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Ovarian cancer hope: new combo shows promise in shrinking tumors before surgery

NCT ID NCT05446870

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tested whether adding an experimental drug (MK-4830) to standard chemotherapy and pembrolizumab (Keytruda) could better shrink high-grade serous ovarian cancer before surgery. 160 participants with stage III or IV disease received either the standard regimen or the standard plus MK-4830. The main goal was to see if the new combination reduced tumor DNA in the blood more effectively, which could indicate better tumor shrinkage.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pembrolizumab (Keytruda) and MK-4830, given with standard chemotherapy (paclitaxel and carboplatin)
What this could lead to
If successful, this combination could shrink ovarian tumors more effectively before surgery, potentially improving long-term outcomes for patients.
What could go wrong
This is an early-phase trial with only 160 participants, so results may not apply to all patients. Adding MK-4830 could also increase side effects without clear benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

160 people

The number who actually took part.

Started

Jul 2022

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * Has histologically-confirmed International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV HGSOC, primary peritoneal cancer, or fallopian tube cancer. * Is a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the neoadjuvant and adjuvant setting. * Is a candidate for interval debulking surgery. * Is able to provide archival tissue or newly obtained core, incisional, or excisional biopsy of a tumor lesion. * Has adequate organ functions. Exclusion Criteria: * Has a non-HGSOC histology. * Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. * Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. * Has received prior treatment for any stage of ovarian cancer (OC), including radiation or systemic anticancer therapy. * Planned or has been administered intraperitoneal chemotherapy as first-line therapy. * Has received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death 1 ligand 1 (PD-L1), anti-programmed cell death 1 ligand 2 (PD-L2), anti-immunoglobulin-like transcript 4 (ILT4), or anti-human leukocyte antigen (HLA)-G agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor. * Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention. * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication. * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. * Has severe hypersensitivity to pembrolizumab, carboplatin, paclitaxel (or docetaxel, if applicable), Avastin or biosimilar (if using) and/or any of their excipients. * Has an active autoimmune disease that has required systemic treatment in past 2 years. * Has an active infection requiring systemic therapy. * Has a known history of human immunodeficiency virus (HIV) infection. * Has a known history of hepatitis B or known active hepatitis C virus infection. * Has received colony-stimulating factors within 4 weeks prior to receiving study intervention on Day 1 of Cycle 1. * Has had surgery \<6 months prior to Screening to treat borderline ovarian tumors, early-stage OC, or early-stage fallopian tube cancer. * Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study. * Has current, clinically relevant bowel obstruction. * Has a history of hemorrhage, hemoptysis, or active gastrointestinal (GI) bleeding within 6 months prior to randomization. * Has uncontrolled hypertension. * Has had an allogenic tissue/solid organ transplant. * Has either had major surgery within 3 weeks of randomization or has not recovered from any effects of any major surgery.

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Conditions

The condition(s) this trial relates to.

fallopian tube cancer ovarian cancer ovarian carcinoma ovarian serous adenocarcinoma primary peritoneal carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

High-grade serous ovarian carcinoma Ovarian carcinoma

Contacts and locations

Locations

  • AZ Maria Middelares-IKG ( Site 1302)

    Ghent, Oost-Vlaanderen, 9000, Belgium

  • Antwerp University Hospital-Oncology ( Site 1301)

    Edegem, Antwerpen, 2650, Belgium

  • Centre Hospitalier de l'Université de Montréal ( Site 0300)

    Montreal, Quebec, H2X 3E4, Canada

  • Changhua Christian Hospital-Obstetrics and Gynecology ( Site 1203)

    Changhua County, Changhua, 50006, Taiwan

  • FALP ( Site 0905)

    Santiago, Region M. de Santiago, 7500921, Chile

  • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Chirurgia Ginecologica ( Site 050

    Milan, Lombardy, 20133, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli-Ginecologia Oncologica ( Site 0502)

    Rome, Lazio, oo168, Italy

  • Fred Hutchinson Cancer Center ( Site 0100)

    Seattle, Washington, 98109, United States

  • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1101)

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1104)

    Madrid, Madrid, Comunidad de, 28041, Spain

  • Instituto Catalan de Oncologia - Hospital Duran i Reynals-Medical Oncology ( Site 1103)

    Hospitalet, Barcelona, 08907, Spain

  • Istituto Europeo di Oncologia IRCCS-Divisione di Ginecologia Oncologica ( Site 0501)

    Milan, 20141, Italy

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Oncologia Sperimentale Uro-Genitale ( Site 0

    Naples, Campania, 80131, Italy

  • James Lind Centro de Investigación del Cáncer ( Site 0903)

    Temuco, Araucania, 4800827, Chile

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0107)

    New York, New York, 10016, United States

  • Mackay Memorial Hospital ( Site 1204)

    Taipei, 10449, Taiwan

  • Mayo Clinic in Florida ( Site 0101)

    Jacksonville, Florida, 32224, United States

  • Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 0701)

    Siedlce, Masovian Voivodeship, 08-110, Poland

  • McGill University Health Centre ( Site 0301)

    Montreal, Quebec, H4A 3J1, Canada

  • Memorial Sloan Kettering Cancer Center ( Site 0102)

    New York, New York, 10065, United States

  • Miami Cancer Institute at Baptist Health, Inc. ( Site 0110)

    Miami, Florida, 33176, United States

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Ginekologii Onkologicznej ( Sit

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • National Cancer Centre Singapore ( Site 1501)

    Singapore, Central Singapore, 168583, Singapore

  • National Cheng Kung University Hospital ( Site 1201)

    Tainan, 704, Taiwan

  • National Taiwan University Hospital-Internal Medicine ( Site 1200)

    Taipei, 10002, Taiwan

  • National University Hospital ( Site 1502)

    Singapore, South West, 119074, Singapore

  • Northwestern Memorial Hospital ( Site 0104)

    Chicago, Illinois, 60611, United States

  • ONCOCENTRO APYS-ACEREY ( Site 0904)

    Viña del Mar, Valparaiso, 2520598, Chile

  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0116)

    Mineola, New York, 11501, United States

  • Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0900)

    Santiago, Region M. de Santiago, 8330032, Chile

  • Rambam Health Care Campus-Gyneco-oncology unit ( Site 0602)

    Haifa, 3109601, Israel

  • Roswell Park Cancer Institute ( Site 0106)

    Buffalo, New York, 14263, United States

  • Rutgers Cancer Institute of New Jersey ( Site 0114)

    New Brunswick, New Jersey, 08901, United States

  • Sanford Cancer Center-Gynecologic Oncology ( Site 0115)

    Sioux Falls, South Dakota, 57104, United States

  • Seoul National University Hospital ( Site 0801)

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System-Gynecologic cancer center ( Site 0800)

    Seoul, 03722, South Korea

  • Shaare Zedek Medical Center ( Site 0601)

    Jerusalem, 9103102, Israel

  • Sheba Medical Center-ONCOLOGY ( Site 0600)

    Ramat Gan, 5265601, Israel

  • Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 0708)

    Kielce, Świętokrzyskie Voivodeship, 25-734, Poland

  • Taichung Veterans General Hospital-GYNECOLOGY ( Site 1202)

    Taichung, 407, Taiwan

  • UZ Leuven ( Site 1300)

    Leuven, Vlaams-Brabant, 3000, Belgium

  • University of Colorado Anschutz Medical Campus-Cancer Clinical Trials Office ( Site 0108)

    Aurora, Colorado, 80045, United States

  • Uniwersytecki Szpital Kliniczny w Poznaniu-Oddzial Ginekologii Onkologicznej ( Site 0709)

    Poznan, Greater Poland Voivodeship, 61-848, Poland

  • Uniwersyteckie Centrum Kliniczne-Klinika Ginekologii, Ginekologii Onkologicznej i Endokrynologii Gi

    Gdansk, Pomeranian Voivodeship, 80-214, Poland

  • Washington University ( Site 0113)

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.