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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004165-58 | EudraCT Number |
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The study was prematurely terminated due to slow patient accrual and discontinuation of clinical development of MOXR0916 due to Sponsor's strategic priorities.
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This is a Phase II, multicenter, randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of MOXR0916 in combination with atezolizumab versus placebo and atezolizumab in participants with locally advanced or metastatic urothelial carcinoma (UC) who have not received prior systemic therapy in the locally advanced/metastatic setting and who are ineligible to receive cisplatin-based therapy.
The study design has been amended after the decision to prematurely stop patient accrual due to enrollment challenges. As only 5 participants were enrolled, the study blinding will not be maintained, and placebo infusions will not be administered. Patients assigned to the MOXR0916 arm may continue study treatment with the combination of atezolizumab and MOXR0916 or with atezolizumab alone based on a discussion of benefit and risk with the treating investigator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MOXR0916 plus Atezolizumab | Experimental |
| |
| Atezolizumab | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MOXR0916 | Drug | MOXR0916, 300 milligram (mg) by intravenous (IV) infusion on Day 1 of each 21-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first. Per RECIST v1.1, progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline); and an absolute increase of >= 5 millimeter (mm) in the sum of diameters. | Up to approximately 45 months |
| Overall Survival (OS) | Kaplan Meier estimate of median OS was defined as the time at which half of the participants had died, regardless of the cause of death. | Up to approximately 45 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response (OR) According to RECIST v1.1 | OR is defined as a complete response (CR) or partial response (PR) on two consecutive occasions >= 4 weeks apart, as determined by the investigator according to RECIST v1.1. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Oncology - HOPE Wilmot | Tucson | Arizona | 85710 | United States | ||
| University of Colorado |
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| ID | Title | Description |
|---|---|---|
| FG000 | MOXR0916 Plus Atezolizumab | Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle. |
| FG001 | Atezolizumab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 29, 2017 |
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The study design has been amended in that the study blinding will not be maintained.
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| Atezolizumab | Drug | Atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle. |
|
| Up to approximately 45 months |
| Duration of Objective Response (DOR) According to RECIST v1.1 | DOR is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first, as determined by the investigator according to RECIST v1.1. Objective response is defined as a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. | Up to approximately 45 months |
| Time to Pain Progression, Pain Palliation, and Fatigue Progression as Measured by Participant-Reported Severity According to the M. D. Anderson Symptom Inventory (MDASI) | The MDASI is a cancer-related, self-reported questionnaire consisting of 19 items assessing symptom severity and interference with different aspects of a participant's life. The MDASI items are rated from 0 to 10, with 0 indicating that the symptom is either not present or does not interfere with the participant's activities and 10 indicating that the symptom is "as bad as you can imagine" or "interfered completely" with the participant's life. | Up to approximately 45 months |
| Percentage of Participants Reporting Symptom Interference With Daily Living at the Time of Progression According to the MDASI | The MDASI is a cancer-related, self-reported questionnaire consisting of 19 items assessing symptom severity and interference with different aspects of a participant's life. The MDASI items are rated from 0 to 10, with 0 indicating that the symptom is either not present or does not interfere with the participant's activities and 10 indicating that the symptom is "as bad as you can imagine" or "interfered completely" with the participant's life. | Up to approximately 45 months |
| Percentage of Participants With Adverse Event (AEs) | An adverse event is any untoward medical occurrence, regardless of causal attribution. | Up to approximately 45 months |
| Area Under the Plasma Drug Concentration-time Curve (AUC) of MOXR0916 and Atezolizumab | AUC represents the body's exposure to an administered drug. | Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predose |
| Maximum Plasma Concentration (Cmax) of MOXR0916 and Atezolizumab | Cmax refers to the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and prior to the administration of a second dose. | Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predose |
| Minimum Plasma Concentration (Cmin) of MOXR0916 and Atezolizumab | Cmin refers to the minimum (trough) serum concentration of a drug in a specified compartment or test area of the body. | Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predose |
| Clearance of MOXR0916 and Atezolizumab | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. | Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predose |
| Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to MOXR0916 and Atezolizumab | ATAs may be produced by the body in response to an administered drug. | Cycles 1 - 4 and 8, 12, and 16 (each cycle is 21 days), Day 1: predose |
| Denver |
| Colorado |
| 80045 |
| United States |
| Yale University | New Haven | Connecticut | 06510 | United States |
| Miami Cancer Institute of Baptist Health, Inc. | Miami | Florida | 33176 | United States |
| University of Chicago; Hematology/Oncology | Chicago | Illinois | 60637 | United States |
| Kansas City - Menorah Medical Center | Kansas City | Kansas | 66209 | United States |
| Maryland Oncology Hematology, P.A. | Columbia | Maryland | 21044 | United States |
| Nebraska Methodist Hospital; Cancer Center | Omaha | Nebraska | 68114 | United States |
| New York Oncology Hematology, P.C. | Albany | New York | 12208 | United States |
| Columbia University Medical Center; Clinical Research Management Office | New York | New York | 10032 | United States |
| Onc/Hem Care Clin Trials LLC | Cincinnati | Ohio | 45242 | United States |
| SCRI Tennessee Oncology Chattanooga | Chattanooga | Tennessee | 37404 | United States |
| Sarah Cannon Research Inst. | Nashville | Tennessee | 37203 | United States |
| Texas Oncology-Baylor Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| Virginia Oncology Associates - Lake Wright Cancer Center | Norfolk | Virginia | 23502 | United States |
| GasthuisZusters Antwerpen | Wilrijk | 2610 | Belgium |
