Clinical trial · Observational
Occurrence of Adverse Effects With Immune Checkpoint Inhibitors Between a Single and Double Dose Regimen
Comparison of the Occurrence of Adverse Effects With Immune Checkpoint Inhibitors Between a Single and Double Dose Regimen
NCT04956783CI-TRIAL-00052780ICI DODOcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a retrospective evaluation of the impact of a double dose regimen of immunotherapy use in cancer treatment compared to the single-dose regimen on the occurrence of clinically significant adverse events. The aim of this study is to provide evidence-based arguments to help clinicians to propose the best treatment regimen for each patient.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To compare the incidence of clinical significant toxicities
- timeFrame
- 18 months
- description
- To compare the incidence of clinical significant toxicities reported for patients treated with a cancer immunotherapy on a simple dose regiment versus double dose regimen
Secondary outcomes (4)
- measure
- To describe the incidence
- timeFrame
- 18 months
- description
- To describe the incidence, type and severity of overall toxicities (serious and non-serious) reported with single and double dose cancer immunotherapy regimens
- measure
- To identify risk factors for the development of severe toxicity
- timeFrame
- 18 months
- description
- To identify risk factors for the development of severe toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: \- Any adult patient with anti-PD-1 or PD-L-1 immune checkpoint inhibitor as monotherapy Exclusion criteria: \- age \< 18
References
Publications (0)
Data not yet available
No reference posted for this study.