Exercise to Boost Response to Checkpoint Blockade Immunotherapy

Merkel Cell Carcinoma Clinical Trial

— EX-BOOST  

Official title:

Exercise to Boost Response to Checkpoint Blockade Immunotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06008977
• Other study ID #: 1805426
• Status: Recruiting
• Phase: N/A
• Start date: June 3, 2024
• Est. completion date: May 2025

Study information

• Verified date: June 2024
• Source: AdventHealth Translational Research Institute
• Contact: Recruitment Department
• Phone: 407-303-7100
• Email: Fh.tri.recruitment[@]adventhealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Males and females =18 years of age.

2. Able to read and speak English fluently.

3. Reported ability to complete 20-30 minutes moderate exercise per positive response to, "Can you currently walk unaided for six minutes or more?"

4. 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:

1. Adjuvant setting: cutaneous melanoma.

2. Neoadjuvant setting: cutaneous melanoma, cuSCC, or Merkel cell carcinoma.

5. States willingness to follow protocol as described, including the prescribed exercise level and completing any forms needed throughout the study.

6. 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:

7. 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.

8. Presence of major postoperative complications for which an exercise intervention may be contraindicated.

9. Currently has a chronic, contagious, infectious disease, such as active tuberculosis, active Hepatitis B or C, HIV, or COVID-19, per self-report.

10. Currently pregnant, lactating or planning to become pregnant (positive result on urine pregnancy testing).

11. 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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Exercise Test
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.

Locations

Country	Name	City	State
United States	AdventHealth Translational Research Institute	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AdventHealth Translational Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse-free survival	For patients treated in the adjuvant setting. Total study duration is dependent upon oncology therapy.; Recurrence-free survival will be assessed.	Up to 12 months
Primary	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.	Up to 12 months

External Links

•   Website for AdventHealth Translational Research Institute