Exercise + Immunotherapy for Cancer

Recruiting in Palo Alto (17 mi)

Overseen ByPeter Kanetsky, PhD, MPH

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

I understand the study and can agree to participate.

I am about to start my first checkpoint inhibitor treatment with drugs like pembrolizumab.

Participant Groups

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.

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.