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A Study of Atezolizumab (an Engineered Anti-Programmed Death-Ligand 1 [PDL1] Antibody) to Evaluate Safety, Tolerability and Pharmacokinetics in Participants With Locally Advanced or Metastatic Solid Tumors

Primary Purpose

Tumors, Hematologic Malignancies

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Atezolizumab

About this trial

This is an interventional treatment trial for Tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participants who are 16 to 17 years old would be enrolled after consultation with the Medical Monitor
Histologically or cytologically documented, incurable or metastatic solid tumor or hematologic malignancy that is advanced (non-resectable) or recurrent and progressing since the last anti-tumor therapy and for which no recognized standard curative therapy exists
Representative tumor specimens in paraffin blocks (preferred) or at least 15 unstained slides, with an associated pathology report
Adequate hematologic and end organ function
Measurable disease per RECIST v1.1 for participants with solid malignancies. Disease-specific criteria for participants with prostate cancer, glioblastoma multiforme (GBM), malignant lymphoma, or multiple myeloma
For women of childbearing potential: agreement to remain abstinent or use contraceptive methods
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
For participants who will undergo serial biopsy in dose-escalation cohort, baseline tumor tissue samples should be of core needle biopsies for deep tumor tissue or organs or excisional or punch biopsies for cutaneous or subcutaneous lesions (>/=5 millimeter [mm] in diameter amenable to serial biopsy)

Exclusion Criteria:

Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases
Known hypersensitivity to pharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
History or risk of autoimmune disease (for example, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis)
History of human immunodeficiency virus (HIV) infection, active hepatitis B (chronic or acute), or hepatitis C infection
Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1
Malignancies other than disease under study within 5 years prior to Cycle 1, Day 1
Participants with prior allogeneic bone marrow transplantation or prior solid organ transplantation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Arm Label

Dose Escalation Cohort: Atezolizumab 0.01 mg/kg

Dose Escalation Cohort: Atezolizumab 0.03 mg/kg

Dose Escalation Cohort: Atezolizumab 0.1 mg/kg

Dose Escalation Cohort: Atezolizumab 0.3 mg/kg

Dose Escalation Cohort: Atezolizumab 1 mg/kg

Dose Escalation Cohort: Atezolizumab 3 mg/kg

Dose Escalation Cohort: Atezolizumab 10 mg/kg

Dose Escalation Cohort: Atezolizumab 20 mg/kg

Expansion Cohort (Atezolizumab)

Arm Description

Participants will receive intravenous (IV) infusion of atezolizumab 0.01 milligrams per kilogram (mg/kg) every 3 weeks (q3w) until DLT is reached or up to end of study or treatment discontinuation or death or until initiation of another anti cancer therapy, whichever occurs first.

Participants will receive IV infusion of atezolizumab 0.03 mg/kg q3w until DLT is reached or up to end of study or treatment discontinuation or death or until initiation of another anti cancer therapy, whichever occurs first.

Participants will receive IV infusion of atezolizumab 0.1 mg/kg q3w until DLT is reached or up to end of study or treatment discontinuation or death or until initiation of another anti cancer therapy, whichever occurs first.

Participants will receive IV infusion of atezolizumab 0.3 mg/kg q3w until DLT is reached or up to end of study or treatment discontinuation or death or until initiation of another anti cancer therapy, whichever occurs first.

Participants will receive IV infusion of atezolizumab 1 mg/kg q3w until DLT is reached or up to end of study or treatment discontinuation or death or until initiation of another anti cancer therapy, whichever occurs first.

Participants will receive IV infusion of atezolizumab 3 mg/kg q3w until DLT is reached or up to end of study or treatment discontinuation or death or until initiation of another anti cancer therapy, whichever occurs first.

Participants will receive IV infusion of atezolizumab 10 mg/kg q3w until DLT is reached or up to end of study or treatment discontinuation or death or until initiation of another anti cancer therapy, whichever occurs first.

Participants will receive IV infusion of atezolizumab 20 mg/kg q3w until DLT is reached or up to end of study or treatment discontinuation or death or until initiation of another anti cancer therapy, whichever occurs first.

Participants will receive IV infusion of atezolizumab q3w up to end of study or treatment discontinuation or death or until initiation of another anti cancer therapy, whichever occurs first. The dose which result in total drug exposure less than or equal to (</=) exposures achieved at the MTD or maximum administered dose (MAD), will be selected for expansion cohort.

