Breast Neoplasms Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the Treatment of Chemotherapy-Candidate Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Locally Recurrent Inoperable or Metastatic Breast Cancer (KEYNOTE-B49)
| Verified date | February 2024 |
| Source | Merck Sharp & Dohme LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The safety and efficacy of pembrolizumab plus the investigator's choice of chemotherapy will be assessed compared to placebo plus the investigator's choice of chemotherapy in the treatment of chemotherapy-candidate hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally recurrent inoperable or metastatic breast cancer. The primary hypotheses are that the combination of pembrolizumab and chemotherapy is superior to placebo and chemotherapy in regards to Progression-Free Survival (PFS) or overall survival (OS) in participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1 and ≥10.
| Status | Active, not recruiting |
| Enrollment | 800 |
| Est. completion date | July 21, 2028 |
| Est. primary completion date | July 21, 2028 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | The key inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: - Has locally recurrent inoperable or metastatic HR+/HER2- breast cancer, which has not been previously treated with cytotoxic chemotherapy in the noncurative setting - Has progressed on prior endocrine therapy and is now a chemotherapy candidate, meeting the characteristics in regard to previous treatments of one of the following 4 groups: - Group 1: Has progressed on 2 or more lines of endocrine therapy for advanced/metastatic HR+/HER2-disease, with at least given in combination with a Cyclin-dependent kinase 4/6 (CDK4/6) inhibitor. Prior treatment with mTOR and/or PI3-K inhibitors is allowed. OR - GROUP 2a: Has progressed on 1 line of previous endocrine therapy for advanced/metastatic disease AND had a disease recurrence within 24 months of definitive surgery for the primary tumor and while on adjuvant endocrine therapy. Prior use of CDK4/6 inhibitors is required, either in the adjuvant and/or metastatic setting. Prior treatment with mTOR and/or PI3-K inhibitors is allowed. OR - GROUP 2b: Has progressed within 12 months of starting 1 line of endocrine therapy with a CDK4/6 inhibitor for advanced/metastatic HR+/HER2- disease. OR - GROUP 3: If no prior treatment with a CDK4/6 inhibitor, for advanced/metastatic disease and/or early stage disease (adjuvant), participants must have progressed within 6 months of starting 1 line of endocrine therapy with or without an mTOR or PI3-K inhibitor for metastatic disease AND had a relapse within 24 months of definitive surgery for primary tumor and while receiving adjuvant endocrine therapy. - Has presented a documented radiographic disease progression (as assessed by the investigator and/or histology [biopsy or cytology] for participants presenting with new metastatic lesions) during or after the last administered endocrine therapy prior to entering the study. - Is a chemotherapy candidate that meets the criteria specified in the protocol - Provides a new or the last obtained core biopsy, preferably consisting of multiple cores, taken from a locally recurrent or a distant (metastatic) lesion not previously irradiated - Has centrally confirmed PD-L1 CPS =1 and HR+ (estrogen receptor [ER] and/or progesterone receptor [PgR]) /HER2- breast cancer as defined by the most recent American Society of Clinical Oncology (ASCO)/(College of American Pathologists) CAP guidelines on most recent tumor biopsy - Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 7 days prior to the first dose of study treatment - Has adequate organ function within 10 days prior to the start of study - Male participants must agree to the following during the treatment period and for at least 6 months after the last dose of chemotherapy: refrain from donating sperm PLUS either be abstinent from heterosexual intercourse as their preferred and usual lifestyle or use contraception and agree to use a male condom plus partner use of an additional contraceptive - A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of childbearing potential (WOCBP) OR is a WOCBP and using a highly-effective contraceptive method during the treatment period and for at least 120 days after the last dose of pembrolizumab and 180 days after the last dose of chemotherapy (whichever occurs last), AND agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period - A WOCBP must have a negative highly sensitive pregnancy test (urine or serum) within 24 hours for urine or within 72 hours for serum before the first dose of study intervention - Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiologist - If receiving bisphosphonates or RANK ligand inhibitors, with stable doses for =4 weeks prior to the date of randomization, the participant may continue receiving this therapy during the study treatment. If participant needs to initiate these agents during the screening period, a bone scan to evaluate bone disease should be performed prior to randomization. - 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 prior to the first dose of study intervention and have undetectable HBV viral load prior to randomization - Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening Exclusion Criteria: - Has breast cancer amenable to treatment with curative intent - Has a history or current evidence of any condition (e.g., transfusion-dependent anemia or thrombocytopenia), therapy, or laboratory abnormality that is specifically contraindicated per the current locally-approved labeling, that might confound the results of the study, interfere with the participant's involvement for the full duration of the study, or is not in the best interest of the participant to be involved, in the opinion of the treating investigator - Has significant cardiac disease, such as: history of myocardial infarction, acute coronary syndrome, coronary angioplasty/stenting/bypass within the last 6 months, congestive heart failure (CHF) New York Heart association (NYHA) Class II-IV, or history of CHF NYHA Class III or IV - Has advanced/metastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications, such as lymphangitic lung metastases, bone marrow