Opevesostat

DRUG12 trials

Sponsors

Merck Sharp & Dohme LLC

Conditions

Breast cancerEndometrial cancerHealthyHealthy ParticipantsHepatic ImpairmentMalignant NeoplasmMetastatic Castration-Resistant Prostate CancerMetastatic Castration-resistant Prostate Cancer (mCRPC)

Phase 1

A Study of Opevesostat (MK-568)4 in Japanese Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-005)

Active, not recruitingNCT06104449

Merck Sharp & Dohme LLCMetastatic Castration-Resistant Prostate Cancer, Prostatic Neoplasms

Start: 2023-11-14End: 2026-04-20Target: 6Updated: 2026-03-06

A Study of Opevesostat (MK-5684) in China Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (MK-5684-001)

CompletedNCT06136598

Merck Sharp & Dohme LLCMetastatic Castration-Resistant Prostate Cancer, Prostatic Neoplasms

Start: 2024-01-30End: 2026-03-09Updated: 2026-03-19

Substudy 01A: Safety and Efficacy of Opevesostat (MK-5684)-Based Treatment Combinations or Opevesostat Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-01A)

RecruitingNCT06353386

Merck Sharp & Dohme LLCProstatic Neoplasms, Castration-Resistant

Start: 2024-05-20End: 2029-01-15Target: 220Updated: 2026-03-24

MK-5684-01A Substudy: A Phase 1/2 Umbrella Substudy of MK-5684-U01 Master Protocol to Evaluate the Safety and Efficacy of MK-5684-based Treatment Combinations or MK-5684 Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (OMAHA-01A)

RecruitingCTIS2023-506288-33-00

Merck Sharp & Dohme LLCMetastatic castration resistant prostate cancer (mCRPC)

Start: 2025-03-03Target: 127Updated: 2026-01-27

A Drug-Drug Interaction Study of Carbamazepine and Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-012)

CompletedNCT06633419

Merck Sharp & Dohme LLCHealthy

Start: 2024-12-18End: 2025-05-13Updated: 2025-05-25

A Study to Evaluate Opevesostat (MK-5684) in Male Participants With Moderate Hepatic Impairment (MK-5684-009)

CompletedNCT06860243

Merck Sharp & Dohme LLCHealthy Participants, Hepatic Impairment

Start: 2025-05-13End: 2026-02-19Updated: 2026-02-24

Phase 2

A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015)

RecruitingNCT06979596

Merck Sharp & Dohme LLCMalignant Neoplasm

Start: 2025-08-11End: 2027-11-04Target: 250Updated: 2026-04-02

A Multicenter, Open-label, Phase 2 Basket Study of MK-5684 in Participants With Selected Solid Tumors (OMAHA-015)

RecruitingCTIS2024-519563-18-00

Merck Sharp & Dohme LLCBreast cancer, Endometrial cancer, Ovarian cancer

Start: 2025-09-02Target: 22Updated: 2025-10-14

Phase 3

Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)

RecruitingNCT06136624

Merck Sharp & Dohme LLCProstate Cancer Metastatic

Start: 2023-12-31End: 2028-08-02Target: 1310Updated: 2026-03-20

A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)

RecruitingNCT06136650

Merck Sharp & Dohme LLCMetastatic Castration-resistant Prostate Cancer (mCRPC), Prostatic Neoplasms

Start: 2023-12-18End: 2030-12-02Target: 1314Updated: 2026-03-30

MK-5684-003: 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)

RecruitingCTIS2023-504899-25-00

Merck Sharp & Dohme LLCMetastatic castration resistant prostate cancer

Start: 2024-04-04Target: 393Updated: 2025-12-04

MK-5684-004: A Phase 3, Randomized, Open-label Study of Opevesostat 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) (OMAHA-004)

SuspendedCTIS2023-504957-11-00

Merck Sharp & Dohme LLCMetastatic castration resistant prostate cancer

Start: 2024-04-05Target: 401Updated: 2025-11-13

Related Papers

Steroidogenesis inhibitor opevesostat (MK-5684) for metastatic castration-resistant prostate cancer: OMAHA-003 and OMAHA-004 trial designs.

2026-02-23

Phase 3 OMAHA-004 study of CYP11A1 inhibitor opevesostat versus next-generation hormonal agent (NHA) switch in patients with metastatic castration-resistant prostate cancer (mCRPC) after 1 prior NHA.

Journal of Clinical Oncology2025-02-101 citations

Phase 1/2 OMAHA-01A substudy of oral CYP11A1 inhibitor opevesostat alone or in combination with other therapies for metastatic castration-resistant prostate cancer (mCRPC).

Journal of Clinical Oncology2025-02-10

OMAHA-003: A phase 3 study of CYP11A1 inhibitor opevesostat versus next-generation hormonal agent (NHA) switch in metastatic castration-resistant prostate cancer (mCRPC) after NHA and taxane-based chemotherapy.

Journal of Clinical Oncology2025-02-10

CYP11A1 inhibitor MK-5684 versus next-generation hormonal agent (NHA) switch in patients with metastatic castration-resistant prostate cancer (mCRPC) after NHA and taxane-based chemotherapy: Phase 3 MK-5684-003 trial.

Journal of Clinical Oncology2024-06-01

CYP11A1 inhibitor MK-5684 versus next-generation hormonal agent (NHA) switch in patients with metastatic castration-resistant prostate cancer (mCRPC) after 1 prior NHA: Phase 3 MK-5684-004 study.

Journal of Clinical Oncology2024-06-01