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

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.

Study Overview

• Status: Completed
• Conditions: Ovarian Carcinoma; High-grade Serous Ovarian Carcinoma
• Intervention / Treatment: Biological: Pembrolizumab; Drug: Paclitaxel; Drug: Carboplatin; Biological: Avastin; Biological: MK-4830; Drug: Docetaxel

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen
    • Edegem, Antwerpen, Belgium, 2650
      • Antwerp University Hospital-Oncology ( Site 1301)
  • Oost-Vlaanderen
    • Ghent, Oost-Vlaanderen, Belgium, 9000
      • AZ Maria Middelares-IKG ( Site 1302)
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • UZ Leuven ( Site 1300)
• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2X 3E4
      • Centre Hospitalier de l'Université de Montréal ( Site 0300)
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre ( Site 0301)
• Chile
  • Region M. de Santiago
    • Santiago, Region M. de Santiago, Chile, 7500921
      • FALP ( Site 0905)
    • Santiago, Region M. de Santiago, Chile, 8330032
      • Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0900)
  • Región de Valparaíso
    • Viña del Mar, Región de Valparaíso, Chile, 2520598
      • ONCOCENTRO APYS-ACEREY ( Site 0904)
  • Región de la Araucanía
    • Temuco, Región de la Araucanía, Chile, 4800827
      • James Lind Centro de Investigación del Cáncer ( Site 0903)
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus-Gyneco-oncology unit ( Site 0602)
  • Jerusalem, Israel, 9103102
    • Shaare Zedek Medical Center ( Site 0601)
  • Ramat Gan, Israel, 5265601
    • Sheba Medical Center-ONCOLOGY ( Site 0600)
• Italy
  • Milan, Italy, 20141
    • Istituto Europeo di Oncologia IRCCS-Divisione di Ginecologia Oncologica ( Site 0501)
  • Campania
    • Napoli, Campania, Italy, 80131
      • Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Oncologia Sperimentale Uro-Genitale ( Site 0
  • Lazio
    • Rome, Lazio, Italy, oo168
      • Fondazione Policlinico Universitario Agostino Gemelli-Ginecologia Oncologica ( Site 0502)
  • Lombardy
    • Milan, Lombardy, Italy, 20133
      • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Chirurgia Ginecologica ( Site 050
• Poland
  • Greater Poland Voivodeship
    • Poznan, Greater Poland Voivodeship, Poland, 61-848
      • Uniwersytecki Szpital Kliniczny w Poznaniu-Oddzial Ginekologii Onkologicznej ( Site 0709)
  • Masovian Voivodeship
    • Siedlce, Masovian Voivodeship, Poland, 08-110
      • Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 0701)
    • Warsaw, Masovian Voivodeship, Poland, 02-781
      • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Ginekologii Onkologicznej ( Sit
  • Pomeranian Voivodeship
    • Gdansk, Pomeranian Voivodeship, Poland, 80-214
      • Uniwersyteckie Centrum Kliniczne-Klinika Ginekologii, Ginekologii Onkologicznej i Endokrynologii Gi
  • Świętokrzyskie Voivodeship
    • Kielce, Świętokrzyskie Voivodeship, Poland, 25-734
      • Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 0708)
• Singapore
  • Central Singapore
    • Singapore, Central Singapore, Singapore, 168583
      • National Cancer Centre Singapore ( Site 1501)
  • South West
    • Singapore, South West, Singapore, 119074
      • National University Hospital ( Site 1502)
• South Korea
  • Seoul, South Korea, 03080
    • Seoul National University Hospital ( Site 0801)
  • Seoul, South Korea, 03722
    • Severance Hospital, Yonsei University Health System-Gynecologic cancer center ( Site 0800)
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1101)
  • Barcelona
    • Hospitalet, Barcelona, Spain, 08907
      • Instituto Catalan de Oncologia - Hospital Duran i Reynals-Medical Oncology ( Site 1103)
  • Madrid, Comunidad de
    • Madrid, Madrid, Comunidad de, Spain, 28041
      • Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1104)
• Taiwan
  • Taichung, Taiwan, 407
    • Taichung Veterans General Hospital-GYNECOLOGY ( Site 1202)
  • Tainan City, Taiwan, 704
    • National Cheng Kung University Hospital ( Site 1201)
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital-Internal Medicine ( Site 1200)
  • Taipei, Taiwan, 10449
    • Mackay Memorial Hospital ( Site 1204)
  • Changhua
    • Changhua County, Changhua, Taiwan, 50006
