Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Infections

Symptoms and General Pathology

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Melanoma

Skin Neoplasms

Melanoma, Cutaneous Malignant

Carcinoma, Merkel Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Communicable Diseases

Polyomavirus Infections

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Carcinoma, Neuroendocrine

Adenocarcinoma

Merkel Cell Carcinoma

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Avelumab

Immunomodulating Agents

Nivolumab

Cemiplimab

Ipilimumab

Relatlimab

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

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.

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.

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.

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.

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

Exercise

Participants will receive clinical care following Moffitt standards for the patient's disease type and therapeutic setting.

Checkpoint Blockade, Immune

Stephanie Forgas

Peter Kanetsky, PhD, MPH

Vernon K Sondak, MD

Ahmad A Tarhini, MD, PhD

Exercise to Boost Response to Checkpoint Blockade Immunotherapy

Proportion of patients approached who consent to participate in study, and investigators will determine the 95% confidence interval

Proportion of participants randomized to the exercise intervention who complete at least 75% of schedule exercise routines; 95% CI will be determined for this proportion.

The length of time without signs or symptoms of cancer

The occurrence of pathological complete response in resected tumor tissue. pCR will be determined by absence of tumor cells.

H. Lee Moffitt Cancer Center and Research Institute

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Breast Neoplasms

Carcinoma, Hepatocellular

Urinary Bladder Neoplasms

Carcinoma, Renal Cell

Small Cell Lung Carcinoma

Head and Neck Neoplasms

Mesothelioma

Mesothelioma, Malignant

Gastrointestinal Neoplasms

Digestive System Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Gastrointestinal Diseases

Adenoma

Neoplasms, Mesothelial

Pleural Neoplasms

Renal Cell Carcinoma

Small Cell Lung Cancer

Clear Cell Renal Cell Carcinoma

Malignant Mesothelioma

Durvalumab

Atezolizumab

Immune checkpoint blockade drugs target the immune system by blocking control pathways regulating anti-tumor immunity and thereby reinvigorate their activities against cancer.

mireille Langouo Fontsa, MD

MIREILLE LANGOUO, MD, PhD

This is a monocentric, prospective, pilot study that will enrol 435 subjects with solid tumours that are treated with immune checkpoint inhibitor(s) (ICI) alone or in combination with chemotherapy or targeted therapy.

For enrolled subjects, clinical and laboratory evaluations will be performed and reported at different time points:

* Early (4-6 weeks after treatment start)
* Midtime (8-11 weeks after treatment start)
* Late (13-18 weeks after treatment start)
* At the occurrence of immune-related adverse events (irAEs), clinical and laboratory evaluation will be performed at two principal time points:

  * For the 1st time of any grade 1 or 2 irAE if the subject developed it.
  * For the 1st time of any grade 3 or 4 irAE if the subject developed it.

Advances in treating patients with immunotherapy has dramatically changed cancer morbidity and mortality. Immune checkpoint inhibitors (ICI), alone or combined with other drugs, are currently used both as standard of care or in experimental settings for various cancers. Currently, ICI treatment induces objective clinical responses in 20-40% of patients, which varies by tumour type. A significant risk of immune-related adverse events (irAE) is also associated with ICI treatment, including the onset of autoimmune diseases. While the incidence of irAE is highly variable and influenced by many factors, phase I and II trials reported rates from 10% to 80% for any grade irAE while an irAE of grade 3 or higher was observed in 2.5% to 18% of subjects. Despite the fact that older adults represent the growing majority of patients diagnosed with cancer, the efficacy and toxicity of ICI in older patients, alone or in combination with other agents, remains controversial. Presently, the specific immune mechanism(s) driving irAE are unknown and biomarkers that predict their onset, particularly high-grade irAE, are urgently needed. The identification of predictive clinical, laboratory and immunological biomarkers (blood and tissue) for toxicity will more accurately identify and quantify patients who are at risk for ICI therapy. Then, this will possibly allow better irAE management.

This is a monocentric, prospective, pilot study that will enrol 435 subjects with solid tumours that are treated with immune checkpoint inhibitor(s) (ICI) alone or in combination with chemotherapy or targeted therapy.

Immunological Variables Associated to ICI Toxicity in Cancer Patients

Modification(s) in the immune blood markers including cytokines, immune cells and serum autoantibody level of treated subjects.

Safety will be assessed and graded by the investigator(s) by using the adverse events reported during the study in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

Jules Bordet Institute

Principal investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Exercise to Boost Response to Checkpoint Blockade Immunotherapy	NCT05358938	Cutaneous Melan... Cutaneous Squam... Merkel Cell Car...	Exercise Checkpoint Bloc...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Exercise to Boost Response to Checkpoint Blockade Immunotherapy	NCT05358938	Cutaneous Melan... Cutaneous Squam... Merkel Cell Car...	Exercise Checkpoint Bloc...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Exercise to Boost Response to Checkpoint Blockade Immunotherapy	NCT05358938	Cutaneous Melan... Cutaneous Squam... Merkel Cell Car...	Exercise Checkpoint Bloc...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Immunological Variables Associated to ICI Toxicity in Cancer Patients	NCT05429866	Breast Cancer Melanoma Non Small Cell ... Non-melanoma Sk... Gastrointestina... Head and Neck C... Renal Cell Carc... Small Cell Lung... Mesothelioma, M... Bladder Cancer Merkel Cell Car... Hepatocellular ... MSI-H Colorecta...	Checkpoint Bloc...	18 Years -	Jules Bordet Institute

Spots Global Cancer Trial Database for checkpoint blockade, immune