Exercise to Boost Response to Checkpoint Blockade Immunotherapy

Merkel Cell Carcinoma Clinical Trial

Official title:

Exercise to Boost Response to Checkpoint Blockade Immunotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05358938
• Other study ID #: MCC-20854
• Status: Recruiting
• Phase: Early Phase 1
• Start date: June 21, 2022
• Est. completion date: September 2024

Study information

• Verified date: May 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: Stephanie Forgas
• Phone: 813-745-5734
• Email: Stephanie.Forgas[@]moffitt.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• Inclusion Criteria:
• Age = 18 years
• Able to read and speak English fluently
• Capable of giving informed consent
• Reported ability to complete 20-30 minutes moderate exercise per positive response to "can you currently walk unaided for six minutes or more?".
• Scheduled for first-time checkpoint blockade immunotherapy with FDA-approved drugs, including avelumab, cemiplimab, ipilimumab, nivolumab, pembrolizumab or relatlimab in the absence of other therapies (e.g. targeted therapy)
• Melanoma patients (adjuvant setting)
• Melanoma patients (neoadjuvant setting)
• cuSCC patients (neoadjuvant setting)
• Merkel cell carcinoma patients (neoadjuvant setting) 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:

• Presence of medical conditions, such as severe cardiovascular disease for which an exercise intervention may not be warranted.
• Presence of major postoperative complications for which an exercise intervention may not be warranted.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Merkel Cell
• Cutaneous Melanoma
• Cutaneous Squamous Cell Carcinoma
• Merkel Cell Carcinoma

Intervention

Other:
• Exercise
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

Drug:
• Checkpoint Blockade, Immune
Participants will receive clinical care following Moffitt standards for the patient's disease type and therapeutic setting.

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Impact of Exercise on Tumor Immunological Biomarkers - Adjuvant Setting	The length of time without signs or symptoms of cancer	Up to 12 Months
Primary	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

External Links

•   Moffitt Cancer Center Clinical Trial Search