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NCT03307616 · ClinicalTrials.gov registry record · Phase 2
Nivolumab With and Without Ipilimumab and Radiation Therapy in Treating Patients With Recurrent or Resectable Undifferentiated Pleomorphic Sarcoma or Dedifferentiated Liposarcoma Before Surgery
A Phase 2 study of Undifferentiated Pleomorphic Sarcoma and Dedifferentiated Liposarcoma, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT03307616: Active Phase 2 study of Undifferentiated Pleomorphic Sarcoma and Dedifferentiated Liposarcoma, sponsored by M.D. Anderson Cancer Center.
NCT03307616 is a Phase 2 study of Undifferentiated Pleomorphic Sarcoma and Dedifferentiated Liposarcoma that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 32 participants, below the 108-participant average among 5 other Undifferentiated Pleomorphic Sarcoma trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03307616, a Phase 2 study of Undifferentiated Pleomorphic Sarcoma and Dedifferentiated Liposarcoma, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well nivolumab with and without ipilimumab and radiation therapy when given before surgery works in treating patients with undifferentiated pleomorphic sarcoma or dedifferentiated liposarcoma that can be removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving nivolumab, ipilimumab, and radiation therapy may work better in treating patients with undifferentiated pleomorphic sarcoma.
Primary Outcome
Pathologic response will be assessed at time of surgical resection by percentage hyalinization. The study will estimate the difference of the pathologic response between the treatment arms (A versus \[vs\] B, C vs D) along with the estimate of variation of the difference. Given the longitudinal nature of the data, linear mixed effect models for longitudinal measures will be employed to assess the change in the magnitude of the measures over time adjusting for multiple covariates including patien
Conditions Studied
Interventions
- RADIATION Radiation Therapy
- BIOLOGICAL Nivolumab
- BIOLOGICAL Ipilimumab
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2017-10-04 |
| Est. Completion | 2027-10-31 |
| Phase | Phase 2 |
What the registry record for NCT03307616 still lists
NCT03307616 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 108-participant average among 5 other Undifferentiated Pleomorphic Sarcoma trials with a reported enrollment target (70% lower).
The record links to 6 conditions, with Undifferentiated Pleomorphic Sarcoma appearing as the primary indexed condition, and to 3 interventions - of which Radiation Therapy is the first listed.
NCT03307616 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03307616 about?
NCT03307616 is a clinical study titled "Nivolumab With and Without Ipilimumab and Radiation Therapy in Treating Patients With Recurrent or Resectable Undifferentiated Pleomorphic Sarcoma or Dedifferentiated Liposarcoma Before Surgery". This phase II trial studies how well nivolumab with and without ipilimumab and radiation therapy when given before surgery works in treating patients with undifferentiated pleomorphic sarcoma or dedifferentiated liposarcoma that can be removed by surgery. Immunotherapy with monoclonal antibodies, su...
What is the current status of trial NCT03307616?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2017-10-04. Estimated completion is 2027-10-31.
What conditions does trial NCT03307616 study?
This clinical trial studies the following conditions: Undifferentiated Pleomorphic Sarcoma, Dedifferentiated Liposarcoma, Recurrent Dedifferentiated Liposarcoma, Resectable Dedifferentiated Liposarcoma, Resectable Undifferentiated Pleomorphic Sarcoma.
What interventions are being tested in trial NCT03307616?
The interventions under investigation include: Radiation Therapy (RADIATION), Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03307616?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03307616 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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