Clinical Trials List
Protocol NumberMK-5684-015
NCT Number(ClinicalTrials.gov Identfier)NCT06979596
Active
2025-07-15 - 2030-12-31
Phase II
Recruiting3
ICD-10C69.40
Malignant neoplasm of unspecified ciliary body
ICD-10C69.41
Malignant neoplasm of right ciliary body
ICD-10C69.42
Malignant neoplasm of left ciliary body
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9190.0
Malignant neoplasm of eyeball, except conjunctiva, cornea, retina and choroid
A Multicenter, Open-label, Phase 2 Basket Study of MK-5684 in Participants With Selected Solid Tumors (OMAHA-015)
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Trial Applicant
Merck Sharp & Dohme (I.A.) LLC
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 呂亭芳 Division of Obstetrics & Gynecology
- 范鈞婷 Division of Obstetrics & Gynecology
- 劉芝谷 Division of Obstetrics & Gynecology
- 王韶靖 Division of Obstetrics & Gynecology
- 孫珞 Division of Obstetrics & Gynecology
- 石宇翔 Division of Obstetrics & Gynecology
- 吳振豪 Division of Radiology
- 黃曉峰 Division of Obstetrics & Gynecology
- 許世典 Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Wei-Pang Chung
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Malignant Neoplasm
Objectives
Primary Objective: To compare the progression-free survival (PFS) of MK-5684 with standard of care (SOC) in subjects with selected solid tumors (all cohorts) assessed by a blinded independent central review (BICR) according to the Rec.1 version of the Solid Tumor Response Assessment Criteria (RECIST 1.1).
Secondary Objectives:
(1) To assess the overall survival (OS) of MK-5684 versus SOC in subjects with selected solid tumors (all cohorts).
(2) To assess the clinical benefit rate (CBR) of MK-5684 versus SOC in subjects with breast cancer (cohort A) according to RECIST 1.1 by BICR.
(3) To assess the objective response rate (ORR) of MK-5684 versus SOC in subjects with selected solid tumors (all cohorts) by BICR according to RECIST 1.1.
(4) To assess the duration of response (DOR) of MK-5684 in subjects with selected solid tumors (all cohorts) by BICR according to RECIST 1.1. (5) Evaluate the safety and tolerability of MK-5684 in subjects with selected solid tumors (all groups).
Test Drug
Tablets
Tablets
Injections
Tablets
Injections
Tablets
Tablets
Injections
Tablets
Injections
Tablets
Active Ingredient
Opevesostat
1004001900
1010000900
6804000910
6804001100
6804000600
1004001900
1010000900
6804000910
6804001100
6804000600
Dosage Form
110
110
270
110
270
110
110
270
110
270
110
Dosage
2.5 mg/Tablet
25 mg/Tablet
50 mg/mL
0.1 mg/Tablet
100 mg
0.5 mg
25 mg/Tablet
50 mg/mL
0.1 mg/Tablet
100 mg
0.5 mg
Endpoints
Subjects with selected solid tumors (all cohorts) were assessed by blinded independent central review (BICR) according to the Solid Tumor Response Assessment Criteria version 1.1 (RECIST 1.1) to compare progression-free survival (PFS) between MK-5684 and standard care (SOC).
Inclution Criteria
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Cohort A:
Has a diagnosis of hormone receptor positive/Human Epidermal Growth Factor Receptor 2 negative (HR+/HER2-) invasive breast carcinoma that is either locally advanced disease not amenable to resection with curative intent (herein called unresectable) or metastatic disease not treatable with curative intent.
Has experienced disease progression on or after at least 1 prior endocrine-based therapy in the metastatic setting.
Cohort B:
Has histologically confirmed high-grade epithelial (including high-grade serous or predominantly serous, high-grade endometrioid, malignant mixed Müllerian tumors [carcinosarcoma], or clear cell) ovarian, fallopian tube, or primary peritoneal carcinoma.
Has received between 4 to 8 cycles of platinum-based doublet chemotherapy in third-line (3L) setting for ovarian cancer.
Cohort C:
Histologically confirmed diagnosis of primary advanced or recurrent low-grade endometrioid carcinoma (eg, Federation of Gynecology and Obstetrics [FIGO] Grade 1/2, or well/moderately differentiated).
Treatment naïve or has received up to 1 prior line of platinum-based therapy in either the advanced/metastatic OR adjuvant/neoadjuvant setting.
All Cohorts :
Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline.
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.
Participants who are Hepatitis B surface antigen positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load.
Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable.
The main inclusion criteria include but are not limited to the following:
Cohort A:
Has a diagnosis of hormone receptor positive/Human Epidermal Growth Factor Receptor 2 negative (HR+/HER2-) invasive breast carcinoma that is either locally advanced disease not amenable to resection with curative intent (herein called unresectable) or metastatic disease not treatable with curative intent.
Has experienced disease progression on or after at least 1 prior endocrine-based therapy in the metastatic setting.
Cohort B:
Has histologically confirmed high-grade epithelial (including high-grade serous or predominantly serous, high-grade endometrioid, malignant mixed Müllerian tumors [carcinosarcoma], or clear cell) ovarian, fallopian tube, or primary peritoneal carcinoma.
Has received between 4 to 8 cycles of platinum-based doublet chemotherapy in third-line (3L) setting for ovarian cancer.
Cohort C:
Histologically confirmed diagnosis of primary advanced or recurrent low-grade endometrioid carcinoma (eg, Federation of Gynecology and Obstetrics [FIGO] Grade 1/2, or well/moderately differentiated).
Treatment naïve or has received up to 1 prior line of platinum-based therapy in either the advanced/metastatic OR adjuvant/neoadjuvant setting.
All Cohorts :
Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline.
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.
Participants who are Hepatitis B surface antigen positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load.
Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable.
Exclusion Criteria
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Cohort A:
Breast cancer amenable to treatment with curative intent.
Has advanced/metastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications, such as lymphangitic lung metastases, radiographic evidence of intratumoral cavitation or invasion/infiltration of a major blood vessel, bone marrow replacement, carcinomatous meningitis, significant symptomatic liver metastases, symptomatic pericardial effusion, symptomatic peritoneal carcinomatosis, or the need to achieve rapid symptom control.
Cohort B:
Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), borderline tumors (low malignant potential), mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor, low-grade serous, low-grade endometrioid, and undifferentiated carcinoma.
Has platinum-resistant ovarian cancer (defined as disease that has progressed per radiographic imaging within 180 days after the last dose of first-line [1L] platinum-based therapy) or platinum-refractory ovarian cancer (defined as disease that has progressed per radiographic imaging while receiving or within 28 days of the last dose of 1L platinum based therapy).
Is a candidate for curative-intent surgery or curative-intent radiotherapy for ovarian cancer.
Cohort C:
Has high-grade (FIGO Grade 3 or poorly differentiated) endometrioid carcinoma and nonendometrioid histologies of any type (including serous, clear cell, mixed, carcinosarcoma), and neuroendocrine tumors are not eligible. Uterine mesenchymal tumors such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas, and adenosarcomas are not eligible.
Is a candidate for curative-intent surgery or curative-intent radiotherapy.
All Cohorts:
Has confirmed or suspected adrenal metastases.
Has known difficulty in tolerating oral medications, unable to swallow orally administered medication, or conditions which would impair absorption of oral medications.
Has any prior history or current condition of adrenal insufficiency.
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
Has known active central nervous system metastases and/or carcinomatous meningitis.
Has a history of stem cell/solid organ transplant.
Has not adequately recovered from major surgery or has ongoing surgical complications.
The main exclusion criteria include but are not limited to the following:
Cohort A:
Breast cancer amenable to treatment with curative intent.
Has advanced/metastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications, such as lymphangitic lung metastases, radiographic evidence of intratumoral cavitation or invasion/infiltration of a major blood vessel, bone marrow replacement, carcinomatous meningitis, significant symptomatic liver metastases, symptomatic pericardial effusion, symptomatic peritoneal carcinomatosis, or the need to achieve rapid symptom control.
Cohort B:
Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), borderline tumors (low malignant potential), mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor, low-grade serous, low-grade endometrioid, and undifferentiated carcinoma.
Has platinum-resistant ovarian cancer (defined as disease that has progressed per radiographic imaging within 180 days after the last dose of first-line [1L] platinum-based therapy) or platinum-refractory ovarian cancer (defined as disease that has progressed per radiographic imaging while receiving or within 28 days of the last dose of 1L platinum based therapy).
Is a candidate for curative-intent surgery or curative-intent radiotherapy for ovarian cancer.
Cohort C:
Has high-grade (FIGO Grade 3 or poorly differentiated) endometrioid carcinoma and nonendometrioid histologies of any type (including serous, clear cell, mixed, carcinosarcoma), and neuroendocrine tumors are not eligible. Uterine mesenchymal tumors such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas, and adenosarcomas are not eligible.
Is a candidate for curative-intent surgery or curative-intent radiotherapy.
All Cohorts:
Has confirmed or suspected adrenal metastases.
Has known difficulty in tolerating oral medications, unable to swallow orally administered medication, or conditions which would impair absorption of oral medications.
Has any prior history or current condition of adrenal insufficiency.
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
Has known active central nervous system metastases and/or carcinomatous meningitis.
Has a history of stem cell/solid organ transplant.
Has not adequately recovered from major surgery or has ongoing surgical complications.
The Estimated Number of Participants
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Taiwan
19 participants
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Global
250 participants