replacement, carcinomatous meningitis, significant symptomatic liver metastases, shortness of breath requiring supplemental oxygen, symptomatic pleural effusion requiring supplemental oxygen, symptomatic pericardial effusion, symptomatic peritoneal carcinomatosis, or the need to achieve rapid symptom control - Has skin only disease - Has a known germline BRCA mutation (deleterious or suspected deleterious) and has not received previous treatment with PARP inhibition. either in the adjuvant or metastatic setting (where available and not medically contraindicated). Single-agent PARP inhibitor therapy does not count as a line of endocrine therapy. - Has received prior chemotherapy for locally recurrent inoperable or metastatic breast cancer - Has received prior therapy with an anti- programmed cell death 1 (PD-1), anti- programmed cell death ligand 1 (PD-L1), or anti- programmed cell death ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137) - Has received prior systemic anticancer therapy with other investigational agents within 4 weeks prior to randomization - Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids. - Has received a live or live attenuated vaccine within 30 days prior to the first dose of study intervention - Has received an investigational agent or has used an investigational device within 4 weeks prior to 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 intervention - Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ excluding cancer in situ of bladder that have undergone potentially curative therapy - Has known active central nervous system (CNS) metastases - Has diagnosed carcinomatous meningitis - Has severe hypersensitivity to pembrolizumab and/or any of its excipients or has any hypersensitivity to the planned chemotherapy agent (paclitaxel, nab-paclitaxel, liposomal doxorubicin, or capecitabine) and/or any of their excipients - Has an active autoimmune disease that has required systemic treatment in past 2 years - Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease - Has an active infection requiring systemic therapy - Has a known history of Human Immunodeficiency Virus (HIV) infection - Has a known COVID-19 infection (symptomatic or asymptomatic) - Has a known history of active tuberculosis (TB) - Has a known psychiatric or substance abuse disorder including alcohol or drug dependency that would interfere with the participant's ability to cooperate with the requirements of the study - Is breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 180 days (or longer as specified by local institutional guidelines) after the last dose of study treatment - Has had an allogenic tissue/solid organ transplant |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Centro de Oncología e Investigación de Buenos Aires ( Site 0400) | Berazategui | Buenos Aires |
| Argentina | Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0403) | Buenos Aires | Caba |
| Argentina | Hospital Aleman-Oncology ( Site 0402) | Buenos Aires | Caba |
| Argentina | Hospital Británico de Buenos Aires-Oncology ( Site 0404) | Ciudad autónoma de Buenos Aires | Buenos Aires |
| Argentina | Fundación CEMAIC ( Site 0410) | Cordoba | |
| Argentina | Hospital Italiano de Córdoba ( Site 0409) | Cordoba | |
| Argentina | Instituto de Investigaciones Clínicas Mar del Plata ( Site 0412) | Mar del Plata | Buenos Aires |
| Argentina | Instituto de Oncología de Rosario ( Site 0401) | Rosario | Santa Fe |
| Argentina | Sanatorio de La Mujer ( Site 0405) | Rosario | Santa Fe |
| Argentina | Sanatorio Parque ( Site 0407) | Rosario | Santa Fe |
| Argentina | Instituto San Marcos ( Site 0408) | San Juan | |
| Australia | Frankston Hospital-Oncology and Haematology ( Site 2103) | Frankston | Victoria |
| Australia | Macquarie University-MQ Health Clinical Trials Unit ( Site 2102) | Macquarie Park | New South Wales |
| Australia | Breast Cancer Research Centre-WA ( Site 2104) | Nedlands | Western Australia |
| Australia | Westmead Hospital-Department of Medical Oncology ( Site 2101) | Westmead | New South Wales |
| Austria | Medizinische Universität Graz-Innere Medizin Klin. Abt. Onkologie ( Site 1609) | Graz | Steiermark |
| Austria | Medizinische Universitaet Innsbruck ( Site 1602) | Innsbruck | Tirol |
| Austria | Uniklinikum Salzburg-Universitätsklinik für Innere Medizin III der PMU mit Hämatologie, internistis | Salzburg | |
| Austria | Medizinische Universität Wien ( Site 1601) | Vienna | Wien |
| Austria | Landesklinikum Wiener Neustadt-Innere Medizin, Hämatologie und internistische Onkologie ( Site 1604) | Wiener Neustadt | Niederosterreich |
| Brazil | Clínica de Oncologia Reichow ( Site 0210) | Blumenau | Santa Catarina |
| Brazil | YNOVA Pesquisa Clínica ( Site 0203) | Florianópolis | Santa Catarina |
| Brazil | Hospital de Câncer de Recife ( Site 0211) | Recife | Pernambuco |
| Brazil | Instituto de Educação, Pesquisa e Gestão em Saúde ( Site 0202) | Rio de Janeiro | |
| Brazil | Instituto Nacional de Câncer - INCA-Pesquisa Clinica HC3 ( Site 0208) | Rio de Janeiro | |
| Brazil | Instituto de Oncologia Saint Gallen ( Site 0206) | Santa Cruz do Sul | Rio Grande Do Sul |
| Canada | Tom Baker Cancer Center ( Site 0107) | Calgary | Alberta |
| Canada | Jewish General Hospital ( Site 0110) | Montreal | Quebec |
| Canada | Centre Hospitalier de l'Université de Montréal ( Site 0105) | Montréal | Quebec |
| Canada | Hopital Du Saint-Sacrement ( Site 0109) | Quebec City | Quebec |
| Canada | North York General Hospital ( Site 0108) | Toronto | Ontario |
| Canada | Princess Margaret Cancer Centre ( Site 0101) | Toronto | Ontario |
| Canada | Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec ( | Trois-Rivières | Quebec |
| Chile | Bradfordhill ( Site 0500) | Santiago | Region M. De Santiago |
| Chile | Clínica RedSalud Vitacura ( Site 0515) | Santiago | Region M. De Santiago |
| Chile | FALP ( Site 0501) | Santiago | Region M. De Santiago |
| Chile | Instituto Nacional del Cancer-CR Investigación ( Site 0511) | Santiago | Region M. De Santiago |
| Chile | Oncovida ( Site 0514) | Santiago | Region M. De Santiago |
| Chile | Centro Investigación del Cáncer James Lind ( Site 0513) | Temuco | Araucania |
| China | Beijing Cancer hospital-Department of Breast Cancer ( Site 2605) | Beijing | Beijing |
| China | Beijing Peking Union Medical College Hospital-Medical Oncology ( Site 2610) | Beijing | Beijing |
| China | Cancer Hospital Chinese Academy of Medical Science ( Site 2635) | Beijing | Beijing |
| China | Jilin Cancer Hospital-oncology department ( Site 2619) | Changchun | Jilin |
| China | Hunan Cancer Hospital ( Site 2608) | Changsha | Hunan |
| China | Xiangya Hospital Central South University-Breast department ( Site 2621) | Changsha | Hunan |
| China | West China Hospital Sichuan University-Head and Neck Oncology ( Site 2630) | Cheng Du | Sichuan |
| China | The First People's Hospital of Foshan-Oncology Department of Breast Cancer ( Site 2620) | Foshan | Guangdong |
| China | Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Breast Oncology Center ( Site 2641) | Guangzhou | Guangdong |
| China | SUN YAT-SEN UNIVERSITY CANCER CENTRE-oncology breast ( Site 2616) | Guangzhou | Guangdong |
| China | Zhejiang Cancer Hospital-Breast Oncology ( Site 2622) | Hangzhou | Zhejiang |
| China | Anhui Cancer Hospital-medical oncology ( Site 2632) | Hefei | Anhui |
| China | Shandong Cancer Hospital-Breast surgery ( Site 2623) | Jinan | Shandong |
| China | Taizhou Hospital of Zhejiang Province ( Site 2636) | Linhai | Zhejiang |
| China | The Third Hospital of Nanchang-Oncology Dept ( Site 2628) | Nanchang | Jiangxi |
| China | Jiangsu provincial people's hospital-Oncology Department ( Site 2607) | Nanjing | Jiangsu |
| China | Guangxi Medical University Affiliated Tumor Hospital-Oncology Dept. of Breast and Bone Soft Tissue ( | Nanning | Guangxi |
| China | Fudan University Shanghai Cancer Center-Oncology ( Site 2600) | Shanghai | Shanghai |
| China | Renji Hospital Shanghai Jiao Tong University School of Medicine-Breast surgery ( Site 2626) | Shanghai | Shanghai |
| China | Peking University Shenzhen Hospital-Oncology Department ( Site 2601) | Shenzhen | Guangdong |
| China | Tianjin Medical University Cancer Institute and Hospital-Department of Breast Cancer ( Site 2612) | Tianjin | Tianjin |
| China | Xinjiang Medical University Cancer Hospital - Urumqi-galactophore department ( Site 2624) | Urumqi | Xinjiang |
| China | The First Affiliated Hospital of Wenzhou Medical University-Thyroid and breast surgery ( Site 2625) | Wenzhou | Zhejiang |
| China | Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2629) | Wuhan | Hubei |
| China | The First Affiliated Hospital of Xian Jiaotong University wa-Oncology ( Site 2604) | Xi'an | Shaanxi |
| China | The First Affiliated hospital of Xiamen University-Breast Surgery ( Site 2613) | Xiamen | Fujian |
| China | Henan Cancer Hospital-Galactophore Department ( Site 2615) | Zhengzhou | Henan |
| Colombia | Clinica de la Costa S.A.S. ( Site 0601) | Barranquilla | Atlantico |
| Colombia | Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 0607) | Bogota | Distrito Capital De Bogota |
| Colombia | Fundación Colombiana de Cancerología Clínica Vida ( Site 0605) | Medellín | Antioquia |
| Colombia | Instituto de Cancerología-Oncology ( Site 0606) | Medellín | Antioquia |
| Colombia | Oncomedica S.A.-Oncomedica S.A ( Site 0604) | Montería | Cordoba |
| Colombia | Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 0603) | Valledupar | Cesar |
| France | Institut de Cancérologie de l'Ouest ( Site 0915) | ANGERS cedex 02 | Maine-et-Loire |
| France | CHU Besançon ( Site 0918) | Besançon | Franche-Comte |
| France | Centre François Baclesse ( Site 0920) | Caen | Calvados |
| France | Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 0901) | Clermont-Ferrand | Puy-de-Dome |
| France | Centre Oscar Lambret ( Site 0921) | Lille | Nord |
| France | CENTRE LEON BERARD ( Site 0919) | Lyon | Rhone-Alpes |
| France | Institut Paoli-Calmettes ( Site 0913) | Marseille | Bouches-du-Rhone |
| France | Centre de Cancérologie du Grand Montpellier ( Site 0912) | Montpellier | Languedoc-Roussillon |
| France | Institut Curie ( Site 0900) | Paris | |
| France | Centre Hospitalier Universitaire de Poitiers-Pôle régional de cancérologie ( Site 0922) | Poitiers | Vienne |
| France | Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen ( Site 0904) | Rouen | Seine-Maritime |
| France | Institut de Cancérologie de l'Ouest ( Site 0907) | Saint Herblain | Loire-Atlantique |
| France | Institut Claudius Regaud ( Site 0902) | Toulouse | Haute-Garonne |
| France | Gustave Roussy ( Site 0914) | Villejuif | Ile-de-France |
| Germany | Vivantes Klinikum Am Urban-Haematologie und Onkologie ( Site 1203) | Berlin | |
| Germany | Gynaekologisches Zentrum Bonn ( Site 1201) | Bonn | Nordrhein-Westfalen |
| Germany | Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Frauenheilkunde und Gebur | Dresden | Sachsen |
| Germany | Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1204) | Düsseldorf | Nordrhein-Westfalen |
| Germany | Universitaetsklinikum Erlangen-Klinik für Gynäkologie und Geburtshilfe ( Site 1202) | Erlangen | Bayern |
| Germany | Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung-Klinike für Senologie/ Brustzentrum ( Site 1200 | Essen | Nordrhein-Westfalen |
| Greece | Alexandra Hospital-ONCOLGOY DEPT. ( Site 0302) | Athens | Attiki |
| Greece | General Hospital of Athens Laiko-First Department of Internal Medicine ( Site 0305) | Athens | Attiki |
| Greece | University General Hospital of Heraklion-Internal Medicine-Oncology ( Site 0303) | Heraklion | Irakleio |
| Greece | Hygeia Hospital-3rd Oncology Department ( Site 0304) | Marousi | Attiki |
| Greece | Euromedica General Clinic Thessaloniki-Oncology Unit ( Site 0301) | Thessaloniki | |
| Guatemala | CELAN,S.A ( Site 0151) | Guatemala | |
| Guatemala | Gastrosoluciones ( Site 0156) | Guatemala | |
| Guatemala | INTEGRA Cancer Institute ( Site 0155) | Guatemala | |
| Guatemala | Centro Medico Integral De Cancerología (CEMIC) ( Site 0154) | Quetzaltenango | |
| Hungary | Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2804) | Kecskemét | Bacs-Kiskun |
| Hungary | Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 2807) | Pécs | Baranya |
| Hungary | Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Onkoterapias Klinika ( Site 2805) | Szeged | Csongrad |
| Ireland | St. James's Hospital ( Site 1530) | Dublin | |
| Ireland | St. Vincent's University Hospital-Medical Oncology Research Department ( Site 1531) | Dublin | |
