RECRUITINGPhase 3INTERVENTIONAL
A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.
A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF PF-06821497 (MEVROMETOSTAT) WITH ENZALUTAMIDE IN METASTATIC CASTRATION RESISTANT PROSTATE CANCER (MEVPRO-2)
About This Trial
This study will explore whether a combination of the investigational drug PF-06821497 and enzalutamide will work better than taking enzalutamide alone in participants with mCRPC who are ARSi or abiraterone naïve.
Who May Be Eligible (Plain English)
Who May Qualify:
- diagnosed by tissue sample (biopsy-confirmed) adenocarcinoma of the prostate without small cell features.
- Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan.
- Progressive disease in the setting of medical or surgical castration.
- You should be able to carry out daily activities with 0 level of ability (ECOG 0) or 1, with a life expectancy of ≥12 months as assessed by the investigator.
Who Should NOT Join This Trial:
- Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that make the participant inappropriate for the study.
- Known history of active inflammatory gastrointestinal disease, chronic diarrhea, or previous gastric resection or lap-band surgery.
- Clinically significant cardiovascular disease.
- Known or suspected brain metastasis or active leptomeningeal disease or clinically significant history of seizure.
- Any history of myelodysplastic syndrome, acute myeloid leukemia, or any other prior malignancy with a few exceptions.
- Participants must be treatment naïve at the mCRPC stage, eg, no cytotoxic chemotherapy, radio-ligand therapy (i.e. 177Lu- PSMA-617), CDK4/6 inhibitors, 5-alpha reductase inhibitors for prostate cancer in any setting, androgen receptor signaling inhibitors (ARSi) including enzalutamide, apalutamide, darolutamide, poly ADP-ribose polymerase (PARP) monotherapy or other systemic anti-cancer treatment with the following exceptions:
1. Treatment with first-generation antiandrogen (ADT) agents, estrogens, progestins, cyproterone acetate;
2. Docetaxel treatment is allowed for mCSPC, as long as no signs of failure, or disease progression occurred during treatment or within 3 months of treatment completion.
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features.
* Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan.
* Progressive disease in the setting of medical or surgical castration.
* ECOG performance status 0 or 1, with a life expectancy of ≥12 months as assessed by the investigator.
Exclusion Criteria:
* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that make the participant inappropriate for the study.
* Known history of active inflammatory gastrointestinal disease, chronic diarrhea, or previous gastric resection or lap-band surgery.
* Clinically significant cardiovascular disease.
* Known or suspected brain metastasis or active leptomeningeal disease or clinically significant history of seizure.
* Any history of myelodysplastic syndrome, acute myeloid leukemia, or any other prior malignancy with a few exceptions.
* Participants must be treatment naïve at the mCRPC stage, eg, no cytotoxic chemotherapy, radio-ligand therapy (i.e. 177Lu- PSMA-617), CDK4/6 inhibitors, 5-alpha reductase inhibitors for prostate cancer in any setting, androgen receptor signaling inhibitors (ARSi) including enzalutamide, apalutamide, darolutamide, poly ADP-ribose polymerase (PARP) monotherapy or other systemic anti-cancer treatment with the following exceptions:
1. Treatment with first-generation antiandrogen (ADT) agents, estrogens, progestins, cyproterone acetate;
2. Docetaxel treatment is allowed for mCSPC, as long as no signs of failure, or disease progression occurred during treatment or within 3 months of treatment completion.
* Previous administration with an investigational product (drug or vaccine) within 30 days or 5 half-lives preceding the first dose of study intervention (whichever is longer).
* Inadequate organ function.
Treatments Being Tested
DRUG
PF-06821497
Oral continuous
DRUG
Placebo
Oral continuous
DRUG
Enzalutamide
Oral continuous
Locations (20)
Ironwood Cancer & Research Centers
Chandler, Arizona, United States
Ironwood Cancer & Research Centers
Gilbert, Arizona, United States
Palo Verde Hematology Oncology
Glendale, Arizona, United States
Ironwood Cancer & Research Centers
Glendale, Arizona, United States
Ironwood Cancer & Research Centers
Goodyear, Arizona, United States
Ironwood Cancer & Research Centers
Mesa, Arizona, United States
Ironwood Cancer & Research Centers
Mesa, Arizona, United States
Ironwood Cancer & Research Centers
Phoenix, Arizona, United States
Ironwood Cancer & Research Centers
Scottsdale, Arizona, United States
Highlands Oncology
Fayetteville, Arkansas, United States
Arkansas Urology - Little Rock
Little Rock, Arkansas, United States
Highlands Oncology
Rogers, Arkansas, United States
Highlands Oncology Group
Springdale, Arkansas, United States
Los Angeles Cancer Network (LACN)
Anaheim, California, United States
Los Angeles Cancer Network (LACN)
Fountain Valley, California, United States
Los Angeles Cancer Network (LACN)
Glendale, California, United States
Los Angeles Cancer Network (LACN)
Glendale, California, United States
Los Angeles Cancer Network (LACN)
Los Angeles, California, United States
Los Angeles Cancer Network (LACN)
Los Angeles, California, United States
Medical Oncology Associates of San Diego
San Diego, California, United States