Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction With First-Line Chemotherapy Plus Pembrolizumab in Triple Negative Breast Cancer (TNBC) (MK-7339-009/KEYLYNK-009)

NCT04191135 | Completed Phase 2 Results FDA Drug

• 7 other identifiers: 7339-009MK-7339-009KEYLYNK-0091950822022-500418-24-00U1111-1275-85752019-001892-35
• Study Type: interventional
• Target: 462
• Locations: 15 countries
• Sites: 122

Brief Summary

The purpose of this study is to compare the efficacy of olaparib (MK-7339) plus pembrolizumab (MK-3475) with chemotherapy plus pembrolizumab after induction with first-line chemotherapy plus pembrolizumab in triple negative breast cancer (TNBC). The primary hypotheses are:

1. 1.Olaparib plus pembrolizumab is superior to chemotherapy plus pembrolizumab with respect to progression-free survival (PFS).
2. 2.Olaparib plus pembrolizumab is superior to chemotherapy plus pembrolizumab with respect to overall survival (OS).

Conditions

Triple Negative Breast Neoplasms

Keywords

Programmed Cell Death Receptor 1 (PD-1, PD1); Programmed Cell Death Receptor Ligand 1 (PD-L1, PDL1); Programmed Cell Death Receptor Ligand 2 (PD-L2, PDL2)

Outcome Measures

Primary Outcomes (2)

• Progression-Free Survival (PFS)

  PFS was defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR), or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters (SOD) of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS is reported based on the product-limit (Kaplan-Meier) method for censored data.

  Up to approximately 29 months

• Overall Survival (OS)

  OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS is reported based on the product-limit (Kaplan-Meier) method for censored data.

  Up to approximately 29 months

Secondary Outcomes (24)

• Progression-Free Survival (PFS) in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Positive Tumors With a Combined Positive Score (CPS) ≥10

  Up to approximately 29 months

• Overall Survival (OS) in Participants With PD-L1 Positive Tumors With a CPS ≥10

  Up to approximately 29 months

• PFS in Participants With Breast Cancer Susceptibility Gene Mutation (BRCAm) Tumors

  Up to approximately 29 months

• OS in Participants With BRCAm Tumors

  Up to approximately 29 months

• Change From Baseline in Health-Related Quality-of-Life (QoL) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 29 and 30 Combined Score

  Baseline and week 18

Study Arms (2)

Pembrolizumab + Olaparib

EXPERIMENTAL

This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle plus olaparib 300 mg orally twice daily during the post-induction period.

Biological: Pembrolizumab; Drug: Olaparib

Pembrolizumab + Carboplatin + Gemcitabine

EXPERIMENTAL

This arm includes participants who randomized following completion of the induction period. Participants continued to receive both carboplatin AUC 2 with gemcitabine 1000 mg/m\^2 intravenously on Days 1 and 8 of each 21-day cycle in addition to pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle in the post-induction period.

