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.
Recruiting · NCT07028853 · Interventional (participants receive a specific treatment) · Lead sponsor: Pfizer
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
- Use of 5-alpha reductase inhibitors is prohibited within 28 days of randomization.
- Prior surgery from which the participant has not fully recovered at least 28 days prior to randomization
- 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.
- Known allergic or hypersensitivity reactions to mevrometostat or its excipients or to enzalutamide or its excipients.
Where it is running
60 locations listed across 21 US states.
- Clearview Cancer Institute (Crestwood) - Huntsville, Alabama, United States
- Clearview Cancer Institute - Huntsville, Alabama, United States
- Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers - Chandler, Arizona, United States
- Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers - Gilbert, Arizona, United States
- Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers - Glendale, Arizona, United States
- Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers - Goodyear, Arizona, United States
- Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers - Mesa, Arizona, United States
- Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers - Mesa, Arizona, United States
- Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers - Phoenix, Arizona, United States
- Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers - Scottsdale, Arizona, United States
- Highlands Oncology Group, PA - Fayetteville, Arkansas, United States
- Highlands Oncology Group, PA - Rogers, Arkansas, United States
- Highlands Oncology Group, PA - Springdale, Arkansas, United States
- UCLA Hematology/Oncology - Alhambra - Alhambra, California, United States
- UCLA Hematology/Oncology - Atascadero - Atascadero, California, United States
- Cedars-Sinai Cancer Beverly Hills (drug treatment and dispensing location) - Beverly Hills, California, United States
- Cedars-Sinai Cancer Beverly Hills - Beverly Hills, California, United States
- UCLA Hematology/Oncology - Beverly Hills - Beverly Hills, California, United States
- UCLA Hematology/Oncology - Burbank - Burbank, California, United States
- UCLA Hematology/Oncology - Encino - Encino, California, United States
- UCLA Hematology/Oncology - Irvine - Irvine, California, United States
- UCLA Hematology/Oncology - Laguna Hills - Laguna Hills, California, United States
- Cedars-Sinai Cancer at Cedars-Sinai Medical Center - Los Angeles, California, United States
- Ronald Reagan UCLA Medical Center - Drug Information Center - Los Angeles, California, United States
- UCLA Department of Medicine - Hematology/Oncology - Los Angeles, California, United States
- UCLA Hematology/Oncology - Los Angeles, California, United States
- UCLA Hematology/Oncology - Marina del Rey - Marina del Rey, California, United States
- UCLA Hematology/Oncology - Pasadena - Pasadena, California, United States
- UCLA Hematology/Oncology - Porter Ranch - Porter Ranch, California, United States
- UCLA Hematology/Oncology - San Luis Obispo - San Luis Obispo, California, United States
- UCLA Hematology/Oncology - Santa Barbara - Santa Barbara, California, United States
- UCLA Hematology/Oncology- Santa Monica - Santa Monica, California, United States
- UCLA Hematology/Oncology - Torrance - Torrance, California, United States
- UCLA Hematology/Oncology - Santa Clarita - Valencia, California, United States
- UCLA Hematology/Oncology - Ventura - Ventura, California, United States
- UCLA Hematology/Oncology - Westlake - Westlake Village, California, United States
- AdventHealth Medical Group Urology of Denver - Denver, Colorado, United States
- Advanced Urology Institute, LLC - Largo, Florida, United States
- Tennessee Oncology, PLLC - Dalton - Dalton, Georgia, United States
- Tennessee Oncology, PLLC - Ringgold - Ringgold, Georgia, United States
- Associated Urological Specialists - Chicago Ridge - Chicago Ridge, Illinois, United States
- Cancer Care Specialists of Illinois - Decatur, Illinois, United States
- Cancer Care Specialists of Illinois - O'Fallon, Illinois, United States
- Michigan Institute of Urology, PC - Troy, Michigan, United States
- MSK Basking Ridge - Basking Ridge, New Jersey, United States
- MSK Monmouth - Middletown, New Jersey, United States
- MSK Bergen - Montvale, New Jersey, United States
- MSK Commack - Commack, New York, United States
- MSKCC-Westchester (500 Westchester Ave.) - Harrison, New York, United States
- Memorial Sloan Kettering Cancer Center (IDS Pharmacy) - Long Island City, New York, United States
- Evelyn H. Lauder Breast and Imaging Center (BAIC). - New York, New York, United States
- Memorial Sloan Kettering Cancer Center - Main Campus - New York, New York, United States
- Sidney Kimmel Center for Prostate and Urological Cancers - Memorial Sloan Kettering Cancer Center - New York, New York, United States
- University of Rochester Medical Center - Rochester, New York, United States
- University of Rochester, Cancer Center Pharmacy (Investigational Product) - Rochester, New York, United States
- Integrated Medical Professionals - Seaford, New York, United States
- Montefiore Einstein Comprehensive Cancer Center - The Bronx, New York, United States
- Montefiore Medical Center- Montefiore Medical Park - The Bronx, New York, United States
- MSK Nassau. - Uniondale, New York, United States
- Duke Cancer Center Cary - Cary, North Carolina, United States
Showing 60 of 337 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →