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Trial Title: A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (MK-2870-020/TroFuse-020/Gog-3101/ENGOT-cx20)

NCT ID: NCT06459180

Condition: Cervical Cancer

Conditions: Official terms:
Uterine Cervical Neoplasms
Gemcitabine
Irinotecan
Pemetrexed
Topotecan
Vinorelbine
Tisotumab vedotin

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: Sacituzumab Tirumotecan
Description: IV infusion
Arm group label: Sacituzumab Tirumotecan

Other name: MK-2870

Intervention type: Drug
Intervention name: Pemetrexed
Description: IV infusion
Arm group label: Treatment of Physician's Choice (TPC)

Intervention type: Biological
Intervention name: Tisotumab Vedotin
Description: IV infusion
Arm group label: Treatment of Physician's Choice (TPC)

Intervention type: Drug
Intervention name: Topotecan
Description: IV infusion
Arm group label: Treatment of Physician's Choice (TPC)

Intervention type: Drug
Intervention name: Vinorelbine
Description: IV infusion
Arm group label: Treatment of Physician's Choice (TPC)

Intervention type: Drug
Intervention name: Gemcitabine
Description: IV infusion
Arm group label: Treatment of Physician's Choice (TPC)

Intervention type: Drug
Intervention name: Irinotecan
Description: IV infusion
Arm group label: Treatment of Physician's Choice (TPC)

Summary: This study will have two phases: a sacituzumab tirumotecan safety run-in and a Phase 3 portion. The safety run-in phase will be used to evaluate the efficacy and safety of sacituzumab tirumotecan at the dose for evaluation in the Phase 3 portion. The purpose of this study is to compare the efficacy and safety of sacituzumab tirumotecan versus treatment of physician's choice as second-line treatment for participants with recurrent or metastatic cervical cancer in the Phase 3 portion. The primary study hypotheses are that, in the Phase 3 portion, sacituzumab tirumotecan results in a superior overall survival compared to TPC in participants with high trophoblast cell surface antigen 2 (TROP2) expression level and in all participants.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Has histologically-confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix - Must have recurrent or metastatic cervical cancer that has progressed on or after treatment with 1 prior line of systemic platinum doublet chemotherapy (with or without bevacizumab) AND must have received anti-PD-1/anti-PD-L1 therapy as part of prior cervical cancer regimens - Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, as assessed by the investigator. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions - Is assigned female sex at birth, at least 18 years of age at the time of providing the informed consent - Has ECOG performance status of 0 or 1 within 7 days before allocation for the Sacituzumab Tirumotecan Run-in or within 7 days before randomization for the Phase 3 portion - Has provided tumor tissue (most recent sample is preferred) from a core or excisional biopsy of a tumor lesion not previously irradiated - HIV-infected participants must have well controlled human immunodeficiency virus (HIV) on antiretroviral therapy (ART) - Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation (Sacituzumab Tirumotecan Run-in) or randomization (Phase 3 portion) - Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening - Has adequate organ function Exclusion Criteria: - Has Grade ≥2 peripheral neuropathy - Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing - Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea) - Has uncontrolled, significant cardiovascular disease or cerebrovascular disease. - Received prior systemic anticancer therapy - Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids - Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed - Has histologically-confirmed diagnosis of glassy cell carcinoma variant, adenoid cystic carcinoma, adenoid basal carcinoma, neuroendocrine tumors, carcinoid, atypical carcinoid, small-carcinoma, large-cell neuroendocrine carcinoma, or undifferentiated carcinoma - Known additional malignancy that is progressing or has required active treatment within the past 3 years - Known active central nervous system (CNS) metastases and/or carcinomatous meningitis - Active infection requiring systemic therapy - HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease - Concurrent active Hepatitis B and active Hepatitis C virus infection - Severe hypersensitivity (≥Grade 3) to sacituzumab tirumotecan or treatment of physician's choice (TPC) and/or any of their excipients, or other biologic therapy - Participants who have not adequately recovered from major surgery or have ongoing surgical complications

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: UCLA Hematology/Oncology - Westwood (Building 100)-Department of OBGYN, Division of Gynecologic Onc

Address:
City: Los Angeles
Zip: 90095
Country: United States

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 310-794-7274

Facility:
Name: University Medical Center New Orleans ( Site 4132)

