MK5684-004 (OMAHA)

The purpose of this study is to assess the efficacy and safety of MK-5684 plus hormone replacement therapy (HRT) compared to alternative abiraterone acetate or enzalutamide in participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) previously treated with one next-generation hormonal agent (NHA). The primary study hypotheses are that MK-5684 is superior to alternative abiraterone acetate or enzalutamide with respect to radiographic progression free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and overall survival (OS), in androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants.

{ "short_title": "MK5684-004 (OMAHA)", "data_mode": "900", "data_mode_number": "000002300", "official_title": "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) That Progressed On or After Prior Treatment With One Next-generation Hormonal Agent (NHA)", "accrual_state": "running", "therapeutic_value": "therapeutic", "therapieansatz_value": "palliativ", "therapieintervention_value": "adjuvant", "therapielinie_value": "second", "ctgov_number": "NCT06136650", "eudract_number": null, "general_contact_email": null, "general_contact_phone": null, "hauptpruefer_dd_name": "Prof. Dr. med. Christian Thomas", "description_laie_de": "Wirksamkeit und Sicherheit von MK5684 bei Patienten mit mCRPC", "description_laie_en": "efficacy and safety of MK-5684 plus hormone replacement therapy (HRT) compared to alternative abiraterone acetate or enzalutamide", "description_expert_de": "Ziel dieser Studie ist es, die Wirksamkeit und Sicherheit von MK-5684 plus Hormonersatztherapie (HRT) im Vergleich zu den Alternativen Abirateronacetat oder Enzalutamid bei Teilnehmern mit metastasiertem kastrationsresistentem Prostatakrebs (mCRPC) zu untersuchen, die zuvor mit einem Hormonpr\u00e4parat der n\u00e4chsten Generation (NHA) behandelt wurden. Die prim\u00e4ren Studienhypothesen lauten, dass MK-5684 den Alternativen Abirateronacetat oder Enzalutamid in Bezug auf das radiografische progressionsfreie \u00dcberleben (rPFS) gem\u00e4\u00df den Modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1) der Prostate Cancer Working Group (PCWG), bewertet durch Blinded Independent Central Review (BICR), und das Gesamt\u00fcberleben (OS) bei Teilnehmern mit positiver und negativer Androgenrezeptor-Ligand-Binding-Domain (AR LBD) Mutation \u00fcberlegen ist.", "description_expert_en": "The purpose of this study is to assess the efficacy and safety of MK-5684 plus hormone replacement therapy (HRT) compared to alternative abiraterone acetate or enzalutamide in participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) previously treated with one next-generation hormonal agent (NHA). The primary study hypotheses are that MK-5684 is superior to alternative abiraterone acetate or enzalutamide with respect to radiographic progression free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and overall survival (OS), in androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants.", "rechtsgrundlage_value": "AMG", "phase_amg_value": "III", "main_cat_id": 11, "sub_cat_id": 54 }