A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211]

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02302807
• Date of registration: 25/11/2014
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211]
• Scientific title: A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer After Failure With Platinum-Containing Chemotherapy
• Date of first enrolment: January 13, 2015
• Target sample size: 931
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02302807
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Belgium, Canada, Czech Republic, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Japan, Korea, Republic of, Netherlands, Norway, Poland, Portugal, Romania, Russian Federation, Serbia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

- Histologically or cytologically documented locally advanced or metastatic UBC
(including renal pelvis, ureters, urinary bladder, and urethra).

- Representative tumor specimens as specified by the protocol

- Disease progression during or following treatment with at least one
platinum-containing regimen for inoperable, locally advanced or metastatic UBC or
disease recurrence

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Life expectancy greater than or equal to (>/=) 12 weeks

- Measurable disease, as defined by RECIST v1.1

- Adequate hematologic and end organ function

- For women of childbearing potential, agreement to refrain from heterosexual
intercourse or use contraceptive methods that result in a failure rate of < 1% per
year during the treatment period and for at least 5 months after the last dose of
atezolizumab, 3 months after the last dose of vinflunine and 6 months from the last
dose of paclitaxel or docetaxel.

- For men, agreement to refrain from heterosexual intercourse or use contraceptive
methods that result in a failure rate of < 1% per year during the treatment period and
for at least 3 months after the last dose of vinflunine and 6 months from the last
dose of paclitaxel or docetaxel, and agreement to refrain from donating sperm

Exclusion Criteria:

- Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment

- Treatment with any other investigational agent or participation in another clinical
trial with therapeutic intent within 28 days prior to enrollment

- Active or untreated central nervous system (CNS) metastases as determined by computed
tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and
prior radiographic assessments

- Leptomeningeal disease

- Malignancies other than UBC within 5 years prior to Cycle 1, Day 1, with the exception
of those with a negligible risk of metastasis or death and treated with expected
curative outcome, or localized prostate cancer treated with curative intent and
absence of prostate-specific antigen (PSA) relapse or incidental prostate cancer

- Pregnant and lactating women

- Significant cardiovascular disease

- Severe infections within 4 weeks prior to randomization

- Major surgical procedure other than for diagnosis within 4 weeks prior to
randomization

- History of severe allergic, anaphylactic, or other hypersensitivity reactions to
chimeric or humanized antibodies or fusion proteins; known hypersensitivity or allergy
to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the
atezolizumab formulation

- History of autoimmune disease

- Prior allogeneic stem cell or solid organ transplant

- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening
chest CT scan

- Positive test for human immunodeficiency virus (HIV) and/or active hepatitis B or
hepatitis C or tuberculosis

- Administration of a live, attenuated vaccine within 4 weeks prior to randomization

- Prior treatment with cluster of differentiation 137 (CD137) agonists or immune
checkpoint blockade therapies, including anti-cytotoxic T-lymphocyte-associated
protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1) or anti-programmed
death-ligand 1 (anti-PD-L1) therapeutic antibodies



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Bladder Cancer

Intervention(s)

Drug: Paclitaxel

Drug: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody

Drug: Docetaxel

Drug: Vinflunine

Primary Outcome(s)

Overall Survival (OS) [Time Frame: Between randomization and death due to any cause, up to approximately 25 months after first participant enrolled]

Secondary Outcome(s)

Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score: Global Health Status Scale [Time Frame: Cycle 1 Day 1 (prior to any health care interaction), on Day 1 of each subsequent cycle, and at 30 days after the last treatment dose (Up to approximately 25 months; each cycle is 21 days)]

Percentage of Participants With Unconfirmed Objective Response Rate (ORR) as Determined by the Investigator With Use of Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) [Time Frame: Up to approximately 25 months after first participant enrolled]

Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score: Fatigue Symptom Scale [Time Frame: Cycle 1 Day 1 (prior to any health care interaction), on Day 1 of each subsequent cycle, and at 30 days after the last treatment dose (Up to approximately 25 months; each cycle is 21 days)]

Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score: Physical Functioning Scale [Time Frame: Cycle 1 Day 1 (prior to any health care interaction), on Day 1 of each subsequent cycle, and at 30 days after the last treatment dose (Up to approximately 25 months; each cycle is 21 days)]

Progression-free Survival (PFS) as Determined by the Investigator With Use of RECIST v1.1 [Time Frame: Up to approximately 25 months after first participant enrolled]

Maximum Observed Serum Atezolizumab Concentration (Cmax) [Time Frame: 30 minutes post dose on Day 1 of Cycles 1]

Minimum Observed Serum Atezolizumab Concentration (Cmin) [Time Frame: Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4 and every 8 cycles thereafter; at treatment discontinuation (up to 25 months); at 120 days after last dose of atezolizumab (up to 25 months; each cycle is 21 days)]

Unconfirmed Duration of Response (DOR) as Determined by the Investigator With Use of RECIST v1.1 [Time Frame: Up to approximately 25 months after first participant enrolled]

Percentage of Participants With Adverse Events (AEs) [Time Frame: Up to approximately 46 months after first participant enrolled]

Percentage of Participants With Post-Baseline Anti-therapeutic Antibodies (ATA) to Atezolizumab [Time Frame: Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4 and every 8 cycles thereafter; at treatment discontinuation (up to 25 months); at 120 days after last dose of atezolizumab (up to 25 months; each cycle is 21 days)]

Secondary ID(s)

2014-003231-19

GO29294

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 11/04/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02302807