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

Neoplasm Metastasis

Neoplastic Processes

Antibodies

Immunoglobulins

Immunologic Factors

Checkpoint blockade immunotherapy (CBI) plus stereotactic body radiation therapy (SBRT)

Checkpoint blockade immunotherapy (CBI) alone

Approved Checkpoint blockade immunotherapy (including anti-CTLA-4 and anti-PD-1/PD-L1 antibodies)

Checkpoint blockade immunotherapy

SBRT at 28.5 Gy (9.5 Gy x3 fractions) will be delivered within 1 - 21 days of the start of Cycle 1 of the CBI plus CBI (approved CBIs including anti-CTLA-4 and anti-PD-1/PD-L1 antibodies)

Checkpoint blockade immunotherapy plus SBRT

Andrew Sharabi, MD, PhD

The purpose of this study is to determine whether stereotactic body radiation therapy (SBRT) combined with checkpoint blockaded immunotherapy (CBI) will improve the response to the anticancer treatment compared to CBI alone in patients with advanced metastatic cancer.

Patients who will receive anti-PD-1/PD-L1 immunotherapy with at least 1 site of measurable metastatic disease which will not be irradiated will be candidates for the study. Patients will be randomized (1:1) to CBI combined with SBRT or CBI alone. SBRT at 9.5Gy x3 fractions will be delivered within 1-21 days of the start of first cycle of CBI. The first six patients will be treated and observed for toxicity in the safety run-in phase for 30 days after radiation before continuing with further accrual. Radiation dose reduction is allowed if necessary to meet tissue constraints (6Gyx3 Minimum Dose). Response rates will be determined from the non-irradiated lesion/lesions. Blood draws will be obtained to analyze anti-tumor immune responses.

Checkpoint Blockade Immunotherapy Combined With Stereotactic Body Radiation in Advanced Metastatic Disease

Randomized Phase II Study of Checkpoint Blockade Immunotherapy Combined With Stereotactic Body Radiation Therapy in Advanced Metastatic Disease

Adverse events assessed from time of first dose to treatment completion (approximately 1 year)

The time from starting treatment to the time of first documented tumor progression or death due to any cause, whichever occurs first

The time from starting treatment until death due to any cause.

The rates of stable disease great than or equal to 6 months during and after SBRT in combination with CBI compared to CBI alone.

Lesion and blood assays performed in the lab.

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
Checkpoint Blockade Immunotherapy Combined With Stereotactic Body Radiation in Advanced Metastatic Disease	NCT02843165	Metastatic Canc...	Checkpoint bloc... Checkpoint bloc...	18 Years -	University of California, San Diego
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

Spots Global Cancer Trial Database for checkpoint blockade immunotherapy