Biological: Pembrolizumab; Drug: Carboplatin; Drug: Gemcitabine

Interventions

Pembrolizumab BIOLOGICAL

intravenous (IV) infusion

Also known as: KEYTRUDA®, MK-3475

Pembrolizumab + Carboplatin + Gemcitabine; Pembrolizumab + Olaparib

Olaparib DRUG

oral tablets

Also known as: LYNPARZA®, MK-7339, AZD2281, KU-0059436

Pembrolizumab + Olaparib

Carboplatin DRUG

IV infusion

Also known as: PARAPLATIN®

Pembrolizumab + Carboplatin + Gemcitabine

Gemcitabine DRUG

IV infusion

Also known as: GEMZAR®

Pembrolizumab + Carboplatin + Gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Induction Period:
• Has locally recurrent inoperable TNBC that has not previously been treated with chemotherapy and that cannot be treated with curative intent OR has metastatic TNBC that has not been previously treated with chemotherapy
• Has been treated with anthracycline and/or a taxane in the neoadjuvant/adjuvant setting, if they received systemic treatment in the neoadjuvant/adjuvant setting, unless anthracycline and/or taxane was contraindicated or not considered the best treatment option for the participant in the opinion of the treating physician
• Has measurable disease based on RECIST 1.1
• Has provided a recently obtained or archival (no more than 3 years old) core or excisional biopsy of a tumor lesion not previously irradiated
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 as assessed within 7 days prior to the start of induction study treatment
• Has a life expectancy ≥27 weeks from the day of first study treatment
• Demonstrate adequate organ function within 10 days prior to the start of study treatment
• A male participant must agree to be abstinent or use contraception and refrain from donating sperm during the intervention period and for at least the time needed to eliminate each study intervention (95 days for olaparib and chemotherapy; no requirement for pembrolizumab)
• A female participant must not be pregnant or breastfeeding and must agree to the following if is a woman of childbearing potential (WOCBP): have a negative pregnancy test within 24 hours before the start of study treatment and agree to be abstinent or use contraception and refrain from donating eggs (ova, oocytes) during the intervention period and for at least the time needed to eliminate each study intervention (180 days for olaparib and chemotherapy; 120 days for pembrolizumab)
• Post-induction Period:
• Has received up to 6 cycles but not less than 4 cycles of induction therapy without permanently discontinuing from pembrolizumab or both carboplatin and gemcitabine
• Has achieved complete response (CR), partial response (PR), or stable disease (SD) based on RECIST 1.1 by Blinded Independent Central Review (BICR) at the Week 18 evaluation
• Is able to complete during post-induction at least the Cycle 1, Day 1 doses of olaparib and pembrolizumab or the Cycle 1, Day 1 doses of at least one of the chemotherapy agents being administered at the end of induction (carboplatin and/or gemcitabine) in addition to pembrolizumab
• Has ECOG performance status of 0 or 1, as assessed within 7 days prior to the start of post-induction study treatment

You may not qualify if:

• Induction Period:
• Has a known additional malignancy that is progressing or has required active treatment within the past 5 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, cervical cancer in situ) that have undergone potentially curative therapy
• 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 treatment
• Has an active autoimmune disease that has required systemic treatment in the past 2 years
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
• Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or has features suggestive of MDS/AML
• Has a history of (non-infectious) pneumonitis\\interstitial lung disease that required steroids or current pneumonitis\\interstitial lung disease
• Has active, or a history of, interstitial lung disease
• Has a known history of active tuberculosis
• Has an active infection requiring systemic therapy
• Has a known history of human immunodeficiency virus (HIV) infection
• Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection
• Has a history of class II-IV congestive heart failure or myocardial infarction within 6 months of first study treatment
• Has neuropathy ≥Grade 2
• Has not recovered (eg, to ≤Grade 1 or to baseline) from AEs due to a previously administered therapy

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (122)

Pacific Cancer Care ( Site 0142)

Monterey, California, 93940, United States

Location

UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0138)

San Francisco, California, 94158, United States

Location

John Wayne Cancer Institute ( Site 0111)

Santa Monica, California, 90404, United States

Location

St. Joseph Heritage Healthcare ( Site 0104)

Santa Rosa, California, 95403, United States

Location

University of Miami Sylvester CC ( Site 0146)

Miami, Florida, 33136, United States

Location

Georgia Cancer Center at Augusta University ( Site 0129)

Augusta, Georgia, 30912, United States

Location

University of Chicago ( Site 0159)

Chicago, Illinois, 60637, United States

Location

Massachusetts General Hospital ( Site 0155)

Boston, Massachusetts, 02114, United States

Location

Henry Ford Health System ( Site 0103)

Detroit, Michigan, 48202, United States

Location

Virginia Piper Cancer Institute ( Site 0157)

Minneapolis, Minnesota, 55407, United States

Location

Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0161)

Middletown, New Jersey, 07748, United States

Location

MSKCC-Bergen ( Site 0162)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan-Kettering Cancer Center at Commack ( Site 0160)

Commack, New York, 11725, United States

Location

Memorial Sloan-Kettering Cancer Center ( Site 0156)

New York, New York, 10065, United States

Location

Mercy Clinic Oncology and Hematology ( Site 0110)

Oklahoma City, Oklahoma, 73120, United States

Location

The Center For Cancer And Blood Disorders ( Site 0151)

Fort Worth, Texas, 76104, United States

Location

Texas Oncology-New Braunfels ( Site 0168)

New Braunfels, Texas, 78130, United States

Location

Texas Oncology-San Antonio Northeast ( Site 0165)

San Antonio, Texas, 78217, United States

Location

Texas Oncology-San Antonio Medical Center ( Site 0158)

San Antonio, Texas, 78240, United States

Location

Texas Oncology - San Antonio Stone Oak ( Site 0166)

San Antonio, Texas, 78258, United States

Location

Renovatio Clinical ( Site 0117)

The Woodlands, Texas, 77380, United States

Location

Virginia Oncology Associates ( Site 0163)

Newport News, Virginia, 23606, United States

Location

Virginia Oncology Associates ( Site 0153)

Norfolk, Virginia, 23502, United States

Location

Virginia Oncology Associates ( Site 0164)

Virginia Beach, Virginia, 23456, United States

Location

YVMH dba Virginia Mason Memorial/North Star Lodge Cancer Center ( Site 0128)

Yakima, Washington, 98902, United States

Location

Princess Margaret Cancer Centre ( Site 0005)

Toronto, Ontario, M5G 2M9, Canada

Location

CSSS de Laval- Hopital de la Cite de la Sante ( Site 0011)

Laval, Quebec, H7M 3L9, Canada

Location

Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0003)

Montreal, Quebec, H2X 3E4, Canada

Location

Jewish General Hospital ( Site 0010)

Montreal, Quebec, H3T 1E2, Canada

Location

McGill University Health Centre ( Site 0002)

Montreal, Quebec, H4A 3J1, Canada

Location

IC La Serena Research ( Site 0511)

La Serena, Coquimbo Region, 1720430, Chile

Location

Fundacion Arturo Lopez Perez ( Site 0500)

Santiago, Region M. de Santiago, 7500921, Chile

Location

Pontificia Universidad Catolica de Chile ( Site 0501)

Santiago, Region M. de Santiago, 8330032, Chile

Location

Centro Investigación del Cáncer James Lind ( Site 0510)

Temuco, Región de la Araucanía, 4780000, Chile

Location

Oncocentro ( Site 0502)

Viña del Mar, Región de Valparaíso, 2520598, Chile

Location

Fundacion Colombiana de Cancerologia Clinica Vida ( Site 0601)

Medellín, Antioquia, 050030, Colombia

Location

Clinica de la Costa Ltda. ( Site 0600)

Barranquilla, Atlántico, 080020, Colombia

Location

Organizacion Clinica Bonnadona-Prevenir S.A.S. ( Site 0609)

Barranquilla, Atlántico, 080020, Colombia

Location

Oncomedica S.A. ( Site 0606)

Montería, Departamento de Córdoba, 230002, Colombia

Location

Fundacion Valle del Lili ( Site 0602)

Cali, Valle del Cauca Department, 760032, Colombia

Location

Hemato Oncologos S.A. ( Site 0603)

Cali, Valle del Cauca Department, 760042, Colombia

Location

Centre Francois Baclesse ( Site 1012)

Caen, Calvados, 14076, France

Location

CHU-Jean Minjoz ( Site 1013)

Besançon, Doubs, 25030, France

Location

Institut Claudius Regaud IUCT Oncopole ( Site 1001)

Toulouse, Haute-Garonne, 31059, France

Location

Centre de Cancerologie du Grand Montpellier ( Site 1009)

Montpellier, Languedoc-Roussillon, 34070, France

Location

CHR-METZ-THIONVILLE - Hopital de Mercy ( Site 1007)

Metz, Moselle, 57085, France

Location

Centre Jean Perrin ( Site 1003)

Clermont-Ferrand, Puy-de-Dome, 63001, France

Location

Centre Leon Berard ( Site 1018)

Lyon, Rhone, 69373, France

Location

Centre Henri Becquerel ( Site 1020)

Rouen, Seine-Maritime, 76038, France

Location

CHU Amiens Hopital Sud ( Site 1023)

Amiens, Somme, 80000, France

Location

Institut Gustave Roussy ( Site 1010)

Villejuif, Val-de-Marne, 94805, France

Location

Institut Sainte Catherine ( Site 1026)

Avignon, Vaucluse, 84918, France

Location

Hôpital Saint-Louis ( Site 1025)

Paris, 75010, France

Location

Universitaetsklinikum Mannheim GmbH ( Site 1213)

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Universitaetsklinikum Erlangen ( Site 1201)

Erlangen, Bavaria, 91054, Germany

Location

Klinik und Poliklinik fuer Frauenheilkunde und Geburtshilfe ( Site 1200)

Munich, Bavaria, 80337, Germany

Location

Hochwaldkrankenhaus Bad Nauheim ( Site 1211)

Bad Nauheim, Hesse, 61231, Germany

Location

Sana Klinikum Offenbach Klinik fuer Gynakologie und Geburtshilfe ( Site 1206)

