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Short-term Fasting Prior to PD-1/PD-L1 Inhibitor Therapy for of Advanced or Metastatic Skin Malignancy

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 7 months later Aug 12, 2026 → Mar 31, 2027
See other at-risk trials from University of Southern California

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Aug 12, 2026 to Mar 31, 2027 Show 4 more changesShow less
    • Study completion pushed from Aug 12, 2027 to Mar 31, 2028
    • Eligibility criteria expanded, about 30 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Site details revised at 1 of 2 sites
  2. Re-verified, no change to tracked fieldsv9
  3. Interventions: Atezolizumab (Drug), Avelumab (Drug), Cemiplimab (Biological), Durvalumab (Biological), Nivolumab (Biological), Pembrolizumab (Biological)… to Atezolizumab (Drug), Avelumab (Drug), Cemiplimab (Biological), Dostarlimab (Biological), Durvalumab (Biological), Nivolumab (Biological)…
    • Eligibility criteria expanded, about 72 words
    v8
  4. Primary completion date: Aug 12, 2025 to Aug 12, 2026
    • Study completion date: Aug 12, 2026 to Aug 12, 2027
    v7
  5. Primary completion date: Aug 12, 2024 to Aug 12, 2025v6 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 16 to confirmed 10
    • Study completion date: Aug 12, 2025 to Aug 12, 2026
    • Site details revised at 2 of 2 sites
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites revised (2)v5
  2. Primary completion date: Aug 12, 2023 to Aug 12, 2024
    • Study completion date: Aug 12, 2024 to Aug 12, 2025
    v4
  3. Primary completion date: Aug 12, 2022 to Aug 12, 2023
    • Study completion date: Aug 12, 2023 to Aug 12, 2024
    v3
  4. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Jun 1, 2022 to Aug 12, 2022
    • Study completion date: Jun 1, 2023 to Aug 12, 2023
    • Start date changed from estimate of Jun 1, 2020 to Aug 12, 2020
    • Site details revised at 2 of 2 sites
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04387084
Lead Sponsor University of Southern California
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Advanced Malignant Skin Neoplasm, Metastatic Malignant Skin Neoplasm
Related terms Skin Neoplasms
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov