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NCT03628716 · ClinicalTrials.gov registry record · Phase 2
CV301 Combined With PD-1/L1 Blockade in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer
A Phase 2 study, sponsored by Bavarian Nordic.
- Completed
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
NCT03628716: Completed Phase 2 study, sponsored by Bavarian Nordic.
NCT03628716 is a Phase 2 study that has completed, run by Bavarian Nordic. The registered enrollment target is 43 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03628716, a Phase 2 study, has completed, sponsored by Bavarian Nordic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
Study Summary
This is a Phase 2, single-arm, multi-institutional clinical trial designed to study the combination of CV301 with atezolizumab in the first-line treatment of UC not eligible for cisplatin-containing chemotherapy (Cohort 1) and in the second-line treatment of UC previously treated with standard first-line cisplatin-based chemotherapy (Cohort 2).
Primary Outcome
ORR is the proportion of subjects in the analysis population with a Complete Response (CR) or Partial Response (PR) based on best overall RECIST v1.1 evaluations as performed by the investigator. According to RECIST v1.1, the sum of the longest diameters of non-nodal target lesions and short axis of nodal target lesions are used to evaluate tumor response. Maximum of 2 target lesions per organ and 5 target lesions are used for the measurement. CR means disappearance of all known disease, confirm
Interventions
- BIOLOGICAL Atezolizumab
- BIOLOGICAL CV301
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2018-09-18 |
| Est. Completion | 2021-02-02 |
| Phase | Phase 2 |
What the finished NCT03628716 record still lists
NCT03628716 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Atezolizumab is the first listed.
NCT03628716 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03628716 about?
NCT03628716 is a clinical study titled "CV301 Combined With PD-1/L1 Blockade in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer". This is a Phase 2, single-arm, multi-institutional clinical trial designed to study the combination of CV301 with atezolizumab in the first-line treatment of UC not eligible for cisplatin-containing chemotherapy (Cohort 1) and in the second-line treatment of UC previously treated with standard first...
What is the current status of trial NCT03628716?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2018-09-18. Estimated completion is 2021-02-02.
What interventions are being tested in trial NCT03628716?
The interventions under investigation include: Atezolizumab (BIOLOGICAL), CV301 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03628716?
This trial is sponsored by Bavarian Nordic, which has 41 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03628716's enrollment target sits among peer trials
43 1332nd of 2000 higher than 662 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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