Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adjuvant Arm with Exercise | Experimental | 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. |
|
| Adjuvant Arm without Exercise | Active Comparator | 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. |
|
| Neoadjuvant Arm with Exercise | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Participants Consenting to Trial | Proportion of patients approached who consent to participate in study, and investigators will determine the 95% confidence interval | Up to 12 months |
| Participants Completing Exercise | 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. | Up to 12 months |
| Impact of Exercise on Tumor Immunological Biomarkers - Adjuvant Setting | The length of time without signs or symptoms of cancer | Up to 12 Months |
| Pathological Complete Response (pCR) - Neoadjuvant Setting | The occurrence of pathological complete response in resected tumor tissue. pCR will be determined by absence of tumor cells. | Up to 4 Months |
Not provided
Not provided
Participants may also be required to have a full COVID vaccination series; the most up-to-date best practice guidelines for research at Moffitt Cancer Center will dictate the need for such a vaccination series.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter Kanetsky, PhD, MPH | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D015266 | Carcinoma, Merkel Cell |
| D009043 | Motor Activity |
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D015444 | Exercise |
| D000082082 | Immune Checkpoint Inhibitors |
| C000609138 | avelumab |
| C000627974 | cemiplimab |
| D000074324 | Ipilimumab |
| D000077594 | Nivolumab |
| C582435 | pembrolizumab |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Neoadjuvant Arm without Exercise | Active Comparator | 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. |
|
| Checkpoint Blockade, Immune | Drug | Participants will receive clinical care following Moffitt standards for the patient's disease type and therapeutic setting. |
|
|
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D027601 | Polyomavirus Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D018278 | Carcinoma, Neuroendocrine |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D001519 | Behavior |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |