A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Mevrometostat (PF-06821497) With Enzalutamide in Metastatic Castration-Sensitive Prostate Cancer (MEVPRO-3)
Study Identifier:
C2321008
CT.gov Identifier:
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
Study Contact Information:
Recruiting
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Study Summary
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.
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Prostate
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase III
Sex
Male
Age
18+ years
Study Drug
Drug: Experimental: Arm A
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Drug: Drug: Enzalutamide
Drug: Active Comparator: Arm B
Drug: Drug: Placebo
Drug: Intervention:
Drug: *Drug: Enzalutamide
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting
Requirements information
Inclusion criteria
- 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.
- CFDA
- 1 Male study participants aged 18 years and above (or the minimum age of informed consent as determined by local regulations) at the time of screening were enrolled.
- 2 Histologically or cytologically confirmed prostate adenocarcinoma without small cell features (neuroendocrine differentiation and other histologic components are permitted if adenocarcinoma is the predominant histologic finding). For study participants without a prior histologic diagnosis, a fresh baseline biopsy specimen must be used to confirm the diagnosis.
- 3 Metastatic prostate cancer confirmed by a positive bone scan (bone lesions) or metastatic lesions (soft tissue/visceral lesions) on CT or MRI scans. a. If no evaluable bone lesions (according to PCWG3 criteria) are present, measurable soft tissue/visceral lesions (according to RECIST v1.1) are required. b. For study participants with only measurable soft tissue lesions, those with only regional lymph node disease (i.e., lymph node disease below the aortic bifurcation) are ineligible for study entry. c. PET and SPECT are not evaluable imaging modalities for this study. d. If a bone scan shows intense, symmetrical activity in the bones (called hyperbone scintigraphy), the patient is considered ineligible.
- 4 Any acute effects of previous treatment have resolved to baseline or CTCAE ≤ Grade 1 (except for AEs that are judged by the investigator not to pose a safety risk).
- 5 Study participants cannot have received any cytotoxic chemotherapy, ARPI (e.g., enzalutamide, apalutamide, abiraterone acetate, or darolutamide), or any other systemic anticancer treatment for mCSPC, with the following exceptions: a. ADT (chemotherapy or surgery) must be started before randomization and must be continued throughout the study. Up to 3 months of previous ADT (with or without antiandrogens) is permitted, with no radiographic evidence of disease progression or elevated PSA levels before study day 1. b. Estrogen, cyproterone acetate, or first-generation antiandrogen therapy is permitted until randomization but must be discontinued before randomization. c. Study participants may have received 1 previous course of palliative radiation therapy or surgery to control secondary symptoms of prostate cancer, which should have been completed at least 2 weeks before randomization. Note: Radical prostate surgery or radical radiation therapy with curative intent for the primary prostate tumor of participants with mCSPC is not permitted.
- 6 Study participants must have an ECOG PS score of 0 or 1
- 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 randomizationCurrent 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.
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START Carolinas
Myrtle Beach, SC, United States, 29572
Investigator
Neal Shore
Status
Recruiting
Condition(s) Treated at Site
Prostate