Can fitness predict how well immunotherapy works? new study aims to find out
NCT ID NCT07354971
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study watches how immunotherapy for advanced cancer changes patients' physical fitness and quality of life. About 67 adults will do fitness tests and fill out questionnaires before starting treatment and again 12 weeks later. Researchers will also track long-term outcomes like survival and side effects. The goal is to understand natural changes in fitness during immunotherapy and gather information to design future exercise programs.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could show how physical fitness changes during immunotherapy and whether it affects treatment tolerance, helping design future exercise programs for cancer patients.
- What could go wrong
- This is an early observational study with only 67 participants, so results may not apply to all patients. It does not test any new treatment, so direct benefits are unlikely.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 67 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Adults aged ≥18 years with histologically confirmed solid malignancies receiving immune checkpoint inhibitors (anti-PD-1, anti-PD-L1, or anti-CTLA-4) at University Hospital Southampton. Recruitment includes patients treated in the adjuvant setting with single-agent therapy after definitive local treatment, and patients in the metastatic or palliative setting receiving single- or dual-agent immunotherapy for advanced disease. The study uses a tumour-agnostic approach and includes any solid tumour for which immunotherapy is indicated. Examples include gastrointestinal, thoracic, skin, genitourinary, gynaecological, head and neck, breast, and other solid cancers treated with checkpoint inhibitors. Participants must have ECOG Performance Status 0-2 and be able to safely undertake cardiopulmonary exercise testing.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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University Hospital Southampton NHS Foundation Trust
RECRUITINGSouthampton, Hampshire, SO16 6YD, United Kingdom
Contact Email: •••••@•••••
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