Study of Atezolizumab in Combination With Cabozantinib Versus Docetaxel in Patients With Metastatic Non-Small Cell Lung Cancer Previously Treated With an Anti-PD-L1/PD-1 Antibody and Platinum-Containing Chemotherapy

Carcinoma, Non-Small-Cell Lung Clinical Trial

— CONTACT-01  

Official title:

A Phase III, Multicenter, Randomized, Open-Label, Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Atezolizumab Given in Combination With Cabozantinib Versus Docetaxel Monotherapy in Patients With Metastatic Non-Small Lung Cancer Previously Treated With an Anti-PD-L1/PD-1 Antibody and Platinum-Containing Chemotherapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04471428
• Other study ID #: GO41892
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 1, 2020
• Est. completion date: October 31, 2024

Study information

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

Clinical Trial Summary

This is a Phase III, multicenter, randomized, open-label study designed to evaluate the efficacy, safety, and pharmacokinetics of atezolizumab given in combination with cabozantinib compared with docetaxel monotherapy in patients with metastatic NSCLC, with no sensitizing EGFR mutation or ALK translocation, who have progressed following treatment with platinum-containing chemotherapy and anti-PD-L1/PD-1 antibody, administered concurrently or sequentially.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 366
• Est. completion date: October 31, 2024
• Est. primary completion date: September 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed metastatic NSCLC

• Documented radiographic disease progression during or following treatment with platinum-containing chemotherapy and anti-PD-L1/PD-1 antibody, administered concurrently or sequentially for metastatic NSCLC

• Measurable disease per RECIST v1.1 outside CNS as assessed by investigator

• Known PD-L1 status or availability of tumor tissue for central PD-L1 testing

• ECOG Performance Status score of 0 or 1

• Recovery to baseline or Grade <=1 NCI CTCAE v5.0 from toxicities related to any prior treatments, unless adverse events are clinically nonsignificant and/or stable on supportive therapy in the opinion of the investigator

• Adequate hematologic and end-organ function

• Negative 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 total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening

• Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening

• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs,

• For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm.

Exclusion Criteria:

• Prior therapy with the following agents for NSCLC: Cabozantinib, Docetaxel, Combination of an anti-PD-L1/PD-1 antibody concurrently with a vascular endothelial growth factor (VEGF)R targeting tyrosine kinase inhibitor (TKI)

• Treatment with investigational therapy within 28 days prior to initiation of study treatment

• Documentation of known sensitizing mutation in the EGFR gene or ALK fusion oncogene

• Patients with known ROS1 rearrangements, BRAF V600E mutations, or other actionable oncogenes with approved therapies if available

• Symptomatic, untreated, or actively progressing CNS metastases

• History of leptomeningeal disease

• Uncontrolled tumor-related pain

• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (more frequently than once monthly)

• Severe hepatic impairment

• Uncontrolled or symptomatic hypercalcemia

• Any other active malignancy at the time of initiation of study treatment or diagnosis of another malignancy within 3 years prior to initiation of study treatment that requires active treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, incidental prostate cancer, or carcinoma in situ of the prostate, cervix, or breast

• Stroke, transient ischemic attack, myocardial infarction or other symptomatic ischemic events within 6 months of initiation of study treatment

• Significant vascular disease within 6 months of initiation of study treatment

• Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina

• Active tuberculosis

• Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that, in the opinion on the investigator, could impact patient safety

• Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment

• Current treatment with anti-viral therapy for HBV

• Major surgical procedure, other than for diagnosis within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study

• Pregnant or lactating females, or intention of becoming pregnant during the treatment with atezolizumab in combination with cabozantinib in the experimental arm or during the treatment with docetaxel in the control arm, or within 5 months after the final dose of atezolizumab and/or 4 months after the final dose of cabozantinib, whichever is later.

