Ovarian Cancer Clinical Trial

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

Summary

The primary objective is to evaluate in participants with high-grade serous ovarian cancer (HGSOC), whether the reduction from baseline in circulating tumor DNA (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.

View Eligibility Criteria

Eligibility Criteria

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 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 treat borderline ovarian tumors, early-stage OC, or 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 is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

160

Study ID:

NCT05446870

Recruitment Status:

Recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 32 Locations for this study

See Locations Near You

University of Colorado Anschutz Medical Campus-Cancer Clinical Trials Office ( Site 0108)
Aurora Colorado, 80045, United States More Info
Study Coordinator
Contact
303-724-2066
Rutgers Cancer Institute of New Jersey ( Site 0114)
New Brunswick New Jersey, 08903, United States More Info
Study Coordinator
Contact
732-235-2465
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0116)
Mineola New York, 11501, United States More Info
Study Coordinator
Contact
857-891-5131
Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0107)
New York New York, 10016, United States More Info
Study Coordinator
Contact
857-891-5131
Memorial Sloan Kettering Cancer Center ( Site 0102)
New York New York, 10065, United States More Info
Study Coordinator
Contact
646-888-4882
Sanford Cancer Center-Gynecologic Oncology ( Site 0115)
Sioux Falls South Dakota, 57104, United States More Info
Study Coordinator
Contact
605-312-3250
AZ Maria Middelares-IKG ( Site 1302)
Gent Oost-Vlaanderen, 9000, Belgium More Info
Study Coordinator
Contact
+3292469522
UZ Leuven ( Site 1300)
Leuven Vlaams-Brabant, 3000, Belgium More Info
Study Coordinator
Contact
+3216344634
Centre Hospitalier de l'Université de Montréal ( Site 0300)
Montréal Quebec, H2X 3, Canada More Info
Study Coordinator
Contact
514890800030777
McGill University Health Centre ( Site 0301)
Montréal Quebec, H4A 3, Canada More Info
Study Coordinator
Contact
514934193431975
James Lind Centro de Investigación del Cáncer ( Site 0903)
Temuco Araucania, 48008, Chile More Info
Study Coordinator
Contact
+56974316500
FALP ( Site 0905)
Santiago Region M. De Santiago, 69009, Chile More Info
Study Coordinator
Contact
+56996792467
Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0900)
Santiago Region M. De Santiago, 83300, Chile More Info
Study Coordinator
Contact
+56942477513
ONCOCENTRO APYS-ACEREY ( Site 0904)
Viña del Mar Valparaiso, 25205, Chile More Info
Study Coordinator
Contact
+56992369820
Rambam Health Care Campus-Gyneco-oncology unit ( Site 0602)
Haifa , 31096, Israel More Info
Study Coordinator
Contact
97247773872
Shaare Zedek Medical Center ( Site 0601)
Jerusalem , 91031, Israel More Info
Study Coordinator
Contact
97226521431
Sheba Medical Center-ONCOLOGY ( Site 0600)
Ramat Gan , 52656, Israel More Info
Study Coordinator
Contact
97235302243
Fondazione Policlinico Universitario Agostino Gemelli-Ginecologia Oncologica ( Site 0502)
Roma Lazio, oo168, Italy More Info
Study Coordinator
Contact
+0630158545
Seoul National University Hospital ( Site 0801)
Seoul , 03080, Korea, Republic of More Info
Study Coordinator
Contact
1588-5700
Severance Hospital, Yonsei University Health System-Gynecologic cancer center ( Site 0800)
Seoul , 03722, Korea, Republic of More Info
Study Coordinator
Contact
1599-1004
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 0701)
Siedlce Mazowieckie, 08-11, Poland More Info
Study Coordinator
Contact
48698826497
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Ginekologii Onkologicznej ( Sit
Warszawa Mazowieckie, 02-78, Poland More Info
Study Coordinator
Contact
48225462295
Uniwersyteckie Centrum Kliniczne-Klinika Ginekologii, Ginekologii Onkologicznej i Endokrynologii Gi
Gdańsk Pomorskie, 80-21, Poland More Info
Study Coordinator
Contact
+48 501 594 010
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 0708)
Kielce Swietokrzyskie, 25-73, Poland More Info
Study Coordinator
Contact
+48 41 36 74 315
National Cancer Centre Singapore ( Site 1501)
Singapore Central Singapore, 16961, Singapore More Info
Study Coordinator
Contact
+65 6436 8000
Instituto Catalan de Oncologia - Hospital Duran i Reynals-Medical Oncology ( Site 1103)
Hospitalet Barcelona, 08907, Spain More Info
Study Coordinator
Contact
932603261
Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1104)
Madrid Madrid, Comunidad De, 28041, Spain More Info
Study Coordinator
Contact
+34 913908626
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1101)
Barcelona , 08035, Spain More Info
Study Coordinator
Contact
+34 93 274 62 47
Changhua Christian Hospital-Obstetrics and Gynecology ( Site 1203)
Changhua County Changhua, 50006, Taiwan More Info
Study Coordinator
Contact
+886-4-7238595
Taichung Veterans General Hospital-GYNECOLOGY ( Site 1202)
Taichung , 407, Taiwan More Info
Study Coordinator
Contact
+886423592525
National Cheng Kung University Hospital ( Site 1201)
Tainan , 704, Taiwan More Info
Study Coordinator
Contact
+88662353535
National Taiwan University Hospital-Internal Medicine ( Site 1200)
Taipei , 10002, Taiwan More Info
Study Coordinator
Contact
+886223123456
Mackay Memorial Hospital ( Site 1204)
Taipei , , Taiwan More Info
Study Coordinator
Contact
+886-2-25433535

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

160

Study ID:

NCT05446870

Recruitment Status:

Recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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