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

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

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.

Study Overview

• Status: Completed
• Conditions: Hematologic Malignancies; Tumors
• Intervention / Treatment: Drug: Atezolizumab

• Study Type: Interventional
• Enrollment (Actual): 661
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69008
    • Centre LEON BERARD
  • Toulouse, France, 31059
    • Institut Claudius Regaud; Departement Oncologie Medicale
  • Villejuif, France, 94805
    • Institut Gustave Roussy; Drct
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
• United Kingdom
  • London, United Kingdom, EC1A 7BE
    • Barts & London School of Med; Medical Oncology
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • HonorHealth Research Institute - Pima Center
  • California
    • Los Angeles, California, United States, 90025
      • The Angeles Clinic
    • Stanford, California, United States, 94305
      • Stanford Univ Medical Center; Dept Central Pharmacy
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale Cancer Center
  • Florida
    • Tampa, Florida, United States, 33647
      • Moffitt Cancer Center
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Uni of Chicago
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • Johns Hopkins Univ Med Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Med Ctr
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Can Ins
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital.
  • Nevada
    • Las Vegas, Nevada, United States, 89169
      • Comprehensive Cancer Centers of Nevada - Eastern Avenue
  • New York
    • Albany, New York, United States, 12206
      • New York Oncology Hematology, P.C.
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • Carolina BioOncology Institute; Can Therapy & Res Ctr
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Inst.
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Oncology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Escalation Cohort: Atezolizumab 0.01 mg/kg; 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.	Drug: Atezolizumab; 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; Other Names: MPDL3280A
Experimental: Dose Escalation Cohort: Atezolizumab 0.03 mg/kg; 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.	Drug: Atezolizumab; 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; Other Names: MPDL3280A
Experimental: Dose Escalation Cohort: Atezolizumab 0.1 mg/kg; 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.	Drug: Atezolizumab; 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; Other Names: MPDL3280A
Experimental: Dose Escalation Cohort: Atezolizumab 0.3 mg/kg; 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.	Drug: Atezolizumab; 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; Other Names: MPDL3280A
Experimental: Dose Escalation Cohort: Atezolizumab 1 mg/kg; 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.	Drug: Atezolizumab; 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; Other Names: MPDL3280A
Experimental: Dose Escalation Cohort: Atezolizumab 3 mg/kg; 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.	Drug: Atezolizumab; 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; Other Names: MPDL3280A
Experimental: Dose Escalation Cohort: Atezolizumab 10 mg/kg; 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.	Drug: Atezolizumab; 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; Other Names: MPDL3280A
Experimental: Dose Escalation Cohort: Atezolizumab 20 mg/kg; 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.	Drug: Atezolizumab; 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; Other Names: MPDL3280A
Experimental: Expansion Cohort (Atezolizumab); 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.	Drug: Atezolizumab; 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; Other Names: MPDL3280A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Dose Limiting Toxicities (DLTs)	Day 1 up to Day 21
Maximum Tolerated Dose (MTD) of Atezolizumab	Day 1 up to Day 21
Recommended Phase 2 Dose (RP2D) of Atezolizumab	Baseline up to time of determination of MTD (up to Day 21)
Percentage of Participants With Adverse Events	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 Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs)		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)
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)	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)
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)	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)
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)	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)
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)	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)
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)	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)
Percentage of Participants With Best Overall Response, Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)		From Baseline up to the first occurrence of progression or death, whichever occurs first (up to approx 7 yrs)
Percentage of Participants With Best Overall Response, Assessed by Immune-Related Response Criteria (irRC)		From Baseline up to the first occurrence of progression or death, whichever occurs first (up to approx 7 yrs)
Percentage of Participants With Objective Response (Complete Response [CR] or Partial Response [PR]), Assessed by RECIST v1.1		From Baseline up to the first occurrence of progression or death, whichever occurs first (up to approx 7 yrs)
Percentage of Participants With Objective Response (CR or PR), Assessed by irRC		From Baseline up to the first occurrence of progression or death, whichever occurs first (up to approx 7 yrs)
Duration of Objective Response, Assessed by RECIST v1.1		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)
Duration of Objective Response, Assessed by irRC		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)
Progression-Free Survival (PFS), Assessed by RECIST v1.1		From Baseline up to the first occurrence of progression or death, whichever occurs first (up to approx 7 yrs)
PFS, Assessed by irRC		From Baseline up to the first occurrence of progression or death, whichever occurs first (up to approx 7 yrs)

Collaborators and Investigators

• Sponsor: Genentech, Inc.

