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Malignant NeoplasmPhase 2NCT06979596

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

A Phase 2 study testing Opevesostat, Fludrocortisone/ Fludrocortisone acetate and Dexamethasone/Dexamethasone acetate in people with Malignant Neoplasm, run by Merck Sharp & Dohme LLC at 60 sites in 13 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Neoplasm
What is being tested?
Opevesostat, Fludrocortisone/ Fludrocortisone acetate and Dexamethasone/Dexamethasone acetate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
60 sitesin 13 countries
Study dates
11 Aug 2025to 4 Nov 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 and received either, 1 line of an approved protocol-specified combination endocrine-based therapy, or 2 or more lines of protocol-specified 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.
Show all 15Show fewer
  • 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.

Who cannot join

  • 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.
Show all 21Show fewer
  • 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.

Trial locations and contacts

60 sites in 13 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

60 sites in 13 countries

United States10 sites, 10 recruiting

  • Alaska Womens Cancer Care ( Site 0037)

    Anchorage, Alaska, 99508

    Study Coordinator, 907-562-2211

    Recruiting

  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0008)

    Columbus, Ohio, 43210

    Study Coordinator, (614) 293-8000

    Recruiting

  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0021)

    Hackensack, New Jersey, 07601

    Study Coordinator, 551-996-5855

    Recruiting

  • Mary Lanning Healthcare ( Site 0019)

    Hastings, Nebraska, 68901

    Study Coordinator, 402-463-4521

    Recruiting

  • Baylor College of Medicine Medical Center ( Site 0004)

    Houston, Texas, 77030

    Study Coordinator, 713-798-2000

    Recruiting

  • Harris Health System ( Site 0040)

    Houston, Texas, 77054

    Study Coordinator, 713-798-1694

    Recruiting

  • Mount Sinai Cancer Center ( Site 0009)

    Miami Beach, Florida, 33140

    Study Coordinator, 305-674-2625

    Recruiting

  • Rockefeller Outpatient Pavilion ( Site 0002)

    New York, New York, 10022

    Study Coordinator, 212-639-2000

    Recruiting

  • Mays Cancer Center ( Site 0039)

    San Antonio, Texas, 78229

    Study Coordinator, 210-450-1000

    Recruiting

  • TRIALS 365 ( Site 0022)

    Shreveport, Louisiana, 71103

    Study Coordinator, 318-408-1198

    Recruiting

Other trials in United States

United Kingdom8 sites, 8 recruiting

  • Queen Elizabeth Hospital ( Site 2305)

    Birmingham, B15 2GW

    Study Coordinator, +4401213718771

    Recruiting

  • University Hospitals Sussex NHS Foundation Trust ( Site 2301)

    East Sussex, Brighton And Hove, BN2 1ES

    Study Coordinator, 01273 696955

    Recruiting

  • Western General Hospital ( Site 2307)

    Edinburgh, Midlothian, EH4 2XU

    Study Coordinator, +441315371859

    Recruiting

  • St Bartholomew's Hospital ( Site 2302)

    London, London, City of, EC1A 7BE

    Study Coordinator, +4402044656670

    Recruiting

  • University College Hospital London ( Site 2303)

    London, London, City of, NW1 2PG

    Study Coordinator, 020 3456 7890

    Recruiting

  • Guy's & St Thomas' NHS Foundation Trust ( Site 2309)

    London, London, City of, SE1 9RT

    Study Coordinator, +4402071881474

    Recruiting

  • The Christie NHS Foundation Trust ( Site 2300)

    Manchester, M20 4BX

    Study Coordinator, 01614463746

    Recruiting

  • The Royal Cornwall Hospital ( Site 2306)

    Truro, Cornwall, TR1 3LJ

    Study Coordinator, 01872 256424

    Recruiting

Other trials in United Kingdom

Brazil6 sites, 6 recruiting

  • Hospital Felicio Rocho ( Site 3105)

    Belo Horizonte, Minas Gerais, 30110-934

    Study Coordinator, +5531986622882

    Recruiting

  • Liga Norte Riograndense Contra o Cancer ( Site 3108)

    Natal, Rio Grande do Norte, 59062-000

    Study Coordinator, +5584991425228

    Recruiting

  • Hospital de Cancer de Pernambuco ( Site 3103)

    Recife, Pernambuco, 50040-000

    Study Coordinator, +558132178084

    Recruiting

  • Instituto Nacional de Câncer - INCA ( Site 3107)

    Rio de Janeiro, 20230-130

    Study Coordinator, +552132072964

    Recruiting

  • Obras Sociais Irma Dulce ( Site 3112)

    Salvador, Estado de Bahia, 41680-430

    Study Coordinator, +557134836649

    Recruiting

  • Hospital Santa Rita de Cassia ( Site 3104)

    Vitória, Espírito Santo, 29043-260

    Study Coordinator, +55 027 99846-9004

    Recruiting

Other trials in Brazil

Canada5 sites, 5 recruiting

  • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0200)

    Montreal, Quebec, H2X 0C1

    Study Coordinator, 514-890-8000

    Recruiting

  • Jewish General Hospital ( Site 0201)

    Montreal, Quebec, H3T 1E2

    Study Coordinator, 514-340-8222

    Recruiting

  • Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 0205)

    Sherbrooke, Quebec, J1H 5N4

    Study Coordinator, 819 346-1110

    Recruiting

  • Sunnybrook Research Institute ( Site 0203)

    Toronto, Ontario, M4N 3M5

    Study Coordinator, 4164807802

    Recruiting

  • Princess Margaret Cancer Centre ( Site 0202)

    Toronto, Ontario, M5G 2M9

    Study Coordinator, 4169462000

    Recruiting

Other trials in Canada

Spain5 sites, 5 recruiting

  • CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 2003)

    A Coruña, La Coruna, 15006

    Study Coordinator, 34981178353

    Recruiting

  • Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2000)

    L'Hospitalet de Llobregat, Barcelona, 08908

    Study Coordinator, 34932607744

    Recruiting

  • Clinica Universitaria Navarra - Madrid ( Site 2004)

    Madrid, Madrid, Comunidad de, 28027

    Study Coordinator, 34913531920/7513

    Recruiting

  • Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2002)

    Madrid, Madrid, Comunidad de, 28034

    Study Coordinator, 34913368263

    Recruiting

  • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2001)

    Madrid, 28223

    Study Coordinator, +34 609378523

    Recruiting

Other trials in Spain

Turkey (Türkiye)5 sites, 5 recruiting

  • Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 2201)

    Adana, 01240

    Study Coordinator, +905446726040

    Recruiting

  • Hacettepe Universitesi ( Site 2200)

    Ankara, 06230

    Study Coordinator, +903122976000

    Recruiting

  • Trakya Üniversitesi Eğitim Araştırma Hastanesi ( Site 2204)

    Edirne, 22030

    Study Coordinator, +902842360909

    Recruiting

  • Istanbul Universitesi Cerrahpasa ( Site 2203)

    Istanbul, 34098

    Study Coordinator, 0090 212 414 30 00

    Recruiting

  • Koc University, School of Medicine ( Site 2202)

    Istanbul, 34450

    Study Coordinator, 0090 850 250 82 50

    Recruiting

Other trials in Turkey (Türkiye)

Chile4 sites, 4 recruiting

  • Fundación Arturo López Pérez ( Site 3300)

    Santiago, Region M. de Santiago, 7500921

    Study Coordinator, +56227067543

    Recruiting

  • Pontificia Universidad Catolica de Chile ( Site 3307)

    Santiago, Region M. de Santiago, 8330032

    Study Coordinator, +56994945927

    Recruiting

  • Bradfordhill ( Site 3301)

    Santiago, Region M. de Santiago, 8420383

    Study Coordinator, 56229490970

    Recruiting

  • ONCOCENTRO APYS ( Site 3302)

    Viña del Mar, Valparaiso, 2520598

    Study Coordinator, +56992369820

    Recruiting

Other trials in Chile

Peru4 sites, 4 recruiting

  • Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO) ( Site 3405)