Offenbach, Hesse, 63069, Germany

Location

Gynaekologisch-onkologische Praxis Hannover ( Site 1207)

Hanover, Lower Saxony, 30177, Germany

Location

Gynaekologisches Zentrum-Schwerpunkt Gyn. Onkologie ( Site 1205)

Bonn, North Rhine-Westphalia, 53111, Germany

Location

Universitaetsklinikum AoeR Duesseldorf ( Site 1210)

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Kliniken Essen-Mitte ( Site 1215)

Essen, North Rhine-Westphalia, 45136, Germany

Location

Frauenklinik St. Louise ( Site 1216)

Paderborn, North Rhine-Westphalia, 33098, Germany

Location

Universitaetsklinikum Carl Gustav Carus ( Site 1203)

Dresden, Saxony, 01307, Germany

Location

Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 1607)

Pécs, Baranya, 7624, Hungary

Location

Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1608)

Kecskemét, Bács-Kiskun county, 6000, Hungary

Location

Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1601)

Szolnok, Jász-Nagykun-Szolnok, 5000, Hungary

Location

Zala Megyei Szent Rafael Korhaz ( Site 1605)

Zalaegerszeg, Zala County, 8900, Hungary

Location

Orszagos Onkologiai Intezet ( Site 1602)

Budapest, 1122, Hungary

Location

Debreceni Egyetem Klinikai Kozpont ( Site 1600)

Debrecen, 4032, Hungary

Location

Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 1604)

Kaposvár, 7400, Hungary

Location

Cork University Hospital ( Site 0902)

Cork, T12 DC4A, Ireland

Location

St Vincents University Hospital ( Site 0900)

Dublin, D04 YN63, Ireland

Location

Aichi Cancer Center Hospital ( Site 2202)

Nagoya, Aichi-ken, 464-8681, Japan

Location

Hyogo College of Medicine Hospital ( Site 2203)

Nishinomiya, Hyōgo, 663-8501, Japan

Location

Fukushima Medical University Hospital ( Site 2201)

Fukushima, 960-1295, Japan

Location

Hiroshima City Hiroshima Citizens Hospital ( Site 2204)

Hiroshima, 730-8518, Japan

Location

National Hospital Organization - Osaka National Hospital - Institute For Clinical Research (Site 2200)

Osaka, 540-0006, Japan

Location

Pleszewskie Centrum Medyczne w Pleszewie Sp. z o.o. ( Site 1909)

Pleszew, Greater Poland Voivodeship, 65-300, Poland

Location

Pratia MCM Krakow ( Site 1919)

Krakow, Lesser Poland Voivodeship, 30-510, Poland

Location

Regionalny Szpital Specjalistyczny Latawiec ( Site 1917)

Swidnica, Lower Silesian Voivodeship, 58-100, Poland

Location

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (Site 1908)

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1913)

Gdynia, Pomeranian Voivodeship, 81-519, Poland

Location

Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1912)

Gliwice, Silesian Voivodeship, 44-102, Poland

Location

National Cancer Center ( Site 2406)

Goyang-si, Kyonggi-do, 10408, South Korea

Location

Seoul National University Bundang Hospital ( Site 2409)

Seongnam-si, Kyonggi-do, 13605, South Korea

Location

Ajou University Hospital ( Site 2407)

Suwon, Kyonggi-do, 16499, South Korea

Location

Kyungpook National University Chilgok Hospital ( Site 2402)

Daegu, Taegu-Kwangyokshi, 41404, South Korea

Location

Gachon University Gil Medical Center ( Site 2408)

Incheon, 21565, South Korea

Location

Seoul National University Hospital ( Site 2403)

Seoul, 03080, South Korea

Location

Severance Hospital Yonsei University Health System ( Site 2401)

Seoul, 03722, South Korea

Location

Asan Medical Center ( Site 2404)

Seoul, 05505, South Korea

Location

Samsung Medical Center ( Site 2405)

Seoul, 06351, South Korea

Location

Hospital Universitario Reina Sofia ( Site 0705)

Córdoba, Andalusia, 14004, Spain

Location

Hospital General Arnau de Vilanova de Valencia ( Site 0706)

Valencia, Valenciana, Comunitat, 46015, Spain

Location

Instituto Oncologico Baselga.Hospital Quiron. ( Site 0707)

Barcelona, 08023, Spain

Location

Hospital Universitari Vall d Hebron ( Site 0701)