Outcomes

Primary Outcome Measures

Number of Participants With Dose Limiting Toxicities (DLTs)

Maximum Tolerated Dose (MTD) of Atezolizumab

Recommended Phase 2 Dose (RP2D) of Atezolizumab

Percentage of Participants With Adverse Events

Secondary Outcome Measures

Percentage of Participants With Anti-Therapeutic Antibodies (ATAs)

Area Under the Concentration-Time Curve (AUC) of Atezolizumab

Dose-Escalation Cohorts: Predose (0 hr), 0.5 hr post-infusion (infusion duration=60 minutes [min]) on Day 1 of Cycles 1-5, 7 (Cycle length=21 days); Days 2, 4, 8, 15 of Cycle 1; predose (0 hr) on Day 1 of Cycles 8, 10, 12, 14, 16, 17, 20, every 8 cycles thereafter (up to approx 7 yrs), at treatment discontinuation & then every 30 days for up to 120 days after last dose of study treatment until death/study closure (up to approx 7 yrs) Expansion Cohort: Predose (0 hr), 0.5 hr post-infusion (infusion duration=60 min) on Day 1 of Cycles 1-4 (Cycle length=21 days); Days 2, 8, 15 of Cycle 1; predose (0 hr) on Day 1 of Cycles 2-5, 7, 8, 16, 17, 20, every 8 cycles thereafter (up to approx 7 yrs), at treatment discontinuation & then every 30 days for up to 120 days after last dose of study treatment until death/study closure (up to approx 7 yrs)

Maximum Serum Concentration (Cmax) of Atezolizumab

Dose-Escalation Cohorts: Predose (0 hr), 0.5 hr post-infusion (infusion duration=60 minutes [min]) on Day 1 of Cycles 1-5, 7 (Cycle length=21 days); Days 2, 4, 8, 15 of Cycle 1; predose (0 hr) on Day 1 of Cycles 8, 10, 12, 14, 16, 17, 20, every 8 cycles thereafter (up to approx 7 yrs), at treatment discontinuation & then every 30 days for up to 120 days after last dose of study treatment until death/study closure (up to approx 7 yrs) Expansion Cohorts: Predose (0 hr), 0.5 hr post-infusion (infusion duration=60 min) on Day 1 of Cycles 1-4 (Cycle length=21 days); Days 2, 8, 15 of Cycle 1; predose (0 hr) on Day 1 of Cycles 2-5, 7, 8, 16, 17, 20, every 8 cycles thereafter (up to approx 7 yrs), at treatment discontinuation & then every 30 days for up to 120 days after last dose of study treatment until death/study closure (up to approx 7 yrs)

Minimum Serum Concentration (Cmin) of Atezolizumab

Dose-Escalation Cohorts: Predose (0 hr), 0.5 hr post-infusion (infusion duration=60 minutes [min]) on Day 1 of Cycles 1-5, 7 (Cycle length=21 days); Days 2, 4, 8, 15 of Cycle 1; predose (0 hr) on Day 1 of Cycles 8, 10, 12, 14, 16, 17, 20, every 8 cycles thereafter (up to approx 7 yrs), at treatment discontinuation & then every 30 days for up to 120 days after last dose of study treatment until death/study closure (up to approx 7 yrs) Expansion Cohorts: Predose (0 hr), 0.5 hr post-infusion (infusion duration=60 min) on Day 1 of Cycles 1-4 (Cycle length=21 days); Days 2, 8, 15 of Cycle 1; predose (0 hr) on Day 1 of Cycles 2-5, 7, 8, 16, 17, 20, every 8 cycles thereafter (up to approx 7 yrs), at treatment discontinuation & then every 30 days for up to 120 days after last dose of study treatment until death/study closure (up to approx 7 yrs)

Clearance (CL) of Atezolizumab

Dose-Escalation Cohorts: Predose (0 hr), 0.5 hr post-infusion (infusion duration=60 minutes [min]) on Day 1 of Cycles 1-5, 7 (Cycle length=21 days); Days 2, 4, 8, 15 of Cycle 1; predose (0 hr) on Day 1 of Cycles 8, 10, 12, 14, 16, 17, 20, every 8 cycles thereafter (up to approx 7 yrs), at treatment discontinuation & then every 30 days for up to 120 days after last dose of study treatment until death/study closure (up to approx 7 yrs) Expansion Cohorts: Predose (0 hr), 0.5 hr post-infusion (infusion duration=60 min) on Day 1 of Cycles 1-4 (Cycle length=21 days); Days 2, 8, 15 of Cycle 1; predose (0 hr) on Day 1 of Cycles 2-5, 7, 8, 16, 17, 20, every 8 cycles thereafter (up to approx 7 yrs), at treatment discontinuation & then every 30 days for up to 120 days after last dose of study treatment until death/study closure (up to approx 7 yrs)

