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NCT02458638

A Study of Atezolizumab in Advanced Solid Tumors

Completed Phase 2 Results posted Last updated 4 June 2021
What this trial tests

Phase 2 trial testing Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody in Tumors in 474 participants. Completed in 28 July 2020.

Timeline
16 July 2015
Primary endpoint
4 April 2018
28 July 2020

Quick facts

Lead sponsorHoffmann-La Roche
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment474
Start date16 July 2015
Primary completion4 April 2018
Estimated completion28 July 2020
Sites48 locations across Denmark, France, Finland, Italy, Netherlands, Russia, Austria, Ireland

Drugs / interventions tested

Conditions studied

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

18 and older, any sex, with Tumors. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Non-progression Rate (NPR) at 18 Weeks Primary · At Week 18

NPR was defined as the percentage of participants with complete response (CR), partial response (PR) or stable disease (SD) as assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST), v1.1 or for malignant pleural mesothelioma according to Malignant Pleural Mesothelioma Response Evaluation Criteria. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions in the absence of CR. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progr

Overall Population
GroupValue95% CI
Atezolizumab26.822.7 – 31.2
Cervical Cancer
GroupValue95% CI
Atezolizumab44.425.5 – 64.7
Nasopharyngeal Carcinoma
GroupValue95% CI
Atezolizumab29.613.8 – 50.2
High Microsatellite Instability (MSI-H) or Mismatch Repair (MMR) Deficient Colorectal Cancer
GroupValue95% CI
Atezolizumab40.012.2 – 73.8
Breast Cancer Type 1/2 Susceptibility Protein (BRCA) Mutated Ovarian Cancer
GroupValue95% CI
Atezolizumab26.77.8 – 55.1
BRCA Mutated Breast Cancer
GroupValue95% CI
Atezolizumab00 – 26.5
Liposarcoma
GroupValue95% CI
Atezolizumab7.70.2 – 36.0
Leiomyosarcoma
GroupValue95% CI
Atezolizumab17.63.8 – 43.4
NPR at 24 Weeks Secondary · At Week 24

NPR was defined as the percentage of participants with complete response (CR), partial response (PR) or stable disease (SD) as assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST), v1.1 or for malignant pleural mesothelioma according to Malignant Pleural Mesothelioma Response Evaluation Criteria. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions in the absence of CR. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progr

Overall Population
GroupValue95% CI
Atezolizumab22.418.6 – 26.6
Cervical Cancer
GroupValue95% CI
Atezolizumab40.722.4 – 61.2
Nasopharyngeal Carcinoma
GroupValue95% CI
Atezolizumab22.28.6 – 42.3
MSI-H or MMR Deficient Colorectal Cancer
GroupValue95% CI
Atezolizumab40.012.2 – 73.8
BRCA Mutated Ovarian Cancer
GroupValue95% CI
Atezolizumab20.04.3 – 48.1
BRCA Mutated Breast Cancer
GroupValue95% CI
Atezolizumab00 – 26.5
Liposarcoma
GroupValue95% CI
Atezolizumab7.70.2 – 36.0
Leiomyosarcoma
GroupValue95% CI
Atezolizumab11.81.5 – 36.4
Overall Response Rate (ORR) Secondary · Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)

ORR was defined as the percentage of participants with CR or PR as assessed by the investigator using RECIST v1.1 or Malignant Pleural Mesothelioma Response Evaluation Criteria. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. For prostate cancer according to Prostate Response Evaluation Criteria. CR: PSA \<5 ng/ml measured twice at least 3 weeks apart or PSA response: PSA \< 50% of the PSA reference value occurring at any time a

Overall Population
GroupValue95% CI
Atezolizumab7.45.1 – 10.3
Cervical Cancer
GroupValue95% CI
Atezolizumab14.84.2 – 33.7
Nasopharyngeal Carcinoma
GroupValue95% CI
Atezolizumab7.40.9 – 24.3
MSI-H or MMR Deficient Colorectal Cancer
GroupValue95% CI
Atezolizumab00 – 30.8
BRCA Mutated Ovarian Cancer
GroupValue95% CI
Atezolizumab13.31.7 – 40.5
BRCA Mutated Breast Cancer
GroupValue95% CI
Atezolizumab00 – 26.5
Liposarcoma
GroupValue95% CI
Atezolizumab00 – 24.7
Leiomyosarcoma
GroupValue95% CI
Atezolizumab5.90.1 – 28.7
Percentage of Participants by Best Overall Response (BOR) Secondary · Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)

