A Phase II Study of Atezolizumab in Combination With Cisplatin + Gemcitabine Before Surgery to Remove the Bladder Cancer

Part of paid clinical trials in Hartford, Connecticut.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT02989584
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to test the safety of the study drug, atezolizumab, when combined with the standard chemotherapy drugs, gemcitabine and cisplatin (or GC). This study will help researchers begin to understand whether combining GC with atezolizumab is better, the same, or worse than the usual approach of using GC alone.

Key Dates

Start date
Dec 20, 2016
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
54 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Atezolizumab, Gemcitabine, Cisplatin
    This is a two phase study with a single study arm for each phase. For Phase 1: Following enrollment participants will be treated with combination therapy on a 21 day cycle x 6 cycles. Gemcitabine (1000 mg/m2 on Day 1 and Day 8), cisplatin (70 mg/m2 on Day 1), and atezolizumab (1200 mg on Day 8) will be administered intravenously. Phase 2: Following enrollment participants will be treated with a single dose of atezolizumab alone followed by combination therapy on a 21-day cycle x 4 cycles, followed by a single dose of atezolizumab alone. Gemcitabine 1000mg/m2, cisplatin (70 mg/m2 on Day 1), and atezolizumab (1200 mg on Day 8) will be administered intravenously.

Primary Outcome Measure

Test the safety of atezolizumab in combination with gemcitabine/cisplatin as assessed by dose limiting toxicity rate. [ Time Frame: Participants will be followed for survival until 5 years from treatment completion or until disease recurrence/progression. ]

Locations (11)

FacilityCityStateZIPSite coordinators
Hartford Healthcare Cancer Institute @ Hartford HospitalHartfordConnecticut06102-
Memorial Sloan Kettering Basking RidgeBasking RidgeNew Jersey--
Memorial Sloan Kettering MonmouthMiddletownNew Jersey07748-
Memorial Sloan Kettering BergenMontvaleNew Jersey07645-
Memorial Sloan Kettering CommackCommackNew York11725-
Memorial Sloan Kettering WestchesterHarrisonNew York10604-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
New York UniversityNew YorkNew York10010-
Memorial Sloan Kettering NassauUniondaleNew York11553-
Ohio State UniversityColumbusOhio43210-
Lehigh Valley Health NetworkAllentownPennsylvania18103-

Find similar trials in Hartford, CT

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Hartford Healthcare Cancer Institute @ Hartford Hospital· Hartford, CTMemorial Sloan Kettering Basking Ridge· Basking Ridge, NJMemorial Sloan Kettering Monmouth· Middletown, NJMemorial Sloan Kettering Bergen· Montvale, NJMemorial Sloan Kettering Commack· Commack, NYMemorial Sloan Kettering Westchester· Harrison, NY

Related Studies