Study of CG0070 Combined With Nivolumab in Cisplatin Ineligible Patients With MIBC

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT04610671
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • CG0070 — DRUG
    CG0070 will be administered at a dose of 1x10\^12 vp intravesically following a sequence of bladder washes with 5% DDM and normal saline.
  • Nivolumab — DRUG
    Two neoadjuvant doses of nivolumab 480 mg Q4W (every 4 weeks) for 2 doses (week 2 and 6)

Study Details

Investigators will evaluate the safety and efficacy of combination neoadjuvant therapy using intravesical CG0070 and IV Nivolumab in cisplatin ineligible patients with Muscle Invasive Bladder Cancer (MIBC).

Key Dates

Start date
Oct 26, 2020
Status verified
Feb 2026
Primary completion
Jul 25, 2024
Completion
Jul 25, 2024

Study Design

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

Arms

  • Experimental: Participants Receiving CG0070 & Nivolumab
    Both CG0070 (x 6 instillations) and nivolumab (x 2 doses) will be administered at their single-agent dose and schedule.

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events [ Time Frame: Up to 24 months after start of treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612-

Find similar trials in Tampa, FL

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Moffitt Cancer Center· Tampa, FL

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