| Israel | Assuta Ashdod Medical Center ( Site 1703) | Ashdod | |
| Israel | Soroka Medical Center-Oncology ( Site 1702) | Be'er Sheva | |
| Israel | Bnai Zion Medical Center-Oncology ( Site 1704) | Haifa | |
| Israel | Sheba Medical Center-ONCOLOGY ( Site 1700) | Ramat Gan | |
| Israel | Sourasky Medical Center-Oncology ( Site 1701) | Tel Aviv | |
| Italy | Instituto Tumori Giovanni Paolo II-ONCOLOGIA MEDICA ( Site 1112) | Bari | |
| Italy | Ospedale Cannizzaro ( Site 1118) | Catania | |
| Italy | Istituto Europeo di Oncologia IRCCS-Divisione di Senologia Medica ( Site 1111) | Milano | |
| Italy | Ospedale San Raffaele-Oncologia Medica ( Site 1110) | Milano | Lombardia |
| Italy | Ospedale San Gerardo-ASST Monza-Research Unit Phase 1 ( Site 1115) | Monza | Lombardia |
| Italy | Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1116) | Napoli | |
| Italy | Istituto Oncologico Veneto IRCCS ( Site 1117) | Padova | |
| Italy | Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 1113) | Roma | Lazio |
| Italy | Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1114) | Rozzano | Milano |
| Japan | Chiba University Hospital ( Site 2212) | Chiba | |
| Japan | National Hospital Organization Kyushu Cancer Center ( Site 2209) | Fukuoka | |
| Japan | Fukushima Medical University ( Site 2200) | Fukushima | |
| Japan | Saitama Medical University International Medical Center ( Site 2208) | Hidaka-city | Saitama |
| Japan | St. Marianna University School of Medicine Hospital ( Site 2205) | Kawasaki | Kanagawa |
| Japan | Kumamoto University ( Site 2203) | Kumamoto | |
| Japan | Hyogo Medical University Hospital ( Site 2201) | Nishinomiya | Hyogo |
| Japan | Kitasato University Hospital ( Site 2204) | Sagamihara | Kanagawa |
| Japan | Tokyo Medical University Hospital ( Site 2206) | Shinjuku-ku | Tokyo |
| Japan | Osaka University Hospital ( Site 2211) | Suita | Osaka |
| Japan | Juntendo University Hospital ( Site 2210) | Tokyo | |
| Japan | St. Luke's International Hospital ( Site 2207) | Tokyo | |
| Korea, Republic of | National Cancer Center-Center for Breast Cancer ( Site 2404) | Goyang-si | Kyonggi-do |
| Korea, Republic of | Seoul National University Bundang Hospital ( Site 2406) | Seongnam | Kyonggi-do |
| Korea, Republic of | Asan Medical Center ( Site 2402) | Seoul | |
| Korea, Republic of | Samsung Medical Center-Division of Hematology/Oncology ( Site 2401) | Seoul | |
| Korea, Republic of | Seoul National University Hospital-Internal Medicine ( Site 2403) | Seoul | |
| Korea, Republic of | Severance Hospital, Yonsei University Health System ( Site 2400) | Seoul | |
| Malaysia | Hospital Pulau Pinang ( Site 2504) | George Town | Pulau Pinang |
| Malaysia | Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 2506) | Kuala Lumpur | |
| Malaysia | Pantai Hospital Kuala Lumpur-Cancer Centre ( Site 2503) | Kuala Lumpur | |
| Malaysia | Sarawak General Hospital-Radiotherapy Unit ( Site 2501) | Kuching | Sarawak |
| Malaysia | University Malaya Medical Centre ( Site 2505) | Lembah Pantai | Kuala Lumpur |
| Mexico | Centro Estatal de Cancerologia-Investigación ( Site 0256) | Chihuahua | |
| Mexico | Hospital Civil Fray Antonio Alcalde-Oncology ( Site 0262) | Guadalajara | Jalisco |
| Mexico | Samadhi Centro Oncológico ( Site 0258) | México | Distrito Federal |
| Mexico | Filios Alta Medicina ( Site 0253) | Monterrey | Nuevo Leon |
| Mexico | Centro de Investigacion Clinica de Oaxaca ( Site 0252) | Oaxaca | |
| Netherlands | Meander Medisch Centrum ( Site 1358) | Amersfoort | Utrecht |
| Netherlands | Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL) ( Site 1351) | Amsterdam | Noord-Holland |
| Netherlands | Jeroen Bosch Hospital ( Site 1359) | Den Bosch | Noord-Brabant |
| Netherlands | Leids Universitair Medisch Centrum-Medical Oncology ( Site 1356) | Leiden | Zuid-Holland |
| Netherlands | Haaglanden MC - locatie Antoniushove-Medical oncology ( Site 1355) | Leidschendam | Zuid-Holland |
| Netherlands | Maastricht UMC+-Medical Oncology ( Site 1353) | Maastricht | Limburg |
| Netherlands | Radboudumc-Medical Oncology ( Site 1360) | Nijmegen | Gelderland |
| Netherlands | Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 1354) | Schiedam | Zuid-Holland |
| Netherlands | Elisabeth-TweeSteden Ziekenhuis-Internal Medicine ( Site 1357) | Tilburg | Noord-Brabant |
| Philippines | East Avenue Medical Center ( Site 0802) | Quezon City | National Capital Region |
| Philippines | CARDINAL SANTOS MEDICAL CENTER-Research Room ( Site 0800) | San Juan | National Capital Region |
| Poland | Bialostockie Centrum Onkologii-Oddzial Onkologii Klinicznej ( Site 1812) | Bialystok | Podlaskie |
| Poland | Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1813) | Bydgoszcz | Kujawsko-pomorskie |
| Poland | Narodowy Instytut Onkologii - Oddzial w Gliwicach-Breast Unit ( Site 1811) | Gliwice | Slaskie |
| Poland | Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1815) | Koszalin | Zachodniopomorskie |
| Poland | Pratia MCM Krakow ( Site 1809) | Krakow | Malopolskie |
| Poland | Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1819) | Przemysl | Podkarpackie |
| Poland | Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1818) | Siedlce | Mazowieckie |
| Poland | Lux med onkologia sp. z o.o. ( Site 1808) | Warsaw | Mazowieckie |
| Poland | Luxmed Onkologia sp. z o. o. ( Site 1820) | Warszawa | Mazowieckie |
| Poland | Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Piersi i Chirurgii ( | Warszawa | Mazowieckie |
| Poland | Wojskowy Instytut Medyczny-Klinika Onkologii ( Site 1803) | Warszawa | Mazowieckie |
| Poland | Mazowiecki Szpital Onkologiczny-BREAST CANCER ( Site 1821) | Wieliszew | Mazowieckie |
| Portugal | Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria ( Site 1004) | Lisbon | Lisboa |
| Portugal | Champalimaud Foundation ( Site 1006) | Lisbon | Lisboa |
| Portugal | UNIDADE LOCAL DE SAUDE DE MATOSINHOS ( Site 1007) | Matosinhos | Porto |
| Portugal | Centro Hospitalar do Porto - Hospital de Santo António-Oncology Service ( Site 1003) | Porto | |
| Portugal | Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 1005) | Porto | |
| Romania | Oncopremium Team-Oncology ( Site 2903) | Baia Mare | Maramures |
| Romania | Cardiomed SRL Cluj-Napoca ( Site 2902) | Cluj-Napoca | Cluj |
