Actively Recruiting
IMMUNO-FIT Observational Study
Led by University Hospital Southampton NHS Foundation Trust · Updated on 2026-04-28
67
Participants Needed
1
Research Sites
144 weeks
Total Duration
On this page
Sponsors
U
University Hospital Southampton NHS Foundation Trust
Lead Sponsor
U
University of Southampton
Collaborating Sponsor
AI-Summary
What this Trial Is About
This observational study will investigate how immunotherapy affects physical fitness, quality of life, and treatment tolerance in adults with solid cancers. Immunotherapy can cause a range of side effects that impact daily functioning and may lead to treatment delays or early discontinuation. Physical fitness may influence how well patients cope with treatment, yet little is known about how fitness changes during immunotherapy or whether baseline fitness is linked to outcomes. Participants will complete fitness testing using cardiopulmonary exercise testing (CPET) and quality-of-life questionnaires before starting immunotherapy and again 12 weeks later. Blood samples will also be taken, and long-term outcomes including survival, disease progression, and quality of life will be followed for up to 24 months. All cancer treatment will remain standard of care. A small number of participants will be invited to take part in an optional research biopsy at week 12 to explore how physical fitness relates to changes in the tumour's immune environment. The study will help researchers understand natural changes in fitness during immunotherapy, identify whether baseline fitness is associated with treatment tolerance or outcomes, and generate information needed to design future trials testing exercise-based interventions during immunotherapy.
CONDITIONS
Official Title
IMMUNO-FIT Observational Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed solid malignancy
- Receiving immune checkpoint inhibitors in one of the following settings:
- Adjuvant: Single-agent anti-PD-1, anti-PD-L1, or anti-CTLA-4
- Metastatic/Palliative: Single-agent or dual-agent anti-PD-1, anti-PD-L1, or anti-CTLA-4
- ECOG Performance Status 0-2
- Able to perform cardiopulmonary exercise testing
- Able to provide written informed consent
- Willing and able to comply with study procedures and follow-up schedule
You will not qualify if you...
- Under 18 years of age
- Prior systemic anti-cancer immunotherapy for unresectable or metastatic disease, except prior adjuvant or neoadjuvant immunotherapy if all treatment-related adverse events have returned to baseline or stabilized
- Prior anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy with less than 6 months since last dose or date of disease recurrence
- Absolute contraindications to cardiopulmonary exercise testing, including:
- Acute myocardial infarction within 6 weeks
- Unstable angina
- Uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise
- Active endocarditis
- Symptomatic severe aortic stenosis
- Uncontrolled heart failure
- Acute pulmonary embolism or pulmonary infarction
- Acute myocarditis or pericarditis
- Suspected or known dissecting aneurysm
- Acute systemic infection
- Inability to perform cardiopulmonary exercise testing due to severe lower limb dysfunction or severe peripheral vascular disease
- Inability to provide informed consent
- Currently enrolled in another interventional clinical trial that would confound study outcomes
- Additional exclusion for research biopsy sub-study:
- Severe cardiopulmonary disease precluding safe sedation
- Suspected bowel obstruction or perforation
- Uncorrectable severe coagulopathy (INR >1.5, platelet count <50,000/µL)
- Severe portal hypertension with high-risk varices
- Lesion inaccessible for safe biopsy as determined by a clinician
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom, SO16 6YD
Actively Recruiting
Research Team
K
Kashuf Khan, MBBS, MRCS
CONTACT
M
Malcolm West, MD, PhD, FEBS, FRCS,
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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