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PD-L1/PD-1 Inhibitor
Fasting + PD-1/PD-L1 Inhibitors for Skin Cancer
Phase 1
Recruiting
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
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 belowSelect...
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:Select...
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)
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)
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
Pembrolizumab
FDA approved
Cemiplimab
FDA approved
Find a Location
Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
936 Previous Clinical Trials
1,613,465 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,984 Total Patients Enrolled
Gino K In, MDPrincipal InvestigatorUniversity of Southern California
1 Previous Clinical Trials
34 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had radiation or certain drug treatments in the last 4 weeks.I have been treated with drugs that target PD-1 or PD-L1.You had allergic reactions to drugs similar to the PD-1 or PD-L1 inhibitor.I have not had major surgery in the last 2 weeks or have recovered from any major complications.I have had 2 or fewer treatments for my cancer, not counting initial treatments.You have a sufficient number of a type of white blood cell called lymphocytes in your blood.I have fainted due to not eating or have a condition that makes fasting unsafe.I am fully active or can carry out light work.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I haven't taken high doses of steroids in the last 2 weeks.My kidney function is within the required range.I haven't needed drugs for an autoimmune disease in the last 2 years, except for hormone replacements.My skin cancer is advanced, can be measured for its size, and might have spread to other parts.My cancer is recommended to be treated with specific immune therapy drugs.Your total bilirubin level is not higher than 1.5 times the upper limit of normal at the institution.I haven't taken immune system drugs within the last 4 weeks.Your AST and ALT blood test results should not be more than three times the normal limit.I have had a solid organ or bone marrow transplant.I am not currently on any other cancer treatments or experimental drugs.I do not have diabetes or I had it but it's resolved and I'm not on medication.I take medications that cannot be stopped or must be taken with food.I do not have brain metastases.You are pregnant, nursing, or breastfeeding, as the treatment could harm the baby.You weigh enough for your height.Your platelet count must be at least 75,000 per microliter.Your absolute neutrophil count is at least 1,000 per microliter.Your hemoglobin level is at least 8.0 grams per deciliter.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (STF, PD-1/PD-L1 inhibitor)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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