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PD-L1/PD-1 Inhibitor

Fasting + PD-1/PD-L1 Inhibitors for Skin Cancer

Phase 1

Waitlist Available

Led By Gino K In, MD

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No more than 2 lines of prior systemic therapy (not including neoadjuvant or adjuvant therapy)

Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Must not have

Prior treatment with any agent that blocks the PD-1 or PD-L1 pathway

Immunosuppressive systemic corticosteroids equivalent to prednisone 10 mg or greater in the 14 days prior to the first dose of PD-1/PD-L1 inhibition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 cycles (each cycle is 21 days)

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Summary

This trial is testing the effects of fasting before treatment with a PD-L1 or PD-1 inhibitor for skin cancer.

Who is the study for?

This trial is for adults with advanced or metastatic skin cancer recommended to receive PD-1/PD-L1 inhibitor immunotherapy. They must have adequate organ function, no more than two prior systemic therapies, and a good performance status. Women and men should agree to use contraception during the study. Exclusions include allergies to similar drugs, diabetes, recent significant weight loss without clear cause, other ongoing treatments or surgeries, active autoimmune diseases requiring treatment in the past 2 years, brain metastases, uncontrolled illnesses that could affect compliance.

What is being tested?

The trial tests if short-term fasting before taking PD-1/PD-L1 inhibitors (like pembrolizumab or atezolizumab) can reduce side effects and improve effectiveness against advanced skin malignancy. It studies how well patients tolerate fasting combined with these immunotherapies which are designed to boost the immune system's ability to fight cancer.

What are the potential side effects?

Potential side effects of PD-1/PD-L1 inhibitors may include fatigue, nausea, itching or rash; inflammation of organs like lungs or intestines; hormonal gland problems leading to changes in mood or behavior; infusion reactions; liver problems; and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had 2 or fewer treatments for my cancer, not counting initial treatments.

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I am fully active or can carry out light work.

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My kidney function is within the required range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with drugs that target PD-1 or PD-L1.

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I haven't taken high doses of steroids in the last 2 weeks.

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I have fainted due to not eating or have a condition that makes fasting unsafe.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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I haven't taken immune system drugs within the last 4 weeks.

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I have had a solid organ or bone marrow transplant.

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I am not currently on any other cancer treatments or experimental drugs.

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I do not have brain metastases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 cycles (each cycle is 21 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 cycles (each cycle is 21 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 cycles (each cycle is 21 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of patients completely adhering to 3 cycles of short term fasting (STF) (9 days of fasting)

Percentage of patients who develop unacceptable fasting-related toxicity

Secondary study objectives

Incidence of acceptable fasting related toxicity

Percentage of patients who can partially adhere to 3 cycles of STF (9 days of fasting)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (STF, PD-1/PD-L1 inhibitor)Experimental Treatment8 Interventions

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, 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

FDA approved

Durvalumab

FDA approved

Nivolumab

FDA approved

Avelumab

FDA approved