Enzalutamide With Ribociclib in Treating Patients With Metastatic Castrate-Resistant, Chemotherapy Naive Prostate Cancer That Retains Retinoblastoma Expression
March 31, 2026 updated by: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Phase IB/II Study of Enzalutamide With Ribociclib in Patients With Metastatic Castrate Resistant, Chemotherapy Naïve Prostate Cancer That Retains RB Expression
This phase Ib/II trial studies the safety, side effects, best dose, and effectiveness of ribociclib when given with enzalutamide in treating patients with castrate-resistant prostate cancer that has spread from the primary site (place where it started) to other places in the body (metastatic), is chemotherapy naive, and retains retinoblastoma expression.
Testosterone can cause the growth of prostate cancer cells.
Hormone therapy using enzalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells.
Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Enzalutamide with ribociclib may be safe, tolerable and/or effective in treating metastatic, castrate-resistant, chemotherapy naive prostate cancer that retains retinoblastoma expression.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
- Other: Laboratory Biomarker Analysis
- Other: Pharmacological Study
- Procedure: Magnetic Resonance Imaging
- Procedure: Biopsy
- Procedure: Computed Tomography
- Procedure: Biospecimen Collection
- Drug: Ribociclib
- Procedure: Echocardiography
- Procedure: Multigated Acquisition Scan
- Drug: Enzalutamide
- Procedure: Bone Scan
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose of ribociclib in combination with 160 mg of enzalutamide. (Phase Ib) II. To determine efficacy with respect to the proportion of subjects that achieve a >= 50% reduction in prostate-specific antigen (PSA) at 12 weeks. (Phase II)
SECONDARY OBJECTIVES:
I. PSA progression-free survival. II. Radiographic progression-free survival (rPFS). III. Safety. IV. Pharmacokinetics.
CORRELATIVE/EXPLORATORY/TERTIARY OBJECTIVES:
I. To evaluate the expression of retinoblastoma (RB) in circulating tumor cells (CTCs) and tumor tissue.
II. To evaluate other mechanisms of castrate resistance (such as androgen receptor [AR]-variant [v]7) in tumor tissue and CTCs.
III. To explore resistance mechanisms of cyclin dependent kinase (CDK)4/6 inhibitors in tumor samples in patients that progress on enzalutamide and ribociclib.
IV. Explore the use/correlation of circulating deoxyribonucleic acid (DNA)/exosomes in castrate-resistant prostate cancer (CRPC) patients treated with enzalutamide with and without ribociclib.
V. Androgen profiles and correlation to clinical outcomes. VI. Development of model explant systems to correlate with the clinical outcome.
OUTLINE: This is a phase I, dose-escalation study of ribociclib followed by a phase II study.
Patients receive enzalutamide orally (PO) once daily (QD) on days 1-28 and ribociclib PO QD on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, tumor biopsy, echocardiography (ECHO) or multigated acquisition scan (MUGA), bone scan, and computed tomography (CT) or magnetic resonance imaging (MRI) on study.
After completion of study treatment, patients are followed up every 3 months for 24 months.