| Romania | Institutul Oncologic-Day Hospital Unit ( Site 2905) | Cluj-Napoca | Cluj |
| Romania | Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2901) | Craiova | Dolj |
| Romania | Sigmedical Services SRL ( Site 2904) | Suceava | |
| Russian Federation | Arkhangelsk Clinical Oncological Dispensary-Chemotherapy department ( Site 1902) | Arkhangelsk | Arkhangel Skaya Oblast |
| Russian Federation | Central Clinical Hospital of the Presidential Administrative Department ( Site 1904) | Moscow | Moskva |
| Russian Federation | Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology MHRF ( Site 1901) | Moscow | Moskva |
| Russian Federation | Moscow Clinical Research Center-Chemotherapy department ( Site 1903) | Moscow | Moskva |
| Russian Federation | Nizhegorodsky Regional Oncology Dispensary-chemotherapy ( Site 1912) | Nizhniy Novgorod | Nizhegorodskaya Oblast |
| Russian Federation | Podolsk Regional Clinical Hospital ( Site 1907) | Podolsk | Moskovskaya Oblast |
| Russian Federation | Ryazan Regional Clinical Oncology Center-Oncology #1 ( Site 1906) | Ryazan | Ryazanskaya Oblast |
| Russian Federation | N.N.Petrov Research Institute of Oncology ( Site 1900) | Saint Petersburg | Sankt-Peterburg |
| Russian Federation | St. Petersburg Clinical Hospital of Russian Academy Of Sciences-Medical Oncology ( Site 1905) | St. Petersburg | Sankt-Peterburg |
| Spain | Hospital Quiron Barcelona ( Site 1326) | Barcelona | Cataluna |
| Spain | HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1333) | Madrid | Madrid, Comunidad De |
| Spain | Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1320) | Madrid | Madrid, Comunidad De |
| Spain | HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1323) | Pozuelo de Alarcon | Madrid |
| Spain | Fundación Instituto Valenciano de Oncología-Oncologico ( Site 1332) | Valencia | Valenciana, Comunitat |
| Sweden | Södra Älvsborg Sjukhus ( Site 1406) | Borås | Vastra Gotalands Lan |
| Sweden | Karolinska Universitetssjukhuset Solna-Tema Cancer - ME Bröst- endokrina tumörer och sarkom ( Site 1 | Stockholm | Stockholms Lan |
| Turkey | Baskent University Dr. Turgut Noyan Research and Training Center ( Site 2013) | Adana | |
| Turkey | ANKARA SEHIR HASTANESI-Medical Oncology ( Site 2014) | Ankara | |
| Turkey | Gazi Universitesi-Oncology ( Site 2010) | Ankara | |
| Turkey | Hacettepe Universitesi-oncology hospital ( Site 2000) | Ankara | |
| Turkey | Memorial Ankara Hastanesi-Medical Oncology ( Site 2002) | Ankara | |
| Turkey | Akdeniz Universitesi Hastanesi-Medical Oncology ( Site 2009) | Antalya | |
| Turkey | Ege University Medicine of Faculty ( Site 2004) | Bornova | Izmir |
| Turkey | Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 2012) | Istanbul | |
| Turkey | TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2005) | Istanbul | |
| Turkey | I.E.U. Medical Point Hastanesi-Oncology ( Site 2016) | Izmir, Karsiyaka | Izmir |
| Turkey | Inönü Üniversitesi Turgut Özal Tip Merkezi Egitim ve Arastirma Hastanesi-Medical Oncology Department | Malatya | |
| United Kingdom | Blackpool Victoria Hospital ( Site 1503) | Blackpool | Lancashire |
| United Kingdom | Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 1502) | Leicester | England |
| United Kingdom | Guy's & St Thomas' NHS Foundation Trust ( Site 1501) | London | London, City Of |
| United Kingdom | St Bartholomew's Hospital ( Site 1508) | London | England |
| United Kingdom | North West Cancer Centre ( Site 1511) | Londonderry | London, City Of |
| United Kingdom | The Christie ( Site 1510) | Manchester | England |
| United Kingdom | The Royal Cornwall Hospital ( Site 1507) | Truro | Cornwall |
| United States | McFarland Clinic, PC ( Site 0041) | Ames | Iowa |
| United States | University Cancer & Blood Center, LLC ( Site 0032) | Athens | Georgia |
| United States | Greater Baltimore Medical Center-Medical Oncology/Hematology ( Site 0062) | Baltimore | Maryland |
| United States | MedStar Good Samaritan Hospital-Oncology Research ( Site 0069) | Baltimore | Maryland |
| United States | MFSMC-HJWCI ( Site 0064) | Baltimore | Maryland |
| United States | University of Alabama at Birmingham-Medicine ( Site 0065) | Birmingham | Alabama |
| United States | Waverly Hematology Oncology ( Site 0015) | Cary | North Carolina |
| United States | University of Illinois at Chicago ( Site 0061) | Chicago | Illinois |
| United States | Henry Ford Hospital ( Site 0003) | Detroit | Michigan |
| United States | Edward-Elmhurst Healthcare, Elmhurst Hospital-Nancy W. Knowles Cancer Center ( Site 0067) | Elmhurst | Illinois |
| United States | Sanford Fargo Medical Center ( Site 0040) | Fargo | North Dakota |
| United States | Parkview Research Center at Parkview Regional Medical Center ( Site 0071) | Fort Wayne | Indiana |
| United States | St Francis Cancer Center ( Site 0058) | Greenville | South Carolina |
| United States | Baptist MD Anderson Cancer Center ( Site 0013) | Jacksonville | Florida |
| United States | Broome Oncology ( Site 0018) | Johnson City | New York |
| United States | Kadlec Clinic Hematology and Oncology ( Site 0055) | Kennewick | Washington |
| United States | University of Tennessee Medical Center ( Site 0039) | Knoxville | Tennessee |
| United States | Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0028) | Marietta | Georgia |
| United States | Miami Cancer Institute at Baptist Health, Inc. ( Site 0070) | Miami | Florida |
| United States | Bon Secours St. Francis Medical Center-Oncology Research ( Site 0020) | Midlothian | Virginia |
| United States | Pacific Cancer Care ( Site 0023) | Monterey | California |
| United States | Edward-Elmhurst Healthcare, Edward Hospital-Edward Cancer Center ( Site 0066) | Naperville | Illinois |
| United States | Hematology Oncology Associates of Rockland ( Site 0044) | Nyack | New York |
| United States | Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0009) | Omaha | Nebraska |
| United States | Edward-Elmhurst Healthcare, Edward Hospital - Plainfield-Edward Cancer Center - Plainfield ( Site 00 | Plainfield | Illinois |
| United States | Miami Cancer Institute - Plantation ( Site 0076) | Plantation | Florida |
| United States | Oregon Health and Science University ( Site 0031) | Portland | Oregon |
