A comparative study of MPDL3280A versus chemotherapy in patients with advanced bladder cancer.

Phase 1

• Conditions: Advanced tumor and metastastic disease; MedDRA version: 20.0 Level: LLT Classification code 10046721 Term: Urothelial carcinoma bladder stage III System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-003231-19-GB
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-28
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 931

Inclusion Criteria

•Age >/= 18 years
•Histologically or cytologically documented locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary bladder, urethra)
•Representative tumor specimens as specified by the protocol
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•Life expectancy >/= 12 weeks
•Measurable disease, as defined by RECIST v1.1
•Adequate hematologic and end organ function
•Disease progression during or following treatment with at least one platinum-containing regimen (e.g., gemcitabine and cisplatin [GC], methotrexate, vinblastine, doxorubicin, and cisplatin [MVAC], CarboGem, etc.) for inoperable locally advanced or metastatic urothelial carcinoma or disease recurrence

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 740
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 191

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 CT or 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 treated with expected curative outcome or incidental prostate cancer
•Pregnant and lactating women
•History of autoimmune disease
•History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
•Serum albumin < 2.5 g/dL
•Positive test for HIV and/or active hepatitis B or hepatitis C or tuberculosis
•Severe infections within 4 weeks prior to Cycle 1, Day 1
•Significant cardiovascular disease
•Major surgical procedure other than for diagnosis within 28 days prior to Cycle 1, Day 1
•Prior allogeneic stem cell or solid organ transplant
•Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1
•Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
•Prior treatment with CD137 agonists or immune checkpoint blockade

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified