NCT05707286

Brief Summary

This research aims to identify clinical strategies to manage adverse events during immune checkpoint inhibitor therapy by (1) determining the impact of checkpoint inhibitors on metabolism through major CYP enzymes and (2) identifying associations between pro-inflammatory cytokine concentrations and negative clinical outcomes during checkpoint inhibitor therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

September 7, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2025

Completed
Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

1.4 years

First QC Date

January 20, 2023

Last Update Submit

January 5, 2026

Conditions

MelanomaGastrointestinal NeoplasmsGenitourinary CancerThoracic CancerSarcoma

Keywords

Checkpoint inhibitorcytokines

Outcome Measures

Primary Outcomes (2)

  • Increases in pro-inflammatory cytokines

    Determine the time course of increases in pro-inflammatory cytokines during treatment with immune checkpoint inhibitor regimens, via plasma cytokine concentrations present in blood samples.

    From baseline (day -30) up to cycle 4 (day 126)

  • Populations of activated T cells

    From baseline (day -30) up to cycle 4 (day 126)

Secondary Outcomes (6)

  • Increases in other cytokines

    From baseline (day -30) up to cycle 4 (day 126)

  • Plasma concentrations of immune checkpoint inhibitors

    From baseline (day -30) up to cycle 4 (day 126)

  • Plasma concentrations of co-administered CYP substrate medications

    From baseline (day -30) up to cycle 4 (day 126)

  • The development of immune-related adverse events

    From baseline (day -30) up to cycle 4 (day 126)

  • The development of adverse drug events attributable to co-administered CYP substrate medications

    From baseline (day -30) up to cycle 4 (day 126)

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults diagnosed with solid cancers and initiating therapy with an immune checkpoint inhibitor

You may qualify if:

  • ≥ 18 years old at the time of informed consent
  • Diagnosed with non-small cell lung cancer (NSCLC) OR melanoma AND initiating therapy with single agent or combination therapy that includes an immune checkpoint inhibitor, (e.g., atezolizumab, cemiplimab, durvalumab, ipilimumab, nivolumab, pembrolizumab)
  • Ability to provide written informed consent and HIPAA authorization

You may not qualify if:

  • Diagnosis or past medical history of autoimmune disorder, including systemic lupus erythematosus, Crohn's disease, Sjogren's syndrome, multiple sclerosis, type 1 diabetes mellitus, Behcet's disease, and ankylosing spondylitis
  • Concomitant treatment with systemic immunosuppressant drugs (see Table A1 in appendix for complete list)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

This study is observational in nature and will involve no medical interventions outside of collecting 5-7 blood samples at 5-7 separate study visits.

MeSH Terms

Conditions

MelanomaGastrointestinal NeoplasmsUrogenital NeoplasmsSarcoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesNeoplasms, Connective and Soft Tissue

Study Officials

  • Tyler Shugg, PharmD, PhD

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Research Professor

Study Record Dates

First Submitted

January 20, 2023

First Posted

January 31, 2023

Study Start

September 7, 2023

Primary Completion

January 20, 2025

Study Completion

January 20, 2025

Last Updated

January 7, 2026

Record last verified: 2026-01

Locations

US(1)