Address:
City: New Orleans
Zip: 70112
Country: United States

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 504-568-4850

Facility:
Name: Willis Knighton Medical Center ( Site 4101)

Address:
City: Shreveport
Zip: 71103
Country: United States

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 318-455-1106

Facility:
Name: The Center of Hope ( Site 4106)

Address:
City: Reno
Zip: 89511
Country: United States

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 775-327-4673

Facility:
Name: Holy Name Medical Center ( Site 4117)

Address:
City: Teaneck
Zip: 07666
Country: United States

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 201-227-6200

Facility:
Name: Oklahoma Cancer Specialists and Research Institute, LLC-Clinical Research ( Site 4116)

Address:
City: Tulsa
Zip: 74146
Country: United States

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 918-505-3200

Facility:
Name: Houston Methodist Hospital OB/GYN ( Site 4102)

Address:
City: Houston
Zip: 77030
Country: United States

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 713-441-6616

Facility:
Name: University of Virginia Cancer Center ( Site 4123)

Address:
City: Charlottesville
Zip: 22908
Country: United States

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 434-982-5385

Facility:
Name: Instituto de Investigaciones Clínicas Mar del Plata ( Site 0107)

Address:
City: Mar del Plata
Zip: B7600FZO
Country: Argentina

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +5492235937663

Facility:
Name: Hospital Aleman-Oncology ( Site 0100)

Address:
City: Buenos Aires
Zip: C1118AAT
Country: Argentina

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 541148277000x2306

Facility:
Name: Instituto Alexander Fleming ( Site 0108)

Address:
City: Caba
Zip: C1426ANZ
Country: Argentina

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 5491165747753

Facility:
Name: Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0109)

Address:
City: Caba
Zip: C1431FWO
Country: Argentina

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 5491140375232

Facility:
Name: Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0104)

Address:
City: La Rioja
Zip: F5300COE
Country: Argentina

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +54 9 443 6443

Facility:
Name: Blacktown Hospital ( Site 3006)

Address:
City: Sydney
Zip: 2148
Country: Australia

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 61298818421

Facility:
Name: Campbelltown Hospital-Macarthur Cancer Therapy Centre Medical Oncology ( Site 3000)

Address:
City: Sydney
Zip: 2560
Country: Australia

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 0246344355

Facility:
Name: Royal Brisbane and Women's Hospital ( Site 3001)

Address:
City: Herston
Zip: 4029
Country: Australia

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 61402240196

Facility:
Name: Monash Health-Oncology Research ( Site 3002)

Address:
City: Clayton
Zip: 3168
Country: Australia

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +61 426 2788 74

Facility:
Name: Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 3005)

Address:
City: Melbourne
Zip: 3000
Country: Australia

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 61385595000

Facility:
Name: Sir Charles Gairdner Hospital ( Site 3003)

Address:
City: Nedlands
Zip: 6009
Country: Australia

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 61893463841

Facility:
Name: Medizinische Universität Wien ( Site 1001)

Address:
City: Wien
Zip: 1090
Country: Austria

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 4314040061030

Facility:
Name: UZ Leuven-Gynecologic Oncology ( Site 2900)

Address:
City: Leuven
Zip: 3000
Country: Belgium

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 3216344634

Facility:
Name: CHU UCL Namur/Site Sainte Elisabeth-Trial Office ( Site 2902)

Address:
City: Namur
Zip: 5000
Country: Belgium

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 003281720531

Facility:
Name: IBCC - Instituto Brasileiro de Controle do Câncer-Centro de Pesquisa Clínica ( Site 0200)

Address:
City: São Paulo
Zip: 04014-002
Country: Brazil

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 5511984680001

Facility:
Name: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 4

Address:
City: Quebec City
Zip: G1J 1Z4
Country: Canada

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 4182558841

Facility:
Name: FALP-UIDO ( Site 0300)

Address:
City: Santiago
Zip: 7500921
Country: Chile

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 96792467

Facility:
Name: Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0302)

Address:
City: Santiago
Zip: 8330032
Country: Chile

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 56223547919

Facility:
Name: ONCOCENTRO APYS-ACEREY ( Site 0303)

Address:
City: Viña del Mar
Zip: 2520598
Country: Chile

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +56992369820

Facility:
Name: Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0401)