      • Changhua Christian Hospital-Obstetrics and Gynecology ( Site 1203)
• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus-Cancer Clinical Trials Office ( Site 0108)
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic in Florida ( Site 0101)
    • Miami, Florida, United States, 33176
      • Miami Cancer Institute at Baptist Health, Inc. ( Site 0110)
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital ( Site 0104)
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University ( Site 0113)
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers Cancer Institute of New Jersey ( Site 0114)
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute ( Site 0106)
    • Mineola, New York, United States, 11501
      • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0116)
    • New York, New York, United States, 10016
      • Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0107)
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center ( Site 0102)
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
      • Sanford Cancer Center-Gynecologic Oncology ( Site 0115)
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Center ( Site 0100)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pembrolizumab + Standard of Care (SOC) + MK-4830; Before 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.	Biological: Pembrolizumab; 200 mg by IV infusion on Day 1 of each 21-day cycle; Other Names: MK-3475; KEYTRUDA®; Drug: Paclitaxel; 175 mg/m^2 by IV infusion on Day 1 of each 21-day cycle; Other Names: TAXOL®; Drug: Carboplatin; AUC 5 to 6 by IV infusion on Day 1 of each 21-day cycle; Other Names: PARAPLATIN®; Biological: Avastin; According to local practice and at the choice of the investigator.; Other Names: Bevacizumab; Zirabev; MVASI; AYBINTIO; Versavo; Onbevezy; OYAVAS; ALYMSYS; Avegra; Biological: MK-4830; 800 mg by IV infusion on Day 1 of each 21-day cycle; Drug: Docetaxel; 75 mg/m^2 by IV infusion on Day 1 of each 21-day cycle
Active Comparator: Pembrolizumab + SOC; Before 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.	Biological: Pembrolizumab; 200 mg by IV infusion on Day 1 of each 21-day cycle; Other Names: MK-3475; KEYTRUDA®; Drug: Paclitaxel; 175 mg/m^2 by IV infusion on Day 1 of each 21-day cycle; Other Names: TAXOL®; Drug: Carboplatin; AUC 5 to 6 by IV infusion on Day 1 of each 21-day cycle; Other Names: PARAPLATIN®; Biological: Avastin; According to local practice and at the choice of the investigator.; Other Names: Bevacizumab; Zirabev; MVASI; AYBINTIO; Versavo; Onbevezy; OYAVAS; ALYMSYS; Avegra; Drug: Docetaxel; 75 mg/m^2 by IV infusion on Day 1 of each 21-day cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Week 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Week 12
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.	Baseline and Week 12
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.	Baseline and Week 12
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.	Baseline and Week 12
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.	Up to approximately 12 weeks
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.	Up to approximately 12 weeks
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.	Up to approximately 26 months
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.	Up to approximately 28 weeks

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information
• Plain Language Summary

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2022
• Primary Completion (Actual): December 20, 2023
• Study Completion (Actual): October 16, 2024

Study Registration Dates

• First Submitted: July 1, 2022
• First Submitted That Met QC Criteria: July 1, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Estimated): October 1, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Ovarian Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Coordination Complexes; Taxoids; Cyclodecanes; Diterpenes; Docetaxel; Bevacizumab; Carboplatin; Paclitaxel; pembrolizumab
• Other Study ID Numbers: 4830-002; MK-4830-002 (Other Identifier: MSD); 2021-005458-27 (EudraCT Number); 2023-505005-16-00 (Registry Identifier: EU CT); U1111-1290-6634 (Registry Identifier: UTN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No