BOR was based on RECIST v1.1, Malignant Pleural Mesothelioma Response Evaluation Criteria or Prostate Response Evaluation Criteria. For an individual participant BOR was obtained as follows: 1) CR: overall tumor response assessment of CR at 2 consecutive visits at least 28 days apart. 2) PR: overall tumor response assessment of PR or CR at 2 consecutive visits at least 28 days apart without being a CR. 3) SD: overall tumor response assessment of SD, PR, or CR at one or more visits at least 42 days after start of study treatment, but was not a confirmed CR or PR. 4) PD: an overall tumor respons

Overall Population: CR
GroupValue95% CI
Atezolizumab0.7
Overall Population: PR
GroupValue95% CI
Atezolizumab6.7
Overall Population: SD
GroupValue95% CI
Atezolizumab36.3
Overall Population: PD
GroupValue95% CI
Atezolizumab53.3
Overall Population: Missing
GroupValue95% CI
Atezolizumab3.0
Cervical Cancer: CR
GroupValue95% CI
Atezolizumab3.7
Cervical Cancer: PR
GroupValue95% CI
Atezolizumab11.1
Cervical Cancer: SD
GroupValue95% CI
Atezolizumab40.7
Clinical Benefit Rate (CBR) Secondary · Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)

CBR was defined as the percentage of participants with CR, PR, or SD according to RECIST v1.1, Malignant Pleural Mesothelioma Response Evaluation Criteria or Prostate Response Evaluation Criteria lasting for \>/=6 weeks. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions in the absence of CR. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions. F

Overall Population
GroupValue95% CI
Atezolizumab43.638.9 – 48.5
Cervical Cancer
GroupValue95% CI
Atezolizumab55.635.3 – 74.5
Nasopharyngeal Carcinoma
GroupValue95% CI
Atezolizumab51.931.9 – 71.3
MSI-H or MMR Deficient Colorectal Cancer
GroupValue95% CI
Atezolizumab40.012.2 – 73.8
BRCA Mutated Ovarian Cancer
GroupValue95% CI
Atezolizumab46.721.3 – 73.4
BRCA Mutated Breast Cancer
GroupValue95% CI
Atezolizumab8.30.2 – 38.5
Liposarcoma
GroupValue95% CI
Atezolizumab30.89.1 – 61.4
Leiomyosarcoma
GroupValue95% CI
Atezolizumab23.56.8 – 49.9
Duration of Objective Response (DOR) Secondary · Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)

DOR, based on RECIST v1.1, was defined as the time from the first occurrence of a documented objective response (CR or PR) to the time of progression or death from any cause, whichever occurred first. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions in the absence of CR. PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions. As pre-specified in the Statistical Analysis Plan (SAP) DOR was not analyzed if there were less than 4 participants available for the ana

Cervical Cancer
GroupValue95% CI
Atezolizumab12.63.0 – 15.2
Nasopharyngeal Carcinoma
GroupValue95% CI
AtezolizumabNA1.1 – NA
Thymoma
GroupValue95% CI
Atezolizumab19.01.5 – NA
Progression-Free Survival (PFS) Secondary · Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)

PFS, based on RECIST v1.1, was defined as the time from the first day of study treatment to the first occurrence of disease progression or death from any cause, whichever occurred first. PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions.

Cervical Cancer
GroupValue95% CI
Atezolizumab4.141.31 – 8.34
Nasopharyngeal Carcinoma
GroupValue95% CI
Atezolizumab3.151.35 – 4.60
MSI-H or MMR Deficient Colorectal Cancer
GroupValue95% CI
Atezolizumab1.510.72 – 10.97
BRCA Mutated Ovarian Cancer
GroupValue95% CI
Atezolizumab2.731.45 – 4.01
BRCA Mutated Breast Cancer
GroupValue95% CI
Atezolizumab1.380.99 – 1.54
Liposarcoma
GroupValue95% CI
Atezolizumab1.511.25 – 4.70
Leiomyosarcoma
GroupValue95% CI
Atezolizumab2.691.28 – 3.12
Gastrointestinal Stromal Tumor (GIST)
GroupValue95% CI
Atezolizumab1.411.15 – 2.79
Time to Progression (TTP) Secondary · Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)

Time to progression (TTP), based on RECIST v1.1, was defined as time from the first day of study treatment to the first occurrence of progressive disease or death due to disease progression, whichever occurred first. PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions.

