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Exercise to Boost Response to Checkpoint Blockade Immunotherapy (EX-BOOST)

Primary Purpose

Cutaneous Melanoma, Cutaneous Squamous Cell Carcinoma, Merkel Cell Carcinoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Test
Sponsored by
AdventHealth Translational Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cutaneous Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Males and females ≥18 years of age. Able to read and speak English fluently. 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) with the following diagnosis: Adjuvant setting: cutaneous melanoma. Neoadjuvant setting: cutaneous melanoma, cuSCC, or Merkel cell carcinoma. States willingness to follow protocol as described, including the prescribed exercise level and completing any forms needed throughout the study. Voluntarily signed and dated an informed consent form, approved by an Institutional Review Board/Independent Ethics Committee, and provided Health Insurance Portability and Accountability Act authorization (HIPAA) or other privacy authorization prior to any participation in study. Exclusion Criteria: Presence of medical conditions, such as severe cardiovascular disease for which exercise may be contraindicated. Participants may be referred to their medical team to obtain a cardiology approval. Presence of major postoperative complications for which an exercise intervention may be contraindicated. Currently has a chronic, contagious, infectious disease, such as active tuberculosis, active Hepatitis B or C, HIV, or COVID-19, per self-report. Currently pregnant, lactating or planning to become pregnant (positive result on urine pregnancy testing). Presence of any condition that, in the opinion of the Investigator, compromises participant safety or data integrity or the participant's ability to complete the study.

Sites / Locations

  • AdventHealth Translational Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

No Intervention

Active Comparator

Arm Label

Standard Group- No Exercise (Adjuvant)

Intervention Group- Moderate Exercise (adjuvant)

Standard Group- No Exercise (Neoadjuvant)

Intervention Group- Moderate Exercise (Neoadjuvant)

Arm Description

Patients randomized to the standard arm will receive clinical care following AH standards for the patient's disease type and therapeutic setting. This includes history and physical and laboratory studies to be conducted on each infusion day before clearing the patient for infusion.

Patients randomized to the exercise arm will complete up to 30 minutes of same-day exercise prior to each administration of checkpoint blockade immunotherapy across all cycles. The preferred exercise is 30 minutes of moderate exertion on a cycle ergometer.

Patients randomized to the standard arm will receive clinical care following AH (AdventHealth) standards for the patient's disease type and therapeutic setting. This includes history and physical and laboratory studies to be conducted on each infusion day before clearing the patient for infusion.

Patients randomized to the exercise arm will complete up to 30 minutes of same-day exercise prior to each administration of checkpoint blockade immunotherapy across all cycles. The preferred exercise is 30 minutes of moderate exertion on a cycle ergometer.

Outcomes

Primary Outcome Measures

Relapse-free survival
For patients treated in the adjuvant setting. Total study duration is dependent upon oncology therapy. Recurrence-free survival will be assessed.
Pathological complete response (pCR)
For patients treated in the neoadjuvant setting. All neoadjuvant patients will have remaining tumor and, when appropriate, its associated nodal basin removed after completion of checkpoint blockade immunotherapy. Total study duration is dependent upon oncology therapy. This will be measured in excised tissues after standard-of-care surgery post completion of checkpoint blockade immunotherapy.

Secondary Outcome Measures

Full Information

First Posted
June 6, 2023
Last Updated
September 11, 2023
Sponsor
AdventHealth Translational Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT06008977
Brief Title
Exercise to Boost Response to Checkpoint Blockade Immunotherapy
Acronym
EX-BOOST
Official Title
Exercise to Boost Response to Checkpoint Blockade Immunotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AdventHealth Translational Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this pilot study will be to provide i) information on feasibility implementing an exercise intervention trial among patients with cutaneous cancers, including melanoma, squamous cell carcinoma (cuSCC), and Merkel cell carcinoma, scheduled to receive checkpoint blockade immunotherapy, and ii) preliminary data on the impact of a day-of-therapy exercise intervention.

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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
We will use stratified block randomization to assure non-biased assignment to the exercise intervention arm. Within each treatment setting, adjuvant and neoadjuvant, 10 patients will be randomized to the exercise intervention arm and 10 to the standard treatment arm. Within the neoadjuvant setting, randomization also will be blocked within disease type.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Group- No Exercise (Adjuvant)
Arm Type
No Intervention
Arm Description
Patients randomized to the standard arm will receive clinical care following AH standards for the patient's disease type and therapeutic setting. This includes history and physical and laboratory studies to be conducted on each infusion day before clearing the patient for infusion.
Arm Title
Intervention Group- Moderate Exercise (adjuvant)
Arm Type
Active Comparator
Arm Description
Patients randomized to the exercise arm will complete up to 30 minutes of same-day exercise prior to each administration of checkpoint blockade immunotherapy across all cycles. The preferred exercise is 30 minutes of moderate exertion on a cycle ergometer.
Arm Title
Standard Group- No Exercise (Neoadjuvant)
Arm Type
No Intervention
Arm Description
Patients randomized to the standard arm will receive clinical care following AH (AdventHealth) standards for the patient's disease type and therapeutic setting. This includes history and physical and laboratory studies to be conducted on each infusion day before clearing the patient for infusion.
Arm Title
Intervention Group- Moderate Exercise (Neoadjuvant)
Arm Type
Active Comparator
Arm Description
Patients randomized to the exercise arm will complete up to 30 minutes of same-day exercise prior to each administration of checkpoint blockade immunotherapy across all cycles. The preferred exercise is 30 minutes of moderate exertion on a cycle ergometer.
Intervention Type
Other
Intervention Name(s)
Exercise Test
Intervention Description
Supervised pedaling on an ergometer (stationary bike) at a moderate pace for a goal of 30 minutes. The exercise test will be scheduled at infusion visits 1, 6, and 12 or 1 and 3 over the treatment cycle, depending on the group assignment.
Primary Outcome Measure Information:
Title
Relapse-free survival
Description
For patients treated in the adjuvant setting. Total study duration is dependent upon oncology therapy. Recurrence-free survival will be assessed.
Time Frame
Up to 12 months
Title
Pathological complete response (pCR)
Description
For patients treated in the neoadjuvant setting. All neoadjuvant patients will have remaining tumor and, when appropriate, its associated nodal basin removed after completion of checkpoint blockade immunotherapy. Total study duration is dependent upon oncology therapy. This will be measured in excised tissues after standard-of-care surgery post completion of checkpoint blockade immunotherapy.
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females ≥18 years of age. Able to read and speak English fluently. 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) with the following diagnosis: Adjuvant setting: cutaneous melanoma. Neoadjuvant setting: cutaneous melanoma, cuSCC, or Merkel cell carcinoma. States willingness to follow protocol as described, including the prescribed exercise level and completing any forms needed throughout the study. Voluntarily signed and dated an informed consent form, approved by an Institutional Review Board/Independent Ethics Committee, and provided Health Insurance Portability and Accountability Act authorization (HIPAA) or other privacy authorization prior to any participation in study. Exclusion Criteria: Presence of medical conditions, such as severe cardiovascular disease for which exercise may be contraindicated. Participants may be referred to their medical team to obtain a cardiology approval. Presence of major postoperative complications for which an exercise intervention may be contraindicated. Currently has a chronic, contagious, infectious disease, such as active tuberculosis, active Hepatitis B or C, HIV, or COVID-19, per self-report. Currently pregnant, lactating or planning to become pregnant (positive result on urine pregnancy testing). Presence of any condition that, in the opinion of the Investigator, compromises participant safety or data integrity or the participant's ability to complete the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Recruitment Department
Phone
407-303-7100
Email
Fh.tri.recruitment@adventhealth.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bret Goodpaster, PhD
Organizational Affiliation
Study Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
AdventHealth Translational Research Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Recruitment Department
Phone
407-303-7100
Email
Fh.tri.recruitment@adventhealth.com
First Name & Middle Initial & Last Name & Degree
Bret Goodpaster, PhD
First Name & Middle Initial & Last Name & Degree
Tarek Mekhail, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
29056514
Citation
Hojman P, Gehl J, Christensen JF, Pedersen BK. Molecular Mechanisms Linking Exercise to Cancer Prevention and Treatment. Cell Metab. 2018 Jan 9;27(1):10-21. doi: 10.1016/j.cmet.2017.09.015. Epub 2017 Oct 19.
Results Reference
background
PubMed Identifier
29713319
Citation
Campbell JP, Turner JE. Debunking the Myth of Exercise-Induced Immune Suppression: Redefining the Impact of Exercise on Immunological Health Across the Lifespan. Front Immunol. 2018 Apr 16;9:648. doi: 10.3389/fimmu.2018.00648. eCollection 2018.
Results Reference
background
PubMed Identifier
32139351
Citation
Martin-Ruiz A, Fiuza-Luces C, Rincon-Castanedo C, Fernandez-Moreno D, Galvez BG, Martinez-Martinez E, Martin-Acosta P, Coronado MJ, Franco-Luzon L, Gonzalez-Murillo A, Ramirez M, Provencio M, Lucia A. Benefits of exercise and immunotherapy in a murine model of human non-small-cell lung carcinoma. Exerc Immunol Rev. 2020;26:100-115.
Results Reference
background
PubMed Identifier
20211907
Citation
Montes J, McDermott MP, Martens WB, Dunaway S, Glanzman AM, Riley S, Quigley J, Montgomery MJ, Sproule D, Tawil R, Chung WK, Darras BT, De Vivo DC, Kaufmann P, Finkel RS; Muscle Study Group and the Pediatric Neuromuscular Clinical Research Network. Six-Minute Walk Test demonstrates motor fatigue in spinal muscular atrophy. Neurology. 2010 Mar 9;74(10):833-8. doi: 10.1212/WNL.0b013e3181d3e308.
Results Reference
background
PubMed Identifier
29945191
Citation
Tetzlaff MT, Messina JL, Stein JE, Xu X, Amaria RN, Blank CU, van de Wiel BA, Ferguson PM, Rawson RV, Ross MI, Spillane AJ, Gershenwald JE, Saw RPM, van Akkooi ACJ, van Houdt WJ, Mitchell TC, Menzies AM, Long GV, Wargo JA, Davies MA, Prieto VG, Taube JM, Scolyer RA. Pathological assessment of resection specimens after neoadjuvant therapy for metastatic melanoma. Ann Oncol. 2018 Aug 1;29(8):1861-1868. doi: 10.1093/annonc/mdy226.
Results Reference
background
PubMed Identifier
28891423
Citation
Weber J, Mandala M, Del Vecchio M, Gogas HJ, Arance AM, Cowey CL, Dalle S, Schenker M, Chiarion-Sileni V, Marquez-Rodas I, Grob JJ, Butler MO, Middleton MR, Maio M, Atkinson V, Queirolo P, Gonzalez R, Kudchadkar RR, Smylie M, Meyer N, Mortier L, Atkins MB, Long GV, Bhatia S, Lebbe C, Rutkowski P, Yokota K, Yamazaki N, Kim TM, de Pril V, Sabater J, Qureshi A, Larkin J, Ascierto PA; CheckMate 238 Collaborators. Adjuvant Nivolumab versus Ipilimumab in Resected Stage III or IV Melanoma. N Engl J Med. 2017 Nov 9;377(19):1824-1835. doi: 10.1056/NEJMoa1709030. Epub 2017 Sep 10.
Results Reference
background
PubMed Identifier
31391869
Citation
Khunger A, Buchwald ZS, Lowe M, Khan MK, Delman KA, Tarhini AA. Neoadjuvant therapy of locally/regionally advanced melanoma. Ther Adv Med Oncol. 2019 Jul 31;11:1758835919866959. doi: 10.1177/1758835919866959. eCollection 2019.
Results Reference
background
Links:
URL
https://www.adventhealthresearchinstitute.com/research/translational-research
Description
Website for AdventHealth Translational Research Institute

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Exercise to Boost Response to Checkpoint Blockade Immunotherapy

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