| United States | Providence Portland Medical Center ( Site 0038) | Portland | Oregon |
| United States | UCSF Medical Center at Mission Bay ( Site 0043) | San Francisco | California |
| United States | New England Cancer Specialists ( Site 0007) | Scarborough | Maine |
| United States | CHRISTUS Highland-Oncology Research ( Site 0073) | Shreveport | Louisiana |
| United States | Louisiana State University Health Sciences Shreveport ( Site 0072) | Shreveport | Louisiana |
| United States | Sanford Cancer Center ( Site 0021) | Sioux Falls | South Dakota |
| United States | Orchard Healthcare Research Inc. ( Site 0037) | Skokie | Illinois |
| United States | Medical Oncology Associates, PS ( Site 0010) | Spokane | Washington |
| United States | Northwest Medical Specialties, PLLC ( Site 0008) | Tacoma | Washington |
| United States | Arizona Oncology Associates-Arizona Oncology ( Site 0049) | Tucson | Arizona |
| United States | Georgetown University Medical Center-Department of Medicine and Oncology ( Site 0026) | Washington | District of Columbia |
| United States | MedStar Washington Hospital Center ( Site 0063) | Washington | District of Columbia |
| United States | University of Massachusetts Medical School-Division of Hematology/Oncology ( Site 0052) | Worcester | Massachusetts |
| United States | North Star Lodge ( Site 0035) | Yakima | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
United States, Argentina, Australia, Austria, Brazil, Canada, Chile, China, Colombia, France, Germany, Greece, Guatemala, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Netherlands, Philippines, Poland, Portugal, Romania, Russian Federation, Spain, Sweden, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) =10 | PFS is defined as the time from randomization to the first documented disease progression (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of =5 mm. The appearance of one or more new lesions is also considered PD. The PFS in participants with a CPS of =10, as assessed by BICR, will be presented. | Up to approximately 33 months | |
| Primary | Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) =1 | PFS is defined as the time from randomization to the first documented disease progression (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of =5 mm. The appearance of one or more new lesions is also considered PD. The PFS in participants with a CPS of =1, as assessed by BICR, will be presented. | Up to approximately 33 months | |
| Primary | Overall Survival (OS) in Participants With Combined Positive Score (CPS) =10 | OS is defined as the time from randomization to death due to any cause. OS for participants with a CPS of =10 will be presented. | Up to approximately 75 months | |
| Primary | OS in Participants With CPS =1 | OS is defined as the time from randomization to death due to any cause. OS for participants with a CPS of =1 will be presented. | Up to approximately 75 months | |
| Secondary | Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Investigator in Participants With Combined Positive Score (CPS) =10 | PFS is defined as the time from randomization to the first documented disease progression (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of =5 mm. The appearance of one or more new lesions is also considered PD. The PFS in participants with a CPS of =10, as assessed by investigator, will be presented. | Up to approximately 75 months | |
| Secondary | Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Investigator in Participants With Combined Positive Score (CPS) =1 | PFS is defined as the time from randomization to the first documented disease progression (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of =5 mm. The appearance of one or more new lesions is also considered PD. The PFS in participants with a CPS of =1, as assessed by investigator, will be presented. | Up to approximately 75 months | |
| Secondary | Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) =10 | ORR is defined as the percentage of participants in the analysis population who achieve confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. ORR for participants with a CPS of =10 will be presented. | Up to approximately 75 months | |
| Secondary | Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) =1 | ORR is defined as the percentage of participants in the analysis population who achieve confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. ORR for participants with a CPS of =1 will be presented. | Up to approximately 75 months | |
| Secondary | Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) =10 | DCR is defined as the percentage of participants who achieve Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions), or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: =20% increase in the sum of diameters of target lesions and an absolute increase of =5 mm. The appearance of one or more new lesions is also considered PD]) for at least 24 weeks. The percentage of participants who experience a confirmed CR, PR, or SD with a CPS of =10 will be presented. | Up to approximately 75 months | |
| Secondary | Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) =1 | DCR is defined as the percentage of participants who achieve Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions), or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: =20% increase in the sum of diameters of target lesions and an absolute increase of =5 mm. The appearance of one or more new lesions is also considered PD]) for at least 24 weeks. The percentage of participants who experience a confirmed CR, PR, or SD with a CPS of =1 will be presented. | Up to approximately 75 months | |
| Secondary | Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) =10 | For participants who demonstrate CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), DOR is defined as the time from the first documented evidence of CR or PR until disease progression (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, or death from any cause, PD is defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of =5 mm. The appearance of one or more new lesions is also considered PD. DOR for participants with a CPS of =10 will be presented. | Up to approximately 75 months | |
| Secondary | Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) =1 | For participants who demonstrate CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), DOR is defined as the time from the first documented evidence of CR or PR until disease progression (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, or death from any cause, PD is defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of =5 mm. The appearance of one or more new lesions is also considered PD. DOR for participants with a CPS of =1 will be presented. | Up to approximately 75 months | |
| Secondary | Change From Baseline in Global Health Status/Quality of Life Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =10 | The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to the questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and Quality of Life (QoL; "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in GHS (EORTC QLQ-C30 Item 29) and QoL (EORTC QLQ-C30 Item 30) combined score will be presented in participants with a CPS of =10. A higher score indicates a better outcome. | Baseline and up to approximately 75 months | |
| Secondary | Change From Baseline in Global Health Status/Quality of Life Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =1 | The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to the questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and Quality of Life (QoL; "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in GHS (EORTC QLQ-C30 Item 29) and QoL (EORTC QLQ-C30 Item 30) combined score will be presented in participants with a CPS of =1. A higher score indicates a better outcome. | Baseline and up to approximately 75 months | |
| Secondary | Change From Baseline in Physical Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =10 | The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning (Items 1-5) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in the physical functioning score will be presented in participants with a CPS of =10. A higher score indicates a better level of function. | Baseline and up to approximately 75 months | |
| Secondary | Change From Baseline in Physical Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =1 | The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning (Items 1-5) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in the physical functioning score will be presented in participants with a CPS of =1. A higher score indicates a better level of function. | Baseline and up to approximately 75 months | |
| Secondary | Change From Baseline in Emotional Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =10 | The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 4 questions about their emotional functioning (Items 21-24) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in the emotional functioning score will be presented in participants with a CPS of =10. A higher score indicates a better level of function. | Baseline and up to approximately 75 months | |
| Secondary | Change From Baseline in Emotional Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =1 | The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 4 questions about their emotional functioning (Items 21-24) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in the emotional functioning score will be presented in participants with a CPS of =1. A higher score indicates a better level of function. | Baseline and up to approximately 75 months | |
| Secondary | Change From Baseline in Fatigue Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =10 | The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 3 questions about their fatigue (Items 10, 12, 18) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in the fatigue score will be presented in participants with a CPS of =10. A lower score indicates a better outcome. | Baseline and up to approximately 75 months | |
| Secondary | Change From Baseline in Fatigue Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =1 | The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 3 questions about their fatigue (Items 10, 12, 18) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in the fatigue score will be presented in participants with a CPS of =1. A lower score indicates a better outcome. | Baseline and up to approximately 75 months | |
| Secondary | Change From Baseline in Diarrhea Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =10 | The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire, including a single-item scale score for diarrhea (QLQ-C30 Item 17). For this item, individual responses to the question "Have you had diarrhea?" are given on a 4-point scale (1=Not at all; 4=Very much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in the diarrhea score will be presented in participants with a CPS of =10. A lower score indicates a better outcome. | Baseline and up to approximately 75 months | |
| Secondary | Change From Baseline in Diarrhea Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =1 | The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire, including a single-item scale score for diarrhea (QLQ-C30 Item 17). For this item, individual responses to the question "Have you had diarrhea?" are given on a 4-point scale (1=Not at all; 4=Very much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in the diarrhea score will be presented in participants with a CPS of =1. A lower score indicates a better outcome. | Baseline and up to approximately 75 months | |
| Secondary | Time to Deterioration (TTD) in Global Health Status/Quality of Life Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =10 | TTD is defined as the time to the first onset of a =10-point deterioration (decrease) from baseline in Global Health Status (GHS; EORTC QLQ-C30 Item 29) & Quality of Life (QoL; EORTC QLQ-C30 Item 30) combined score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a =10-point deterioration (decrease) from baseline in GHS and QoL combined score, will be presented in participants with a CPS of =10. A longer TTD indicates a better outcome. | Up to approximately 75 months | |
