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

Triple-Negative Breast Cancer Clinical Trial

— IMpassion131  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03125902
• Other study ID #: MO39196
• Secondary ID: 2016-004024-29
• Status: Completed
• Phase: Phase 3
• Start date: August 25, 2017
• Est. completion date: January 17, 2023

Study information

• Verified date: March 2024
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 653
• Est. completion date: January 17, 2023
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Neoplasms
• Triple-Negative Breast Cancer

Intervention

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.
• Atezolizumab Placebo
Placebo matching to atezolizumab will be administered via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle.
• 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.

Locations

Country	Name	City	State
Argentina	Centro Oncologico Riojano Integral (CORI)	La Rioja
Brazil	Centro de Pesquisas Clinicas em Oncologia - CPCO	Cachoeiro de Itapemirim	ES
Brazil	Hospital Araujo Jorge; Departamento de Ginecologia E Mama	Goiania	GO
Brazil	Hospital Nossa Senhora da Conceicao	Porto Alegre	RS
Brazil	Hospital Sao Lucas - PUCRS	Porto Alegre	RS
Brazil	Santa Casa de Misericordia de Salvador	Salvador	BA
Brazil	Hospital Perola Byington	Sao Paulo	SP
Canada	Tom Baker Cancer Centre-Calgary	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Kingston General Hospital	Kingston	Ontario
Canada	Grand River Hospital	Kitchener	Ontario
Canada	London Regional Cancer Centre	London	Ontario
Canada	McGill University; Glen Site; Oncology	Montreal	Quebec
Canada	Hopital du Saint Sacrement	Quebec City	Quebec
Canada	Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont	Sherbrooke	Quebec
Canada	Sunnybrook Odette Cancer Centre	Toronto	Ontario
China	Beijing Union Hospital	Beijing
China	Cancer Hospital Chinese Academy of Medical Sciences.	Beijing
China	West China Hospital, Sichuan University; Department of Breast	Chengdu
China	Sun Yat-sen Memorial Hospital	Guangzhou
China	Harbin Medical University Cancer Hospital	Harbin
China	Shandong Cancer Hospital	Jinan
China	Jiangsu Cancer Hospital	Nanjing City
China	Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)	Nanjing City
China	Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)	Shanghai
China	Fudan University Shanghai Cancer Center	Shanghai City
China	Liaoning cancer Hospital & Institute	Shenyang
China	Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)	Shijiazhuang
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin
China	First Affiliated Hospital of Medical College of Xi'an Jiaotong University	Xi'an
China	The Second Affiliated Hospital of Xi'an Jiao Tong University	Xi'an City
China	Zhejiang Cancer Hospital	Zhejiang
China	Henan Cancer Hospital	Zhengzhou
Croatia	Clinical Hospital Centre Zagreb	Zagreb
Czechia	Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology	Hradec Kralove
Czechia	Fakultni nemocnice Olomouc; Onkologicka klinika	Olomouc
Czechia	Fakultni nemocnice Ostrava; Klinika onkologicka FNO a LF OU	Ostrava-Poruba
Czechia	Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika	Praha 2
France	Clinique Sainte Catherine; Hopital De Semaine	Avignon
France	HOPITAL JEAN MINJOZ; Oncologie	Besancon
France	Polyclinique Bordeaux Nord Aquitaine	Bordeaux
France	Hopital Morvan	Brest
France	CHD Les Oudairies	La Roche Sur Yon
France	Centre Oscar Lambret; Senologie	Lille
France	Centre Leon Berard; Departement Oncologie Medicale	Lyon
France	Centre D'Oncologie de Gentilly; Oncology	Nancy
France	Hopital Caremeau; Hematologie Oncologie	Nimes
France	Ch Pitie Salpetriere; Oncologie Medicale	Paris
France	Hopital Saint Louis, Service D Oncologie Medicale	Paris
France	Hopital Tenon	Paris
France	Institut Curie; Oncologie Medicale	Paris
France	Centre Eugene Marquis; Service d'oncologie	Rennes
France	Centre Paul Strauss; Oncologie Medicale	Strasbourg
France	Institut Claudius Regaud; Departement Oncologie Medicale	Toulouse
France	Institut Gustave Roussy; Sitep	VILLEJUIF Cedex
Germany	Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters	Berlin
Germany	Onkologische Schwerpunktpraxis Bielefeld	Bielefeld
Germany	Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum	Essen
Germany	HOPA im Struensee-Haus, Dres. Erik Engel, Wiebke Hollburg	Hamburg
Germany	Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg	Heidelberg
Germany	St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe	Koeln
Germany	Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde	Mainz
Germany	OnkoNet Marburg GmbH	Marburg
Germany	Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt	München
Germany	Gemeinschaftspraxis für Hämatologie und Onkologie	Münster
Germany	Klinikum Ernst von Bergmann; Frauenklinik	Potsdam
Germany	Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis	Troisdorf
Germany	Universitätsklinik Tübingen; Frauenklinik	Tübingen
Greece	Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine	Athens
Greece	ARETAIEION UNIVERSITY HOSPITAL; oncology unit	Athens
Greece	Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.	Kifisia
Greece	Papageorgiou General Hospital; Medical Oncology	Thessaloniki
India	Manipal Hospital; Department of Oncology	Bangalore	Karnataka
India	Apollo Speciality Hospital	Chennai	Tamil NADU
India	MAX Balaji Hospital	Delhi
India	Yashoda Hospital	Hyderabad	Andhra Pradesh
