Exercise to Boost Immunotherapy Response in Advanced Kidney Cancer
Official title: Promoting Response to IMmunotherapy by Exercise in Patients With Advanced Renal Cell Carcinoma
Run by Radboud University Medical Center · NCT07680556 · Data updated 2026-11-12
In this pilot study, adults with advanced renal cell carcinoma receiving first-line nivolumab plus ipilimumab will try a supervised HIIT exercise program to see if it helps them better tolerate treatment and possibly improve immune and clinical outcomes.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Radboud University Medical Center Academic / other |
| Drugs / interventions | nivolumab, ipilimumab, immunotherapy, chemotherapy |
| Locations | 2 sites (Arnhem, Gelderland and 1 other locations) |
| Status | Recruiting |
| Started | July 22, 2026 |
| Main results expected | July 1, 2028 |
| Study ends | September 1, 2028 |
| Registry record updated | August 28, 2026 |
| Trial ID | NCT07680556 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with advanced RCC who are scheduled to start first-line nivolumab plus ipilimumab and can participate in supervised exercise.
✕Probably not a fit
Patients who cannot safely participate in high-intensity exercise or have conditions severely limiting activity may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This two-arm randomized pilot trial will enroll 30 adults with advanced RCC planned for first-line dual immune checkpoint inhibitor therapy. Participants will be randomized to a supervised HIIT exercise program plus usual care or to usual care alone, over the course of treatment. The HIIT intervention consists of two 60-minute supervised sessions per week plus one weekly home-based moderate exercise session, administered by oncology-trained physiotherapists. The study will collect data on immune cell phenotype and function, gut microbiota, physical fitness, patient-reported outcomes, and clinical outcomes to generate preliminary signals of feasibility and potential benefit. The trial builds on preclinical and clinical evidence suggesting exercise may modulate the tumor microenvironment and treatment tolerance, though its feasibility during immunotherapy in advanced RCC remains to be established.
Why it matters
Potential benefit: If successful, the intervention could improve physical fitness, quality of life, and tolerance to immunotherapy, potentially enhancing treatment effectiveness.
How similar studies have gone: Prior exercise trials in cancer have shown feasibility and benefits mainly during chemotherapy or radiotherapy; data during immunotherapy are limited but promising.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years. * Diagnosed with advanced RCC with indication for standard-of-care dual ICI treatment. * Able and willing to give written informed consent. Exclusion Criteria: * Life expectancy \<6 months. * Unable to perform basic activities of daily living such as walking. * Presence of cognitive impairment or severe emotional instability (e.g. schizophrenia, Alzheimer's disease, alcohol addiction), at the discretion of the investigator. * Presence of other disabling comorbidities that may interfere with the ability to perform physical exercise (e.g., heart failure, chronic obstructive pulmonary disease (COPD, GOLD stage 3 or 4), orthopaedic conditions, or neurological disorders such as hernia, paresis, amputation or active rheumatoid arthritis), at the discretion of the investigator. * Current participation in structured vigorous aerobic and/or resistance exercise ≥ 2 times per week at a level comparable to the intervention
Where it's running
-
Rijnstate
Arnhem, Gelderland, Netherlands Recruiting -
Radboudumc
Nijmegen, Gelderland, Netherlands Recruiting
Study contacts
- Principal investigator: Laurien M Buffart, PhD — Radboud University Medical Center
- Study coordinator: Laurien Buffart, PhD
- Email: laurien.buffart@radboudumc.nl
- Phone: +31 24 3667310
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.