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AzTrials

TumorsPhase 1NCT01375842

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 1 study testing Atezolizumab in people with Tumors and Hematologic Malignancies, run by Genentech, Inc. at 21 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tumors, Hematologic Malignancies
What is being tested?
Atezolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
661 participants
Where
21 sitesin 4 countries
Study dates
21 Jun 2011to 30 Sep 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

21 sites in 4 countries.

21 sites in 4 countries

United States16 sites

  • New York Oncology Hematology, P.C.

    Albany, New York, 12206

  • Johns Hopkins Univ Med Center

    Baltimore, Maryland, 21231

  • Massachusetts General Hospital.

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Med Ctr

    Boston, Massachusetts, 02215

  • Dana Farber Can Ins

    Boston, Massachusetts, 02215

  • Uni of Chicago

    Chicago, Illinois, 60637

  • Carolina BioOncology Institute; Can Therapy & Res Ctr

    Huntersville, North Carolina, 28078

  • Comprehensive Cancer Centers of Nevada - Eastern Avenue

    Las Vegas, Nevada, 89169

  • The Angeles Clinic

    Los Angeles, California, 90025

  • Sarah Cannon Research Inst.

    Nashville, Tennessee, 37203

  • Vanderbilt

    Nashville, Tennessee, 37232

  • Yale Cancer Center

    New Haven, Connecticut, 06520

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • HonorHealth Research Institute - Pima Center

    Scottsdale, Arizona, 85258

  • Stanford Univ Medical Center; Dept Central Pharmacy

    Stanford, California, 94305

  • Moffitt Cancer Center

    Tampa, Florida, 33647

Other trials in United States

France3 sites

  • Centre Leon Berard

    Lyon, 69008

  • Institut Claudius Regaud; Departement Oncologie Medicale

    Toulouse, 31059

  • Institut Gustave Roussy; Drct

    Villejuif, 94805

Other trials in France

Spain1 site

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

Other trials in Spain

United Kingdom1 site

  • Barts & London School of Med; Medical Oncology

    London, EC1A 7BE

Other trials in United Kingdom

About this study

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

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.

Being tested
Atezolizumab
Medical subject headings
Neoplasms, Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabDrug

    Also called MPDL3280A

    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.

Study groups in NCT01375842
Study groupRoleWhat they receive
Dose Escalation Cohort: Atezolizumab 0.01 mg/kgExperimentalParticipants 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.
Receives: Drug: Atezolizumab
Dose Escalation Cohort: Atezolizumab 0.03 mg/kgExperimentalParticipants 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.
Receives: Drug: Atezolizumab
Dose Escalation Cohort: Atezolizumab 0.1 mg/kgExperimentalParticipants 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.
Receives: Drug: Atezolizumab
Dose Escalation Cohort: Atezolizumab 0.3 mg/kgExperimentalParticipants 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.
Receives: Drug: Atezolizumab
Dose Escalation Cohort: Atezolizumab 1 mg/kgExperimentalParticipants 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.
Receives: Drug: Atezolizumab
Dose Escalation Cohort: Atezolizumab 3 mg/kgExperimentalParticipants 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.
Receives: Drug: Atezolizumab
Dose Escalation Cohort: Atezolizumab 10 mg/kgExperimentalParticipants 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.
Receives: Drug: Atezolizumab
Dose Escalation Cohort: Atezolizumab 20 mg/kgExperimentalParticipants 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.
Receives: Drug: Atezolizumab
Expansion Cohort (Atezolizumab)ExperimentalParticipants 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.
Receives: Drug: Atezolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Dose Limiting Toxicities (DLTs)

    Measured: Day 1 up to Day 21

  2. Maximum Tolerated Dose (MTD) of Atezolizumab

    Measured: Day 1 up to Day 21

  3. Recommended Phase 2 Dose (RP2D) of Atezolizumab

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

  4. Percentage of Participants With Adverse Events

    Measured: 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 outcomes (14)

  1. Percentage of Participants With Anti-Therapeutic Antibodies (ATAs)

    Measured: 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)

  2. 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)

    Measured: 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)

  3. 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)

    Measured: 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)

  4. 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)

    Measured: 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)

  5. 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)

    Measured: 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)

  6. 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)

    Measured: 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)

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

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

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

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

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

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

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

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

  11. Duration of Objective Response, Assessed by RECIST v1.1

    Measured: 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)

  12. Duration of Objective Response, Assessed by irRC

    Measured: 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)

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

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

  14. PFS, Assessed by irRC

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2011 (estimated)
  2. Study start21 Jun 2011
  3. Primary completion30 Sep 2018
  4. Study completion30 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
661 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01375842
Sponsor's protocol ID
PCD4989g
Other IDs
2011-001422-23, GO27831
Status last verified
Dec 2018
First submitted
16 Jun 2011
Last updated
11 Dec 2018
Results posted
No

Publications

  • Kondo S, Kitano S, Sato J, Katsuya Y, Kogawa T, Mizugaki H, Miyamoto I, Iwasawa S, Imaizumi T, Tomita H, Murakami C, Miyake T, Yamamoto N. An investigation of extended-interval dosing of atezolizumab in Japanese patients with advanced solid tumors: safety and pharmacokinetics of a dose of 1680 mg every 4 weeks. Invest New Drugs. 2025 Jun;43(3):602-608. doi: 10.1007/s10637-024-01498-0. Epub 2025 May 1.

    PubMed 40310568

  • 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.

    PubMed 33568344

  • 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.

    PubMed 33241650

  • 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.

    PubMed 32586767

  • 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.

    PubMed 31647026

  • 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.

    PubMed 31542806

  • 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.

    PubMed 31358540

  • 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.

    PubMed 31204078

  • 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.

    PubMed 30242306

  • 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.

    PubMed 30219915

  • 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.

    PubMed 30077125

  • 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.

    PubMed 30073642

  • 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.

    PubMed 29423515

  • 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.

    PubMed 26755520

  • 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.

    PubMed 25428504

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Atezolizumab in people with Tumors and Hematologic Malignancies, run by Genentech, Inc. at 21 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, France, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Dose Limiting Toxicities (DLTs) (time frame: Day 1 up to Day 21). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01375842, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2018.

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