Trial Radar KI | ||
|---|---|---|
Die klinische Studie NCT06136624 (OMAHA-003) für Metastasierender Prostatakrebs ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003) (OMAHA-003) Phase 3 1.310 Randomisiert Offene Studie Gesamtüberleben
A Phase 3 Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Previously Treated With Next-generation Hormonal Agent (NHA) and Taxane-based Chemotherapy (OMAHA-003)
- OMAHA-003
- 5684-003
- 2023-504899-25-00 (Andere Kennung) (EU CT)
- MK-5684-003 (Andere Kennung) (MSD)
- jRCT2031240029 (Registerkennung) (Japan Registry of Clinical Trials (jRCT))
- U1111-1287-5304 (Registerkennung) (UTN)
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellOpevesostat Participants receive opevesostat 5 mg by oral tablets twice daily (bid) plus dexamethasone 1.5 mg by oral tablets once daily (qd) and 0.1 mg fludrocortisone acetate by oral tablet qd until progression. Hydrocortisone 100 mg (oral or intramuscular \[IM\]) dose will also be provided to participants for use as rescue medication. | Opevesostat Administered orally Hydrocortisone Administered orally or IM as a rescue medication Fludrocortisone acetate Administered orally Dexamethasone Administered orally as rescue medication |
Aktives VergleichspräparatAbiraterone Acetate or Enzalutamide Participants receive abiraterone 1000 mg qd by oral tablets plus prednisone 5 mg bid by oral tablets or enzalutamide 160 mg qd by oral tablets. | Abirateronacetat Administered orally Enzalutamide Administered orally Prednisone Administered orally |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Overall Survival (OS) in Androgen Receptor Ligand Binding Domain (AR LBD) Mutation-Positive Participants | OS is defined as time from randomization to death due to any cause. OS in AR LBD mutation-positive participants will be reported for each study arm. | Up to ~54 months |
OS in AR LBD Mutation-Negative Participants | OS is defined as time from randomization to death due to any cause. OS in AR LBD mutation-negative participants will be reported for each study arm. | Up to ~54 months |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review in AR LBD Mutation-Positive Participants | rPFS is defined as the time from randomization to the first documented disease progression per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) or death due to any cause, whichever occurs first. rPFS in AR LBD mutation-positive participants will be reported for each study arm. | Up to ~36 months |
rPFS Per Prostate Cancer Working Group-modifiedRECIST 1.1 as Assessed by Blinded Independent Central Review in AR LBD Mutation-Negative Participants | rPFS is defined as the time from randomization to the first documented disease progression per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) or death due to any cause, whichever occurs first. rPFS in AR LBD mutation-positive participants will be reported for each study arm. | Up to ~36 months |
Time to Initiation of the First Subsequent Anti-Cancer Therapy or Death (TFST) | TFST is defined as the time from randomization to initiation of the first subsequent anticancer therapy or death, whichever occurs first. | Up to ~54 months |
Objective Response (OR) | OR is determined by PCWG-modified RECIST 1.1 as assessed by BICR. | Up to ~54 months |
Duration of Response (DOR) | DOR is determined by PCWG-modified RECIST 1.1 as assessed by BICR. | Up to ~54 months |
Time to Pain Progression (TTPP) | TTPP is assessed by Brief Pain Inventory-Short Form (BPI-SF) Item 3 ("Worst Pain in 24 Hours") and opiate analgesic use (Analgesic Quantification Algorithm \[AQA\] Score). | Up to ~54 months |
Time to Prostate-specific Antigen (PSA) Progression | The time from randomization to PSA progression. The PSA progression date is defined as the date of either: 1) ≥25% increase and ≥2 ng/mL above the nadir, confirmed by a second value ≥3 weeks later if there is PSA decline from baseline 2) ≥25% increase and ≥2 ng/mL increase from baseline beyond 12 weeks if there is no PSA decline from baseline. | Up to ~54 months |
Time to First Symptomatic Skeletal-related Event (SSRE) | The time from randomization to the first occurrence of any of the following symptomatic skeletal-related events: 1) Use of EBRT to prevent or relieve skeletal symptoms; 2) new symptomatic pathologic bone fracture (vertebral or nonvertebral); 3) spinal cord compression; or 4) tumor-related orthopedic surgical intervention. | Up to ~54 months |
Number of Participants Who Experience an Adverse Event | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to ~54 months |
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to ~54 months |
- Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology.
- Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months before Screening
- Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI).
- Has disease that progressed during or after treatment with 1 novel hormonal agent (NHA)
- Has received 1 but no more than 2 taxane-based chemotherapy regimens for metastatic castration-resistant prostate cancer (mCRPC) and has had progressive disease (PD) during or after treatment
- Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<1.7 nM)
- Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization
- Has had prior treatment with PARPi or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment
- Has received prior 177Lu-PSMA-617 or were deemed ineligible to receive 177Lu-PSMA-617 treatment by the investigator or refused 177Lu-PSMA-617 treatment
- Participants who have not received cabazitaxel can be enrolled if they are ineligible for cabazitaxel treatment as determined by the investigator or have refused treatment
- If participant received first generation anti-androgen therapy before screening, the participant has evidence of disease progression >4 weeks since the last flutamide treatment and >6 weeks since the last bicalutamide or nilutamide treatment
- Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses for ≥ 4 weeks before the date of randomization
- Participants with human immunodeficiency virus (HIV) infection must have well controlled HIV on antiretroviral therapy (ART)
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at Screening.
- Participants who can produce sperm must agree to the following during the study treatment period and for at least 7 days after the last dose of opevesostat, for at least 30 days after the last dose of abiraterone acetate, and for at least 3 months after the last dose of enzalutamide: EITHER be abstinent OR must agree to use male condom
- Has a gastrointestinal disorder that might affect absorption
- Has a history of pituitary dysfunction
- Has poorly controlled diabetes mellitus
- Has clinically significant abnormal serum potassium or sodium level
- Has a history of active or unstable cardio/cerebro-vascular disease, including thromboembolic events
- Has a history of seizure within 6 months of providing documented informed consent or any condition that may predispose to seizures within 12 months before the date of randomization
- Has a history of clinically significant ventricular arrhythmias
- Has received an anticancer monoclonal antibody (mAb) within 4 weeks before the date of randomization, or has not recovered from adverse events (AEs) due to mAbs administered more than 4 weeks before the date of randomization
- Has undergone major surgery, including local prostate intervention (except prostate biopsy), within 28 days before the date of randomization, and has not recovered from the toxicities and/or complications
- Participants who have not adequately recovered from major surgery or have ongoing surgical complications
- Has used herbal or medicinal products that may have hormonal anti-prostate cancer activity and/or are known to decrease prostate-specific Antigen (PSA) (eg, saw palmetto, megesterol acetate, citrus pectin polysaccharide) within 4 weeks before the date of randomization
- Has received radium-223 or lutetium-177 within 4 weeks before the date of randomization, or has not recovered to Grade ≤1 or baseline from AEs due to radium-223 or lutetium-177 administered more than 4 weeks before the date of randomization
- Has received treatment with 5-αreductase inhibitors (eg, finasteride or dutasteride), estrogens, or cyproterone within 4 weeks before the date of randomization
- Has received colony-stimulating factors within 28 days before the date of randomization
- Has received a whole blood transfusion in the last 120 days before the date of randomization. Packed red blood cells and platelet transfusions are acceptable if not given within 28 days of the date of randomization
- Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention as follows: enzalutamide or apalutamide within 3 weeks or abiraterone acetate + prednisone or darolutamide within 2 weeks
- Has a "superscan" bone scan
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has an active autoimmune disease that has required systemic treatment in past 2 years
- Has an active infection requiring systemic therapy
- Has concurrent active HBV or known active HCV infection
- Has a history of long QTc syndrome
- Has any of the following at Screening Visit: hypotension (systolic BP <110 mm Hg) or uncontrolled hypertension (systolic BP ≥160 mm Hg or diastolic BP ≥90 mm Hg, in 2 out of 3 recordings with optimized antihypertensive therapy)
- Is unable to swallow capsules/tablets
- Is currently being treated with cytochrome 450-inducing antiepileptic drugs for seizures
- Participants on an unstable dose of thyroid hormone therapy within 6 months before the start of the study intervention
- Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
- Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- Systemic use of the following medications within 2 weeks before the first dose of study intervention: strong CYP3A4 inducers (eg, avasimibe, carbamazepine, lumacaftor, phenobarbital, rifampicin, rifapentine, or St John's Wort); P-gp inhibitors (eg, erythromycin, clarithromycin, rifampicin, ketoconazole, itraconazole, posaconazole, artesunate-pyronaridine, ritonavir, indinavir, nelfinavir, atazanavir, glecaprevir-pibrentasvir, simeprevir, ledipasvir-sofosbuvir, verapamil, diltiazem, dronedarone, propafenone, quinidine, cyclosporine, valspodar, or milk thistle \[Silybum marianum\])
- Use of aldosterone antagonist (eg, spironolactone, eplerenone) and phenytoin within 4 weeks before the start of the study intervention
Bavaria
Mecklenburg-Vorpommern
North Rhine-Westphalia
Schleswig-Holstein
Thuringia
Styria
Upper Austria
California
Colorado
Connecticut
Florida
Illinois
Iowa
Kentucky
Louisiana
Maryland
Michigan
Minnesota
Missouri
Nebraska
Nevada
New Jersey
New York
Ohio
Oregon
Pennsylvania
South Carolina
South Dakota
Tennessee
Texas
Virginia
Washington
Wisconsin
Buenos Aires
Buenos Aires F.D.
Santa Fe Province
New South Wales
Queensland
Victoria
Espírito Santo
Estado de Bahia
Minas Gerais
Paraná
Santa Catarina
São Paulo
Alberta
Ontario
Quebec
Coquimbo Region
Los Ríos Region
Maule Region
Region M. de Santiago
Anhui
Beijing Municipality
Chongqing Municipality
Fujian
Guangdong
Hubei
Hunan
Jiangsu
Jiangxi
Shaanxi
Shandong
Shangai
Shanghai Municipality
Sichuan
Tianjin Municipality
Xinjiang
Yunnan
Zhejiang
Bogota D.C.
Cesar Department
Departamento de Córdoba
Santander Department
Valle del Cauca Department
Brno-mesto
Moravskoslezský kraj
Olomoucký kraj
Praha 5
Capital Region
Region Syddanmark
Northern Savonia
Pirkanmaa
Southwest Finland
Alsace
Gard
Ille-et-Vilaine
Puy-de-Dome
Pyrenees-Atlantiques
Val-de-Marne
Bács-Kiskun county
Nógrád megye
Pest County
Dublin
Emilia-Romagna
Lombardy
Chiba
Ehime
Fukuoka
Hokkaido
Hyōgo
Ishikawa-ken
Kagawa-ken
Kanagawa
Nagasaki
Nara
Okinawa
Osaka
Saga-ken
Tokyo
Johor
Kuala Lumpur
Putrajaya
Sarawak
Jalisco
Mexico City
Nuevo León
Yucatán
Gelderland
Limburg
North Brabant
North Holland
Provincie Friesland
South Holland
Utrecht
Bay of Plenty
Otago
Akershus
Sor-Trondelag
Østfold fylke
Departamento de Junín
La Libertad
Kuyavian-Pomeranian Voivodeship
Masovian Voivodeship
West Pomeranian Voivodeship
Świętokrzyskie Voivodeship
Central Singapore
Seoul
Cadiz
Madrid, Comunidad de
Orense
Valenciana, Comunitat
Stockholm County
Uppsala County
Västra Götaland County
Bangkok
Changwat Khon Kaen
Changwat Songkhla
Cambridgeshire
England
Glasgow City
Hammersmith and Fulham
London, City of