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High-grade Serous Ovarian CarcinomaPhase 2NCT05446870

Pembrolizumab With Chemotherapy and MK-4830 for Treating Participants With Ovarian Cancer (MK-4830-002)

A Phase 2 study testing Pembrolizumab, Paclitaxel and Carboplatin in people with High-grade Serous Ovarian Carcinoma and Ovarian Carcinoma, run by Merck Sharp & Dohme LLC at 45 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The primary objective is to evaluate in participants with high-grade serous ovarian cancer (HGSOC), whether the reduction from baseline in circulating tumor deoxyribonucleic acid (ctDNA) at Cycle 3 (ΔctDNA) is larger in participants receiving MK-4830 + pembrolizumab in combination with standard of care (SOC) therapy… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Pembrolizumab, Paclitaxel and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
45 sitesin 11 countries
Study dates
25 Jul 2022to 16 Oct 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 23Show fewer
  • 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.

Trial locations and contacts

45 sites in 11 countries.

45 sites in 11 countries

United States12 sites

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

    Aurora, Colorado, 80045

  • Roswell Park Cancer Institute ( Site 0106)

    Buffalo, New York, 14263

  • Northwestern Memorial Hospital ( Site 0104)

    Chicago, Illinois, 60611

  • Mayo Clinic in Florida ( Site 0101)

    Jacksonville, Florida, 32224

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

    Miami, Florida, 33176

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

    Mineola, New York, 11501

  • Rutgers Cancer Institute of New Jersey ( Site 0114)

    New Brunswick, New Jersey, 08901

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

    New York, New York, 10016

  • Memorial Sloan Kettering Cancer Center ( Site 0102)

    New York, New York, 10065

  • Fred Hutchinson Cancer Center ( Site 0100)

    Seattle, Washington, 98109

  • Sanford Cancer Center-Gynecologic Oncology ( Site 0115)

    Sioux Falls, South Dakota, 57104

  • Washington University ( Site 0113)

    St Louis, Missouri, 63110

Other trials in United States

Poland5 sites

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

    Gdansk, Pomeranian Voivodeship, 80-214

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

    Kielce, Świętokrzyskie Voivodeship, 25-734

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

    Poznan, Greater Poland Voivodeship, 61-848

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

    Siedlce, Masovian Voivodeship, 08-110

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

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

Taiwan5 sites

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

    Changhua County, Changhua, 50006

  • Taichung Veterans General Hospital-GYNECOLOGY ( Site 1202)

    Taichung, 407

  • National Cheng Kung University Hospital ( Site 1201)

    Tainan, 704

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

    Taipei, 10002

  • Mackay Memorial Hospital ( Site 1204)

    Taipei, 10449

Other trials in Taiwan

Chile4 sites

  • FALP ( Site 0905)

    Santiago, Region M. de Santiago, 7500921

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

    Santiago, Region M. de Santiago, 8330032

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

    Temuco, Araucania, 4800827

  • ONCOCENTRO APYS-ACEREY ( Site 0904)

    Viña del Mar, Valparaiso, 2520598

Other trials in Chile

Italy4 sites

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

    Milan, Lombardy, 20133

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

    Milan, 20141

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

    Naples, Campania, 80131

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

    Rome, Lazio, oo168

Other trials in Italy

Belgium3 sites

  • Antwerp University Hospital-Oncology ( Site 1301)

    Edegem, Antwerpen, 2650

  • AZ Maria Middelares-IKG ( Site 1302)

    Ghent, Oost-Vlaanderen, 9000

  • UZ Leuven ( Site 1300)

    Leuven, Vlaams-Brabant, 3000

Other trials in Belgium

Israel3 sites

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

    Haifa, 3109601

  • Shaare Zedek Medical Center ( Site 0601)

    Jerusalem, 9103102

  • Sheba Medical Center-ONCOLOGY ( Site 0600)

    Ramat Gan, 5265601

Other trials in Israel

Spain3 sites

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

    Barcelona, 08035

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

    Hospitalet, Barcelona, 08907

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

    Madrid, Madrid, Comunidad de, 28041

Other trials in Spain

Canada2 sites

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

    Montreal, Quebec, H2X 3E4

  • McGill University Health Centre ( Site 0301)

