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

NCT04610671 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2026-02-27

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • CG Oncology, Inc.

    collaborator INDUSTRY

  • Richard M. Shulze Family Foundation

    collaborator UNKNOWN

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Roger Li, MD · Moffitt Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-26
Primary Completion
2024-07-25
Completion
2024-07-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04610671 on ClinicalTrials.gov