CancerNCT03409016
Biomarkers of Immune-Related Toxicity
An observational study of Cancer and Metastatic Cancer, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This is a single-center, correlative pilot study evaluating potential biomarkers predictive of immune-related adverse events associated with immune checkpoint inhibitor therapy. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cancer, Metastatic Cancer
- What is being tested?
- Blood Testing
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2018to 17 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: These patients will be enrolled only at the University of Colorado Cancer Center in the outpatient clinic setting.
Who may be able to join
- Metastatic solid tumor cancer of any primary site, with the exception of lymphoma
- ≥18 years of age
- Life expectancy >6 months
- 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)
- Provision to sign and date the consent form
- Stated willingness to comply with all study procedures and be available for the duration of the study
Who cannot join
- Prior immune checkpoint inhibitor therapy with anti-CTLA4, anti-PD1 or anti-PD-L1 targeting agent
- Known autoimmune disease
- Known acute or chronic infection, including viral infections such as Hepatitis B, C, and HIV
- Chronic treatment with immune suppressive medications, including steroids, at the time of study enrollment
- Concomitant treatment with a monoclonal antibody in addition to cytotoxic chemotherapy (i.e. bevacizumab, cetuximab, trastuzumab) (control arm only)
- Known pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
Official title: Identifying Biomarkers of Immune-Related Toxicity in Cancer Patients Treated With Immune Checkpoint Inhibitors; A Pilot Project
This is a single-center, correlative pilot study evaluating potential biomarkers predictive of immune-related adverse events associated with immune checkpoint inhibitor therapy.
Read the detailed 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.
- Conditions
- Cancer, Metastatic Cancer
- Being tested
- Blood Testing
- Keywords
- Immune Checkpoint Inhibitors, Biomarkers, Immune Related Adverse Event
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood TestingOther
Patients will undergo therapy per standard protocol. There are no study-related medications or interventions beyond blood testing.
| Study group | Role | What they receive |
|---|---|---|
| Immune Checkpoint Inhibitor Therapy | 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. Receives: Other: Blood Testing | |
| Control | An additional 18 patients starting standard chemotherapy will be enrolled as a control population. Patients will receive chemotherapy per standard protocol Receives: Other: Blood Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identifying biomarkers predictive of immune-related toxicity associated with immune checkpoint inhibitor therapy.
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
Measured: 30 Months
Secondary outcomes (2)
Change in inflammatory/autoimmune markers.
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
Measured: 6 Months
Change in inflammatory/autoimmune markers
To evaluate the impact of change in these markers on patient reported adverse events using the PRO-CTCAE
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start18 Apr 2018
- Primary completion28 May 2025
- Study completion17 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer League of Colorado
- Responsible party
- Sponsor
- Investigators
- Sarah L Davis, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409016
- Sponsor's protocol ID
- 17-1940.cc
- Status last verified
- Aug 2026
- First submitted
- 17 Jan 2018
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Biomarkers of Immune-Related Toxicity in Cancer Patients Treated With Immune Checkpoint Inhibitors; A Pilot Project
- ClinicalTrials.gov ID
- NCT03409016
- Acronym / sponsor ID
- 17-1940.cc
- Conditions
- Cancer, Metastatic Cancer
- Keywords
- Immune Checkpoint Inhibitors, Biomarkers, Immune Related Adverse Event
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Cancer League of Colorado
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 17 Oct 2026 (estimated)
- First posted
- 24 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, correlative pilot study evaluating potential biomarkers predictive of immune-related adverse events associated with immune checkpoint inhibitor therapy.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immune Checkpoint Inhibitor Therapy | – | Other: Blood TestingPatients 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. |
| Control | – | Other: Blood TestingAn additional 18 patients starting standard chemotherapy will be enrolled as a control population. Patients will receive chemotherapy per standard protocol |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- These patients will be enrolled only at the University of Colorado Cancer Center in the outpatient clinic setting.
Key inclusion criteria (6 listed)
- Metastatic solid tumor cancer of any primary site, with the exception of lymphoma
- ≥18 years of age
- Life expectancy >6 months
- 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)
- Provision to sign and date the consent form
Key exclusion criteria (6 listed)
- Prior immune checkpoint inhibitor therapy with anti-CTLA4, anti-PD1 or anti-PD-L1 targeting agent
- Known autoimmune disease
- Known acute or chronic infection, including viral infections such as Hepatitis B, C, and HIV
- Chronic treatment with immune suppressive medications, including steroids, at the time of study enrollment
- Concomitant treatment with a monoclonal antibody in addition to cytotoxic chemotherapy (i.e. bevacizumab, cetuximab, trastuzumab) (control arm only)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood TestingPatients will undergo therapy per standard protocol. There are no study-related medications or interventions beyond blood testing. | Other | Control, Immune Checkpoint Inhibitor Therapy |
Primary outcome
Identifying biomarkers predictive of immune-related toxicity associated with immune checkpoint inhibitor therapy.
Time frame: 30 Months
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
2 secondary outcomes
Change in inflammatory/autoimmune markers.
Time frame: 6 Months
Change in inflammatory/autoimmune markers
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah L Davis, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Metastatic Cancer, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identifying biomarkers predictive of immune-related toxicity associated with immune checkpoint inhibitor therapy. (time frame: 30 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.