This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide Will Work Better Than Taking Enzalutamide Alone in Participants With mCSPC Who Are ARPI naïve.
Purpose
This study will explore whether a combination of the investigational drug mevrometostat (PF-06821497) and enzalutamide will work better than taking enzalutamide alone in participants with mCSPC who are ARPI naïve and have not yet received chemotherapy in the mCSPC setting.
Conditions
- Metastatic Castration Sensitive Prostate Cancer (mCSPC)
- Hormone Sensitive Prostate Cancer
- Prostate Cancer
- Cancer of the Prostate
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Male participants aged ≥18 years (or the minimum age of consent in accordance with local regulations) at screening. - Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features. - Metastatic prostate cancer documented by positive bone scan (for bone disease) or metastatic lesion(s) on CT or MRI (for soft tissue/visceral disease). - Resolution of acute effects of any prior therapy to either baseline severity or CTCAE Grade ≤1 (except for AEs which do not constitute a safety risk in the investigator's judgement). - Participants must have ECOG PS 0 or 1.
Exclusion Criteria
- Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. - Clinically significant cardiovascular disease. - Known or suspected brain metastasis or active leptomeningeal disease. - Participants must be treatment naïve at the mCSPC stage, eg, participants cannot have received any cytotoxic chemotherapy with the following exceptions: Treatment with first-generation antiandrogen (ADT) agents is allowed for mCSPC. - Previous administration with an investigational product (drug or vaccine) within 30 days. - Current use or anticipated need for drugs that are known strong CYP3A4/5 inhibitors and inducers (with exception of enzalutamide as part of this study). - Inadequate organ function.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- This is a double-blind study. Participants will receive mevrometostat or matching placebo in a blinded fashion. Participants, investigators and site staff, and sponsor staff will be aware that participants in both study arms are receiving enzalutamide. Enzalutamide will be provided in an open-label manner to participants in each treatment arm. Participants and their caregivers will be blinded to their assigned study intervention. Investigators and other site staff will be blinded to participants' assigned study intervention Sponsor staff will be blinded to participants' assigned study intervention, except for sponsor staff involved in the assignment or distribution of study intervention.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm A |
Participants will receive mevrometostat/PF-06821497 (875 mg) BID (twice daily) + enzalutamide 160 mg QD (once daily) |
|
|
Active Comparator Arm B |
Participants will receive Placebo BID (twice daily) + enzalutamide 160 mg QD (once daily) |
|
Recruiting Locations
Ironwood Cancer & Research Centers
Chandler, Arizona 85224
Chandler, Arizona 85224
Ironwood Cancer & Research Centers
Gilbert, Arizona 85297
Gilbert, Arizona 85297
Ironwood Cancer & Research Centers
Glendale, Arizona 85306
Glendale, Arizona 85306
Ironwood Cancer & Research Centers
Goodyear, Arizona 85395
Goodyear, Arizona 85395
Ironwood Cancer & Research Centers
Mesa, Arizona 85202
Mesa, Arizona 85202
Ironwood Cancer & Research Centers
Mesa, Arizona 85206
Mesa, Arizona 85206
Ironwood Cancer & Research Centers
Phoenix, Arizona 85028
Phoenix, Arizona 85028
Ironwood Cancer & Research Centers
Scottsdale, Arizona 85260
Scottsdale, Arizona 85260
Highlands Oncology Group, PA
Fayetteville, Arkansas 72703
Fayetteville, Arkansas 72703
Highlands Oncology Group, PA
Rogers, Arkansas 72758
Rogers, Arkansas 72758
Highlands Oncology Group, PA
Springdale, Arkansas 72762
Springdale, Arkansas 72762
Cancer Care Specialists of Illinois
Decatur, Illinois 62526
Decatur, Illinois 62526
Cancer Care Specialists of Illinois
O'Fallon, Illinois 62269
O'Fallon, Illinois 62269
Montefiore Einstein Comprehensive Cancer Center
The Bronx, New York 10461
The Bronx, New York 10461
Montefiore Medical Center- Montefiore Medical Park
The Bronx, New York 10461
The Bronx, New York 10461
University Hospitals Seidman Cancer Center at UH Avon Health Center
Avon, Ohio 44011
Avon, Ohio 44011
TriState Urologic Services PSC Inc. dba The Urology Group
Cincinnati, Ohio 45212
Cincinnati, Ohio 45212
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
Cleveland, Ohio 44106
University Hospitals Seidman Cancer Center at UH Mentor Health Center
Mentor, Ohio 44060
Mentor, Ohio 44060
UH Minoff Health Center at Chagrin Highlands
Orange, Ohio 44122
Orange, Ohio 44122
The Centers for Advanced Urology, LLP d/b/a Keystone Urology Specialists
Lancaster, Pennsylvania 17604
Lancaster, Pennsylvania 17604
Grand Strand Medical Center
Myrtle Beach, South Carolina 295724607
Myrtle Beach, South Carolina 295724607
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina 29572
Myrtle Beach, South Carolina 29572
Parkway Surgery Center
Myrtle Beach, South Carolina 29572
Myrtle Beach, South Carolina 29572
Urology Associates, P.C.
Nashville, Tennessee 37209
Nashville, Tennessee 37209
US Oncology Investigational Product Center (IPC)
Irving, Texas 75063
Irving, Texas 75063
Huntsman Cancer Institute
Salt Lake City, Utah 84112
Salt Lake City, Utah 84112
Blue Ridge Cancer Care
Blacksburg, Virginia 24060
Blacksburg, Virginia 24060
Blue Ridge Cancer Care
Low Moor, Virginia 24457
Low Moor, Virginia 24457
Blue Ridge Cancer Care
Roanoke, Virginia 24014
Roanoke, Virginia 24014
Blue Ridge Cancer Care
Salem, Virginia 24153
Salem, Virginia 24153
Blue Ridge Cancer Care
Wytheville, Virginia 24382
Wytheville, Virginia 24382
Northwest Medical Specialties, PLLC
Bonney Lake, Washington 98391
Bonney Lake, Washington 98391
Northwest Medical Specialties, PLLC
Federal Way, Washington 98003
Federal Way, Washington 98003
Northwest Medical Specialties, PLLC
Gig Harbor, Washington 98332
Gig Harbor, Washington 98332
Northwest Medical Specialties, PLLC
Puyallup, Washington 98373
Puyallup, Washington 98373
Northwest Medical Specialties, PLLC
Tacoma, Washington 98405
Tacoma, Washington 98405
More Details
- Status
- Recruiting
- Sponsor
- Pfizer
Detailed Description
This is a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study evaluating mevrometostat in combination with enzalutamide versus placebo in combination with enzalutamide in participants with mCSPC who have not received systemic anticancer treatments with the exception of androgen-deprivation therapy (ADT) and first-generation antiandrogen agents. Prior therapy with up to 3 months of ADT (chemical or surgical) is allowed, with no radiographic evidence of disease progression or rising PSA levels prior to Day 1. This study consists of a Screening Phase, Randomization, Treatment Phase, Safety Follow-up, and Long-Term Follow-up. Participants will be randomized on a 1:1 basis to receive (Arm A) mevrometostat (PF-06821497) in combination with enzalutamide, or (Arm B) placebo in combination with enzalutamide.