Gemcitabine, Cisplatin, Plus Nivolumab in Patients With Muscle-invasive Bladder Cancer With Selective Bladder Sparing

Part of paid clinical trials in Duarte, California.

Sponsor
Matthew Galsky
Study ID
NCT03558087
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Nivolumab 360mg will be administered on Day 1 of each 21 day cycle for four 21-day cycles. Based on response and a balanced patient-physician discussion, subjects may receive nivolumab 240 mg for 8 cycles (cycle = 14 days).
  • Gemcitabine — DRUG
    Gemcitabine 1000mg/m\^2 will be administered on Days 1 and 8 for four 21-day cycles.
  • Cisplatin — DRUG
    Cisplatin 70mg\^m2 will be administered on Day 1 for four 21-day cycles.

Study Details

This is a phase 2 trial seeking to define the safety and activity of gemcitabine, cisplatin, plus nivolumab as neoadjuvant therapy in patients with muscle-invasive bladder cancer and to define the role of clinical complete response in predicting benefit in patients opting to avoid cystectomy.

Key Dates

Start date
Jul 13, 2018
Status verified
May 2024
Primary completion
Feb 16, 2024
Completion
Mar 7, 2024

Study Design

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

Arms

  • Experimental: Gemcitabine, Cisplatin and Nivolumab
    Combination Therapy: Nivolumab 360mg IV, Gemcitabine 100mg/m\^2 IV ,Cisplatin 70mg/m\^2 IV for four 21-day cycles. At restaging, subjects with cT0 or cTa status may undergo cystectomy or continue maintenance Nivolumab 240mg IV for up to 8 14-day cycles. Subjects with \> cTa status will undergo cystectomy.

Primary Outcome Measure

Clinical Complete Response (CCR) Rate [ Time Frame: 24 months ]

Locations (7)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
Univerity of Southern CaliforniaLos AngelesCalifornia90033-
Icahn School of Medicine: Tisch Cancer Institute at Mount Sinai Medical CenterNew YorkNew York10029-
Oregon Health & Science UniversityPortlandOregon97239-
Penn Medicine Abramson Cancer CenterPhiladelphiaPennsylvania19104-
Huntsman Cancer Institute University of UtahSalt Lake CityUtah84112-
University of WisconsinMadisonWisconsin53705-

Find similar trials in Duarte, CA

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
City of Hope· Duarte, CAUniverity of Southern California· Los Angeles, CAIcahn School of Medicine: Tisch Cancer Institute at Mount Sinai Medical Center· New York, NYOregon Health & Science University· Portland, ORPenn Medicine Abramson Cancer Center· Philadelphia, PAHuntsman Cancer Institute University of Utah· Salt Lake City, UT

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