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NCT03420521 · ClinicalTrials.gov registry record · Phase 2
Nivolumab With Ipilimumab in Subjects With Neuroendocrine Tumors
A Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Terminated
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
NCT03420521: Clinical Trial Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT03420521 is a Phase 2 study that was terminated before completion, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 9 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03420521, a Phase 2 study, was terminated before completion, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
Study Summary
This is a single arm open-label design study looking at Nivolumab plus Ipilimumab in patients with Advanced Neuroendocrine Tumors. Patients will be dosed Nivolumab 240mg IV over 60 minutes every 2 weeks (Q2W) and Ipilimumab 1mg/kg IV over 30 minutes every 6 weeks (Q6W). One cycle will include 3 doses of Nivolumab and 1 dose of Ipilimumab. The objective of this study is to evaluate the objective response rate of combination Nivolumab and Ipilimumab in advanced, well-differentiated neuroendocrine tumors. Durability of response, and progression free survival (PFS) will also be described.
Primary Outcome
The number of subjects who have at least one scan with an Objective Response (OR) of confirmed complete response (CR) or partial response (PR), per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions as assessed by CT scan: Objective Response (OR), a response of CR or PR from baseline to PD, palliative local therapy, or subsequent anticancer therapy; Complete Response (CR), the disappearance of all target lesions and any pathological lymph nodes (target or non-
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2018-03-09 |
| Est. Completion | 2021-11-24 |
| Phase | Phase 2 |
Why NCT03420521 stopped before completion
NCT03420521 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.
NCT03420521 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03420521 about?
NCT03420521 is a clinical study titled "Nivolumab With Ipilimumab in Subjects With Neuroendocrine Tumors". This is a single arm open-label design study looking at Nivolumab plus Ipilimumab in patients with Advanced Neuroendocrine Tumors. Patients will be dosed Nivolumab 240mg IV over 60 minutes every 2 weeks (Q2W) and Ipilimumab 1mg/kg IV over 30 minutes every 6 weeks (Q6W). One cycle will include 3 dose...
What is the current status of trial NCT03420521?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2018-03-09. Estimated completion is 2021-11-24.
What interventions are being tested in trial NCT03420521?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG).
Who is sponsoring clinical trial NCT03420521?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03420521's enrollment target sits among peer trials
9 1989th of 2000 higher than 11 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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