Biomarkers of Immune-Related Toxicity

University of Colorado Denver (CU Denver)

Status: Active, not recruiting

Conditions: Metastatic Cancer; Cancer

Treatments: Other: Blood Testing

Study type: Observational

Funder types: Other

Identifiers

NCT03409016

17-1940.cc

Details and patient eligibility

About

This is a single-center, correlative pilot study evaluating potential biomarkers predictive of immune-related adverse events associated with immune checkpoint inhibitor therapy.

Full description

This is a single-center, correlative pilot study evaluating potential biomarkers predictive of immune-related adverse events associated with immune checkpoint inhibitor therapy. The study includes a control population of patients receiving standard chemotherapy as a comparator. Patients will undergo blood draws at 4 time-points while on standard of care treatment. There are no study-related medications or interventions beyond blood sampling.

Enrollment: 69 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

69 participants in 2 patient groups

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.

Treatment:

Other: Blood Testing

Control

Description:

An additional 18 patients starting standard chemotherapy will be enrolled as a control population. Patients will receive chemotherapy per standard protocol

Treatment:

Other: Blood Testing