India	Apollo Gleneagles Hospitals	Kolkata	WEST Bengal
India	TATA Medical Centre; Medical Oncology	Kolkata	WEST Bengal
India	Tata Memorial Hospital; Dept of Medical Oncology	Mumbai	Maharashtra
India	Dr. B L Kapur Memorial Hospital; BLK Cancer Centre	New Delhi	Delhi
India	Indraprastha Apollo Hospitals	New Delhi	Delhi
India	Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology	New Delhi	Delhi
India	Max Super Speciality Hospital; Medical Oncology	North WEST Delhi	Delhi
India	Jehangir Hospital	Pune	Maharashtra
Israel	Hadassah Ein Karem Hospital; Oncology Dept	Jerusalem
Israel	Rabin MC; Davidof Center - Oncology Institute	Petach Tikva
Israel	Sheba Medical Center	Ramat Gan
Israel	Rambam Health Corporation; Oncology Institute	Rambam
Israel	Kaplan Medical Center	Rehovot
Israel	Tel Aviv Sourasky Medical Ctr; Oncology	Tel Aviv
Israel	Assaf Harofeh; Oncology	Zerifin
Italy	Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)	Bergamo	Lombardia
Italy	Asst Degli Spedali Civili Di Brescia	Brescia	Lombardia
Italy	Fondazione Del Piemonte Per L'oncologia IRCC Di Candiolo	Candiolo	Piemonte
Italy	Fondazione Università G. D'Annunzio; Clinical Research Center (CRC); Centro Studi (CESI)	Chieti	Abruzzo
Italy	Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia	Firenze	Toscana
Italy	Presidio Ospedaliero S. Giovanni Di Dio; U.O. Di Oncologia	Frattamaggiore	Campania
Italy	A.O. Universitaria S. Martino Di Genova	Genova	Liguria
Italy	Ospedale Civile; Unita Operativa Di Oncologia Medica	Livorno	Toscana
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori	Milano	Lombardia
Italy	Hospital San Raffaele	Milano	Lombardia
Italy	IEO Istituto Europeo di Oncologia;Divisione Oncologia Medica	Milano	Lombardia
Italy	Azienda Ospedaliero - Universitaria di Modena Policlinico	Modena	Emilia-Romagna
Italy	Azienda Ospedaliera Universitaria Federico II	Napoli	Campania
Italy	Istituto Nazionale Tumori Fondazione G. Pascale	Napoli	Campania
Italy	IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II	Padova	Veneto
Italy	Azienda Policlinico Umberto I	Roma	Lazio
Italy	IRCCS Istituto Regina Elena (IFO); Oncologia Medica B	Roma	Lazio
Italy	Universita Campus Bio-Medico di Roma (UCBM)	Roma	Lazio
Italy	IRCCS Istituto Clinico Humanitas; Oncologia	Rozzano (MI)	Lombardia
Italy	Ospedale S. Vincenzo; Oncologia Medica	Taormina	Sicilia
Japan	Gunma Prefectural Cancer Center	Gunma
Japan	Hiroshima City Hiroshima Citizens Hospital	Hiroshima
Japan	Sagara Hospital	Kagoshima
Japan	Kanagawa Cancer Center	Kanagawa
Japan	Tokai University Hospital	Kanagawa
Japan	Niigata Cancer Center Hospital	Niigata
Japan	Naha-nishi Clinic	Okinawa
Japan	Osaka International Cancer Institute	Osaka
Japan	Saitama Cancer Center	Saitama
Japan	The Cancer Institute Hospital of JFCR	Tokyo
Morocco	Centre Hospitalier Universitaire Mohamed VI; Oncologie-Hématologie	Marrakech
Morocco	Institut National D'oncologie Sidi Mohammed Ben Abdellah; Anatomopathologie	Rabat
Romania	Prof. Dr. I. Chiricuta Institute of Oncology	Cluj Napoca
Romania	Centrul de Oncologie Sfantul Nectarie	Craiova
Russian Federation	Russian Oncology Research Center n.a. N.N. Blokhin	Moscow	Moskovskaja Oblast
Russian Federation	Petrov Research Inst. of Oncology	Sankt Petersburg
Saudi Arabia	King Fahad Specialist Hospital; Oncology	Dammam
Saudi Arabia	International Medical Center (IMC)	Jeddah
Saudi Arabia	King Fahad Medical City; Gastroentrology	Riyadh
Slovakia	Narodny Onkologicky Ustav; Oddelenie klinickej onkologie A	Bratislava
Slovakia	POKO Poprad; Department of Oncology	Poprad
South Africa	Private Oncology Centre	Pretoria
South Africa	Wilgers Oncology Centre	Pretoria
South Africa	Sandton Oncology Medical Group	Sandton
Spain	Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia	A Coruña	LA Coruña
Spain	Hospital Clínic i Provincial; Servicio de Hematología y Oncología	Barcelona
Spain	Hospital Universitario de Fuenlabrada; Servicio de Oncologia	Madrid
Spain	Hospital Universitario Virgen del Rocio; Servicio de Oncologia	Sevilla
Spain	Hospital Universitario Virgen Macarena; Servicio de Oncologia	Sevilla
Turkey	Adana Baskent University Medical Faculty; Oncology	Adana
Turkey	Ankara Bilkent City Hospital	Ankara
Turkey	Uludag University Medical Faculty; Internal Medicine	Bursa
Turkey	Dicle Uni Medical Faculty; Internal Medicine	Diyarbakir
Turkey	Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi	Edirne
Turkey	Izmir Ataturk Training and Research Hospital	Izmir
Turkey	Kocaeli University Faculty of Medicine; Medical oncology	Izmit
Turkey	Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology	Kadiköy
United Kingdom	Guys and St Thomas NHS Foundation Trust, Guys Hospital	London
United Kingdom	Christie Hospital	Manchester
United Kingdom	Mount Vernon Cancer Centre	Northwood
United States	Florida Cancer Specialists; Department of Oncology	Fort Myers	Florida
United States	HCA Midwest Health	Kansas City	Missouri
United States	Northwest Georgia Oncology Centers PC - Marietta	Marietta	Georgia
United States	Tennessee Oncology; Sarah Cannon Research Institute	Nashville	Tennessee
United States	The Valley Hospital	Paramus	New Jersey
United States	Magee-Woman's Hospital	Pittsburgh	Pennsylvania
United States	Florida Cancer Specialist, North Region	Saint Petersburg	Florida
United States	Stanford Cancer Center	Stanford	California
Vietnam	K hospital	Hanoi
Vietnam	Hochiminh city oncology hospital	Hochiminh city