• Ongoing Grade >= 2 sensory or motor neuropathy

• Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, granulomatosis with polyangiitis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis with the following exceptions: Patients with a history of autoimmune-mediated hypothyroidism who are on thyroid replacement hormone are eligible for the study. Patients with controlled Type 1 diabetes mellitus are eligible for the study. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only are eligible for the study provided all of following conditions are met: Rash must cover < 10% of body surface area.

• Pharmacologically uncompensated, symptomatic hypothyroidism

• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan

• Prior allogeneic stem cell or solid organ transplantation

• Administration of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab

• Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2) within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment

• Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions: Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication are eligible for the study after Medical Monitor confirmation has been obtained. Patients who received mineralocorticoids, inhaled or low-dose systemic corticosteroids for COPD or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.

• History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins

• Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation

• Known allergy or hypersensitivity to any component of the cabozantinib formulation

• History of severe hypersensitivity to docetaxel or to other drugs formulated with polysorbate 80

• Concomitant anticoagulation with coumarin agents, direct thrombin inhibitor dabigatran, direct factor Xa inhibitor betrixaban, or platelet inhibitors

• History of risk factors for torsades de pointes

• Corrected QT interval corrected through use of Fridericia's formula (QTcF) > 480 ms per ECG within 14 days before initiation of study treatment

• Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg or diastolic BP > 90 mm Hg despite optimal antihypertensive treatment

• Tumors invading the GI-tract, active peptic ulcer disease, acute pancreatitis, acute obstruction of the pancreatic or biliary duct, appendicitis, cholangitis, cholecystitis, diverticulitis, gastric outlet obstruction, or inflammatory bowel disease

• Abdominal fistula, bowel obstruction, GI perforation, or intra-abdominal abscess within 6 months before initiation of study treatment

• Known cavitating pulmonary lesion(s) or known endobronchial disease manifestation

• Lesions invading major pulmonary blood vessels

• Clinically significant hematuria, hematemesis, hemoptysis of > 0.5 teaspoon (2.5 mL) of red blood, coagulopathy, or other history of significant bleeding within 3 months before initiation of study treatment

• Serious non-healing wound/ulcer/bone fracture

• Malabsorption syndrome

• Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption are also excluded.

• Requirement for hemodialysis or peritoneal dialysis

• Inability to swallow tablets

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Cabozantinib
Cabozantinib will be administered orally, once daily at a dose of 40 mg on Days 1-21 of each cycle.
• Atezolizumab
Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.
• Docetaxel
Docetaxel will be administered by IV infusion at a starting dose of 75mg/m2 on Day 1 of each 21-day cycle.

Locations

Country	Name	City	State
Australia	Flinders Medical Centre	Bedford Park	South Australia
Australia	Austin Hospital Olivia Newton John Cancer Centre	Heidelberg	Victoria
Australia	Affinity Oncology	Nedlands	Western Australia
Australia	Royal North Shore Hospital; Oncology	St. Leonards	New South Wales
Australia	Townsville Hospital	Townsville	Queensland
Austria	LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie	Graz
Austria	Ordensklinikum Linz Elisabethinen	Linz
Austria	Lhk Feldkirch; Interne Medizin Abt.	Rankweil
Austria	Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.	Salzburg
Austria	Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie	Wien
Belgium	Institut Jules Bordet	Anderlecht
Belgium	Cliniques Universitaires St-Luc	Bruxelles
Belgium	UZ Gent	Gent
Belgium	Clinique Ste-Elisabeth	Namur
France	Clinique de l'Europe	Amiens
France	CHU Angers,Service de Pneumologie	Angers
France	CHU de Grenoble	Grenoble
France	Hopital Dupuytren; Pneumologie	Limoges
France	Hôpital Saint Joseph; Oncologie Medicale	Marseille
France	Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque; Service d oncologie	Montpellier
France	Centre Hospitalier de Mulhouse - Hopital Emile Muller	Mulhouse
France	Hopital Tenon;Pneumologie	Paris
Germany	Zentralklinik Bad Berka GmbH; Pneumologie	Bad Berka
Germany	KEM/Evang. Kliniken Essen Mitte gGmbH; Klinik für Internistische Onkologie / Hämatologie	Essen
Germany	Universitaetsklinikum Giessen und Marburg GmbH; Medizinische Klinik IV und V	Gießen
Germany	KRH Klinikum Siloah-Oststadt-Heidehaus	Hannover
Germany	Klinikum Koeln-Merheim; Lungenklinik	Köln
Germany	Universitaetsklinikum Giessen und Marburg	Marburg
Germany	Brüderkrankenhaus St. Josef Paderborn	Paderborn
Greece	Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine	Athens
Greece	Henri Dunant Hospital; Oncology Dept.	Athens
Greece	Uoa Sotiria Hospital; Oncology	Athens
Greece	Univ General Hosp Heraklion; Medical Oncology	Heraklion
Greece	Euromedical General Clinic of Thessaloniki; Oncology Department	Thessaloniki
Italy	Irccs Centro Di Riferimento Oncologico (CRO)	Aviano	Friuli-Venezia Giulia
Italy	Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica	Bologna	Emilia-Romagna
Italy	ASST Spedali Civili di Brescia	Brescia	Lombardia
Italy	A.O.U Careggi	Florence	Toscana
Italy	IRCCS AOU San Martino - IST	Genova	Liguria
Italy	Ospedale Vito Fazzi	Lecce	Puglia
Italy	Instituto Europeo di Oncologia	Milano	Lombardia
Italy	AORN Ospedali dei Colli Ospedale Monaldi; UOC Pneumologia ad indirizzo Oncologico	Napoli	Campania
Italy	Azienda Ospedaliero Universitaria di Parma	Parma	Emilia-Romagna
Italy	Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica	Ravenna	Emilia-Romagna
Italy	Azienda Ospedaliera San Camillo Forlanini	Roma	Lazio
Italy	Policlinico Umberto I, Oncologia B	Roma	Lazio
Italy	Istituto Clinico Humanitas	Rozzano (MI)	Lombardia
Japan	Hyogo Cancer Center	Hyogo
Japan	Sendai Kousei Hospital	Miyagi
Japan	Osaka International Cancer Institute	Osaka
Japan	National Cancer Center Hospital	Tokyo
Japan	The Cancer Institute Hospital of JFCR	Tokyo
Korea, Republic of	Chungbuk National University Hospital	Cheongju si
Korea, Republic of	National Cancer Center	Goyang-si
Korea, Republic of	Ajou University Medical Center	Gyeonggi-do
