22 Participants Needed

Exercise + Immunotherapy for Cancer

SF
Overseen ByStephanie Forgas
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Must be taking: Checkpoint immunotherapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that participants should be scheduled for first-time checkpoint blockade immunotherapy without other therapies, which might imply some restrictions.

Is the combination of exercise and immunotherapy generally safe for humans?

Checkpoint inhibitors, a type of immunotherapy, can cause immune-related side effects, including bone fractures and endocrine issues, by activating the immune system against normal tissues. Exercise's impact on these side effects is not well understood, but it is important to monitor for these potential adverse events during treatment.12345

How does the treatment of exercise combined with checkpoint blockade immunotherapy differ from other cancer treatments?

This treatment is unique because it combines exercise with checkpoint blockade immunotherapy, which may enhance the immune system's ability to fight cancer by improving immune cell circulation and tumor blood flow, potentially overcoming resistance seen in some cancers with immunotherapy alone.678910

What data supports the effectiveness of the treatment combining exercise and checkpoint blockade immunotherapy for cancer?

Research suggests that exercise can enhance the effectiveness of checkpoint blockade immunotherapy by improving the immune system's response to cancer. Exercise helps mobilize immune cells to the tumor area, potentially boosting the treatment's ability to fight cancer.12679

Who Is on the Research Team?

PK

Peter Kanetsky, PhD, MPH

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

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 a patient with cutaneous squamous cell carcinoma.
I understand the study and can agree to participate.
I have Merkel cell carcinoma and am considering treatment before surgery.
See 5 more

Exclusion Criteria

I have a severe heart condition that may not allow for exercise.
I have major complications after surgery that may not allow me to exercise.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Treatment

Participants receive up to 4 cycles of checkpoint blockade immunotherapy with or without exercise

Up to 4 months
Visits for each cycle, with blood samples collected at baseline, post-exercise, and post-infusion

Adjuvant Treatment

Participants receive 9-18 cycles of checkpoint blockade immunotherapy with or without exercise

Up to 12 months
Visits for each cycle, with blood samples collected at baseline, post-exercise, and post-infusion

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Checkpoint Blockade Immunotherapy
  • Exercise
Trial Overview 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.
How Is the Trial Designed?
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials
576
Recruited
145,000+

Published Research Related to This Trial

Exercise and physical activity can enhance immune function in cancer patients, potentially improving their responses to immunotherapies like immune checkpoint inhibitors and CAR T cell therapies.
Chronic exercise is linked to better physical fitness and a healthier immune profile, including reduced dysfunctional T cells, suggesting that incorporating exercise into cancer treatment plans could lead to better outcomes.
Exercise and the immune system: taking steps to improve responses to cancer immunotherapy.Gustafson, MP., Wheatley-Guy, CM., Rosenthal, AC., et al.[2023]
Exercise may enhance the effectiveness of immune checkpoint inhibition (ICI) in cancer therapy by promoting the movement and distribution of immune cells to the tumor microenvironment, potentially improving anti-tumor immunity.
The review highlights the importance of various factors such as cancer type, exercise frequency, intensity, time, and type (FITT) in determining how exercise influences cancer immunosurveillance and the response to ICI.
Can Exercise Enhance the Efficacy of Checkpoint Inhibition by Modulating Anti-Tumor Immunity?Brummer, C., Pukrop, T., Wiskemann, J., et al.[2023]
In a study of 251 patients undergoing immune checkpoint inhibitor (ICI) treatment, higher levels of physical activity were linked to a significantly lower risk of severe immune-related adverse events (irAEs), with moderate and high activity reducing the odds by up to 81%.
Patients with higher physical activity levels also experienced prolonged overall survival, suggesting that engaging in more physical activity at the start of ICI treatment may enhance treatment outcomes.
Physical activity and checkpoint inhibition: association with toxicity and survival.Verheijden, RJ., Cabané Ballester, A., Smit, KC., et al.[2023]

Citations

1.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Comprehensive rehabilitation of immune-mediated adverse events in cancer patients receiving checkpoint inhibitor therapy]. [2022]
Exercise and the immune system: taking steps to improve responses to cancer immunotherapy. [2023]
Can Exercise Enhance the Efficacy of Checkpoint Inhibition by Modulating Anti-Tumor Immunity? [2023]
Physical activity and checkpoint inhibition: association with toxicity and survival. [2023]
Effects of exercise and anti-PD-1 on the tumour microenvironment. [2022]
[Management of adverse events associated with cancer immunotherapy]. [2021]
Bone fracture as a novel immune-related adverse event with immune checkpoint inhibitors: Case series and large-scale pharmacovigilance analysis. [2021]
A real-world retrospective study of incidence and associated factors of endocrine adverse events related to PD-1/PD-L1 inhibitors. [2023]
Voluntary wheel running can lead to modulation of immune checkpoint molecule expression. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Exercise as Adjunct Therapy in Cancer. [2020]
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