Address:
City: Valledupar
Zip: 200001
Country: Colombia

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 57 3175150103

Facility:
Name: Oncomedica S.A.S ( Site 0402)

Address:
City: Montería
Zip: 230002
Country: Colombia

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +57 3205669416

Facility:
Name: FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Sit

Address:
City: Bogota
Country: Colombia

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 57159486505715593

Facility:
Name: Oncologos del Occidente ( Site 0405)

Address:
City: Pereira
Zip: 660001
Country: Colombia

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +573154208077

Facility:
Name: Fundación Valle del Lili ( Site 0406)

Address:
City: Cali
Zip: 760032
Country: Colombia

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +57 2 3319090 EXT 4022

Facility:
Name: Aarhus Universitetshospital, Skejby ( Site 1301)

Address:
City: Aarhus
Zip: 8200
Country: Denmark

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 4591167356

Facility:
Name: Odense Universitetshospital-Department of oncology ( Site 1302)

Address:
City: Odense C
Zip: 5000
Country: Denmark

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 40768360

Facility:
Name: Tampereen yliopistollinen sairaala-Gynecology and Obstetrics ( Site 1404)

Address:
City: Tampere
Zip: 33520
Country: Finland

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 358407274241

Facility:
Name: Agios Andreas Hospital Patras ( Site 1701)

Address:
City: Patras
Zip: 263 35
Country: Greece

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 00306942402626

Facility:
Name: Mater Misericordiae University Hospital ( Site 1901)

Address:
City: Dublin
Zip: D07 R2WY
Country: Ireland

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +35318032000

Facility:
Name: Rambam Health Care Campus ( Site 2002)

Address:
City: Haifa
Zip: 3109601
Country: Israel

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 972-54-4867977

Facility:
Name: Edith Wolfson Medical Center ( Site 2003)

Address:
City: Holon
Zip: 5810001
Country: Israel

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +972522801565

Facility:
Name: Hadassah Medical Center ( Site 2000)

Address:
City: Jerusalem
Zip: 9112001
Country: Israel

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 972545615563

Facility:
Name: IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlin-DEPARTMENT OF EXPERIMENTAL, DIAGNOSTIC

Address:
City: Bologna
Zip: 40138
Country: Italy

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +39 0512144548

Facility:
Name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Ginecologia Oncologica ( Site 2102)

Address:
City: Roma
Zip: 00168
Country: Italy

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +390630154994

Facility:
Name: Istituto Europeo di Oncologia IRCCS ( Site 2108)

Address:
City: Milano
Zip: 20141
Country: Italy

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 390257489543

Facility:
Name: Humanitas University ( Site 2112)

Address:
City: Rozzano
Zip: 20089
Country: Italy

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +39 02 69517533

Facility:
Name: Ospedale San Raffaele ( Site 2106)

Address:
City: Milano
Zip: 20132
Country: Italy

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +39 0226438003

Facility:
Name: National Hospital Organization Shikoku Cancer Center ( Site 5109)

Address:
City: Matsuyama
Zip: 791-0280
Country: Japan

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +81-89-999-1111

Facility:
Name: Hokkaido University Hospital ( Site 5106)

Address:
City: Sapporo
Zip: 060-8648
Country: Japan

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +81-11-716-1161

Facility:
Name: Saitama Medical University International Medical Center ( Site 5117)

Address:
City: Hidaka
Zip: 350-1298
Country: Japan

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +81-42-984-4111

Facility:
Name: The Cancer Institute Hospital of JFCR ( Site 5111)

Address:
City: Koto
Zip: 135-8550
Country: Japan

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +81-3-3520-0111

Facility:
Name: Seoul National University Hospital ( Site 3403)

Address:
City: Seoul
Zip: 03080
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 82220723511

Facility:
Name: Severance Hospital, Yonsei University Health System ( Site 3402)

Address:
City: Seoul
Zip: 03722
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 82222282230

Facility:
Name: Asan Medical Center-Division of Gynecologic Oncology, Dept. of Obstetrics & Gynecology ( Site 3401)

Address:
City: Seoul
Zip: 05505
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 82230103640

Facility:
Name: Samsung Medical Center ( Site 3400)

Address:
City: Seoul
Zip: 06351
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +82-2-3410-3513

Facility:
Name: Pantai Hospital Kuala Lumpur ( Site 3100)

Address:
City: Kuala Lumpur
Zip: 59100
Country: Malaysia

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 60322960800

Facility:
Name: Radboudumc-Medical Oncology ( Site 2202)

Address:
City: Nijmegen
Zip: 6525 GA
Country: Netherlands

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +31652649894

Facility:
Name: Catharina Ziekenhuis-Oncology ( Site 2203)

Address:
City: Eindhoven
Zip: 5623 EJ
Country: Netherlands

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +3140 239 9111

Facility:
Name: Amsterdam UMC, locatie VUmc ( Site 2201)

Address:
City: Amsterdam
Zip: 1081HV
Country: Netherlands

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +31 020 44 43329

Facility:
Name: Erasmus Medisch Centrum-Medical Oncology ( Site 2200)

Address:
City: Rotterdam
Zip: 3015 GD
Country: Netherlands

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +3110 704 0704

Facility:
Name: Oslo universitetssykehus, Radiumhospitalet ( Site 2300)

Address:
City: Oslo
Zip: 0379
Country: Norway

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +47-48512384

Facility:
Name: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Ginekologii Onkologicznej ( Sit

Address:
City: Warszawa
Zip: 02-781
Country: Poland

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 48225462295

Facility:
Name: Bialostockie Centrum Onkologii-Oddzial Onkologii Ginekologicznej ( Site 2402)

Address:
City: Bialystok
Zip: 15-027
Country: Poland

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 48856646728

Facility:
Name: UPR Comprehensive Cancer Center-Comprehensive Cancer Center Hospital ( Site 0601)

Address:
City: San Juan
Zip: 00935
Country: Puerto Rico

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 787-407-3797

Facility:
Name: National Cancer Centre Singapore ( Site 3300)

Address:
City: Singapore
Zip: 168583
Country: Singapore

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +65 64368000

Facility:
Name: HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Sit

Address:
City: Barcelona
Zip: 08036
Country: Spain

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 34932275402

Facility:
Name: Institut Català d'Oncologia (ICO) - Girona-Oncología Médica ( Site 2507)

Address:
City: Girona
Zip: 17007
Country: Spain

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +34 97222 5828

Facility:
Name: Clinica Universidad de Navarra ( Site 2510)

Address:
City: Madrid
Zip: 28027
Country: Spain

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 34913531920

Facility:
Name: Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2502)

Address:
City: Madrid
Zip: 28034
Country: Spain

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 34913368263

Facility:
Name: Fundación Instituto Valenciano de Oncología-Oncologico ( Site 2503)

Address:
City: Valencia
Zip: 46009
Country: Spain

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 34961114013

Facility:
Name: Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2500)

Address:
City: Barcelona
Zip: 08035
Country: Spain

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 34 932 543 452 Ext. 8607

Facility:
Name: Hospital Universitario Reina Sofia-Oncologia Medica ( Site 2501)

Address:
City: Cordoba
Zip: 14004
Country: Spain

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +34957011456

Facility:
Name: Hospital Universitario La Paz-Oncología Médica ( Site 2504)

Address:
City: Madrid
Zip: 28046
Country: Spain

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +34679927508

Facility:
Name: Skåne Universitetssjukhus ( Site 2602)

Address:
City: Lund
Zip: 221 85
Country: Sweden

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +4646171000

Facility:
Name: Akademiska sjukhuset ( Site 2603)

Address:
City: Uppsala
Zip: 751 85
Country: Sweden

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 46186110000

Facility:
Name: University Hospital Basel-Gynecology & Gynecologic Oncology ( Site 2701)

Address:
City: Basel
Zip: 4031
Country: Switzerland

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 111-111-1111

Facility:
Name: Inselspital Bern-Oncology ( Site 2700)

Address:
City: Berne
Zip: 3010
Country: Switzerland

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 41316326416

Start date: July 24, 2024

Completion date: October 23, 2028

Lead sponsor:
Agency: Merck Sharp & Dohme LLC
Agency class: Industry

Collaborator:
Agency: European Network of Gynaecological Oncological Trial Groups (ENGOT)
Agency class: Other

Collaborator:
Agency: GOG Foundation
Agency class: Other

Source: Merck Sharp & Dohme LLC

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06459180
https://www.merckclinicaltrials.com/
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=2870-020&&kw=2870-020

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