously administered drug called an immune checkpoint inhibitor, which acts to activate the immune system to kill cancer cells. Atezolizumab is ineffective on its own in most patients with prostate cancer, but is being tested in combination with other drugs for prostate cancer in other clinical trials. Multiple research groups have demonstrated in laboratory model systems that abemaciclib can may make immune checkpoint inhibitors more effective.
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
The study design divides study participants into two separate cohorts. The first cohort is a set of subjects whose tumors are not known to have mutations in the CDK12 gene (the "biomarker unselected cohort") - either because tumor tissue never underwent genetic profiling, or because genetic profiling was performed but did not demonstrate a mutation in the CDK12 gene. In this "biomarker unselected cohort," this study will be testing whether abemaciclib alone or in combination with atezolizumab is an effective treatment strategy.
The second cohort of participants is a set of subjects whose tumors are known to have mutations in the CDK12 gene based on genetic profiling of the tumor that occurred prior to enrollment on this study. Prior studies suggest that cancers with mutations in the CDK12 gene can shrink in response to immune checkpoint inhibitors. This study will be testing in study participants whose tumors are known to have mutations in CDK12 whether atezolizumab alone or in combination with abemaciclib is an effective treatment strategy.
In addition, the trial is testing the safety of the combination of the two drugs in both cohorts.
Participants will receive study treatment for as long as they do not have serious side effects and their disease does not get worse. Participants will be followed after completion of study treatment for up to 24 months
It is expected that about 75 people will take part in this research study.
Eli Lilly and Company is supporting this research study by providing funding for research and the study drug abemaciclib. Genentech, Inc. is supporting the study by providing the study drug atezolizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Biomarker-Unselected Abemaciclib Monotherapy (Randomized) | Experimental | Drug: AbemaciclibParticipants 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 |
| Biomarker-Unselected Abemaciclib + Atezolizumab (Randomized) | Experimental | Drug: Abemaciclib, Drug: AtezolizumabParticipants 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 |
| CDK12 Mutation Atezolizumab Monotherapy (Non-Randomized) | Experimental | Drug: AtezolizumabParticipants 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 |
| CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) | Experimental | Drug: Abemaciclib, Drug: AtezolizumabParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- Diagnosis of metastatic castration resistant prostate cancer (mCRPC), with histologic confirmation of adenocarcinoma of the prostate (without evidence of small cell carcinoma), with progressive disease at the time of study entry by either
- Adult males 18 years of age or older.
- ECOG performance status of 0 or 1
- 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
- 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.
Key exclusion criteria (22 listed)
- Clinical evidence of, or known and untreated metastatic CNS disease.
- Concurrent active malignancy.
- Patients who have had chemotherapy or radiotherapy within 4 weeks 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbemaciclibAlso: VerzenioTaken orally 2x daily | Drug | Biomarker-Unselected Abemaciclib + Atezolizumab (Randomized), Biomarker-Unselected Abemaciclib Monotherapy (Randomized), CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) |
| AtezolizumabAlso: TecentriqIntravenously Day 1 of 21 day cycle | Drug | Biomarker-Unselected Abemaciclib + Atezolizumab (Randomized), CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized), CDK12 Mutation Atezolizumab Monotherapy (Non-Randomized) |
Primary outcome
6-month Progression Free Survival (PFS) Rate
Time frame: 6 months
The percentage of participants alive and progression-free at 6 months, as assessed by RECIST 1.1 and PCWG3.
Objective Response Rate (ORR)
Time frame: 6 months
The percentage of evaluable patients who had radiographic response (complete response or partial response) by RECIST 1.1 criteria OR 50% decline in PSA from pretreatment baseline per PCWG3 criteria.
Number of Participants Experiencing Dose Limiting Toxicity (DLT) in Biomarker-Unselected Abemaciclib + Atezolizumab (Randomized) and CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) Arms
Time frame: DLTs were collected while participants on treatment. Treatment duration up to 18 months.
DLT was assessed by Bayesian Continuous Toxicity Monitoring in Biomarker-Unselected Abemaciclib + Atezolizumab (Randomized) and CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arms.
6 secondary outcomes
Clinical Benefit Rate (CBR)
Time frame: From treatment initiation to end of treatment, with follow-up for up to 2 years after treatment discontinuation
Duration of Response (DOR)
Time frame: From the date of first documented CR or PR until disease progression or death, or up to 2 years
Duration of Therapy (DOT)
Time frame: From treatment initiation until treatment discontinuation for any reason
Time to Progression (TTP)
Time frame: From treatment initiation until documented disease progression, or assessed up to 2 years
12-month Overall Survival (OS)
Time frame: 12 months
Number of Participants With Maximum Grade Adverse Events by CTCAE v5.0
Time frame: From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atish Choudhury, MD, PhD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abemaciclib and Atezolizumab in people with Prostate Cancer and Metastatic Castration-resistant Prostate Cancer, run by Dana-Farber Cancer Institute at 1 site 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 31 inclusion and 22 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: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 2 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
6-month Progression Free Survival (PFS) Rate (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2026.