| Secondary | Time to Deterioration (TTD) in Global Health Status/Quality of Life Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =1 | TTD is defined as the time to the first onset of a =10-point deterioration (decrease) from baseline in Global Health Status (GHS; EORTC QLQ-C30 Item 29) & Quality of Life (QoL; EORTC QLQ-C30 Item 30) combined score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a =10-point deterioration (decrease) from baseline in GHS and QoL combined score, will be presented in participants with a CPS of =1. A longer TTD indicates a better outcome. | Up to approximately 75 months | |
| Secondary | Time to Deterioration (TTD) in Physical Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =10 | TTD is defined as the time to the first onset of a =10-point deterioration (decrease) from baseline in physical functioning score (EORTC QLQ-C30 Items 1-5). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a =10-point deterioration (decrease) from baseline in physical functioning score, will be presented in participants with a CPS of =10. A longer TTD indicates a better outcome. | Up to approximately 75 months | |
| Secondary | Time to Deterioration (TTD) in Physical Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =1 | TTD is defined as the time to the first onset of a =10-point deterioration (decrease) from baseline in physical functioning score (EORTC QLQ-C30 Items 1-5). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a =10-point deterioration (decrease) from baseline in physical functioning score, will be presented in participants with a CPS of =1. A longer TTD indicates a better outcome. | Up to approximately 75 months | |
| Secondary | Time to Deterioration (TTD) in Emotional Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =10 | TTD is defined as the time to the first onset of a =10-point deterioration (decrease) from baseline in emotional functioning score (EORTC QLQ-C30 Items 21-24). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a =10-point deterioration (decrease) from baseline in emotional functioning score, will be presented in participants with a CPS of =10. A longer TTD indicates a better outcome. | Up to approximately 75 months | |
| Secondary | Time to Deterioration (TTD) in Emotional Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =1 | TTD is defined as the time to the first onset of a =10-point deterioration (decrease) from baseline in emotional functioning score (EORTC QLQ-C30 Items 21-24). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a =10-point deterioration (decrease) from baseline in emotional functioning score, will be presented in participants with a CPS of =1. A longer TTD indicates a better outcome. | Up to approximately 75 months | |
| Secondary | Time to Deterioration (TTD) in Fatigue Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =10 | TTD is defined as the time to the first onset of a =10-point deterioration (decrease) from baseline in fatigue score (EORTC QLQ-C30 Items 10, 12, 18). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a =10-point deterioration (decrease) from baseline in fatigue score, will be presented in participants with a CPS of =10. A longer TTD indicates a better outcome. | Up to approximately 75 months | |
| Secondary | Time to Deterioration (TTD) in Fatigue Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =1 | TTD is defined as the time to the first onset of a =10-point deterioration (decrease) from baseline in fatigue score (EORTC QLQ-C30 Items 10, 12, 18). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a =10-point deterioration (decrease) from baseline in fatigue score, will be presented in participants with a CPS of =1. A longer TTD indicates a better outcome. | Up to approximately 75 months | |
| Secondary | Time to Deterioration (TTD) in Diarrhea Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =10 | TTD is defined as the time to the first onset of a =10-point deterioration (decrease) from baseline in diarrhea score (EORTC QLQ-C30 Item 17). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a =10-point deterioration (decrease) from baseline in diarrhea score, will be presented in participants with a CPS of =10. A longer TTD indicates a better outcome. | Up to approximately 75 months | |
| Secondary | Time to Deterioration (TTD) in Diarrhea Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS =1 | TTD is defined as the time to the first onset of a =10-point deterioration (decrease) from baseline in diarrhea score (EORTC QLQ-C30 Item 17). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a =10-point deterioration (decrease) from baseline in diarrhea score, will be presented in participants with a CPS of =1. A longer TTD indicates a better outcome. | Up to approximately 75 months | |
| Secondary | Percentage of Participants who Experience an Adverse Event (AE) | An AE is 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 can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience one or more adverse events will be presented. | Up to approximately 75 months | |
| Secondary | Percentage of Participants who Discontinue Study Drug due to an AE | An AE is 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 can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study treatment due to an adverse event will be presented. | Up to approximately 75 months |
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Phase 2 | |
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NCT02151071 -
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Phase 1/Phase 2 | |
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TR(ACE) Assay Clinical Specimen Study
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N/A | |
| Active, not recruiting |
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A Study to Determine the Safety of BTP-114 for Treatment in Patients With Advanced Solid Tumors With BRCA Mutations
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Phase 1 | |
| Not yet recruiting |
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N/A | |
| Completed |
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N/A | |
| Recruiting |
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Breast Cancer Chemotherapy Risk Prediction Mathematical Model
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N/A | |
| Completed |
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Phase 1 | |
| Completed |
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N/A | |
| Completed |
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N/A |