NCT07354971Recruiting
IMMUNO-FIT Observational Study
The Immuno-FIT Observational Study: A Phase II Window Observational Study Investigating the Effects of Immunotherapy on Cardiopulmonary Fitness, Quality of Life, and Treatment Outcomes in Patients With Advanced Cancer
Source: ClinicalTrials.gov · Last updated 28 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 67 (estimated)
- First submitted
- 24 Nov 2025
- Start date
- Mar 2026
- Primary completion date
- Dec 2026
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- NCT number
- NCT07354971
What you commit to
- Study type: Observational
- Planned participants: 67
- From Mar 2026 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 at least 6 months since last dose and date of disease recurrence
Other illness
- Acute myocardial infarction within 6 weeks
- Unstable angina
- Uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise
- Uncontrolled heart failure
- Acute systemic infection
- Inability to perform cardiopulmonary exercise testing (e.g., severe lower limb dysfunction, severe peripheral vascular disease)
- Severe cardiopulmonary disease precluding safe sedation (for endoscopic biopsies)
- Suspected bowel obstruction or perforation (for gastrointestinal biopsies)
- Severe portal hypertension with high-risk varices (for upper endoscopy)
Lab values
- Uncorrectable severe coagulopathy (INR \>1.5, platelet count \<50,000/µL)
Age
- Age \<18 years
Other
- Absolute contraindications to cardiopulmonary exercise testing:
- Active endocarditis
- Symptomatic severe aortic stenosis
- Acute pulmonary embolism or pulmonary infarction
- Acute myocarditis or pericarditis
- Suspected or known dissecting aneurysm
- Inability to provide informed consent
- Currently enrolled in another interventional clinical trial that would confound study outcomes
- ADDITIONAL EXCLUSION CRITERIA FOR RESEARCH BIOPSY SUB-STUDY:
- Lesion inaccessible for safe biopsy as determined by a performing clinician
Who the study is looking for
- Age ≥18 years
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Southampton NHS Foundation Trust Coordinator of this site? Confirm its status | Southampton | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.