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

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT04387084
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Advanced Malignant Skin Neoplasm
  • Metastatic Malignant Skin Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Given IV
  • Avelumab — DRUG
    Given IV
  • Cemiplimab — BIOLOGICAL
    Given IV
  • Durvalumab — BIOLOGICAL
    Given IV
  • Nivolumab — BIOLOGICAL
    Given IV
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Short-Term Fasting — OTHER
    Undergo STF
  • Dostarlimab — BIOLOGICAL
    Given IV
  • Retifanlimab — BIOLOGICAL
    Given IV
  • Toripalimab — BIOLOGICAL
    Given IV
  • Tislelizumab — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
Aug 12, 2020
Status verified
Mar 2026
Primary completion
Aug 12, 2026
Completion
Aug 12, 2027

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Treatment (STF, PD-1/PD-L1 inhibitor)
    Patients undergo STF for 47-48 hours prior to immunotherapy and for 24 hours after immunotherapy with standard of care pembrolizumab given IV over 30 minutes, nivolumab IV over 30 minutes, cemiplimab IV over 30 minutes, dostarlimab IV over 30 minutes, retifanlimab IV over 30 minutes, toripalimab IV over 60 minutes, 30 minutes for subsequent dose, tislelizumab IV over 60 minutes for 1st dose, 30 minutes for subsequent doses, avelumab IV over 60 minutes, atezolizumab IV over 60 minutes, or durvalumab IV over 60 minutes on day 3. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Percentage of patients completely adhering to 3 cycles of short term fasting (STF) (9 days of fasting) [ Time Frame: Up to 3 cycles (each cycle is 21 days) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Los Angeles General Medical CenterLos AngelesCalifornia90033-
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-

Find similar trials in Los Angeles, CA

By research site
Los Angeles General Medical Center· Los Angeles, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CA

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