Trials / Completed
CompletedNCT04610671
Study of CG0070 Combined With Nivolumab in Cisplatin Ineligible Patients With MIBC
A Phase 1 Study of CG0070 Combined With Nivolumab in Cisplatin Ineligible Patients With Muscle Invasive Bladder Cancer (MIBC)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CG0070 | CG0070 will be administered at a dose of 1x10\^12 vp intravesically following a sequence of bladder washes with 5% DDM and normal saline. |
| DRUG | Nivolumab | Two neoadjuvant doses of nivolumab 480 mg Q4W (every 4 weeks) for 2 doses (week 2 and 6) |
Timeline
- Start date
- 2020-10-26
- Primary completion
- 2024-07-25
- Completion
- 2024-07-25
- First posted
- 2020-10-30
- Last updated
- 2026-02-27
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04610671. Inclusion in this directory is not an endorsement.