Last reviewed · How we verify
Atezolizumab With Bevacizumab in Previously Untreated Metastatic/Unresectable Urothelial Cancer
Phase 2 trial testing Atezolizumab in Urothelial Carcinoma in 16 participants. Terminated before completion.
| Lead sponsor | Arjun Balar, MD |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 16 |
| Start date | 13 September 2017 |
| Primary completion | 27 May 2021 |
| Estimated completion | 17 March 2022 |
| Sites | 8 locations across United States |
Arjun Balar, MD
18 and older, any sex, with Urothelial Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Determine the percentage of overall survival at 1 years from the initiation of treatment. Overall survival is defined as the time from treatment start until death or date of last contact.
| Group | Value | 95% CI |
|---|---|---|
| Arm A - Atezolizumab + Bevacizumab | 67 |
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter(LD) of target lesions; Progressive Disease (PD): \>= 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as ref
| Group | Value | 95% CI |
|---|---|---|
| Arm A - Atezolizumab + Bevacizumab | 6.67 |
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. DOR is defined as time from measurement criteria are met for complete or partial response (whichever status is recorded first) until the date that recurrent o
| Group | Value | 95% CI |
|---|---|---|
| Arm A - Atezolizumab + Bevacizumab | 6.54 |
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. PFS is defined as time from the date of treatment start until the criteria for disease progression is met as defined by RECIST 1.1 or death occurs
| Group | Value | 95% CI |
|---|---|---|
| Arm A - Atezolizumab + Bevacizumab | 3.25 | 2.07 – NA |
Adverse events were recorded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.
| Group | Value | 95% CI |
|---|---|---|
| Arm A - Atezolizumab + Bevacizumab | 16 |
Time frame: All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Arm A - Atezolizumab + Bev… |
|---|---|---|
| SEPSIS | Infections and infestations | — |
| URINARY TRACT INFECTION | Infections and infestations | — |
| ANEMIA | Blood and lymphatic system disorders | — |
| BLOOD BILIRUBIN INCREASED | Investigations | — |
| ENCEPHALOPATHY | Nervous system disorders | — |
| FEVER | General disorders | — |
| HEPATIC FAILURE | Hepatobiliary disorders | — |
| HYPERGLYCEMIA | Metabolism and nutrition disorders | — |
| KIDNEY INFECTION | Infections and infestations | — |
| NAUSEA | Gastrointestinal disorders | — |
| PAIN | General disorders | — |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | — |
| SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY | Surgical and medical procedures | — |
| WOUND INFECTION | Infections and infestations | — |
| Reaction | System | Arm A - Atezolizumab + Bev… |
|---|---|---|
| ANEMIA | Blood and lymphatic system disorders | — |
| FATIGUE | General disorders | — |
| CREATININE INCREASED | Investigations | — |
| HYPERTENSION | Vascular disorders | — |
| PRURITUS | Skin and subcutaneous tissue disorders | — |
| ABDOMINAL PAIN | Gastrointestinal disorders | — |
| BACK PAIN | Musculoskeletal and connective tissue disorders | — |
| CHILLS | General disorders | — |
| FEVER | General disorders | — |
| GENERALIZED MUSCLE WEAKNESS | Musculoskeletal and connective tissue disorders | — |
| PROTEINURIA | Renal and urinary disorders | — |
| ANOREXIA | Metabolism and nutrition disorders | — |
| CONSTIPATION | Gastrointestinal disorders | — |
| HYPONATREMIA | Metabolism and nutrition disorders | — |
| NAUSEA | Gastrointestinal disorders | — |
| URINARY TRACT INFECTION | Infections and infestations | — |
| VOMITING | Gastrointestinal disorders | — |
| ALKALINE PHOSPHATASE INCREASED | Investigations | — |
| CONFUSION | Psychiatric disorders | — |
| DYSPNEA | Respiratory, thoracic and mediastinal disorders | — |
| EDEMA LIMBS | General disorders | — |
| HYPOALBUMINEMIA | Metabolism and nutrition disorders | — |
| HYPOTENSION | Vascular disorders | — |
| MUSCLE WEAKNESS LOWER LIMB | Musculoskeletal and connective tissue disorders | — |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | — |
| SINUS TACHYCARDIA | Cardiac disorders | — |
| WEIGHT LOSS | Investigations | — |
| AGITATION | Psychiatric disorders | — |
| ALLERGIC RHINITIS | Respiratory, thoracic and mediastinal disorders | — |
| COUGH | Respiratory, thoracic and mediastinal disorders | — |
| DEHYDRATION | Metabolism and nutrition disorders | — |
| DIARRHEA | Gastrointestinal disorders | — |
| DIZZINESS | Nervous system disorders | — |
| DRY SKIN | Skin and subcutaneous tissue disorders | — |
| GASTROESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | — |
| HEMATURIA | Renal and urinary disorders | — |
| HOARSENESS | Respiratory, thoracic and mediastinal disorders | — |
| HYPOKALEMIA | Metabolism and nutrition disorders | — |
| HYPOTHYROIDISM | Endocrine disorders | — |
| MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY | Musculoskeletal and connective tissue disorders | — |
Most-reported serious reactions: SEPSIS, URINARY TRACT INFECTION, ANEMIA, BLOOD BILIRUBIN INCREASED, ENCEPHALOPATHY, FEVER, HEPATIC FAILURE, HYPERGLYCEMIA.
Data from ClinicalTrials.gov NCT03272217 adverse events section.
This is a phase II study assessing the activity of bevacizumab combined with atezolizumab in metastatic urothelial carcinoma patients who are ineligible for cisplatin-based therapy.
8 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
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/NCT03272217.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing