Clinical trial · Interventional
Exercise to Boost Response to Checkpoint Blockade Immunotherapy
NCT05358938CI-TRIAL-00102735active not recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
30 minutes of moderate exercise on an arm ergometer, a cycle ergometer, or a treadmill prior to each administration of standard of care checkpoint blockade immunotherapy across all cycles
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous Melanoma | Cutaneous Melanoma | ONTOLOGY_EXACT | 0.98 |
| Cutaneous Squamous Cell Carcinoma | Skin Squamous Cell Carcinoma | ALIAS | 0.90 |
| Merkel Cell Carcinoma | Merkel Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Checkpoint Blockade, Immune | Drug | — | UNRESOLVED |
| Exercise | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Adjuvant Arm with Exercise
- description
- Participants will receive clinical care following Moffitt standards for the patient's disease type and therapeutic setting. Adjuvant participants will receive 1 year \[currently 9-18 cycles\] of therapy with avelumab, cemiplimab, ipilimumab, nivolumab, pembrolizumab or relatlimab, or currently approved standard of care treatment, either alone or in combination. Participants also will complete 30 minutes of moderate exercise on an arm ergometer, a cycle ergometer, or a treadmill prior to each administration of standard of care checkpoint blockade immunotherapy across all cycles. Blood samples will be collected at 1) baseline (upon arrival to clinic), 2) post-exercise, and 3) post-infusion. Blood samples will be obtained on the first, third, midpoint, and final infusion dates.
- interventionNames
- Other: Exercise
- Drug: Checkpoint Blockade, Immune
- type
- ACTIVE_COMPARATOR
- label
- Adjuvant Arm without Exercise
- description
- Participants will receive clinical care following Moffitt standards for the patients disease type and therapeutic setting. Adjuvant participants will receive one year \[currently 9-18 cycles\] of therapy with avelumab, cemiplimab, ipilimumab, nivolumab, pembrolizumab, relatlimab, or currently approved standard of care treatment, either alone or in combination. Blood samples will be collected at 1) baseline (upon arrival to clinic) and 2) post-infusion. Blood samples will be obtained on the first, third, midpoint, and final infusion dates.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* Inclusion Criteria: * Age ≥ 18 years * Able to read and speak English fluently * Capable of giving informed consent * Reported ability to complete 20-30 minutes moderate exercise per positive response to "can you currently walk unaided for six minutes or more?". * Scheduled for first-time checkpoint blockade immunotherapy with FDA-approved drugs, including avelumab, cemiplimab, ipilimumab, nivolumab, pembrolizumab or relatlimab in the absence of other therapies (e.g. targeted therapy) * Melanoma patients (adjuvant setting) * Melanoma patients (neoadjuvant setting) * cuSCC patients (neoadjuvant setting) * Merkel cell carcinoma patients (neoadjuvant setting) Participants may also be required to have a full COVID vaccination series; the most up-to-date best practice guidelines for research at Moffitt Cancer Center will dictate the need for such a vaccination series. Exclusion Criteria: * Presence of medical conditions, such as severe cardiovascular disease for which an exercise intervention may not be warranted. * Presence of major postoperative complications for which an exercise intervention may not be warranted.
References
Publications (0)
Data not yet available
No reference posted for this study.