    Concepción, Departamento de Junín, 12125

    Study Coordinator, +51983582526

    Recruiting

  • IPOR Instituto Peruano de Oncología & Radioterapia ( Site 3400)

    Lima, 15036

    Study Coordinator, +012241598

    Recruiting

  • Instituto Nacional de Enfermedades Neoplásicas ( Site 3401)

    Lima, 15038

    Study Coordinator, +5112016500

    Recruiting

  • Clínica San Antonio ( Site 3404)

    Trujillo, La Libertad, 13008

    Study Coordinator, +5144716018

    Recruiting

Other trials in Peru

Argentina3 sites, 3 recruiting

  • Centro Medico Dr. Doreski - Fundación Respirar ( Site 0302)

    Buenos Aires, Buenos Aires F.D., C1118AAT

    Study Coordinator, +541147815331

    Recruiting

  • Instituto Alexander Fleming ( Site 0303)

    Buenos Aires, Buenos Aires F.D., C1426ANZ

    Study Coordinator, +541132218900

    Recruiting

  • Hospital Aleman ( Site 0301)

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1118AAT

    Study Coordinator, +5491148277000

    Recruiting

Other trials in Argentina

Malaysia3 sites, 3 recruiting

  • Pantai Hospital Kuala Lumpur ( Site 0603)

    Kuala Lumpur, 59100

    Study Coordinator, +60322960888

    Recruiting

  • University Malaya Medical Centre ( Site 0601)

    Kuala Lumpur, 59100

    Study Coordinator, +60379492495

    Recruiting

  • Sarawak General Hospital ( Site 0602)

    Kuching, Sarawak, 93586

    Study Coordinator, +6082276666

    Recruiting

Other trials in Malaysia

Taiwan3 sites, 3 recruiting

  • Taichung Veterans General Hospital ( Site 1004)

    Taichung, 407

    Study Coordinator, 886423592525x5822

    Recruiting

  • National Cheng Kung University Hospital ( Site 1003)

    Tainan, 704

    Study Coordinator, 88662353535x6729

    Recruiting

  • Mackay Memorial Hospital ( Site 1002)

    Taipei, 10449

    Study Coordinator, +886225433535x3941

    Recruiting

Other trials in Taiwan

Thailand3 sites, 3 recruiting

  • Faculty of Medicine Siriraj Hospital ( Site 1111)

    Bangkok, Bangkok, 10700

    Study Coordinator, +6624141895

    Recruiting

  • Chulalongkorn Hospital ( Site 1114)

    Pathumwan, Bangkok, 10330

    Study Coordinator, +6622516704

    Recruiting

  • Songklanagarind Hospital ( Site 1113)

    Songkhla, 90110

    Study Coordinator, +6674451469

    Recruiting

Other trials in Thailand

Singapore1 site, 1 recruiting

  • National Cancer Centre Singapore ( Site 0800)

    Singapore, Central Singapore, 168583

    Study Coordinator, +6564368000

    Recruiting

Other trials in Singapore

About this study

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

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.

Being tested
Opevesostat, Fludrocortisone/ Fludrocortisone acetate, Dexamethasone/Dexamethasone acetate, Rescue Medications, Fulvestrant
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OpevesostatDrug

    Also called MK-5684

    Tablet for oral administration.

  • Fludrocortisone/ Fludrocortisone acetateDrug

    Tablet for oral administration.

  • Dexamethasone/Dexamethasone acetateDrug

    Tablet for oral administration.

  • Rescue MedicationsDrug

    Hydrocortisone or hydrocortisone/hydrocortisone acetate administered via intramuscular injection as rescue medication.

  • FulvestrantDrug

    Administered via intramuscular injection.

  • ExemestaneDrug

    Tablet for oral administration.

  • Megestrol acetate/Medroxyprogesterone acetateDrug

    Tablet for oral administration.

  • TamoxifenDrug

    Tablet for oral administration.

  • LetrozoleDrug

    Tablet for oral administration.

Study groups in NCT06979596
Study groupRoleWhat they receive
MK-5684 and Daily CorticosteroidsExperimentalParticipants with breast cancer, ovarian cancer, or endometrial cancer will receive 5 mg of MK-5684 orally twice daily. Participants will also receive fludrocortisone/fludrocortisone acetate starting at 0.1 mg orally, and dexamethasone/dexamethasone acetate starting at 1 mg orally; both will be adjusted individually during the study. Participants will receive treatment until one of the conditions for discontinuation of study intervention is met.
Receives: Drug: Opevesostat; Drug: Fludrocortisone/ Fludrocortisone acetate; Drug: Dexamethasone/Dexamethasone acetate; Drug: Rescue Medications
Fulvestrant or ExemestaneExperimentalParticipants with breast cancer receive endocrine therapy of the physician's choice: either 500 mg of fulvestrant on Day 1 and Day 15 of Cycle 1 and Day 1 of every cycle thereafter (cycles are 28 days in length) or 25 mg of exemestane once daily (QD). Participants will receive treatment until one of the conditions for discontinuation of study intervention is met.
Receives: Drug: Fulvestrant; Drug: Exemestane
Observation (No Treatment)No interventionParticipants with ovarian cancer will be observed but will receive no treatment for the duration of the study.
Treatment of Physician's ChoiceExperimentalParticipants with endometrial cancer will receive the physician's choice of either 80 mg megestrol acetate/medroxyprogesterone acetate twice daily, or alternating between 80 mg megestrol acetate twice daily for three weeks and 20 mg tamoxifen twice daily for three weeks, or 2.5 mg letrozole once daily. Participants will receive treatment until one of the conditions for discontinuation of study intervention is met.
Receives: Drug: Megestrol acetate/Medroxyprogesterone acetate; Drug: Tamoxifen; Drug: Letrozole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS) - All Cohorts

    For all cohorts, PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.

    Measured: Up to approximately 2 years

Secondary outcomes (6)

  1. Overall Survival (OS) - All Cohorts

    For all cohorts, OS is defined the time from randomization to death due to any cause.

    Measured: Up to approximately 2 years

  2. Clinical Benefit Rate (CBR) - Cohort A

    For cohort A (participants with breast cancer), CBR is defined as the percentage of participants who have complete response (CR): disappearance of all target lesions; partial response (PR): At least a 30% decrease in the sum of diameters of target lesions; or stable disease (SD): Neither sufficient decrease to qualify for PR nor sufficient increase to qualify for progressive disease (PD), with reference to the smallest sum diameters while on study) for ≥24 weeks per RECIST 1.1 as assessed by BICR.

    Measured: Up to approximately 2 years

  3. Objective Response Rate (ORR) - All Cohorts

    For all cohorts, ORR is defined as the percentage of participants who have achieved confirmed Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by BICR.

    Measured: Up to approximately 2 years

  4. Duration of Response (DOR) - All Cohorts

    For all cohorts, for participants who demonstrate CR or PR, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.

    Measured: Up to approximately 2 years

  5. Number of Participants who Discontinue Study Intervention Due to an Adverse Event (AE) - All Cohorts

    An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Measured: Up to approximately 8 months

  6. Number of Participants who Experience One or More Adverse Events (AEs) - All Cohorts

    An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Measured: Up to approximately 11 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2025
  2. Study start11 Aug 2025
  3. Primary completion4 Nov 2027 (estimated)
  4. Study completion4 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06979596
Sponsor's protocol ID
5684-015
Other IDs
2024-519563-18-00, U1111-1315-5430, MK-5684-015, OMAHA-015
Status last verified
Oct 2026
First submitted
13 May 2025
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Opevesostat, Fludrocortisone/ Fludrocortisone acetate and Dexamethasone/Dexamethasone acetate in people with Malignant Neoplasm, run by Merck Sharp & Dohme LLC at 60 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in United States, United Kingdom, Brazil, Canada, Spain and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) - All Cohorts (time frame: Up to approximately 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06979596.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

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