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NCT04387461 · ClinicalTrials.gov registry record · Phase 2

Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin

A Phase 2 study, sponsored by CG Oncology.

Completed
Registry status
Phase 2
Development phase
35
Enrollment target

NCT04387461: Completed Phase 2 study, sponsored by CG Oncology.

NCT04387461 is a Phase 2 study that has completed, run by CG Oncology. The registered enrollment target is 35 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04387461, a Phase 2 study, has completed, sponsored by CG Oncology.

COMPLETED
Registry status
Phase 2
Development phase
35 participants
Enrollment target

Study Summary

To evaluate the activity of intravesical administration of CG0070 and intravenous administration of Pembrolizumab in patients with tissue pathology-confirmed non-muscle invasive bladder cancer (NMIBC) who have Bacillus-Calmette-Guerin (BCG) unresponsive disease with carcinoma in situ (CIS) with or without Ta/T1 papillary disease.

Primary Outcome

Percentage of patients with a complete response as defined by FDA guidance document dated February 2018 for NMIBC.

Interventions

  • BIOLOGICAL Pembrolizumab Injection
  • BIOLOGICAL CG0070
  • OTHER n-dodecyl-B-D-maltoside

Trial Details

FieldValue
Enrollment Target 35 participants
Start Date 2020-12-08
Est. Completion 2024-05-28
Phase Phase 2
CG Oncology

6 total trials

What the finished NCT04387461 record still lists

NCT04387461 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).

The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab Injection is the first listed.

NCT04387461 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04387461 about?

NCT04387461 is a clinical study titled "Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin". To evaluate the activity of intravesical administration of CG0070 and intravenous administration of Pembrolizumab in patients with tissue pathology-confirmed non-muscle invasive bladder cancer (NMIBC) who have Bacillus-Calmette-Guerin (BCG) unresponsive disease with carcinoma in situ (CIS) with or w...

What is the current status of trial NCT04387461?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2020-12-08. Estimated completion is 2024-05-28.

What interventions are being tested in trial NCT04387461?

The interventions under investigation include: Pembrolizumab Injection (BIOLOGICAL), CG0070 (BIOLOGICAL), n-dodecyl-B-D-maltoside (OTHER).

Who is sponsoring clinical trial NCT04387461?

This trial is sponsored by CG Oncology, which has 6 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04387461's enrollment target sits among peer trials

35 1524th of 2000 higher than 462 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04387461, the US trial registry maintained by the National Library of Medicine. NCT04387461 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.