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NCT04387084 · ClinicalTrials.gov registry record · Phase 1
Short-term Fasting Prior to PD-1/PD-L1 Inhibitor Therapy for of Advanced or Metastatic Skin Malignancy
A Phase 1 study of Metastatic Malignant Skin Neoplasm and Advanced Malignant Skin Neoplasm, sponsored by University of Southern California.
- Active
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 2
- Study locations
NCT04387084: Active Phase 1 study of Metastatic Malignant Skin Neoplasm and Advanced Malignant Skin Neoplasm, sponsored by University of Southern California.
NCT04387084 is a Phase 1 study of Metastatic Malignant Skin Neoplasm and Advanced Malignant Skin Neoplasm that is active but no longer recruiting, run by University of Southern California. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04387084, a Phase 1 study of Metastatic Malignant Skin Neoplasm and Advanced Malignant Skin Neoplasm, is active but no longer recruiting, sponsored by University of Southern California.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 2
- Study locations
Study Summary
This trial studies the side effects of short-term fasting in patients with skin malignancy that has spread to other places in the body (advanced or metastatic) treated with a PD-L1 or PD-1 inhibitor. Immunotherapy with monoclonal antibodies, such as pembrolizumab, nivolumab, cemiplimab, avelumab, atezolizumab, or durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Undergoing short-term fasting prior to treatment with one of these PD-L1 or PD-1 inhibitors may potentially reduce the side effects of immunotherapy or even improve the effectiveness of immunotherapy in patients with skin malignancy.
Primary Outcome
Complete adherence will be defined as patients who adhere to STF (consumption of less than 200 kilocalorie \[kCal\] per 24 hours) in combination with PD-1/PD-L1 inhibition therapy for all 3 cycles of therapy (total of 9 days of fasting). Will be described with descriptive statistics.
Conditions Studied
Interventions
- DRUG Atezolizumab
- BIOLOGICAL Durvalumab
- BIOLOGICAL Cemiplimab
- BIOLOGICAL Nivolumab
- DRUG Avelumab
Study Locations (2)
California
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2020-08-12 |
| Est. Completion | 2027-08-12 |
| Phase | Phase 1 |
What the registry record for NCT04387084 still lists
NCT04387084 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 2 conditions, with Metastatic Malignant Skin Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Atezolizumab is the first listed.
NCT04387084 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04387084 about?
NCT04387084 is a clinical study titled "Short-term Fasting Prior to PD-1/PD-L1 Inhibitor Therapy for of Advanced or Metastatic Skin Malignancy". This trial studies the side effects of short-term fasting in patients with skin malignancy that has spread to other places in the body (advanced or metastatic) treated with a PD-L1 or PD-1 inhibitor. Immunotherapy with monoclonal antibodies, such as pembrolizumab, nivolumab, cemiplimab, avelumab, at...
What is the current status of trial NCT04387084?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2020-08-12. Estimated completion is 2027-08-12.
What conditions does trial NCT04387084 study?
This clinical trial studies the following conditions: Metastatic Malignant Skin Neoplasm, Advanced Malignant Skin Neoplasm.
What interventions are being tested in trial NCT04387084?
The interventions under investigation include: Atezolizumab (DRUG), Durvalumab (BIOLOGICAL), Cemiplimab (BIOLOGICAL), Nivolumab (BIOLOGICAL), Avelumab (DRUG).
Who is sponsoring clinical trial NCT04387084?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04387084 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04387084's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
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