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A Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer (Cohort 2)

Status
Completed
Cancer Type
Ureter Cancer
Urethral Cancer
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT02108652
Protocol IDs
GO29293 (primary)
Study Sponsor
Hoffmann-La Roche

Summary

This Phase II, single-arm study is designed to evaluate the effect of atezolizumab
treatment in participants with locally advanced or metastatic urothelial bladder cancer.
Participants will be enrolled into 1 of 2 cohorts. Cohort 1 will consist of participants
who are treatment-naïve and ineligible for cisplatin-containing chemotherapy. The results
of Cohort 1 are reported separately (NCT02951767). Cohort 2 (reported here) will contain
participants who have progressed during or following a prior platinum-based chemotherapy
regimen. Participants in both cohorts will be given a 1200 milligrams (mg) intravenous
(IV) dose of atezolizumab on Day 1 of 21-day cycles. Treatment of participants in Cohort
1 will continue until disease progression per Response Evaluation Criteria in Solid
Tumors Version 1.1 (RECIST v1.1) or unmanageable toxicity. Treatment of participants in
Cohort 2 will continue until loss of clinical benefit or unmanageable toxicity.

Eligibility

  1. Histologically or cytologically documented locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary bladder, urethra)
  2. Representative tumor specimens as specified by the protocol
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  4. Life expectancy greater than or equal to (>=) 12 weeks
  5. Measurable disease, as defined by RECIST v1.1
  6. Adequate hematologic and end organ function Cohort 2-Specific Inclusion Criteria
  7. 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.
  8. A regimen was defined as participants receiving at least two cycles of a platinum-containing regimen. Participants who had received one cycle of a platinum-containing regimen but discontinued due to Grade 4 hematologic toxicity or Grade 3 or 4 non-hematologic toxicity could also be eligible.
  9. Participants who received prior adjuvant/neoadjuvant chemotherapy and progressed within 12 months of treatment with a platinum-containing adjuvant/neoadjuvant regimen were considered as second-line participants.
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.