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan Comprehensive Cancer Center
-
-
New York
-
Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Willing and able to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information; NOTE: HIPAA authorization may be either included in the informed consent or obtained separately; consent and HIPPA authorization must be obtained prior to any screening procedures
- Histological or cytological proof of prostate cancer
Documented progressive metastatic (m)CRPC based on at least one of the following criteria:
- PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 2 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 2 ng/mL
- Soft-tissue progression defined as an increase >= 20% in the sum of the longest diameter (LD) of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions
- Progression of bone disease (evaluable disease) or (new bone lesion[s]) by bone scan
- Have testosterone < 50 ng/dL; patients must continue primary androgen deprivation with an luteinizing hormone-releasing hormone (LHRH) analogue (agonist or antagonist) if they have not undergone orchiectomy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Patients on long term (> 6 months) anti-androgen therapy (e.g., flutamide, bicalutamide, nilutamide) will need to be off anti-androgen for 4 weeks (wash out period) and show evidence of disease progression off the anti-androgen; patients that have been on an anti-androgen 6 months or less will need to discontinue anti-androgen therapy prior to treatment start (no wash out period required)
- Absolute neutrophil count >= 1.5 × 10^9/L (obtained within 14 days prior to treatment start)
- Platelets (UNVPLT) >= 100 x 10^9/L (obtained within 14 days prior to treatment start)
- Hemoglobin (HGB) >= 9 g/dl (obtained within 14 days prior to treatment start)
- Potassium (K) within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication (obtained within 14 days prior to treatment start)
- Total calcium (CA) (corrected for serum albumin) within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication (obtained within 14 days prior to treatment start)
- Magnesium within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication (obtained within 14 days prior to treatment start)
- Phosphorus within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication (obtained within 14 days prior to treatment start)
- International normalized ratio (INR) =< 1.5 (obtained within 14 days prior to treatment start)
- Serum creatinine (CREAT) =< 1.5 mg/dL or creatinine clearance >= 50 mL/min (obtained within 14 days prior to treatment start)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x upper limit of normal (ULN); if the patient has liver metastases, ALT and AST must still be =< 2.5 x ULN; patients with liver metastases and AST/ALT above this limit will not be enrolled (obtained within 14 days prior to treatment start)
- Total serum bilirubin =< 1.5 x ULN; or total bilirubin (TBILI) =< 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert's syndrome (obtained within 14 days prior to treatment start)
- Men must agree to use adequate contraception prior to enrollment, for the duration of study participation and for at least 3 months thereafter
- Must be able to take oral medication without crushing, dissolving or chewing tablets
Exclusion Criteria:
- Prior exposure to abiraterone acetate or other specific cytochrome P450 (CYP)-17 inhibitors; abiraterone acetate given in the castration-sensitive setting is permissible if stopped at least 6 months prior to initial protocol treatment
- Prior exposure to enzalutamide, apalutamide, or other investigational AR directed therapy
- Prior chemotherapy for castration resistant disease; chemotherapy given in the castration-sensitive setting is permissible if stopped at least 4 weeks prior to treatment start
- Prior isotope therapy with strontium-89, samarium or radium-223 within 12 weeks of treatment start
- Administration of antifungal agents (itraconazole, fluconazole, etc) within 4 weeks of treatment start or unrecovered adverse events (AEs) due to agents administered more than 4 weeks of treatment start
- History of pituitary or adrenal dysfunction, active or symptomatic viral hepatitis or chronic liver disease
- Known symptomatic brain metastases
- Use of any prohibited concomitant medications: immunotherapy, 5 alpha reductase inhibitors, spironolactone, diethystilbestrol (DES), ketoconazole, newer medications targeting ARs; NOTE: the concurrent use of all other drugs, over-the-counter medications, or alternative therapies must be documented; the principal investigator should be alerted if the patient is taking any agent that interacts with CYP450 system
- Treatment-related toxicity from prior therapy > grade 2
- Peripheral neuropathy >= 2
- History of hypersensitivity to ribociclib or compounds of similar chemical or biologic composition to ribociclib including to peanut and soy or other drugs formulated with polysorbate 80; or enzalutamide
- Currently taking any herbal, alternative or food supplements (i.e., prostate cancer [PC]-Spes, saw palmetto, St John wort, etc.); all herbal, alternative and food supplements must be discontinued prior to treatment start; patients may continue on a daily multi-vitamin, calcium and vitamin D
- Planned surgery or radiation therapy during protocol treatment
- Hormonal-acting agents (including DES, aldosterone, and spironolactone but not including gonadotropin-releasing hormone [GnRH] agonists or antagonists) are forbidden during the trial and must be stopped prior to treatment start; no washout period will be required for any of these agents
- Initiation of bisphosphonate/denosumab therapy during protocol treatment; patients on stable doses of bisphosphonates or denosumab which have been started no less than 4 weeks prior to treatment start may continue on this medication; NOTE: initiation of bisphosphonate/denosumab therapy will be allowed for the treatment of osteoporosis or prevention of skeletal-related events (SRE) during protocol treatment
- Patient has a concurrent malignancy or malignancy within 3 years of treatment start, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer
- Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
- Patient has a known history of human immunodeficiency virus (HIV) infection (testing not mandatory)
- Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g., chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, etc.)
Patient has clinically significant, uncontrolled heart disease and/or recent events including any of the following:
- History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) or symptomatic pericarditis within 12 months prior to treatment start
- History of documented congestive heart failure (New York Heart Association functional classification III-IV)
- Documented cardiomyopathy
- Patient has a left ventricular ejection fraction (LVEF) < 50% as determined by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO) at screening
- History of any cardiac arrhythmias, eg., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality within 12 months prior to treatment start
- Family history of corrected QT interval (QTc) prolongation or of unexplainable sudden death at < 50 years of age
- On screening 12 lead electrocardiogram (ECG), any of the following cardiac parameters: bradycardia (heart rate < 50 at rest), tachycardia (heart rate > 90 at rest), PR interval > 220 msec, QRS interval > 109 msec, or Fridericia corrected QT (QTcF) > 450 msec; congenital long QT syndrome or family history of long QT syndrome
- Systolic blood pressure (SBP) > 160 mmHg or < 90 mmHg
- Bradycardia (heart rate < 50 at rest), by ECG or pulse, at screening
- On screening, inability to determine the QTcF interval on the ECG (i.e.: unreadable or not interpretable) or QTcF > 450 msec (using Fridericia's correction); all as determined by screening ECG (mean of triplicate ECGs)
Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior to treatment start:
- Known strong inducers or inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)/cytochrome P450, family 3, subfamily A, polypeptide 4 (5), including grapefruit, grapefruit hybrids, pummelos, star-fruit, and Seville oranges
- That have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5
- That have a known risk to prolong the QT interval or induce Torsades de Pointes
- Herbal preparations/medications, dietary supplements
Patient is currently receiving or has received systemic corticosteroids within < 2 weeks prior to treatment start, or who have not fully recovered from side effects of such treatment
* The following uses of corticosteroids are permitted: a short duration (< 5 days) of systemic corticosteroids; any duration of topical applications (e.g. for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular)
- Patient is currently receiving warfarin or other coumarin-derived anticoagulant for treatment, prophylaxis or otherwise; therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed
- PatientParticipation in other studies involving investigational drug(s) within 30 days prior to randomization or within 5 half-lives of the investigational product (whichever is longer) or participation in any other type of medical research judged not to be scientifically or medically compatible with this study. If the patient is enrolled or planned to be enrolled in another study that does not involve an investigational drug, the agreement of the Novartis study medical lead is required to establish eligibility
- Patient who has received radiotherapy =< 4 weeks or limited field radiation for palliation =< 2 weeks prior to treatment start, and who has not recovered to grade 1 or better from related side effects of such therapy (exceptions include alopecia) and/or in whom >= 30% of the bone marrow was irradiated
Patients with central nervous system (CNS) involvement unless they meet ALL of the following criteria:
- At least 4 weeks from prior therapy completion (including radiation and/or surgery) to treatment start
- Clinically stable CNS tumor at the time of screening and not receiving steroids and/or enzyme-inducing anti-epileptic medications for brain metastases
- Patient has had major surgery within 14 days prior to treatment start or has not recovered from major side effects (tumor biopsy is not considered as major surgery)
- Patient has not recovered from all toxicities related to prior anticancer therapies to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade < 1 (exception to this criterion: patients with grade 1 taxane-induced neuropathy, any grade of alopecia, amenorrhea or other toxicities not considered a safety risk for the patient as per investigator's discretion, are allowed to enter the study)
- Patient with a Child-Pugh score B or C
- Patient has a history of non-compliance to medical regimen or inability to grant consent
- Sexually active males unless they use a condom during intercourse while taking the drug and for 30 days after stopping treatment and should not father a child in this period; a condom is required to be used by vasectomized men in order to prevent delivery of the drug via seminal fluid
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Phase I: 200 mg Ribociclib + Enzalutamide
Enzalutamide will be administered at a dose of 160 mg (40 mg X 4 pills) once daily.
200 mg Ribociclib will be given daily for 21 out of 28 days.
The phase I portion of this study will follow a traditional 3+3 design, escalating to the next higher dose cohort if 3 patients are treated and no DLTs are observed in the first cycle of therapy.
|
Correlative studies
Correlative studies
Undergo MRI
Other Names:
Undergo tumor biopsy
Other Names:
Undergo CT
Other Names:
Undergo blood sample collection
Other Names:
Given PO
Other Names:
Undergo ECHO
Other Names:
Undergo MUGA
Other Names:
Given PO
Other Names:
Undergo bone scan
Other Names:
|
|
Experimental: Phase I: 400 mg Ribociclib + Enzalutamide
Enzalutamide will be administered at a dose of 160 mg (40 mg X 4 pills) once daily.
400 mg Ribociclib will be given daily for 21 out of 28 days.
The phase I portion of this study will follow a traditional 3+3 design, escalating to the next higher dose cohort if 3 patients are treated and no DLTs are observed in the first cycle of therapy.
|
Correlative studies
Correlative studies
Undergo MRI
Other Names:
Undergo tumor biopsy
Other Names:
Undergo CT
Other Names:
Undergo blood sample collection
Other Names:
Given PO
Other Names:
Undergo ECHO
Other Names:
Undergo MUGA
Other Names:
Given PO
Other Names:
Undergo bone scan
Other Names:
|
|
Experimental: Phase I: 600 mg Ribociclib + Enzalutamide
Enzalutamide will be administered at a dose of 160 mg (40 mg X 4 pills) once daily.
600 mg Ribociclib will be given daily for 21 out of 28 days.
The phase I portion of this study will follow a traditional 3+3 design, escalating to the next higher dose cohort if 3 patients are treated and no DLTs are observed in the first cycle of therapy.
|
Correlative studies
Correlative studies
Undergo MRI
Other Names:
Undergo tumor biopsy
Other Names:
Undergo CT
Other Names:
Undergo blood sample collection
Other Names:
Given PO
Other Names:
Undergo ECHO
Other Names:
Undergo MUGA
Other Names:
Given PO
Other Names:
Undergo bone scan
Other Names:
|
|
Active Comparator: Phase II: Enzalutamide Only
Patients receive Enzalutamide 160mg PO QD once daily on Days 1-28 of each 28-day cycle.
This is one of two randomized arms in the Phase II portion.
Treatment continues until disease progression or unacceptable toxicity.
Patients also undergo blood sample collection, tumor biopsy, ECHO or MUGA, bone scan, and CT or MRI on study.
|
Correlative studies
Correlative studies
Undergo MRI
Other Names:
Undergo tumor biopsy
Other Names:
Undergo CT
Other Names:
Undergo blood sample collection
Other Names:
Undergo ECHO
Other Names:
Undergo MUGA
Other Names:
Given PO
Other Names:
Undergo bone scan
Other Names:
|
|
Experimental: Ribociclib at RP2D + Enzalutamide
Patients receive Ribociclib 600mg PO QD once daily on Days 1-21 of each 28-day cycle in combination with Enzalutamide 160mg PO QD once daily.
This is one of two randomized arms in the Phase II portion.
Patients will continue treatment until disease progression or unacceptable toxicity.
Patients also undergo blood sample collection, tumor biopsy, ECHO or MUGA, bone scan, and CT or MRI on study.
|
Correlative studies
Correlative studies
Undergo MRI
Other Names:
Undergo tumor biopsy
Other Names:
Undergo CT
Other Names:
Undergo blood sample collection
Other Names:
Given PO
Other Names:
Undergo ECHO
Other Names:
Undergo MUGA
Other Names:
Given PO
Other Names:
Undergo bone scan
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Dose Limiting Toxicity of Ribociclib (Phase IB)
Time Frame: 28 days
|
Will be defined as an adverse event or clinically significant abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications.
All analysis will be descriptive.
|
28 days
|
|
Number of Patients With a >= 50% Reduction in Prostate Specific Antigen (PSA) (Phase II)
Time Frame: 12 weeks
|
The primary objective for the phase II component of this study is to determine efficacy with respect to the proportion of subjects that achieve a ≥ 50% reduction in PSA at 12 weeks.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PSA Progression Free Survival (PFS)
Time Frame: Time of first dose until progression (25% increase in PSA from nadir) or death, assessed up to 2 years
|
Summarized by treatment arm using Kaplan-Meier plots.
Median PFS will be estimated from the Kaplan-Meier analysis.
|
Time of first dose until progression (25% increase in PSA from nadir) or death, assessed up to 2 years
|
|
Radiographic PFS (rPFS)
Time Frame: From first dose to disease progression in bone or soft-tissue, or death, whichever occurs first, assessed up to 40 months
|
Summarized using Kaplan-Meier plots.
Median rPFS will be estimated from the Kaplan-Meier analysis.
|
From first dose to disease progression in bone or soft-tissue, or death, whichever occurs first, assessed up to 40 months
|
|
Overall Survival
Time Frame: From first dose until death from any cause, assessed up to 60 months
|
To determine the overall safety and survival for patients treated with enzalutamide with and without ribociclib in patients with chemotherapy naïve mCRPC.
|
From first dose until death from any cause, assessed up to 60 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Patients With RB Positive Tumors
Time Frame: Baseline
|
The proportion of patients with RB positive tumors among the screened patients by IHC and gene signature will be estimated
|
Baseline
|
|
Number of Participants With Samples Where RB Status Can Successfully be Obtained
Time Frame: Baseline
|
Proportion of samples where RB status can successfully be obtained.
Estimated as a measure of feasibility.
|
Baseline
|
|
Androgen Profiles
Time Frame: Up to 2 years
|
Association of androgen profiles with clinical outcomes will use logistic regression or Cox proportional hazards regression, as appropriate.
|
Up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: William Kevin Kelly, MD, Thomas Jefferson University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2015
Primary Completion (Actual)
December 7, 2022
Study Completion (Actual)
September 1, 2023
Study Registration Dates
First Submitted
September 14, 2015
First Submitted That Met QC Criteria
September 18, 2015
First Posted (Estimated)
September 21, 2015
Study Record Updates
Last Update Posted (Actual)
April 22, 2026
Last Update Submitted That Met QC Criteria
March 31, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Genital Neoplasms, Male
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Genital Diseases, Male
- Prostatic Diseases
- Male Urogenital Diseases
- Prostatic Neoplasms
- Investigative Techniques
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Surgical Procedures, Operative
- Cytological Techniques
- Cytodiagnosis
- Physical Phenomena
- Diagnostic Techniques, Surgical
- Chemistry Techniques, Analytical
- Spectrum Analysis
- Electromagnetic Phenomena
- Magnetic Phenomena
- Electromagnetic Radiation
- Radiation
- Radiation, Ionizing
- Biopsy
- Specimen Handling
- Magnetic Resonance Spectroscopy
- enzalutamide
- X-Rays
- ribociclib
- benzamide
Other Study ID Numbers
- 15G.322
- CLEE011XUS12T (Other Identifier: Novartis)
- c15-153 (Other Identifier: PCCTC)
- JT 7786 (Other Identifier: JeffTrial Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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