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NCT03452332 · ClinicalTrials.gov registry record · Phase 1
Stereotactic Body Radiation Therapy, Tremelimumab and Durvalumab in Treating Participants With Recurrent or Metastatic Cervical, Vaginal, or Vulvar Cancers
A Phase 1 study of Metastatic Cervical Carcinoma and Advanced Cervical Adenocarcinoma, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT03452332: Completed Phase 1 study of Metastatic Cervical Carcinoma and Advanced Cervical Adenocarcinoma, sponsored by M.D. Anderson Cancer Center.
NCT03452332 is a Phase 1 study of Metastatic Cervical Carcinoma and Advanced Cervical Adenocarcinoma that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 20 participants, below the 136-participant average among 3 other Metastatic Cervical Carcinoma trials with a reported enrollment target (85% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03452332, a Phase 1 study of Metastatic Cervical Carcinoma and Advanced Cervical Adenocarcinoma, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase I trial studies how well stereotactic body radiation therapy works in combination with tremelimumab and durvalumab in treating participants with cervical, vaginal, or vulvar cancers that have come back (recurrent) or spread to other areas of the body (metastatic). Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Immunotherapy with monoclonal antibodies, such as tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Giving stereotactic body radiation therapy, tremelimumab, and durvalumab may work better in treating participants with cervical, vaginal, or vulvar cancers.
Primary Outcome
Will be assessed based on dose limiting toxicities (DLTs) and based on adverse events (AEs) throughout the entire treatment period. In the overall assessment of adverse events, AEs will be tabulated by body system, type and grade, overall and by disease cohort. The number and percentage of patients experiencing at least one grade 3 or higher AE will also be reported.
Conditions Studied
Interventions
- BIOLOGICAL Durvalumab
- OTHER Laboratory Biomarker Analysis
- RADIATION Stereotactic Radiosurgery
- BIOLOGICAL Tremelimumab
Study Locations (2)
Texas
- UT Southwestern/Simmons Cancer Center-Dallas - Dallas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2018-07-18 |
| Est. Completion | 2023-08-11 |
| Phase | Phase 1 |
What the finished NCT03452332 record still lists
NCT03452332 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 136-participant average among 3 other Metastatic Cervical Carcinoma trials with a reported enrollment target (85% lower).
The record links to 10 conditions, with Metastatic Cervical Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Durvalumab is the first listed.
NCT03452332 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03452332 about?
NCT03452332 is a clinical study titled "Stereotactic Body Radiation Therapy, Tremelimumab and Durvalumab in Treating Participants With Recurrent or Metastatic Cervical, Vaginal, or Vulvar Cancers". This phase I trial studies how well stereotactic body radiation therapy works in combination with tremelimumab and durvalumab in treating participants with cervical, vaginal, or vulvar cancers that have come back (recurrent) or spread to other areas of the body (metastatic). Stereotactic body radiat...
What is the current status of trial NCT03452332?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2018-07-18. Estimated completion is 2023-08-11.
What conditions does trial NCT03452332 study?
This clinical trial studies the following conditions: Metastatic Cervical Carcinoma, Advanced Cervical Adenocarcinoma, Human Papillomavirus-Related Cervical Squamous Cell Carcinoma, Human Papillomavirus-Related Vulvar Squamous Cell Carcinoma, Advanced Vaginal Carcinoma.
What interventions are being tested in trial NCT03452332?
The interventions under investigation include: Durvalumab (BIOLOGICAL), Laboratory Biomarker Analysis (OTHER), Stereotactic Radiosurgery (RADIATION), Tremelimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03452332?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03452332 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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