Korea, Republic of	St. Vincent's Hospital	Gyeonggi-do
Korea, Republic of	Samsung Changwon Hospital	Gyeongsangnam-do
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Seoul St Mary's Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	Ulsan University Hosiptal	Ulsan
Poland	Centrum Onkologii im. Prof. Franciszka ?ukaszczyka; Ambulatorium Chemioterapii	Bydgoszcz
Poland	SP ZOZ Wojewódzki Szpital Specjalistyczny nr 4; Oddzial Onkologii Klinicznej	Bytom
Poland	Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; III Klin. Radioter. i Chemioter.	Gliwice
Poland	Szpital Wojewódzki im. Miko?aja Kopernika; Oddzia? Dzienny Chemioterapii	Koszalin
Poland	Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii	Otwock
Portugal	Hospital Pulido Valente; Servico de Pneumologia	Lisboa
Portugal	Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia	Porto
Portugal	Hospital CUF Porto; Servico Pneumologia	Porto
Portugal	IPO do Porto; Servico de Oncologia Medica	Porto
Portugal	CHVNG/E_Unidade 1; Servico de Pneumologia	Vila Nova de Gaia
Russian Federation	MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy	Moscow	Moskovskaja Oblast
Russian Federation	S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)	Saint-Petersburg	Sankt Petersburg
Russian Federation	GBUZ Leningradskaya state clinical hospital	St. Petersburg	Sankt Petersburg
Russian Federation	Regional Clinical Oncology Hospital	Yaroslavl	Jaroslavl
Spain	Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia	A Coruña	LA Coruña
Spain	Institut Catala d Oncologia Hospital Duran i Reynals	Barcelona
Spain	Vall d?Hebron Institute of Oncology (VHIO), Barcelona	Barcelona
Spain	Hospital Universitario La Paz; Servicio de Oncologia	Madrid
Spain	Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia	Sevilla
Spain	Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia	Valencia
Spain	Hospital Universitari i Politecnic La Fe; Oncologia	Valencia
United Kingdom	Addenbrookes Hospital	Cambridge
United Kingdom	Beatson West of Scotland Cancer Centre	Glasgow
United Kingdom	Huddersfield Royal Infirmary; The Learning Centre	Huddersfield
United Kingdom	Barts & London School of Med; Medical Oncology	London
United Kingdom	Chelsea & Westminster Hospital	London
United Kingdom	Royal Free Hospital	London
United Kingdom	University College London Hospital	London
United States	Regional Cancer Care Associates	Bethesda	Maryland
United States	Consultants in Medical Oncology and Hematology	Broomall	Pennsylvania
United States	Charleston Oncology, P .A	Charleston	South Carolina
United States	Texas Oncology - Baylor Charles A. Sammons Cancer Center	Dallas	Texas
United States	Rocky Mountain Cancer Centers	Denver	Colorado
United States	Karmanos Cancer Center	Detroit	Michigan
United States	Virginia Cancer Specialists (Fairfax) - USOR	Fairfax	Virginia
United States	Stanford University	Palo Alto	California
United States	Oncology and Hematology Associates of Southwest Virginia, Inc.,-Blacksburg	Roanoke	Virginia
United States	Minnesota Oncology Hematology	Saint Paul	Minnesota
United States	Huntsman Cancer Institute at The University of Utah	Salt Lake City	Utah
United States	Kaiser Permanente - San Diego	San Diego	California
United States	Sansum Clinic	Santa Barbara	California

Sponsors (2)

Lead Sponsor	Collaborator
Hoffmann-La Roche	Exelixis

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  France,  Germany,  Greece,  Italy,  Japan,  Korea, Republic of,  Poland,  Portugal,  Russian Federation,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	OS was defined as the time from randomization to death from any cause. Participants alive at the time of the analysis were censored at the date when they were last known to be alive as documented by the investigator. Kaplan-Meier method was used to estimate the median. 95% CI for median was computed using the method of Brookmeyer and Crowley.	Up to approximately 24 months
Secondary	Progression-Free Survival (PFS) as Determined by Investigator	PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator according to RECIST v1.1, or death from any cause (whichever occurred first). Progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters of the target lesions recorded since the treatment started, including screening, or the appearance of one or more new lesions. Participants who were alive and did not experience disease progression at the time of analysis, were censored on the date of last tumor assessment. Participants with no post-baseline tumor assessment were censored at the date of randomization.	Up to approximately 24 months
Secondary	Confirmed Objective Response Rate (ORR) as Determined by Investigator	Confirmed ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) on two consecutive occasions >=4 weeks apart, as determined by the investigator according to RECIST v1.1. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters.	Up to approximately 24 months
Secondary	Duration of Response (DOR) as Determined by Investigator	DOR for participants with confirmed ORR was defined as time from first occurrence of documented objective response to disease progression (PD), as determined by investigator according to RECIST v1.1, or death from any cause (whichever occurred first). PD was defined as at least 20% increase in sum of longest diameters of target lesions, taking as reference the smallest sum of longest diameters of target lesions recorded since treatment started, including screening, or appearance of one or more new lesions. Confirmed ORR was defined as percentage of participants with a CR or PR on two consecutive occasions >=4 weeks apart, as determined by the investigator according to RECIST v1.1. Participants who had not progressed and who did not die at the time of analysis were censored at the time of last tumor assessment date. Kaplan-Meier method was used to estimate median. 95% CI for median was computed using method of Brookmeyer and Crowley.	Up to approximately 24 months
Secondary	Time to Confirmed Deterioration in Patient-Reported Physical Functioning (PF)	Time to confirmed deterioration (TTCD) analyses was performed for patient-reported physical functioning (PF) (items 1 to 5) of European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30). The PF is measured on 4-point scale (1='Not at all' to 4='Very much'). TTCD for PF is defined as time from date of randomization to first confirmed clinically meaningful decrease from baseline in PF score held for at least 2 consecutive assessments or initial clinically meaningful decrease from baseline followed by death from any cause within 21 days or until next tumor assessment, whichever occurs first. A score change of >=of 10-point on EORTC QLQ-C30 PF scale was determined as being clinically meaningful. Scores were averaged, transformed to 0-100 scale; where higher score represented high/healthy level of functioning. Kaplan-Meier method was used to estimate the median. 95% CI for median was computed using the method of Brookmeyer and Crowley	Up to approximately 24 months
Secondary	Time to Confirmed Deterioration in Patient-Reported Global Health Status (GHS)	Time to confirmed deterioration (TTCD) analyses was performed for global health status (GHS) and quality of life (QoL) (items 29 and 30) of EORTC QLQ-C30. GHS/ QoL items are scored on a 7-point scale that ranges from "very poor" to "excellent." TTCD for GHS/QoL is defined as the time from the date of randomization to the first confirmed clinically meaningful decrease from baseline in GHS/QoLscore held for at least two consecutive assessments or an initial clinically meaningful decrease from baseline followed by death from any cause within 21 days or until the next tumor assessment, whichever occurs first. A score change of >=10-point on the EORTC QLQ-C30 GHS/QoL scale was determined as being clinically meaningful. Scores were averaged, transformed to 0-100 scale; where higher score for GHS/QoL=better health-related QoL. Kaplan-Meier method was used to estimate the median. 95% CI for median was computed using the method of Brookmeyer and Crowley.	Up to approximately 24 months
Secondary	PFS Rates Assessed by Investigator	PFS rates were defined as the percentage of participants alive and without progression as assessed by the investigator according to RECIST v1.1. Progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters of the target lesions recorded since the treatment started, including screening, or the appearance of one or more new lesions.	6 months and 1 year
Secondary	OS Rates	Overall Survival (OS) rate is defined as the percentage of participants who were alive at 1 year and 2 years. Participants alive at the time of the analysis were censored at the date when they were last known to be alive as documented by the investigator.	1 and 2 years
Secondary	Percentage of Participants With Adverse Events	An adverse event is any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, regardless of causal attribution. AEs were assessed using National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE, v5.0)	From signing the informed consent form up to the study completion date: 28 February 2024 (i.e., approximately 41 months)
Secondary	Minimum Serum Concentration (Cmin) of Atezolizumab		Predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (each cycle is 21 days)
Secondary	Maximum Serum Concentration (Cmax) of Atezolizumab		Postdose on Day 1 of Cycle 1 (each cycle is 21 days)
Secondary	Minimum Plasma Concentration (Cmin) of Cabozantinib		Predose on Day 1 of Cycles 1, 2, 3, 4, and 5 (each cycle is 21 days)
Secondary	Maximum Plasma Concentration (Cmax) of Cabozantinib		Predose on Day 1 of Cycles 1, 2, 3, 4, and 5 (each cycle is 21 days)
Secondary	Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab		Predose on Day 1 of Cycles 1,2,3,4,8,12 and 16 (each cycle is 21 days) and at post-treatment follow-up visit (= 30 days after final dose)

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