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NCT05024968 · ClinicalTrials.gov registry record · Phase 2
Sintilimab in Cancer of Unknown Primary
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT05024968: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT05024968 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 10 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05024968, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
This is a Phase 2 clinical trial evaluating the efficacy and safety of sintilimab in subjects with CUP. Up to 45 subjects with CUP will be enrolled. Subjects will be treated with sintilimab at 200 mg via intravenous (IV) administration on Cycle 1 Day 1. The treatment will repeat every 3 weeks until progressive disease (PD), intolerable toxicity, initiation of new anti-tumor therapy, withdrawal of consent, lost to follow-up, death, completion of therapy, or any other investigator-determined reasons for treatment discontinuation (whichever occurs first). Treatment will continue for a maximum period of 24 months (starting from the first dose). During the trial, tumor imaging evaluation will be initially performed once every 9 weeks (± 7 days) and will be based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. After the completion or discontinuation of the study treatment, safety follow-up and survival follow-up will be performed. Considering the rareness of the disease, the patient accrual rate is expected to be approximately 2 patients per month. The total study duration is expected to be between 24-27 months with 6-month follow up.
Interventions
- DRUG Sintilimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-08-26 |
| Est. Completion | 2025-04-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05024968
The ClinicalTrials.gov registry entry for NCT05024968 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sintilimab is the first listed.
NCT05024968 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05024968 about?
NCT05024968 is a clinical study titled "Sintilimab in Cancer of Unknown Primary". This is a Phase 2 clinical trial evaluating the efficacy and safety of sintilimab in subjects with CUP. Up to 45 subjects with CUP will be enrolled. Subjects will be treated with sintilimab at 200 mg via intravenous (IV) administration on Cycle 1 Day 1. The treatment will repeat every 3 weeks until...
What is the current status of trial NCT05024968?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2021-08-26. Estimated completion is 2025-04-03.
What interventions are being tested in trial NCT05024968?
The interventions under investigation include: Sintilimab (DRUG).
Who is sponsoring clinical trial NCT05024968?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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