| Princess Margaret Cancer Center | Toronto | Ontario | M5G 1Z5 | Canada |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center - Oncology | Seoul | 05505 | South Korea |
| Leicester Royal Infirmary NHS Trust | Leicester | LE1 5WW | United Kingdom |
| Barts and the London NHS Trust. | London | EC1A 7BE | United Kingdom |
Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | MOXR0916 Plus Atezolizumab | Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle. |
| BG001 | Atezolizumab | Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first. Per RECIST v1.1, progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline); and an absolute increase of >= 5 millimeter (mm) in the sum of diameters. | Due to early termination, no formal analyses were performed for PFS. | Posted | Up to approximately 45 months |
|
| ||||||||||||||||||||||
| Primary | Overall Survival (OS) | Kaplan Meier estimate of median OS was defined as the time at which half of the participants had died, regardless of the cause of death. | Due to early termination, no formal analyses were performed for OS. | Posted | Up to approximately 45 months |
|
| ||||||||||||||||||||||
| Secondary | Objective Response (OR) According to RECIST v1.1 | OR is defined as a complete response (CR) or partial response (PR) on two consecutive occasions >= 4 weeks apart, as determined by the investigator according to RECIST v1.1. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. | Due to early termination, no formal analyses were performed for OR. | Posted | Up to approximately 45 months |
|
| ||||||||||||||||||||||
| Secondary | Duration of Objective Response (DOR) According to RECIST v1.1 | DOR is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first, as determined by the investigator according to RECIST v1.1. Objective response is defined as a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. | Due to early termination, no formal analyses were performed for DOR. | Posted | Up to approximately 45 months |
|
| ||||||||||||||||||||||
| Secondary | Time to Pain Progression, Pain Palliation, and Fatigue Progression as Measured by Participant-Reported Severity According to the M. D. Anderson Symptom Inventory (MDASI) | The MDASI is a cancer-related, self-reported questionnaire consisting of 19 items assessing symptom severity and interference with different aspects of a participant's life. The MDASI items are rated from 0 to 10, with 0 indicating that the symptom is either not present or does not interfere with the participant's activities and 10 indicating that the symptom is "as bad as you can imagine" or "interfered completely" with the participant's life. | Due to early termination, no formal analyses were performed for time to pain progression, pain palliation and fatigue progression. | Posted | Up to approximately 45 months |
|
| ||||||||||||||||||||||
| Secondary | Percentage of Participants Reporting Symptom Interference With Daily Living at the Time of Progression According to the MDASI | The MDASI is a cancer-related, self-reported questionnaire consisting of 19 items assessing symptom severity and interference with different aspects of a participant's life. The MDASI items are rated from 0 to 10, with 0 indicating that the symptom is either not present or does not interfere with the participant's activities and 10 indicating that the symptom is "as bad as you can imagine" or "interfered completely" with the participant's life. | Due to early termination, no formal analyses were performed for percentage of participants reporting symptom interference with daily living at the time of progression according to the MDASI | Posted | Up to approximately 45 months |
|
| ||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Event (AEs) | An adverse event is any untoward medical occurrence, regardless of causal attribution. | The safety population was defined as all participants who have received at least one dose of study medication. Data were collected but are not being summarized due to privacy concerns with the low number of patients analyzed. | Posted | Up to approximately 45 months |
|
| ||||||||||||||||||||||
| Secondary | Area Under the Plasma Drug Concentration-time Curve (AUC) of MOXR0916 and Atezolizumab | AUC represents the body's exposure to an administered drug. | Due to early termination, no formal analyses were performed for any of the pharmacokinetic measures. | Posted | Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predose |
|
| ||||||||||||||||||||||
| Secondary | Maximum Plasma Concentration (Cmax) of MOXR0916 and Atezolizumab | Cmax refers to the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and prior to the administration of a second dose. | Due to early termination, no formal analyses were performed for any of the pharmacokinetic measures. | Posted | Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predose |
|
| ||||||||||||||||||||||
| Secondary | Minimum Plasma Concentration (Cmin) of MOXR0916 and Atezolizumab | Cmin refers to the minimum (trough) serum concentration of a drug in a specified compartment or test area of the body. | Due to early termination, no formal analyses were performed for any of the pharmacokinetic measures. | Posted | Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predose |
|
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| Secondary | Clearance of MOXR0916 and Atezolizumab | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. | Due to early termination, no formal analyses were performed for any of the pharmacokinetic measures. | Posted | Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predose |
|
| ||||||||||||||||||||||
| Secondary | Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to MOXR0916 and Atezolizumab | ATAs may be produced by the body in response to an administered drug. | Due to early termination, no formal analyses were performed for percentage of participants with ATAs to MOXR0916 and Atezolizumab. | Posted | Cycles 1 - 4 and 8, 12, and 16 (each cycle is 21 days), Day 1: predose |
|
|
Up to approximately 45 months
The safety population is defined as all patients who received at least one dose of the study medication. Data were collected for the adverse events but are not being summarized due to privacy concerns with low number of patients analyzed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MOXR0916 Plus Atezolizumab | Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle. | 1 | 4 | 0 | 0 | 0 | 0 |
| EG001 | Atezolizumab | Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle. | 0 | 1 | 0 | 0 | 0 | 0 |
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The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Apr 24, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D002295 | Carcinoma, Transitional Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000594389 | atezolizumab |
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| >=65 years |
|
| Male |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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| Participants |
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| Participants |
|