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Checkpoint Inhibitor
Exercise + Immunotherapy for Cancer
Phase < 1
Recruiting
Led By Peter Kanetsky, PhD, MPH
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years
Capable of giving informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
Study Summary
This trial is testing whether adding 30 minutes of exercise before each immunotherapy treatment can improve outcomes.
Who is the study for?
This trial is for adults who can read and speak English, give informed consent, and are able to do moderate exercise like walking unaided for at least six minutes. It's specifically for those with certain skin cancers or neuroendocrine carcinoma about to start checkpoint blockade immunotherapy. People with severe heart disease or major postoperative complications cannot join.Check my eligibility
What is being tested?
The study tests if doing 30 minutes of moderate exercise before each dose of standard checkpoint blockade immunotherapy (drugs like avelumab, cemiplimab) improves treatment response in cancer patients.See study design
What are the potential side effects?
Potential side effects from the immunotherapy drugs may include fatigue, flu-like symptoms, skin reactions, digestive issues, and possible immune-related effects on organs such as the liver or lungs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I understand the study and can agree to participate.
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I am about to start my first checkpoint inhibitor treatment with drugs like pembrolizumab.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Impact of Exercise on Tumor Immunological Biomarkers - Adjuvant Setting
Participants Completing Exercise
Participants Consenting to Trial
+1 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Neoadjuvant Arm with ExerciseExperimental Treatment2 Interventions
Participants will complete 30 minutes of moderate exercise on an arm ergometer, a cycle ergometer, or a treadmill prior to each administration of standard of care checkpoint blockade immunotherapy across all cycles. Neoadjuvant participants will receive up to 4 cycles of therapy with avelumab, cemiplimab, ipilimumab, nivolumab, pembrolizumab, or relatlimab, or currently approved standard of care treatment, either alone or in combination. Blood samples will be collected at 1) baseline (upon arrival to clinic), 2) post-exercise, and 3) post-infusion. Blood samples will be obtained on the first and third infusion dates.
Group II: Adjuvant Arm with ExerciseExperimental Treatment2 Interventions
Participants will receive clinical care following Moffitt standards for the patient's disease type and therapeutic setting. Adjuvant participants will receive 1 year [currently 9-18 cycles] of therapy with avelumab, cemiplimab, ipilimumab, nivolumab, pembrolizumab or relatlimab, or currently approved standard of care treatment, either alone or in combination. Participants also will complete 30 minutes of moderate exercise on an arm ergometer, a cycle ergometer, or a treadmill prior to each administration of standard of care checkpoint blockade immunotherapy across all cycles. Blood samples will be collected at 1) baseline (upon arrival to clinic), 2) post-exercise, and 3) post-infusion. Blood samples will be obtained on the first, third, midpoint, and final infusion dates.
Group III: Neoadjuvant Arm without ExerciseActive Control1 Intervention
Participants will receive clinical care following Moffitt standards for the patient's disease type and therapeutic setting. Neoadjuvant participants will receive up to 4 cycles of therapy with avelumab, cemiplimab, ipilimumab, nivolumab, pembrolizumab, or relatlimab, or currently approved standard of care treatment, either alone or in combination. Participants also will complete 30 minutes of moderate exercise on an arm ergometer, a cycle ergometer, or a treadmill prior to each administration of standard of care checkpoint blockade immunotherapy across all cycles. Blood samples will be collected at 1) baseline (upon arrival to clinic), 2) post-exercise, and 3) post-infusion. Blood samples will be obtained on the first and third infusion dates.
Group IV: Adjuvant Arm without ExerciseActive Control1 Intervention
Participants will receive clinical care following Moffitt standards for the patients disease type and therapeutic setting. Adjuvant participants will receive one year [currently 9-18 cycles] of therapy with avelumab, cemiplimab, ipilimumab, nivolumab, pembrolizumab, relatlimab, or currently approved standard of care treatment, either alone or in combination. Blood samples will be collected at 1) baseline (upon arrival to clinic) and 2) post-infusion. Blood samples will be obtained on the first, third, midpoint, and final infusion dates.
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Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
543 Previous Clinical Trials
135,463 Total Patients Enrolled
Peter Kanetsky, PhD, MPHPrincipal InvestigatorMoffitt Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am a patient with cutaneous squamous cell carcinoma.I have a severe heart condition that may not allow for exercise.I understand the study and can agree to participate.I have Merkel cell carcinoma and am considering treatment before surgery.I can walk unaided for six minutes or more.I have major complications after surgery that may not allow me to exercise.I have melanoma and am receiving treatment before surgery.I am a melanoma patient receiving additional treatment after the primary treatment.I am about to start my first checkpoint inhibitor treatment with drugs like pembrolizumab.
Research Study Groups:
This trial has the following groups:- Group 1: Neoadjuvant Arm without Exercise
- Group 2: Neoadjuvant Arm with Exercise
- Group 3: Adjuvant Arm without Exercise
- Group 4: Adjuvant Arm with Exercise
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current number of participants in this clinical trial?
"Affirmative, the information available on clinicaltrials.gov indicates that this trial is presently seeking volunteers. It was first listed in April 26th 2022 and has since been updated to reflect new details as of September 21st 2022. There are 32 slots across a single research site up for grabs."
Answered by AI
Is this clinical research still accepting participants?
"Affirmative. Clinicaltrials.gov shows that enrollment for this trial is currently ongoing; it was initially announced on April 26th 2022 and the most recent update was made in September of 2022. Specifically, 32 patients are required across a single medical centre."
Answered by AI
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