Clinical trial NCT05446870: Pembrolizumab With Chemotherapy and MK-4830 for Treating Participants With Ovarian Cancer (MK-4830-002)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: High-grade Serous Ovarian Carcinoma
Ovarian Carcinoma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2022-07-07
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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 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.

Primary outcomes:
measure: Change From Baseline in Circulating Tumor Deoxyribonucleic Acid (ctDNA)
timeFrame: Baseline and Week 7
Secondary outcomes:
measure: Change From Baseline in Neoadjuvant ctDNA
timeFrame: Baseline and Week 7
measure: Pathological Complete Response (pCR) Rate
timeFrame: Up to approximately 12 weeks
measure: Chemotherapy Response Score (CRS)
timeFrame: Up to approximately 12 Weeks
measure: Number of Participants Who Experienced an Adverse Event (AE)
timeFrame: Up to approximately 40 Weeks
measure: Number of Participants Who Discontinued Study Treatment Due to an AE
timeFrame: Up to approximately 28 Weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus-Cancer Clinical Trials Office ( Site 0108)
state: Colorado
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida ( Site 0101)
state: Florida
city: Miami
country: United States
facility: Miami Cancer Institute at Baptist Health, Inc. ( Site 0110)
state: Florida
city: Chicago
country: United States
facility: Northwestern Memorial Hospital ( Site 0104)
state: Illinois
city: Saint Louis
country: United States
facility: Washington University ( Site 0113)
state: Missouri
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey ( Site 0114)
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute ( Site 0106)
state: New York
city: Mineola
country: United States
facility: Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0116)
state: New York
city: New York
country: United States
facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0107)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center ( Site 0102)
state: New York
city: Sioux Falls
country: United States
facility: Sanford Cancer Center-Gynecologic Oncology ( Site 0115)
state: South Dakota
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center ( Site 0100)
state: Washington
city: Edegem
country: Belgium
facility: Antwerp University Hospital-Oncology ( Site 1301)
state: Antwerpen
city: Gent
country: Belgium
facility: AZ Maria Middelares-IKG ( Site 1302)
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Leuven ( Site 1300)
state: Vlaams-Brabant
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal ( Site 0300)
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre ( Site 0301)
state: Quebec
city: Temuco
country: Chile
facility: James Lind Centro de Investigación del Cáncer ( Site 0903)
state: Araucania
city: Santiago
country: Chile
facility: FALP ( Site 0905)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0900)
state: Region M. De Santiago
city: Viña del Mar
country: Chile
facility: ONCOCENTRO APYS-ACEREY ( Site 0904)
state: Valparaiso
city: Haifa
country: Israel
facility: Rambam Health Care Campus-Gyneco-oncology unit ( Site 0602)
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center ( Site 0601)
city: Ramat Gan
country: Israel
facility: Sheba Medical Center-ONCOLOGY ( Site 0600)
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Oncologia Sperimentale Uro-Genitale ( Site 0
state: Campania
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli-Ginecologia Oncologica ( Site 0502)
state: Lazio
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Chirurgia Ginecologica ( Site 050
state: Lombardia
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia IRCCS-Divisione di Ginecologia Oncologica ( Site 0501)
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 0801)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System-Gynecologic cancer center ( Site 0800)
city: Siedlce
country: Poland
facility: Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 0701)
state: Mazowieckie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Ginekologii Onkologicznej ( Sit
state: Mazowieckie
city: Gdańsk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne-Klinika Ginekologii, Ginekologii Onkologicznej i Endokrynologii Gi
state: Pomorskie
city: Kielce
country: Poland
facility: Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 0708)
state: Swietokrzyskie
city: Poznan
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Poznaniu-Oddzial Ginekologii Onkologicznej ( Site 0709)
state: Wielkopolskie
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore ( Site 1501)
state: Central Singapore
city: Singapore
country: Singapore
facility: National University Hospital ( Site 1502)
state: South West
city: Hospitalet
country: Spain
facility: Instituto Catalan de Oncologia - Hospital Duran i Reynals-Medical Oncology ( Site 1103)
state: Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1104)
state: Madrid, Comunidad De
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1101)
city: Changhua County
country: Taiwan
facility: Changhua Christian Hospital-Obstetrics and Gynecology ( Site 1203)
state: Changhua
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital-GYNECOLOGY ( Site 1202)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 1201)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital-Internal Medicine ( Site 1200)
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital ( Site 1204)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: