Clinical trial · Observational
Biomarkers of Immune-Related Toxicity
Identifying Biomarkers of Immune-Related Toxicity in Cancer Patients Treated With Immune Checkpoint Inhibitors; A Pilot Project
NCT03409016CI-TRIAL-00120744active not recruitingClinicalTrials.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 single-center, correlative pilot study evaluating potential biomarkers predictive of immune-related adverse events associated with immune checkpoint inhibitor therapy.
Conditions
Conditions (2)
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 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Testing | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Immune Checkpoint Inhibitor Therapy
- description
- Patients starting treatment with ipilimumab, nivolumab, pembrolizumab, or atezolizumab, alone or in combination, for treatment of a metastatic solid tumor cancer will be enrolled. Patients will receive checkpoint inhibitor therapy per standard protocol. There are no study-related medications or interventions beyond blood testing.
- interventionNames
- Other: Blood Testing
- label
- Control
- description
- An additional 18 patients starting standard chemotherapy will be enrolled as a control population. Patients will receive chemotherapy per standard protocol
- interventionNames
- Other: Blood Testing
Primary outcomes (1)
- measure
- Identifying biomarkers predictive of immune-related toxicity associated with immune checkpoint inhibitor therapy.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: 1. Metastatic solid tumor cancer of any primary site, with the exception of lymphoma 2. ≥18 years of age 3. Life expectancy \>6 months 4. Starting new regimen of ipilimumab, nivolumab, pembrolizumab or atezolizumab as a single agent or in combination according to standard of care or through compassionate use granted by the pharmaceutical company (immune checkpoint inhibitor arm only) OR Starting new regimen of standard cytotoxic chemotherapy (control arm only) 5. Provision to sign and date the consent form 6. Stated willingness to comply with all study procedures and be available for the duration of the study Exclusion Criteria: 1. Prior immune checkpoint inhibitor therapy with anti-CTLA4, anti-PD1 or anti-PD-L1 targeting agent 2. Known autoimmune disease 3. Known acute or chronic infection, including viral infections such as Hepatitis B, C, and HIV 4. Chronic treatment with immune suppressive medications, including steroids, at the time of study enrollment 5. Concomitant treatment with a monoclonal antibody in addition to cytotoxic chemotherapy (i.e. bevacizumab, cetuximab, trastuzumab) (control arm only) 6. Known pregnancy or lactation
References
Publications (0)
Data not yet available
No reference posted for this study.