Cervical Cancer
GroupValue95% CI
Atezolizumab4.141.31 – 8.34
Nasopharyngeal Carcinoma
GroupValue95% CI
Atezolizumab3.451.35 – 4.60
MSI-H or MMR Deficient Colorectal Cancer
GroupValue95% CI
Atezolizumab1.510.72 – 10.97
BRCA Mutated Ovarian Cancer
GroupValue95% CI
Atezolizumab2.731.45 – 4.01
BRCA Mutated Breast Cancer
GroupValue95% CI
Atezolizumab1.380.99 – 1.54
Liposarcoma
GroupValue95% CI
Atezolizumab1.511.25 – 4.70
Leiomyosarcoma
GroupValue95% CI
Atezolizumab2.691.28 – 3.12
Gastrointestinal Stromal Tumor (GIST)
GroupValue95% CI
Atezolizumab1.411.15 – 2.79
Overall Survival (OS) Secondary · Baseline until death due to any cause (up to 4.5 years)

OS was defined as the time from the first day of study treatment to death from any cause.

Cervical Cancer
GroupValue95% CI
Atezolizumab14.7810.55 – 26.51
Nasopharyngeal Carcinoma
GroupValue95% CI
Atezolizumab17.978.90 – 27.56
MSI-H or MMR Deficient Colorectal Cancer
GroupValue95% CI
Atezolizumab6.410.99 – 22.90
BRCA Mutated Ovarian Cancer
GroupValue95% CI
Atezolizumab24.024.11 – NA
BRCA Mutated Breast Cancer
GroupValue95% CI
Atezolizumab5.091.77 – 7.03
Liposarcoma
GroupValue95% CI
Atezolizumab12.714.37 – 24.44
Leiomyosarcoma
GroupValue95% CI
Atezolizumab9.663.12 – 13.67
Gastrointestinal Stromal Tumor (GIST)
GroupValue95% CI
Atezolizumab7.392.89 – 11.70
Number of Participants With Adverse Events Secondary · Baseline up to 4.5 years

An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

GroupValue95% CI
Atezolizumab435
Treatment Duration of Atezolizumab Secondary · Baseline up to approximately 4.5 years
GroupValue95% CI
Atezolizumab2.5130.03 – 52.47
Mean Number of Doses of Atezolizumab Secondary · Baseline up to approximately 4.5 years
GroupValue95% CI
Atezolizumab9.0± 11.28

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to approximately 4.5 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Atezolizumab
Serious: 142/474 (30%)
Deaths: 310/474

Serious adverse events (135 terms)

ReactionSystemAtezolizumab
PYREXIAGeneral disorders—
PNEUMONIAInfections and infestations—
ANAEMIABlood and lymphatic system disorders—
DYSPNOEARespiratory, thoracic and mediastinal disorders—
URINARY TRACT INFECTIONInfections and infestations—
SEPSISInfections and infestations—
COLITISGastrointestinal disorders—
FATIGUEGeneral disorders—
GENERAL PHYSICAL HEALTH DETERIORATIONGeneral disorders—
CEREBROVASCULAR ACCIDENTNervous system disorders—
ACUTE KIDNEY INJURYRenal and urinary disorders—
PLEURAL EFFUSIONRespiratory, thoracic and mediastinal disorders—
PULMONARY EMBOLISMRespiratory, thoracic and mediastinal disorders—
FEBRILE NEUTROPENIABlood and lymphatic system disorders—
THROMBOCYTOPENIABlood and lymphatic system disorders—
INAPPROPRIATE ANTIDIURETIC HORMONE SECRETIONEndocrine disorders—
ABDOMINAL PAINGastrointestinal disorders—
CONSTIPATIONGastrointestinal disorders—
GASTRIC ULCERGastrointestinal disorders—
GASTROINTESTINAL HAEMORRHAGEGastrointestinal disorders—
PANCREATITISGastrointestinal disorders—
MALAISEGeneral disorders—
HEPATITISHepatobiliary disorders—
ERYSIPELASInfections and infestations—
INFECTIONInfections and infestations—
Other adverse events (22 terms — click to expand)