Barcelona, 08035, Spain

Location

Hospital Clinic I Provincial de Barcelona ( Site 0702)

Barcelona, 08036, Spain

Location

Clinica Universitaria Navarra - Madrid ( Site 0700)

Madrid, 28027, Spain

Location

Kaohsiung Chang Gung Memorial Hospital ( Site 2304)

Kaohsiung City, 83301, Taiwan

Location

National Cheng Kung University Hospital ( Site 2303)

Tainan, 704, Taiwan

Location

MacKay Memorial Hospital ( Site 2301)

Taipei, 10449, Taiwan

Location

Koo Foundation Sun Yat-Sen Cancer Center ( Site 2300)

Taipei, 112, Taiwan

Location

China Medical University Hospital ( Site 2302)

Taipei, 40447, Taiwan

Location

Chernihiv Medical Center of Modern Oncology ( Site 1520)

Chernihiv, Chernihiv Oblast, 14029, Ukraine

Location

Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC ( Site 1502)

Dnipro, Dnipropetrovsk Oblast, 49102, Ukraine

Location

CI Krivorizhskiy oncology dispensery ( Site 1504)

Kryviy Rih, Dnipropetrovsk Oblast, 50048, Ukraine

Location

MI Precarpathian Clinical Oncology Center ( Site 1506)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018, Ukraine

Location

Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 1508)

Kharkiv, Kharkivs’ka Oblast’, 61024, Ukraine

Location

Communal non profit enterprise Regional Clinical Oncology Center ( Site 1512)

Kharkiv, Kharkivs’ka Oblast’, 61070, Ukraine

Location

SI-Zaytsev institute of general and urgent surgery-NAMS ( Site 1518)

Kharkiv, Kharkivs’ka Oblast’, 61103, Ukraine

Location

Medical Centre Consilium Medical ( Site 1514)

Kyiv, Kyivska Oblast, 04050, Ukraine

Location

Medical center of the Limited Liability Company Yulis ( Site 1517)

Zaporizhzhia, Zaporizhzhia Oblast, 69035, Ukraine

Location

Medical Centre LLC Oncolife ( Site 1510)

Zaporizhzhya, Zaporizhzhia Oblast, 69104, Ukraine

Location

Zhytomyr Regional Oncology Center ( Site 1515)

Zhytomyr, Zhytomyr Oblast, 10002, Ukraine

Location

Medical Center Verum ( Site 1501)

Kyiv, 03039, Ukraine

Location

Raigmore Hospital ( Site 0915)

Inverness, Highland, IV2 3UJ, United Kingdom

Location

Blackpool Victoria Hospital ( Site 0921)

Blackpool, Lancashire, FY3 8NR, United Kingdom

Location

Barts Health NHS Trust ( Site 0912)

London, London, City of, EC1M 6BQ, United Kingdom

Location

North West Cancer Centre ( Site 0922)

Londonderry, London, City of, BT47 6SB, United Kingdom

Location

Musgrove Park Hospital ( Site 0918)

Taunton, Somerset, TA1 5DA, United Kingdom

Location

The Christie NHS Foundation Trust ( Site 0914)

Manchester, M20 4BX, United Kingdom

Location

Related Publications (1)

• Rugo HS, Cescon DW, Robson ME, Im SA, Dalenc F, Yanez Ruiz E, Reyes-Cosmelli F, Walshe JM, Im YH, Kulyk S, Dudnichenko O, Llinas-Quintero N, Saji S, Miyoshi Y, Bardia A, Harbeck N, Haiderali A, Fan L, Mejia JA, Karantza V, Llombart-Cussac A. KEYLYNK-009: Pembrolizumab plus Olaparib in Locally Recurrent Inoperable or Metastatic Triple-Negative Breast Cancer after Clinical Benefit from First-Line Pembrolizumab plus Chemotherapy. Clin Cancer Res. 2026 Mar 2;32(5):883-893. doi: 10.1158/1078-0432.CCR-25-1818.

  PMID: 41405563 RESULT

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

pembrolizumab; olaparib; Carboplatin; Gemcitabine

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 9, 2019
• Study Start: December 19, 2019
• Primary Completion: December 15, 2022
• Study Completion: November 26, 2025
• Last Updated: March 3, 2026
• Results First Posted: February 14, 2024

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

FR (12); US (25); CO (6); GB (6); CA (5); CL (5); KR (9); UA (12); ES (6); TW (5); JP (5); HU (7); IE (2); DE (11); PL (6)