Volume at Steady State (Vss) of Atezolizumab

Dose-Escalation Cohorts: Predose (0 hr), 0.5 hr post-infusion (infusion duration=60 minutes [min]) on Day 1 of Cycles 1-5, 7 (Cycle length=21 days); Days 2, 4, 8, 15 of Cycle 1; predose (0 hr) on Day 1 of Cycles 8, 10, 12, 14, 16, 17, 20, every 8 cycles thereafter (up to approx 7 yrs), at treatment discontinuation & then every 30 days for up to 120 days after last dose of study treatment until death/study closure (up to approx 7 yrs) Expansion Cohorts: Predose (0 hr), 0.5 hr post-infusion (infusion duration=60 min) on Day 1 of Cycles 1-4 (Cycle length=21 days); Days 2, 8, 15 of Cycle 1; predose (0 hr) on Day 1 of Cycles 2-5, 7, 8, 16, 17, 20, every 8 cycles thereafter (up to approx 7 yrs), at treatment discontinuation & then every 30 days for up to 120 days after last dose of study treatment until death/study closure (up to approx 7 yrs)

Percentage of Participants With Best Overall Response, Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Percentage of Participants With Best Overall Response, Assessed by Immune-Related Response Criteria (irRC)

Percentage of Participants With Objective Response (Complete Response [CR] or Partial Response [PR]), Assessed by RECIST v1.1

Percentage of Participants With Objective Response (CR or PR), Assessed by irRC

Duration of Objective Response, Assessed by RECIST v1.1

Duration of Objective Response, Assessed by irRC

Progression-Free Survival (PFS), Assessed by RECIST v1.1

PFS, Assessed by irRC

Full Information

NCT ID

NCT01375842

First Posted

June 16, 2011

Last Updated

December 10, 2018

Sponsor

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01375842

Brief Title

A Study of Atezolizumab (an Engineered Anti-Programmed Death-Ligand 1 [PDL1] Antibody) to Evaluate Safety, Tolerability and Pharmacokinetics in Participants With Locally Advanced or Metastatic Solid Tumors

Official Title

A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Atezolizumab (MPDL3280A) Administered Intravenously as a Single Agent to Patients With Locally Advanced or Metastatic Solid Tumors or Hematologic Malignancies

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

June 21, 2011 (Actual)

Primary Completion Date

September 30, 2018 (Actual)

Study Completion Date

September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Genentech, Inc.

4. Oversight

5. Study Description

Brief Summary

This Phase I, multicenter, first-in-human, open-label, dose-escalation study will evaluate the safety, tolerability, and pharmacokinetics of atezolizumab (MPDL3280A) administered as single agent to participants with locally advanced or metastatic solid malignancies or hematologic malignancies. The study will be conducted in two cohorts: Dose-escalation cohort and Expansion cohort.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tumors, Hematologic Malignancies

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

661 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dose Escalation Cohort: Atezolizumab 0.01 mg/kg

Arm Type

Experimental

Arm Description

Arm Title

Dose Escalation Cohort: Atezolizumab 0.03 mg/kg

Arm Type

Experimental

Arm Description

Arm Title

Dose Escalation Cohort: Atezolizumab 0.1 mg/kg

Arm Type

Experimental

Arm Description

Arm Title

Dose Escalation Cohort: Atezolizumab 0.3 mg/kg

Arm Type

Experimental

Arm Description

Arm Title

Dose Escalation Cohort: Atezolizumab 1 mg/kg

Arm Type

Experimental

Arm Description

Arm Title

Dose Escalation Cohort: Atezolizumab 3 mg/kg

Arm Type

Experimental

Arm Description

Arm Title

Dose Escalation Cohort: Atezolizumab 10 mg/kg

Arm Type

Experimental

Arm Description

Arm Title

Dose Escalation Cohort: Atezolizumab 20 mg/kg

Arm Type

Experimental

Arm Description

Arm Title

Expansion Cohort (Atezolizumab)

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Atezolizumab

Other Intervention Name(s)

MPDL3280A

Intervention Description

Atezolizumab will be administered as IV infusion at eight dose levels (0.01, 0.03, 0.1, 0.3, 1, 3, 10, 20 mg/kg) in dose escalation cohort and at a dose which result in total drug exposure </= exposures achieved at the MTD or MAD, will be selected for expansion cohort.

Primary Outcome Measure Information:

Title

Number of Participants With Dose Limiting Toxicities (DLTs)

Time Frame

Day 1 up to Day 21

Title

Maximum Tolerated Dose (MTD) of Atezolizumab

Time Frame

Day 1 up to Day 21

Title

Recommended Phase 2 Dose (RP2D) of Atezolizumab

Time Frame

Baseline up to time of determination of MTD (up to Day 21)

Title

Percentage of Participants With Adverse Events

Time Frame

Baseline up to 90 days after the last dose of study treatment or until initiation of another anti-cancer therapy, whichever occurs first (up to approximately [approx] 7 years [yrs])

Secondary Outcome Measure Information:

Title

Percentage of Participants With Anti-Therapeutic Antibodies (ATAs)

Time Frame

Predose(0 hour[hr])on Day 1 of Cycles 1,2,4,8,16,17,20(Cycle length=21 days), every 8 cycles thereafter, at treatment discontinuation & then every 30 days for up to 120 days after last dose of study treatment until death/study closure(up to approx 7 yrs)

Title

Area Under the Concentration-Time Curve (AUC) of Atezolizumab

Description

Time Frame

Predose (0 hr) on Day 1 of Cycle 1 up to 120 days after last dose of study treatment until death/study closure (up to approx 7 yrs) (Detailed timeframe provided in outcome measure description)

Title

Maximum Serum Concentration (Cmax) of Atezolizumab

Description

Dose-Escalation Cohorts: Predose (0 hr), 0.5 hr post-infusion (infusion duration=60 minutes [min]) on Day 1 of Cycles 1-5, 7 (Cycle length=21 days); Days 2, 4, 8, 15 of Cycle 1; predose (0 hr) on Day 1 of Cycles 8, 10, 12, 14, 16, 17, 20, every 8 cycles thereafter (up to approx 7 yrs), at treatment discontinuation & then every 30 days for up to 120 days after last dose of study treatment until death/study closure (up to approx 7 yrs) Expansion Cohorts: Predose (0 hr), 0.5 hr post-infusion (infusion duration=60 min) on Day 1 of Cycles 1-4 (Cycle length=21 days); Days 2, 8, 15 of Cycle 1; predose (0 hr) on Day 1 of Cycles 2-5, 7, 8, 16, 17, 20, every 8 cycles thereafter (up to approx 7 yrs), at treatment discontinuation & then every 30 days for up to 120 days after last dose of study treatment until death/study closure (up to approx 7 yrs)

Time Frame

Predose (0 hr) on Day 1 of Cycle 1 up to 120 days after last dose of study treatment until death/study closure (up to approx 7 yrs) (Detailed timeframe provided in outcome measure description)

Title

Minimum Serum Concentration (Cmin) of Atezolizumab

Description

Dose-Escalation Cohorts: Predose (0 hr), 0.5 hr post-infusion (infusion duration=60 minutes [min]) on Day 1 of Cycles 1-5, 7 (Cycle length=21 days); Days 2, 4, 8, 15 of Cycle 1; predose (0 hr) on Day 1 of Cycles 8, 10, 12, 14, 16, 17, 20, every 8 cycles thereafter (up to approx 7 yrs), at treatment discontinuation & then every 30 days for up to 120 days after last dose of study treatment until death/study closure (up to approx 7 yrs) Expansion Cohorts: Predose (0 hr), 0.5 hr post-infusion (infusion duration=60 min) on Day 1 of Cycles 1-4 (Cycle length=21 days); Days 2, 8, 15 of Cycle 1; predose (0 hr) on Day 1 of Cycles 2-5, 7, 8, 16, 17, 20, every 8 cycles thereafter (up to approx 7 yrs), at treatment discontinuation & then every 30 days for up to 120 days after last dose of study treatment until death/study closure (up to approx 7 yrs)

Time Frame

Predose (0 hr) on Day 1 of Cycle 1 up to 120 days after last dose of study treatment until death/study closure (up to approx 7 yrs) (Detailed timeframe provided in outcome measure description)

Title

Clearance (CL) of Atezolizumab

Description

Dose-Escalation Cohorts: Predose (0 hr), 0.5 hr post-infusion (infusion duration=60 minutes [min]) on Day 1 of Cycles 1-5, 7 (Cycle length=21 days); Days 2, 4, 8, 15 of Cycle 1; predose (0 hr) on Day 1 of Cycles 8, 10, 12, 14, 16, 17, 20, every 8 cycles thereafter (up to approx 7 yrs), at treatment discontinuation & then every 30 days for up to 120 days after last dose of study treatment until death/study closure (up to approx 7 yrs) Expansion Cohorts: Predose (0 hr), 0.5 hr post-infusion (infusion duration=60 min) on Day 1 of Cycles 1-4 (Cycle length=21 days); Days 2, 8, 15 of Cycle 1; predose (0 hr) on Day 1 of Cycles 2-5, 7, 8, 16, 17, 20, every 8 cycles thereafter (up to approx 7 yrs), at treatment discontinuation & then every 30 days for up to 120 days after last dose of study treatment until death/study closure (up to approx 7 yrs)

Time Frame

Predose (0 hr) on Day 1 of Cycle 1 up to 120 days after last dose of study treatment until death/study closure (up to approx 7 yrs) (Detailed timeframe provided in outcome measure description)

Title

Volume at Steady State (Vss) of Atezolizumab

Description

Dose-Escalation Cohorts: Predose (0 hr), 0.5 hr post-infusion (infusion duration=60 minutes [min]) on Day 1 of Cycles 1-5, 7 (Cycle length=21 days); Days 2, 4, 8, 15 of Cycle 1; predose (0 hr) on Day 1 of Cycles 8, 10, 12, 14, 16, 17, 20, every 8 cycles thereafter (up to approx 7 yrs), at treatment discontinuation & then every 30 days for up to 120 days after last dose of study treatment until death/study closure (up to approx 7 yrs) Expansion Cohorts: Predose (0 hr), 0.5 hr post-infusion (infusion duration=60 min) on Day 1 of Cycles 1-4 (Cycle length=21 days); Days 2, 8, 15 of Cycle 1; predose (0 hr) on Day 1 of Cycles 2-5, 7, 8, 16, 17, 20, every 8 cycles thereafter (up to approx 7 yrs), at treatment discontinuation & then every 30 days for up to 120 days after last dose of study treatment until death/study closure (up to approx 7 yrs)

Time Frame

Predose (0 hr) on Day 1 of Cycle 1 up to 120 days after last dose of study treatment until death/study closure (up to approx 7 yrs) (Detailed timeframe provided in outcome measure description)

Title

Percentage of Participants With Best Overall Response, Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Time Frame

From Baseline up to the first occurrence of progression or death, whichever occurs first (up to approx 7 yrs)

Title

Percentage of Participants With Best Overall Response, Assessed by Immune-Related Response Criteria (irRC)

Time Frame

From Baseline up to the first occurrence of progression or death, whichever occurs first (up to approx 7 yrs)

Title

Percentage of Participants With Objective Response (Complete Response [CR] or Partial Response [PR]), Assessed by RECIST v1.1

Time Frame

From Baseline up to the first occurrence of progression or death, whichever occurs first (up to approx 7 yrs)

Title

Percentage of Participants With Objective Response (CR or PR), Assessed by irRC

Time Frame

From Baseline up to the first occurrence of progression or death, whichever occurs first (up to approx 7 yrs)

Title

Duration of Objective Response, Assessed by RECIST v1.1

Time Frame

Time from the first occurrence of a documented objective response to the time of relapse or death from any cause (up to approx 7 yrs)

Title

Duration of Objective Response, Assessed by irRC

Time Frame

Time from the first occurrence of a documented objective response to the time of relapse or death from any cause (up to approx 7 yrs)

Title

Progression-Free Survival (PFS), Assessed by RECIST v1.1

Time Frame

From Baseline up to the first occurrence of progression or death, whichever occurs first (up to approx 7 yrs)

Title

PFS, Assessed by irRC

Time Frame

From Baseline up to the first occurrence of progression or death, whichever occurs first (up to approx 7 yrs)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participants who are 16 to 17 years old would be enrolled after consultation with the Medical Monitor Histologically or cytologically documented, incurable or metastatic solid tumor or hematologic malignancy that is advanced (non-resectable) or recurrent and progressing since the last anti-tumor therapy and for which no recognized standard curative therapy exists Representative tumor specimens in paraffin blocks (preferred) or at least 15 unstained slides, with an associated pathology report Adequate hematologic and end organ function Measurable disease per RECIST v1.1 for participants with solid malignancies. Disease-specific criteria for participants with prostate cancer, glioblastoma multiforme (GBM), malignant lymphoma, or multiple myeloma For women of childbearing potential: agreement to remain abstinent or use contraceptive methods Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 For participants who will undergo serial biopsy in dose-escalation cohort, baseline tumor tissue samples should be of core needle biopsies for deep tumor tissue or organs or excisional or punch biopsies for cutaneous or subcutaneous lesions (>/=5 millimeter [mm] in diameter amenable to serial biopsy) Exclusion Criteria: Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases Known hypersensitivity to pharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation History or risk of autoimmune disease (for example, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis) History of human immunodeficiency virus (HIV) infection, active hepatitis B (chronic or acute), or hepatitis C infection Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1 Malignancies other than disease under study within 5 years prior to Cycle 1, Day 1 Participants with prior allogeneic bone marrow transplantation or prior solid organ transplantation

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Genentech, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

HonorHealth Research Institute - Pima Center

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85258

Country

United States

Facility Name

The Angeles Clinic

City

Los Angeles

State/Province

California

ZIP/Postal Code

90025

Country

United States

Facility Name

Stanford Univ Medical Center; Dept Central Pharmacy

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

Yale Cancer Center

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

Facility Name

Moffitt Cancer Center

City

Tampa

State/Province

Florida

ZIP/Postal Code

33647

Country

United States

Facility Name

Uni of Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

Johns Hopkins Univ Med Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21231

Country

United States

Facility Name

Massachusetts General Hospital.

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Beth Israel Deaconess Med Ctr

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Dana Farber Can Ins

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Comprehensive Cancer Centers of Nevada - Eastern Avenue

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89169

Country

United States

Facility Name

New York Oncology Hematology, P.C.

City

Albany

State/Province

New York

ZIP/Postal Code

12206

Country

United States

Facility Name

Carolina BioOncology Institute; Can Therapy & Res Ctr

City

Huntersville

State/Province

North Carolina

ZIP/Postal Code

28078

Country

United States

Facility Name

Sarah Cannon Research Inst.

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Vanderbilt

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

Virginia Oncology Associates

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

Facility Name

Centre Leon Berard

City

Lyon

ZIP/Postal Code

69008

Country

France

Facility Name

Institut Claudius Regaud; Departement Oncologie Medicale

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

Institut Gustave Roussy; Drct

City

Villejuif

ZIP/Postal Code

94805

Country

France

Facility Name

Hospital Universitari Vall d'Hebron

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Barts & London School of Med; Medical Oncology

City

London

ZIP/Postal Code

EC1A 7BE

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

33568344

Citation

Petrylak DP, Loriot Y, Shaffer DR, Braiteh F, Powderly J, Harshman LC, Conkling P, Delord JP, Gordon M, Kim JW, Sarkar I, Yuen K, Kadel EE 3rd, Mariathasan S, O'Hear C, Narayanan S, Fasso M, Carroll S, Powles T. Safety and Clinical Activity of Atezolizumab in Patients with Metastatic Castration-Resistant Prostate Cancer: A Phase I Study. Clin Cancer Res. 2021 Jun 15;27(12):3360-3369. doi: 10.1158/1078-0432.CCR-20-1981. Epub 2021 Feb 10.

Results Reference

derived

PubMed Identifier

33241650

Citation

Shemesh CS, Chan P, Legrand FA, Shames DS, Das Thakur M, Shi J, Bailey L, Vadhavkar S, He X, Zhang W, Bruno R. Pan-cancer population pharmacokinetics and exposure-safety and -efficacy analyses of atezolizumab in patients with high tumor mutational burden. Pharmacol Res Perspect. 2020 Dec;8(6):e00685. doi: 10.1002/prp2.685.

Results Reference

derived

PubMed Identifier

32586767

Citation

Chiang AC, Sequist LVD, Gilbert J, Conkling P, Thompson D, Marcoux JP, Gettinger S, Kowanetz M, Molinero L, O'Hear C, Fasso M, Lam S, Gordon MS. Clinical Activity and Safety of Atezolizumab in a Phase 1 Study of Patients With Relapsed/Refractory Small-Cell Lung Cancer. Clin Lung Cancer. 2020 Sep;21(5):455-463.e4. doi: 10.1016/j.cllc.2020.05.008. Epub 2020 May 12.

Results Reference

derived

PubMed Identifier

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A Study of Atezolizumab (an Engineered Anti-Programmed Death-Ligand 1 [PDL1] Antibody) to Evaluate Safety, Tolerability and Pharmacokinetics in Participants With Locally Advanced or Metastatic Solid Tumors

Tumors, Hematologic Malignancies

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