Publications and helpful links

General Publications

• 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.
• Morrissey KM, Marchand M, Patel H, Zhang R, Wu B, Phyllis Chan H, Mecke A, Girish S, Jin JY, Winter HR, Bruno R. Alternative dosing regimens for atezolizumab: an example of model-informed drug development in the postmarketing setting. Cancer Chemother Pharmacol. 2019 Dec;84(6):1257-1267. doi: 10.1007/s00280-019-03954-8. Epub 2019 Sep 21.
• 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.
• 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.
• Molinero L, Li Y, Chang CW, Maund S, Berg M, Harrison J, Fasso M, O'Hear C, Hegde P, Emens LA. Tumor immune microenvironment and genomic evolution in a patient with metastatic triple negative breast cancer and a complete response to atezolizumab. J Immunother Cancer. 2019 Oct 23;7(1):274. doi: 10.1186/s40425-019-0740-8.
• Hamid O, Molinero L, Bolen CR, Sosman JA, Munoz-Couselo E, Kluger HM, McDermott DF, Powderly JD, Sarkar I, Ballinger M, Fasso M, O'Hear C, Chen DS, Hegde PS, Hodi FS. Safety, Clinical Activity, and Biological Correlates of Response in Patients with Metastatic Melanoma: Results from a Phase I Trial of Atezolizumab. Clin Cancer Res. 2019 Oct 15;25(20):6061-6072. doi: 10.1158/1078-0432.CCR-18-3488. Epub 2019 Jul 29.
• Liu JF, Gordon M, Veneris J, Braiteh F, Balmanoukian A, Eder JP, Oaknin A, Hamilton E, Wang Y, Sarkar I, Molinero L, Fasso M, O'Hear C, Lin YG, Emens LA. Safety, clinical activity and biomarker assessments of atezolizumab from a Phase I study in advanced/recurrent ovarian and uterine cancers. Gynecol Oncol. 2019 Aug;154(2):314-322. doi: 10.1016/j.ygyno.2019.05.021. Epub 2019 Jun 14.
• Emens LA, Cruz C, Eder JP, Braiteh F, Chung C, Tolaney SM, Kuter I, Nanda R, Cassier PA, Delord JP, Gordon MS, ElGabry E, Chang CW, Sarkar I, Grossman W, O'Hear C, Fasso M, Molinero L, Schmid P. Long-term Clinical Outcomes and Biomarker Analyses of Atezolizumab Therapy for Patients With Metastatic Triple-Negative Breast Cancer: A Phase 1 Study. JAMA Oncol. 2019 Jan 1;5(1):74-82. doi: 10.1001/jamaoncol.2018.4224.
• Colevas AD, Bahleda R, Braiteh F, Balmanoukian A, Brana I, Chau NG, Sarkar I, Molinero L, Grossman W, Kabbinavar F, Fasso M, O'Hear C, Powderly J. Safety and clinical activity of atezolizumab in head and neck cancer: results from a phase I trial. Ann Oncol. 2018 Nov 1;29(11):2247-2253. doi: 10.1093/annonc/mdy411.
• Horn L, Gettinger SN, Gordon MS, Herbst RS, Gandhi L, Felip E, Sequist LV, Spigel DR, Antonia SJ, Balmanoukian A, Cassier PA, Liu B, Kowanetz M, O'Hear C, Fasso M, Grossman W, Sandler A, Soria JC. Safety and clinical activity of atezolizumab monotherapy in metastatic non-small-cell lung cancer: final results from a phase I study. Eur J Cancer. 2018 Sep;101:201-209. doi: 10.1016/j.ejca.2018.06.031. Epub 2018 Aug 1.
• Lukas RV, Rodon J, Becker K, Wong ET, Shih K, Touat M, Fasso M, Osborne S, Molinero L, O'Hear C, Grossman W, Baehring J. Clinical activity and safety of atezolizumab in patients with recurrent glioblastoma. J Neurooncol. 2018 Nov;140(2):317-328. doi: 10.1007/s11060-018-2955-9. Epub 2018 Aug 2.
• Petrylak DP, Powles T, Bellmunt J, Braiteh F, Loriot Y, Morales-Barrera R, Burris HA, Kim JW, Ding B, Kaiser C, Fasso M, O'Hear C, Vogelzang NJ. Atezolizumab (MPDL3280A) Monotherapy for Patients With Metastatic Urothelial Cancer: Long-term Outcomes From a Phase 1 Study. JAMA Oncol. 2018 Apr 1;4(4):537-544. doi: 10.1001/jamaoncol.2017.5440.
• McDermott DF, Sosman JA, Sznol M, Massard C, Gordon MS, Hamid O, Powderly JD, Infante JR, Fasso M, Wang YV, Zou W, Hegde PS, Fine GD, Powles T. Atezolizumab, an Anti-Programmed Death-Ligand 1 Antibody, in Metastatic Renal Cell Carcinoma: Long-Term Safety, Clinical Activity, and Immune Correlates From a Phase Ia Study. J Clin Oncol. 2016 Mar 10;34(8):833-42. doi: 10.1200/JCO.2015.63.7421. Epub 2016 Jan 11.
• Herbst RS, Soria JC, Kowanetz M, Fine GD, Hamid O, Gordon MS, Sosman JA, McDermott DF, Powderly JD, Gettinger SN, Kohrt HE, Horn L, Lawrence DP, Rost S, Leabman M, Xiao Y, Mokatrin A, Koeppen H, Hegde PS, Mellman I, Chen DS, Hodi FS. Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients. Nature. 2014 Nov 27;515(7528):563-7. doi: 10.1038/nature14011.

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2011
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: June 16, 2011
• First Submitted That Met QC Criteria: June 16, 2011
• First Posted (Estimate): June 17, 2011

Study Record Updates

• Last Update Posted (Actual): December 11, 2018
• Last Update Submitted That Met QC Criteria: December 10, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Hematologic Diseases; Neoplasms; Hematologic Neoplasms; Antineoplastic Agents; Atezolizumab
• Other Study ID Numbers: PCD4989g; 2011-001422-23 (EudraCT Number); GO27831 (Other Identifier: Hoffmann-La Roche)