    Montreal, Quebec, H4A 3J1

Other trials in Canada

Singapore2 sites

  • National Cancer Centre Singapore ( Site 1501)

    Singapore, Central Singapore, 168583

  • National University Hospital ( Site 1502)

    Singapore, South West, 119074

Other trials in Singapore

South Korea2 sites

  • Seoul National University Hospital ( Site 0801)

    Seoul, 03080

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

    Seoul, 03722

Other trials in South Korea

About this study

Official title: A Randomized, Phase 2 Study of Pembrolizumab And Chemotherapy With or Without MK-4830 as Neoadjuvant Treatment for High-Grade Serous Ovarian Cancer

The primary objective is to evaluate in participants with high-grade serous ovarian cancer (HGSOC), whether the reduction from baseline in circulating tumor deoxyribonucleic acid (ctDNA) at Cycle 3 (ΔctDNA) is larger in participants receiving MK-4830 + pembrolizumab in combination with standard of care (SOC) therapy than in those receiving pembrolizumab + SOC therapy.

Being tested
Pembrolizumab, Paclitaxel, Carboplatin, Avastin, MK-4830
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • PembrolizumabBiological

    Also called MK-3475, KEYTRUDA®

    200 mg by IV infusion on Day 1 of each 21-day cycle

  • PaclitaxelDrug

    Also called TAXOL®

    175 mg/m^2 by IV infusion on Day 1 of each 21-day cycle

  • CarboplatinDrug

    Also called PARAPLATIN®

    AUC 5 to 6 by IV infusion on Day 1 of each 21-day cycle

  • AvastinBiological

    Also called Bevacizumab, Zirabev, MVASI, AYBINTIO

    According to local practice and at the choice of the investigator.

  • MK-4830Biological

    800 mg by IV infusion on Day 1 of each 21-day cycle

  • DocetaxelDrug

    75 mg/m^2 by IV infusion on Day 1 of each 21-day cycle

Study groups in NCT05446870
Study groupRoleWhat they receive
Pembrolizumab + Standard of Care (SOC) + MK-4830ExperimentalBefore surgery participants will receive pembrolizumab 200 mg, paclitaxel 175 mg/m^2 (or docetaxel 75 mg/m^2), carboplatin Area Under the Curve (AUC) 5 to 6, and MK-4830 800 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks [Q3W]) for 3 cycles. After surgery participants will receive pembrolizumab 200 mg, paclitaxel 175 mg/m^2 (or docetaxel 75 mg/m^2), carboplatin AUC 5 to 6, and MK-4830 800 mg (with avastin [or biosimilar] at the investigator's discretion and per insitutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.
Receives: Biological: Pembrolizumab; Drug: Paclitaxel; Drug: Carboplatin; Biological: Avastin; Biological: MK-4830; Drug: Docetaxel
Pembrolizumab + SOCActive comparatorBefore surgery participants will receive pembrolizumab 200 mg, paclitaxel 175 mg/m^2 (or docetaxel 75 mg/m^2), and carboplatin AUC 5 to 6 by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles. After surgery participants will receive pembrolizumab 200 mg, paclitaxel 175 mg/m^2 (or docetaxel 75 mg/m^2), and carboplatin AUC 5 to 6 (with avastin [or biosimilar] at the investigator's discretion and per insitutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.
Receives: Biological: Pembrolizumab; Drug: Paclitaxel; Drug: Carboplatin; Biological: Avastin; Drug: Docetaxel

What is being measured

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

  1. Change From Baseline in Circulating Tumor Deoxyribonucleic Acid (ctDNA)

    Blood samples were collected to determine levels of ctDNA. The fold change in the mean mutant/tumor molecules per mL (MTM/mL) at Cycle 3 from baseline is presented.

    Measured: Baseline and Week 7

Secondary outcomes (8)

  1. Participants With Surgery and Pathological Complete Response (pCR): Change From Baseline in ctDNA

    Blood samples were collected to determine levels of ctDNA. pCR was defined as all surgical specimens collected during the interval debulking surgery microscopically negative for residual tumor. Per protocol, change from baseline in ctDNA in participants with surgery and pCR was reported.

    Measured: Baseline and Week 12

  2. Association of Change From Baseline in ctDNA With pCR

    Blood samples were collected to determine levels of ctDNA. pCR was defined as all surgical specimens collected during the interval debulking surgery microscopically negative for residual tumor. pCR rate was defined as percentage of participants with pCR. Per protocol, the association of change from baseline in ctDNA with pCR in participants with surgery and pCR was reported.

    Measured: Baseline and Week 12

  3. Participants With Surgery and Chemotherapy Response Score (CRS): Change From Baseline in ctDNA

    Blood samples were collected to determine levels of ctDNA. CRS is a 3-tiered scoring system (CRS1-3) based on the pathological analysis of surgically removed omental masses. CRS was defined as CRS1 (minimal or no tumor response, mainly viable tumor), CRS2 (appreciable tumor response amidst viable tumor that is readily identifiable and regularly distributed), and CRS3 (complete or near-complete response, characterized by the lack of residual tumor cells in the omentum or presence of tumor foci up to 2 mm maximum size); higher values indicate greater response. Per protocol, change from baseline in ctDNA in participants with surgery and CRS was reported.

    Measured: Baseline and Week 12

  4. Association of Change From Baseline in ctDNA With CRS3

    Blood samples were collected to determine levels of ctDNA. CRS is a 3-tiered scoring system (CRS1-3) based on the pathological analysis of surgically removed omental masses. CRS was defined as CRS1 (minimal or no tumor response, mainly viable tumor), CRS2 (appreciable tumor response amidst viable tumor that is readily identifiable and regularly distributed), and CRS3 (complete or near-complete response, characterized by the lack of residual tumor cells in the omentum or presence of tumor foci up to 2 mm maximum size); higher values indicate greater response. CRS3 rate was defined as percentage of participants with CRS3. Per protocol, the association of change from baseline in ctDNA with CRS3 in participants with surgery and CRS was reported.

    Measured: Baseline and Week 12

  5. pCR Rate

    pCR rate was defined as the percentage of participants with all surgical specimens collected during the interval debulking surgery that were microscopically negative for residual tumor. The pCR rate as assessed by local pathologist was reported.

    Measured: Up to approximately 12 weeks

  6. CRS3 Rate

    CRS is a 3-tiered scoring system (CRS1-3) based on the pathological analysis of surgically removed omental masses. CRS was defined as CRS1 (minimal or no tumor response, mainly viable tumor), CRS2 (appreciable tumor response amidst viable tumor that is readily identifiable and regularly distributed), and CRS3 (complete or near-complete response, characterized by the lack of residual tumor cells in the omentum or presence of tumor foci up to 2 mm maximum size); higher values indicate greater response. CRS3 rate was defined as percentage of participants with CRS3. Per protocol, CRS3 rate as assessed by local pathologist was reported.

    Measured: Up to approximately 12 weeks

  7. Number of Participants Who Experienced an Adverse Event (AE)

    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 have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated). The number of participants who experienced one or more AEs was reported.

    Measured: Up to approximately 26 months

  8. Number of Participants Who Discontinued Study Intervention Due to an AE

    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 have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated). The number of participants who discontinued study intervention due to an AE was reported.

    Measured: Up to approximately 28 weeks

Timeline

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

  1. First posted7 Jul 2022
  2. Study start25 Jul 2022
  3. Primary completion20 Dec 2023
  4. Study completion16 Oct 2024

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
None (open label)
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05446870
Sponsor's protocol ID
4830-002
Other IDs
MK-4830-002, 2023-505005-16-00, U1111-1290-6634, 2021-005458-27, 2023
Status last verified
Sep 2025
First submitted
1 Jul 2022
Last updated
1 Oct 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab, Paclitaxel and Carboplatin in people with High-grade Serous Ovarian Carcinoma and Ovarian Carcinoma, run by Merck Sharp & Dohme LLC at 45 sites in 11 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 5 inclusion and 23 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: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States, Poland, Taiwan, Chile, Italy and 6 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?

Yes. Results are posted in the registry (first posted 17 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Circulating Tumor Deoxyribonucleic Acid (ctDNA) (time frame: Baseline and Week 7). 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 NCT05446870.

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 1 Oct 2025.

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