ReactionSystemAtezolizumab
FATIGUEGeneral disorders—
DIARRHOEAGastrointestinal disorders—
NAUSEAGastrointestinal disorders—
DECREASED APPETITEMetabolism and nutrition disorders—
PYREXIAGeneral disorders—
ANAEMIABlood and lymphatic system disorders—
ASTHENIAGeneral disorders—
VOMITINGGastrointestinal disorders—
DYSPNOEARespiratory, thoracic and mediastinal disorders—
CONSTIPATIONGastrointestinal disorders—
COUGHRespiratory, thoracic and mediastinal disorders—
RASHSkin and subcutaneous tissue disorders—
ABDOMINAL PAINGastrointestinal disorders—
HYPOTHYROIDISMEndocrine disorders—
OEDEMA PERIPHERALGeneral disorders—
PRURITUSSkin and subcutaneous tissue disorders—
BACK PAINMusculoskeletal and connective tissue disorders—
MYALGIAMusculoskeletal and connective tissue disorders—
HEADACHENervous system disorders—
ASPARTATE AMINOTRANSFERASE INCREASEDInvestigations—
WEIGHT DECREASEDInvestigations—
HYPOKALAEMIAMetabolism and nutrition disorders—

Most-reported serious reactions: PYREXIA, PNEUMONIA, ANAEMIA, DYSPNOEA, URINARY TRACT INFECTION, SEPSIS, COLITIS, FATIGUE.

Data from ClinicalTrials.gov NCT02458638 adverse events section.

Sponsor's own description

The primary efficacy objective for this study is to evaluate non-progression rate (NPR) at 18 weeks in participants with advanced solid tumors treated with atezolizumab, defined as the percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1, or according to disease-specific criteria for prostate cancer and malignant pleural mesothelioma.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Immunotherapy in pancreatic cancer treatment: a new frontier.
    Thind K, Padrnos LJ, Ramanathan RK, Borad MJ. · · 2017 · cited 65× · PMID 28286568 · DOI 10.1177/1756283x16667909
  2. Emerging therapeutic targets in metastatic progression: A focus on breast cancer.
    Li Z, Kang Y. · · 2016 · cited 51× · PMID 27000769 · DOI 10.1016/j.pharmthera.2016.03.003
  3. Promoter methylation of the immune checkpoint receptor <i>PD-1</i> (<i>PDCD1</i>) is an independent prognostic biomarker for biochemical recurrence-free survival in prostate cancer patients following radical prostatectomy.
    Goltz D, Gevensleben H, Dietrich J, Ellinger J, et al · · 2016 · cited 42× · PMID 27853645 · DOI 10.1080/2162402x.2016.1221555
  4. Next generation sequencing-based emerging trends in molecular biology of gastric cancer.
    Verma R, Sharma PC. · · 2018 · cited 38× · PMID 29511593
  5. Immunotherapy for Prostate Cancer: Where We Are Headed.
    Schepisi G, Farolfi A, Conteduca V, Martignano F, et al · · 2017 · cited 38× · PMID 29206214 · DOI 10.3390/ijms18122627
  6. Very low expression of PD-L1 in medullary thyroid carcinoma.
    Bongiovanni M, Rebecchini C, Saglietti C, Bulliard JL, et al · · 2017 · cited 38× · PMID 28420659 · DOI 10.1530/erc-17-0104
  7. Phase II multicohort study of atezolizumab monotherapy in multiple advanced solid cancers.
    Tabernero J, Andre F, Blay JY, Bustillos A, et al · · 2022 · cited 30× · PMID 35305400 · DOI 10.1016/j.esmoop.2022.100419
  8. The Immune Checkpoint Regulator PDL1 is an Independent Prognostic Biomarker for Biochemical Recurrence in Prostate Cancer Patients Following Adjuvant Hormonal Therapy.
    Li H, Wang Z, Zhang Y, Sun G, et al · · 2019 · cited 29× · PMID 31289580 · DOI 10.7150/jca.30384

Verify or expand the search:

Other trials of Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody

Trials testing the same drug.

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Other Hoffmann-La Roche trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02458638.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing