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Checkpoint Inhibitor

Exercise + Immunotherapy for Cancer

Phase < 1

Waitlist Available

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

No Placebo-Only Group

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.

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.

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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Impact of Exercise on Tumor Immunological Biomarkers - Adjuvant Setting

Participants Completing Exercise

Participants Consenting to Trial

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial 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.

0 / 3Eligibility criteria met