A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC) (IMpassion131)

March 1, 2024 updated by: Hoffmann-La Roche

A Phase III, Multicenter, Randomised, Double-Blind, Placebo-Controlled Study of Atezolizumab (Anti-Pd-L1 Antibody) in Combination With Paclitaxel Compared With Placebo With Paclitaxel for Patients With Previously Untreated Inoperable Locally Advanced or Metastatic Triple Negative Breast Cancer

This Phase 3, multicenter, randomized, double-blind, placebo controlled study is designed to evaluate the efficacy and safety of atezolizumab (MPDL3280A, an anti-programmed death-ligand 1 [PD-L1] antibody) administered in combination with paclitaxel compared with placebo in combination with paclitaxel in participants with previously untreated, inoperable locally advanced or metastatic, centrally confirmed TNBC. Participants will be randomized in a 2:1 ratio to receive atezolizumab or placebo plus paclitaxel until disease progression or unacceptable toxicity or end of study, whichever occurs first (maximum up to approximately 40 months). In addition, the Sponsor may decide to terminate the study at any time.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

653

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • La Rioja, Argentina, F5300COE
        • Centro Oncologico Riojano Integral (Cori)
  • Brazil
    • BA
      • Salvador, BA, Brazil, 40050-410
        • Santa Casa de Misericordia de Salvador
    • ES
      • Cachoeiro de Itapemirim, ES, Brazil, 29308-014
        • Centro de Pesquisas Clínicas Em Oncologia - CPCO
    • GO
      • Goiania, GO, Brazil, 74605-070
        • Hospital Araujo Jorge; Departamento de Ginecologia E Mama
    • RS
      • Porto Alegre, RS, Brazil, 90610-000
        • Hospital Sao Lucas - PUCRS
      • Porto Alegre, RS, Brazil, 90040-373
        • Hospital Nossa Senhora da Conceicao
    • SP
      • Sao Paulo, SP, Brazil, 01317-000
        • Hospital Perola Byington
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre-Calgary
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston General Hospital
      • Kitchener, Ontario, Canada, N2G 1G3
        • Grand River Hospital
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Centre
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Odette Cancer Centre
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University; Glen Site; Oncology
      • Quebec City, Quebec, Canada, G1S 4L8
        • Hopital du Saint Sacrement
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont
  • China
      • Beijing, China, 100021
        • Cancer Hospital Chinese Academy of Medical Sciences.
      • Beijing, China, 100730
        • Beijing Union Hospital
      • Chengdu, China, 610041
        • West China Hospital, Sichuan University; Department of Breast
      • Guangzhou, China, 510000
        • Sun Yat-Sen Memorial Hospital
      • Harbin, China, 150081
        • Harbin Medical University Cancer Hospital
      • Jinan, China, 250117
        • Shandong Cancer Hospital
      • Nanjing City, China, 211100
        • Jiangsu Cancer Hospital
      • Nanjing City, China, 210029
        • Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
      • Shanghai, China, 200025
        • Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)
      • Shanghai City, China, 200120
        • Fudan University Shanghai Cancer Center
      • Shenyang, China, 110042
        • Liaoning Cancer Hospital & Institute
      • Shijiazhuang, China, 050035
        • Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
      • Tianjin, China, 3000060
        • Tianjin Medical University Cancer Institute & Hospital
      • Xi'an, China, 710061
        • First Affiliated Hospital of Medical College of Xi'an Jiaotong University
      • Xi'an City, China, 710004
        • The Second Affiliated Hospital of Xi'an Jiao Tong University
      • Zhejiang, China, 310022
        • Zhejiang Cancer Hospital
      • Zhengzhou, China, 450008
        • Henan Cancer Hospital
  • Croatia
      • Zagreb, Croatia, 10000
        • Clinical Hospital Centre Zagreb
  • Czechia
      • Hradec Kralove, Czechia, 500 05
        • Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology
      • Olomouc, Czechia, 779 00
        • Fakultni nemocnice Olomouc; Onkologicka klinika
      • Ostrava-Poruba, Czechia, 70852
        • Fakultni nemocnice Ostrava; Klinika onkologicka FNO a LF OU
      • Praha 2, Czechia, 128 08
        • Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
  • France
      • Avignon, France, 84918
        • Clinique Sainte Catherine; Hopital De Semaine
      • Besancon, France, 25030
        • HOPITAL JEAN MINJOZ; Oncologie
      • Bordeaux, France, 33300
        • Polyclinique Bordeaux Nord Aquitaine
      • Brest, France, 29200
        • Hopital Morvan
      • La Roche Sur Yon, France, 85925
        • CHD Les Oudairies
      • Lille, France, 59020
        • Centre Oscar Lambret; Senologie
      • Lyon, France, 69373
        • Centre Leon Berard; Departement Oncologie Medicale
      • Nancy, France, 54100
        • Centre D'Oncologie de Gentilly; Oncology
      • Nimes, France, 30029
        • Hopital Caremeau; Hematologie Oncologie
      • Paris, France, 75231
        • Institut Curie; Oncologie Medicale
      • Paris, France, 75020
        • Hôpital Tenon
      • Paris, France, 75475
        • Hopital Saint Louis, Service D Oncologie Medicale
      • Paris, France, 75651
        • Ch Pitie Salpetriere; Oncologie Medicale
      • Rennes, France, 35042
        • Centre Eugene Marquis; Service d'oncologie
      • Strasbourg, France, 67065
        • Centre Paul Strauss; Oncologie Medicale
      • Toulouse, France, 31059
        • Institut Claudius Regaud; Departement Oncologie Medicale
      • VILLEJUIF Cedex, France, 94805
        • Institut Gustave Roussy; Sitep
  • Germany
      • Berlin, Germany, 13581
        • Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters
      • Bielefeld, Germany, 33604
        • Onkologische Schwerpunktpraxis Bielefeld
      • Essen, Germany, 45136
        • Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
      • Hamburg, Germany, 22767
        • HOPA im Struensee-Haus, Dres. Erik Engel, Wiebke Hollburg
      • Heidelberg, Germany, 69120
        • Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
      • Koeln, Germany, 50935
        • St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe
      • Mainz, Germany, 55131
        • Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde
      • Marburg, Germany, 35037
        • OnkoNet Marburg GmbH
      • München, Germany, 80336
        • Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt
      • Münster, Germany, 48153
        • Gemeinschaftspraxis für Hämatologie und Onkologie
      • Potsdam, Germany, 14467
        • Klinikum Ernst von Bergmann; Frauenklinik
      • Troisdorf, Germany, 53840
        • Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis
      • Tübingen, Germany, 72076
        • Universitätsklinik Tübingen; Frauenklinik
  • Greece
      • Athens, Greece, 115 28
        • ARETAIEION UNIVERSITY HOSPITAL; oncology unit
      • Athens, Greece, 115 22
        • Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine
      • Kifisia, Greece, 145 64
        • Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.
      • Thessaloniki, Greece, 564 29
        • Papageorgiou General Hospital; Medical Oncology
  • India
      • Delhi, India, 1100092
        • MAX Balaji Hospital
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500082
        • Yashoda Hospital
    • Delhi
      • New Delhi, Delhi, India, 110076
        • Indraprastha Apollo Hospitals
      • New Delhi, Delhi, India, 110085
        • Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology
      • New Delhi, Delhi, India, 110005
        • Dr. B L Kapur Memorial Hospital; BLK Cancer Centre
      • North WEST Delhi, Delhi, India, 110088
        • Max Super Speciality Hospital; Medical Oncology
    • Karnataka
      • Bangalore, Karnataka, India, 560017
        • Manipal Hospital; Department of Oncology
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Tata Memorial Hospital; Dept of Medical Oncology
      • Pune, Maharashtra, India, 411001
        • Jehangir Hospital
    • Tamil NADU
      • Chennai, Tamil NADU, India, 600035
        • Apollo Speciality Hospital
    • WEST Bengal
      • Kolkata, WEST Bengal, India, 700156
        • TATA Medical Centre; Medical Oncology
      • Kolkata, WEST Bengal, India, 700054
        • Apollo Gleneagles Hospitals
  • Israel
      • Jerusalem, Israel, 9112000
        • Hadassah Ein Karem Hospital; Oncology Dept
      • Petach Tikva, Israel, 4941492
        • Rabin MC; Davidof Center - Oncology Institute
      • Ramat Gan, Israel, 5262100
        • Sheba Medical Center
      • Rambam, Israel, 3525408
        • Rambam Health Corporation; Oncology Institute
      • Rehovot, Israel, 7610001
        • Kaplan Medical Center
      • Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Ctr; Oncology
      • Zerifin, Israel, 6093000
        • Assaf Harofeh; Oncology
  • Italy
    • Abruzzo
      • Chieti, Abruzzo, Italy, 66103
        • Fondazione Università G. D'Annunzio; Clinical Research Center (CRC); Centro Studi (CESI)
    • Campania
      • Frattamaggiore, Campania, Italy, 80027
        • Presidio Ospedaliero S. Giovanni Di Dio; U.O. Di Oncologia
      • Napoli, Campania, Italy, 80131
        • Istituto Nazionale Tumori Fondazione G. Pascale
      • Napoli, Campania, Italy, 80131
        • Azienda Ospedaliera Universitaria Federico Ii
    • Emilia-Romagna
      • Modena, Emilia-Romagna, Italy, 41110
        • Azienda Ospedaliero - Universitaria di Modena Policlinico
    • Lazio
      • Roma, Lazio, Italy, 00161
        • Azienda Policlinico Umberto I
      • Roma, Lazio, Italy, 00128
        • Università Campus Bio-Medico di Roma (UCBM)
      • Roma, Lazio, Italy, 00144
        • IRCCS Istituto Regina Elena (IFO); Oncologia Medica B
    • Liguria
      • Genova, Liguria, Italy, 16132
        • A.O. Universitaria S. Martino Di Genova
    • Lombardia
      • Bergamo, Lombardia, Italy, 24127
        • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
      • Brescia, Lombardia, Italy, 25123
        • ASST degli Spedali Civili di Brescia
      • Milano, Lombardia, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Milano, Lombardia, Italy, 20132
        • Hospital San Raffaele
      • Milano, Lombardia, Italy, 20141
        • IEO Istituto Europeo di Oncologia;Divisione Oncologia Medica
      • Rozzano (MI), Lombardia, Italy, 20089
        • IRCCS Istituto Clinico Humanitas; Oncologia
    • Piemonte
      • Candiolo, Piemonte, Italy, 10060
        • Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo
    • Sicilia
      • Taormina, Sicilia, Italy, 98030
        • Ospedale S. Vincenzo; Oncologia Medica
    • Toscana
      • Firenze, Toscana, Italy, 50134
        • Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia
      • Livorno, Toscana, Italy, 57100
        • Ospedale Civile; Unita Operativa Di Oncologia Medica
    • Veneto
      • Padova, Veneto, Italy, 35128
        • IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
  • Japan
      • Gunma, Japan, 373-8550
        • Gunma Prefectural Cancer Center
      • Hiroshima, Japan, 730-8518
        • Hiroshima City Hiroshima Citizens Hospital
      • Kagoshima, Japan, 892-0833
        • Sagara Hospital
      • Kanagawa, Japan, 241-8515
        • Kanagawa Cancer Center
      • Kanagawa, Japan, 259-1193
        • Tokai University Hospital
      • Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital
      • Okinawa, Japan, 901-0154
        • Naha-nishi Clinic
      • Osaka, Japan, 541-8567
        • Osaka International Cancer Institute
      • Saitama, Japan, 362-0806
        • Saitama Cancer Center
      • Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital Of JFCR
  • Morocco
      • Marrakech, Morocco, 40000
        • Centre Hospitalier Universitaire Mohamed VI; Oncologie-Hématologie
      • Rabat, Morocco, 10000
        • Institut National D'oncologie Sidi Mohammed Ben Abdellah; Anatomopathologie
  • Romania
      • Cluj Napoca, Romania, 400015
        • Prof. Dr. I. Chiricuta Institute of Oncology
      • Craiova, Romania, 200347
        • Centrul de Oncologie Sfantul Nectarie
  • Russian Federation
      • Sankt Petersburg, Russian Federation, 197758
        • Petrov Research Inst. of Oncology
    • Moskovskaja Oblast
      • Moscow, Moskovskaja Oblast, Russian Federation, 115478
        • Russian Oncology Research Center n.a. N.N. Blokhin
  • Saudi Arabia
      • Dammam, Saudi Arabia, 31444
        • King Fahad Specialist Hospital; Oncology
      • Jeddah, Saudi Arabia, 21451
        • International Medical Center (IMC)
      • Riyadh, Saudi Arabia, 11525
        • King Fahad Medical City; Gastroentrology
  • Slovakia
      • Bratislava, Slovakia, 833 10
        • Narodny Onkologicky Ustav; Oddelenie klinickej onkologie A
      • Poprad, Slovakia, 058 01
        • POKO Poprad; Department of Oncology
  • South Africa
      • Pretoria, South Africa, 0001
        • Wilgers Oncology Centre
      • Pretoria, South Africa, 0081
        • Private Oncology Centre
      • Sandton, South Africa, 2196
        • Sandton Oncology Medical Group
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clínic i Provincial; Servicio de Hematología y Oncología
      • Madrid, Spain, 28943
        • Hospital Universitario de Fuenlabrada; Servicio de Oncologia
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen Macarena; Servicio de Oncologia
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio; Servicio de Oncologia
    • LA Coruña
      • A Coruña, LA Coruña, Spain, 15006
        • Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
  • Turkey
      • Adana, Turkey, 01220
        • Adana Baskent University Medical Faculty; Oncology
      • Ankara, Turkey, 06490
        • Ankara Bilkent City Hospital
      • Bursa, Turkey, 16059
        • Uludag University Medical Faculty; Internal Medicine
      • Diyarbakir, Turkey, 10000
        • Dicle Uni Medical Faculty; Internal Medicine
      • Edirne, Turkey, 22030
        • Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
      • Izmir, Turkey, 35965
        • Izmir Ataturk Training and Research Hospital
      • Izmit, Turkey, 31380
        • Kocaeli University Faculty of Medicine; Medical oncology
      • Kadiköy, Turkey, 34722
        • Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology
  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • Guys and St Thomas NHS Foundation Trust, Guys Hospital
      • Manchester, United Kingdom, M20 3BG
        • Christie Hospital
      • Northwood, United Kingdom, HA6 2RN
        • Mount Vernon Cancer Centre
  • United States
    • California
      • Stanford, California, United States, 94305-5820
        • Stanford Cancer Center
    • Florida
      • Fort Myers, Florida, United States, 33901-8101
        • Florida Cancer Specialists; Department of Oncology
      • Saint Petersburg, Florida, United States, 33705
        • Florida Cancer Specialist, North Region
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Northwest Georgia Oncology Centers PC - Marietta
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • HCA Midwest Health
    • New Jersey
      • Paramus, New Jersey, United States, 07652
        • The Valley Hospital
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee-Woman's Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology; Sarah Cannon Research Institute
  • Vietnam
      • Hanoi, Vietnam, 100000
        • K hospital
      • Hochiminh city, Vietnam, 700000
        • Hochiminh city oncology hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants with locally advanced or metastatic, histologically documented TNBC (absence of human epidermal growth factor receptor 2 [HER2], estrogen receptor [ER], and progesterone receptor [PR] expression), not amenable to surgical therapy
  • Participants eligible for taxane monotherapy
  • No prior chemotherapy or targeted systemic therapy (including endocrine therapy) for inoperable locally advanced or metastatic TNBC
  • Availability of formalin-fixed paraffin-embedded (FFPE) tumor block (preferred) or at least 17 unstained slides, collected ≤3 months prior to randomization, with an associated pathology report, if available. If a tumour sample taken within 3 months before randomisation is not available and a tumour biopsy is not clinically feasible, the primary surgical resection sample or the most recent FFPE tumour biopsy sample may be used. Of these additional options, the most recent sample should be used.
  • Eastern Cooperative Oncology Group performance status of 0 or 1
  • Life expectancy at least 12 weeks
  • Measurable disease, as defined by RECIST v1.1
  • Adequate hematologic and end-organ function
  • Negative human immunodeficiency virus (HIV) test at screening.
  • Negative hepatitis B surface antigen (HBsAg) test at screening
  • Negative total hepatitis B core antibody (HBcAb) test at screening, or positive HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening. The HBV DNA test will be performed only for patients who have a positive HBcAb test.
  • Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening. The HCV RNA test will be performed only for patients who have a positive HCV antibody test.
  • Women of child bearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of study drug
  • For men and women of child bearing potential: agreement to remain abstinent or use protocol defined contraceptive measures during the treatment period and for at least 5 months after the last dose of atezolizumab/placebo, or for at least 6 months after the last dose of paclitaxel

Exclusion Criteria:

  • Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for at least 2 weeks prior to randomization
  • Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases
  • Leptomeningeal disease
  • Uncontrolled pleural effusion, pericardial effusion, or ascites
  • Uncontrolled tumor-related pain, or uncontrolled hypercalcemia or clinically significant (symptomatic) hypercalcemia
  • Malignancies other than TNBC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer)
  • Pregnant or breast-feeding women, or intending to become pregnant during the study
  • Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant liver disease, cardiovascular disease, and presence of an abnormal electrocardiogram (ECG)
  • Serious infection requiring antibiotics within 2 weeks prior to randomization, including but not limited to infections requiring hospitalization or IV antibiotics, such as bacteremia, or severe pneumonia
  • Major surgical procedure within 4 weeks prior to randomization or anticipation of the need for a major surgical procedure during the study other than for diagnosis
  • Treatment with investigational therapy within 30 days prior to initiation of study treatment
  • History of hypersensitivity reactions to study drug or any component of the study drug formulation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo and Paclitaxel
Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
Drug: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody
Atezolizumab will be administered at a dose of 840 mg via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle.
Other Names:
  • MPDL3280A, TECENTRIQ
Drug: Paclitaxel
Paclitaxel will be administered at a dose of 90 mg/m^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle.
Experimental: Atezolizumab and Paclitaxel
Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
Drug: Paclitaxel
Paclitaxel will be administered at a dose of 90 mg/m^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle.
Drug: Atezolizumab Placebo
Placebo matching to atezolizumab will be administered via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Subpopulation With Programmed Death-Ligand 1 (PD-L1)-Positive Tumour Status
Time Frame: From Day 1 to disease progression (PD) or death from any cause, assessed up to primary completion date (approximately 26 months)
PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (>/=) 20 percent (%) relative increase and >/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
From Day 1 to disease progression (PD) or death from any cause, assessed up to primary completion date (approximately 26 months)
Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Intent-to-Treat (ITT) Population
Time Frame: From Day 1 to disease progression (PD) or death from any cause, assessed up to primary completion date (approximately 26 months)
PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (>/=) 20 percent (%) relative increase and >/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
From Day 1 to disease progression (PD) or death from any cause, assessed up to primary completion date (approximately 26 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Are Alive Without Progression Event at Month 12 Assessed Using RECIST v1.1
Time Frame: From Day 1 to PD or death from any cause, assessed up to 12 months
PD is defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
From Day 1 to PD or death from any cause, assessed up to 12 months
Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the PD-L1-Positive Population (Confirmed, Investigator-Assessed )
Time Frame: From Day 1 to PD, assessed up to primary completion date (approximately 26 months)
Objective response is defined as complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1 criteria. CR is defined as the disappearance of all TLs and SA reduction to less than (<) 10mm for nodal TLs/ non-TLs. PR is defined as >/=30% decrease in SD of TLs, taking as reference the baseline SD. Responses were confirmed after 8 weeks if within first 12 months or after 12 weeks if later.
From Day 1 to PD, assessed up to primary completion date (approximately 26 months)
Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the PD-L1-Positive Population (Unconfirmed, Investigator-Assessed)
Time Frame: From Day 1 to PD, assessed up to primary completion date (approximately 26 months)
Objective response is defined as complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1 criteria. CR is defined as the disappearance of all TLs and SA reduction to less than (<) 10mm for nodal TLs/ non-TLs. PR is defined as >/=30% decrease in SD of TLs, taking as reference the baseline SD.
From Day 1 to PD, assessed up to primary completion date (approximately 26 months)
Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the Response-Evaluable Population (Confirmed, Investigator-Assessed )
Time Frame: From Day 1 to PD, assessed up to primary completion date (approximately 26 months)
Objective response is defined as complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1 criteria. CR is defined as the disappearance of all TLs and SA reduction to less than (<) 10mm for nodal TLs/ non-TLs. PR is defined as >/=30% decrease in SD of TLs, taking as reference the baseline SD. Responses were confirmed after 8 weeks if within first 12 months or after 12 weeks if later.
From Day 1 to PD, assessed up to primary completion date (approximately 26 months)
Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the Response-Evaluable Population (Unconfirmed, Investigator-Assessed )
Time Frame: From Day 1 to PD, assessed up to primary completion date (approximately 26 months)
Objective response is defined as complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1 criteria. CR is defined as the disappearance of all TLs and SA reduction to less than (<) 10mm for nodal TLs/ non-TLs. PR is defined as >/=30% decrease in SD of TLs, taking as reference the baseline SD.
From Day 1 to PD, assessed up to primary completion date (approximately 26 months)
Duration of Objective Response (DOR) Assessed Using RECIST v1.1 in DOR-evaluable Population (Unconfirmed)
Time Frame: From objective response to PD, assessed up to primary completion date (approximately 26 months)
DOR is defined as the time period from the date of initial CR or PR until the date of PD or death from any cause, whichever occurs first. CR is defined as the disappearance of all TLs and SA reduction to <10mm for nodal TLs/ non-TLs. PR is defined as >/=30% decrease in SD of TLs, taking as reference the baseline SD. PD is defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
From objective response to PD, assessed up to primary completion date (approximately 26 months)
Percentage of Participants With Clinical Benefit Assessed Using RECIST v1.1 in Response-evaluable Population
Time Frame: From Day 1 to PD, assessed up to primary completion date (approximately 26 months)
Clinical benefit is defined as the achievement of CR, PR, or stable disease according to RECIST v1.1 that lasts for at least 6 months. CR is defined as the disappearance of all TLs and SA reduction to <10mm for nodal TLs/ non-TLs. PR is defined as >/=30% decrease in SD of TLs, taking as reference the baseline SD. PD is defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference smallest SD since treatment started.
From Day 1 to PD, assessed up to primary completion date (approximately 26 months)
Minimum Observed Serum Concentration (Cmin) of Atezolizumab in PK Evaluable Population
Time Frame: Pre-dose (0 hours) on Day 1 of Cycles 2-4 and at treatment discontinuation (TD), (approximately 9 months).
Pre-dose (0 hours) on Day 1 of Cycles 2-4 and at treatment discontinuation (TD), (approximately 9 months).
Maximum Observed Serum Concentration (Cmax) of Atezolizumab in PK-evaluable Population
Time Frame: C1D1 30 min postdose
C1D1 30 min postdose
Minimum Observed Plasma Concentration (Cmin) of Paclitaxel
Time Frame: Pre-dose (0 hours) on Day 1 of Cycle 3 (1 Cycle = 28 days)
Pre-dose (0 hours) on Day 1 of Cycle 3 (1 Cycle = 28 days)
Maximum Observed Plasma Concentration (Cmax) of Paclitaxel
Time Frame: Pre-dose (0 hours), 5-10 min before and after paclitaxel infusion, 60 min after paclitaxel infusion on Day 1 of Cycles 1 and 3 (paclitaxel infusion duration= 60 min) (1 Cycle = 28 days)
Pre-dose (0 hours), 5-10 min before and after paclitaxel infusion, 60 min after paclitaxel infusion on Day 1 of Cycles 1 and 3 (paclitaxel infusion duration= 60 min) (1 Cycle = 28 days)
Percentage of Participants With Anti-Drug Antibodies' (ADAs) Against Atezolizumab in ADA Evaluable Population
Time Frame: Pre-dose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8, 12, 16, and at every 8 cycles thereafter until TD, at TD, and at 90-150 days after TD (maximum up to 45 months) (1 Cycle = 28 days)
Pre-dose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8, 12, 16, and at every 8 cycles thereafter until TD, at TD, and at 90-150 days after TD (maximum up to 45 months) (1 Cycle = 28 days)
Progression Free Survival by PD-L1 Status, Intent to Treat Population
Time Frame: From Day 1 up to primary completion date (approximately 26 months)
From Day 1 up to primary completion date (approximately 26 months)
Duration of Confirmed Response (C-DoR) in (C-DoR)-Evaluable Population
Time Frame: From objective response to PD, assessed up to primary completion date (approximately 26 months)
C-DoR is defined as the time from the first occurrence of a documented confirmed response (CR or PR) in C-DOR evaluable population until the date of disease progression per RECIST v1.1 or death from any cause, whichever occurs first. Responses were confirmed after 8 weeks if within first 12 months or after 12 weeks if later.
From objective response to PD, assessed up to primary completion date (approximately 26 months)
Overall Survival (OS) in the PD-L1-Positive Subpopulation
Time Frame: From Day 1 to death from any cause, assessed up 36 months
OS is defined as the time from randomization to death from any cause. Results from a pre-specified interim analysis.
From Day 1 to death from any cause, assessed up 36 months
Overall Survival (OS) in the ITT Population
Time Frame: From Day 1 to death from any cause, assessed up to end of study (up to approximately 36 months)
OS is defined as the time from randomization to death from any cause. Results from a pre-specified interim analysis.
From Day 1 to death from any cause, assessed up to end of study (up to approximately 36 months)
Percentage of Participants Who Are Alive at 12 and 18 Months
Time Frame: From Day 1 to death from any cause, assessed up to 12 and 18 months
From Day 1 to death from any cause, assessed up to 12 and 18 months
Time to Deterioration (TTD) in Global Health Status/ Health Related Quality of Life (HRQoL) in the PRO Evaluable Population
Time Frame: From Day 1 to deterioration, assessed up 64 months
Deterioration in Global Health Status/HRQoL is defined as a decrease of at least 10 points on the Global Health Status /HRQoL scale (comprised of 2 items: 29 and 30) of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The 2 items use 7-point scale (1 = very poor to 7 = Excellent). Scores are averaged, transformed to 0-100 scale; where higher score=better level of functioning or greater degree of symptoms.
From Day 1 to deterioration, assessed up 64 months
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Time Frame: From Day 1 From baseline up to 64 months
Investigator text for AEs is coded using MedDRA version 25.1
From Day 1 From baseline up to 64 months
Overall Survival by PD-L1 Status, Intent to Treat Population
Time Frame: From Day 1 up to 66 months
From Day 1 up to 66 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2017

Primary Completion (Actual)

November 15, 2019

Study Completion (Actual)

January 17, 2023

Study Registration Dates

First Submitted

April 20, 2017

First Submitted That Met QC Criteria

April 20, 2017

First Posted (Actual)

April 24, 2017

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MO39196
  • 2016-004024-29 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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