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New treatment option for Malignant Neoplasm
Official title A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015)
ClinicalTrials.gov ID: NCT06979596
What this study is testing
What is Opevesostat?
Opevesostat is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for malignant neoplasm.
Also referred to as MK-5684.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The main 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...
- Has experienced disease progression on or after at least 1 prior endocrine-based therapy in the metastatic setting and received either, 1 line of an...
- Cohort B:
You likely can't join if
- 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...
- Cohort B:
- Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), borderline tumors (low malignant potential), mucinous, seromucinous that is...
See the full eligibility criteria
- The main 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...
- Has experienced disease progression on or after at least 1 prior endocrine-based therapy in the metastatic setting and received either, 1 line of an approved protocol-specified combination endocrine-based therapy, or 2...
- 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...
- 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 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...
- 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...
- 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...
- 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...
- 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 study team makes the final eligibility decision.
Where it's taking place
- Anchorage, Alaska, United States
- Miami Beach, Florida, United States
- Shreveport, Louisiana, United States
- Hastings, Nebraska, United States
- Hackensack, New Jersey, United States
- New York, New York, United States
- Columbus, Ohio, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
- Buenos Aires, Buenos Aires F.D., Argentina
- Vitória, Espírito Santo, Brazil
- Salvador, Estado de Bahia, Brazil
- Belo Horizonte, Minas Gerais, Brazil
- Recife, Pernambuco, Brazil
- Natal, Rio Grande do Norte, Brazil
- Rio de Janeiro, Brazil
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Santiago, Region M. de Santiago, Chile
+ 26 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anchorage, Alaska, United States; Miami Beach, Florida, United States; Shreveport, Louisiana, United States; Hastings, Nebraska, United States; Hackensack, New Jersey, United States; New York, New York, United States and 40 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.