IMMUNO-FIT: How immunotherapy affects fitness and quality of life in adults with solid cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study follows adults with solid tumors who are starting immune checkpoint inhibitors to see how treatment affects cardiorespiratory fitness, quality of life, and treatment tolerance. Participants complete cardiopulmonary exercise testing (CPET) and quality-of-life questionnaires before immunotherapy and again at 12 weeks; blood samples are collected and a small subset may be invited for an optional research biopsy at week 12. Clinical outcomes including survival, disease progression, treatment interruptions, and ongoing quality-of-life measures are tracked for up to 24 months while patients receive standard-of-care treatment. No experimental therapies are given; the study links objective fitness measures and biomarkers to treatment side effects and longer-term outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* Age \<18 years
* 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
* Absolute contraindications to cardiopulmonary exercise testing:
* 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 (e.g., severe lower limb dysfunction, severe peripheral vascular disease)
* 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:

* Severe cardiopulmonary disease precluding safe sedation (for endoscopic biopsies)
* Suspected bowel obstruction or perforation (for gastrointestinal biopsies)
* Uncorrectable severe coagulopathy (INR \>1.5, platelet count \<50,000/µL)
* Severe portal hypertension with high-risk varices (for upper endoscopy)
* Lesion inaccessible for safe biopsy as determined by a performing clinician

Where it's running

• University Hospital Southampton NHS Foundation Trust
  Southampton, Hampshire, United Kingdom Recruiting

Study contacts

• Principal investigator: Kashuf Khan, MBBS, MRCS — University of Southampton
• Study coordinator: Kashuf Khan, MBBS, MRCS
• Email: k.a.khan@soton.ac.uk
• Phone: +442381204308

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.