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Vietnam,  Argentina,  Brazil,  Canada,  China,  Croatia,  Czechia,  France,  Germany,  Greece,  India,  Israel,  Italy,  Japan,  Morocco,  Romania,  Russian Federation,  Saudi Arabia,  Slovakia,  South Africa,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Primary	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	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	Overall Survival (OS) in the PD-L1-Positive Subpopulation	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
Secondary	Overall Survival (OS) in the ITT Population	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)
Secondary	Percentage of Participants Who Are Alive at 12 and 18 Months		From Day 1 to death from any cause, assessed up to 12 and 18 months
Secondary	Time to Deterioration (TTD) in Global Health Status/ Health Related Quality of Life (HRQoL) in the PRO Evaluable Population	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
Secondary	Percentage of Participants Who Are Alive Without Progression Event at Month 12 Assessed Using RECIST v1.1	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
Secondary	Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the PD-L1-Positive Population (Confirmed, Investigator-Assessed )	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)
Secondary	Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the PD-L1-Positive Population (Unconfirmed, Investigator-Assessed)	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)
Secondary	Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the Response-Evaluable Population (Confirmed, Investigator-Assessed )	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)
Secondary	Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the Response-Evaluable Population (Unconfirmed, Investigator-Assessed )	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)
Secondary	Duration of Objective Response (DOR) Assessed Using RECIST v1.1 in DOR-evaluable Population (Unconfirmed)	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)
Secondary	Percentage of Participants With Clinical Benefit Assessed Using RECIST v1.1 in Response-evaluable Population	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)
Secondary	Minimum Observed Serum Concentration (Cmin) of Atezolizumab in PK Evaluable Population		Pre-dose (0 hours) on Day 1 of Cycles 2-4 and at treatment discontinuation (TD), (approximately 9 months).
Secondary	Maximum Observed Serum Concentration (Cmax) of Atezolizumab in PK-evaluable Population		C1D1 30 min postdose
Secondary	Minimum Observed Plasma Concentration (Cmin) of Paclitaxel		Pre-dose (0 hours) on Day 1 of Cycle 3 (1 Cycle = 28 days)
Secondary	Maximum Observed Plasma Concentration (Cmax) of Paclitaxel		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)
Secondary	Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)	Investigator text for AEs is coded using MedDRA version 25.1	From Day 1 From baseline up to 64 months
Secondary	Percentage of Participants With Anti-Drug Antibodies' (ADAs) Against Atezolizumab in ADA Evaluable Population		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)
Secondary	Overall Survival by PD-L1 Status, Intent to Treat Population		From Day 1 up to 66 months
Secondary	Progression Free Survival by PD-L1 Status, Intent to Treat Population		From Day 1 up to primary completion date (approximately 26 months)
Secondary	Duration of Confirmed Response (C-DoR) in (C-DoR)-Evaluable Population	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)

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