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ACTIVE NOT RECRUITING
NCT04387084
PHASE1

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

Sponsor: University of Southern California

View on ClinicalTrials.gov

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.

Official title: Short-Term Fasting Prior to Standard Checkpoint Blockade Using PD-1/PD-L1 Inhibition: A Pilot Safety and Feasibility Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2020-08-12

Completion Date

2027-08-12

Last Updated

2026-03-23

Healthy Volunteers

No

Interventions

DRUG

Atezolizumab

Given IV

DRUG

Avelumab

Given IV

BIOLOGICAL

Cemiplimab

Given IV

BIOLOGICAL

Durvalumab

Given IV

BIOLOGICAL

Nivolumab

Given IV

BIOLOGICAL

Pembrolizumab

Given IV

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Short-Term Fasting

Undergo STF

BIOLOGICAL

Dostarlimab

Given IV

BIOLOGICAL

Retifanlimab

Given IV

BIOLOGICAL

Toripalimab

Given IV

BIOLOGICAL

Tislelizumab

Given IV

Locations (2)

Los Angeles General Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States