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Exercise to Boost Response to Checkpoint Blockade Immunotherapy

Primary Purpose

Cutaneous Melanoma, Cutaneous Squamous Cell Carcinoma, Merkel Cell Carcinoma

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Exercise
Checkpoint Blockade, Immune
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutaneous Melanoma focused on measuring Exercise, Checkpoint Blockade Immunotherapy, Immunotherapy, Skin Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • Inclusion Criteria:
  • Age ≥ 18 years
  • Able to read and speak English fluently
  • Capable of giving informed consent
  • Patient has received a complete COVID-19 vaccination series.
  • 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 avelumab, cemiplimab, ipilimumab, nivolumab, or pembrolizumab 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)

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.

Sites / Locations

  • Moffitt Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Adjuvant Arm with Exercise

Adjuvant Arm without Exercise

Neoadjuvant Arm with Exercise

Neoadjuvant Arm without Exercise

Arm Description

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.

Outcomes

Primary Outcome Measures

Participants Consenting to Trial
Proportion of patients approached who consent to participate in study, and investigators will determine the 95% confidence interval
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.
Impact of Exercise on Tumor Immunological Biomarkers - Adjuvant Setting
The length of time without signs or symptoms of cancer
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.

Secondary Outcome Measures

Full Information

First Posted
April 28, 2022
Last Updated
June 5, 2023
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05358938
Brief Title
Exercise to Boost Response to Checkpoint Blockade Immunotherapy
Official Title
Exercise to Boost Response to Checkpoint Blockade Immunotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Melanoma, Cutaneous Squamous Cell Carcinoma, Merkel Cell Carcinoma
Keywords
Exercise, Checkpoint Blockade Immunotherapy, Immunotherapy, Skin Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adjuvant Arm with Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Adjuvant Arm without Exercise
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Neoadjuvant Arm with Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Neoadjuvant Arm without Exercise
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Checkpoint Blockade, Immune
Other Intervention Name(s)
Avelumab, Cemiplimab, Ipilimumab, Nivolumab, Pembrolizumab
Intervention Description
Participants will receive clinical care following Moffitt standards for the patient's disease type and therapeutic setting.
Primary Outcome Measure Information:
Title
Participants Consenting to Trial
Description
Proportion of patients approached who consent to participate in study, and investigators will determine the 95% confidence interval
Time Frame
Up to 12 months
Title
Participants Completing Exercise
Description
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.
Time Frame
Up to 12 months
Title
Impact of Exercise on Tumor Immunological Biomarkers - Adjuvant Setting
Description
The length of time without signs or symptoms of cancer
Time Frame
Up to 12 Months
Title
Pathological Complete Response (pCR) - Neoadjuvant Setting
Description
The occurrence of pathological complete response in resected tumor tissue. pCR will be determined by absence of tumor cells.
Time Frame
Up to 4 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Forgas
Phone
813-745-5734
Email
Stephanie.Forgas@moffitt.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Kanetsky, PhD, MPH
Organizational Affiliation
Moffitt Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Forgas
Phone
813-745-5734
Email
Stephanie.Forgas@moffitt.org
First Name & Middle Initial & Last Name & Degree
Peter Kanetsky, PhD, MPH
First Name & Middle Initial & Last Name & Degree
Vernon K Sondak, MD
First Name & Middle Initial & Last Name & Degree
Ahmad A Tarhini, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://moffitt.org/clinical-trials-research/clinical-trials/?gclid=EAIaIQobChMImIymzIa-9gIVAZ2GCh3uzAWJEAAYASAAEgI0ovD_BwE
Description
Moffitt Cancer Center Clinical Trial Search

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Exercise to Boost Response to Checkpoint Blockade Immunotherapy

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