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

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.

Conditions

• Advanced Malignant Skin Neoplasm
• Metastatic Malignant Skin Neoplasm

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• University of Southern California

  lead OTHER

Principal Investigators

• Gino K In, MD · University of Southern California

Study Design

Allocation

NA

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-12

Primary Completion

2026-08-12

Completion

2027-08-12

FDA Drug

Yes

Countries

• United States

Study Locations