Clinical trial NCT06979596: A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015)
Official title: A Multicenter, Open-label, Phase 2 Basket Study of MK-5684 in Participants With Selected Solid Tumors (OMAHA-015)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Malignant Neoplasm
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2025-05-20
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Researchers want to learn if MK-5684 (the study medicine) can treat breast cancer, ovarian cancer, and endometrial cancer. MK-5684, the study medicine, is designed to treat cancer by blocking the body from making steroid hormones.

Researchers will compare MK-5684 to the standard treatments for each cancer type in this study.

The goal of this study is to learn if people who receive MK-5684 live longer without the cancer growing or spreading compared to people who receive a standard treatment.


Eligibility 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.

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) endometroid 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.

Primary outcomes:
measure: Progression-Free Survival (PFS) - All Cohorts
timeFrame: Up to approximately 5 years
Secondary outcomes:
measure: Overall Survival (OS) - All Cohorts
timeFrame: Up to approximately 5 years
measure: Clinical Benefit Rate (CBR) - Cohort A
timeFrame: Up to approximately 5 years
measure: Objective Response Rate (ORR) - All Cohorts
timeFrame: Up to approximately 5 years
measure: Duration of Response (DOR) - All Cohorts
timeFrame: Up to approximately 5 years
measure: Number of Participants who Discontinue Study Intervention Due to an Adverse Event (AE) - All Cohorts
timeFrame: Up to approximately 8 months
measure: Number of Participants who Experience One or More Adverse Events (AEs) - All Cohorts
timeFrame: Up to approximately 11 months
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: