Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

Neoplastic Processes

Antineoplastic Agents

All Drugs and Chemicals

Immune Checkpoint Inhibitors

Pembrolizumab

Nivolumab

Atezolizumab

Ipilimumab

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.

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

Patients will undergo therapy per standard protocol. There are no study-related medications or interventions beyond blood testing.

Blood Testing

Andrea Glass

Mark Morrow

Sarah L Davis, MD

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

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.

Biomarkers of Immune-Related Toxicity

Identifying Biomarkers of Immune-Related Toxicity in Cancer Patients Treated With Immune Checkpoint Inhibitors; A Pilot Project

Difference in baseline inflammatory/autoimmune marker(s) in patients developing immune-related adverse events on immune checkpoint inhibitor therapy according to CTCAE v 4.0 versus those who do not

To evaluate the change in inflammatory/autoimmune markers prior to and at 3 time points on immune checkpoint inhibitor therapy, with comparison to patients treated with standard chemotherapy

To evaluate the impact of change in these markers on patient reported adverse events using the PRO-CTCAE

Cancer League of Colorado

University of Colorado, Denver

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Melanoma

Carcinoma, Non-Small-Cell Lung

Carcinoma, Renal Cell

Lung Neoplasms

Neoplasms by Histologic Type

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Immunomodulating Agents

No intervention

Donna Graham, MD

Hannah Frost

Leanna Goodwin

Donna Graham

This study will explore the ability of patients on first line combination immunotherapy to sample cytokines at home. The data from this study will be used to evaluate the feasibility of in-home testing and the ability to analyse patients cytokine profiles retrospectively to help feed the development of further studies.

Patients will be informed of the study and given a minimum of 24 hours to consider. Once consented patients will enter the study where they will take cytokine samples at home over a 12 week period.

NOTION: iN-home Sampling Of cyTokines in ImmunOtherapy patieNts

The association between these statistics and the development of immune-related adverse events will be estimated using a logistic regression analysis.

The patient satisfaction level will be assessed by survey interviews.

the number of DBS samples successfully collected against the number of total expected samples

the number of DBS samples passing quality assurance checks against the number of DBS samples successfully collected.

The changes of cytokine concentrations will be estimated by the log-ratio of cytokine concentrations measured at two time points. The trend of cytokine concentration during treatment will be estimated by fitting a linear regression model based on all cytokine concentrations collected during treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Biomarkers of Immune-Related Toxicity	NCT03409016	Cancer Metastatic Canc...	Blood Testing	18 Years - 100 Years	University of Colorado, Denver
Biomarkers of Immune-Related Toxicity	NCT03409016	Cancer Metastatic Canc...	Blood Testing	18 Years - 100 Years	University of Colorado, Denver
NOTION: iN-home Sampling Of cyTokines in ImmunOtherapy patieNts	NCT04960059	Cancer Metastatic Mela... Renal Cell Carc... Non-small Cell ...	No intervention	18 Years -	The Christie NHS Foundation Trust

Spots Global Cancer Trial Database for immune related adverse event