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RecruitingNCT04871542Updated Nov 6, 2026

Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors

An observational study in Malignant Solid Neoplasm, sponsored by SWOG Cancer Research Network. Recruiting at 849 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by SWOG Cancer Research Network · Observational

From the registry’s dates

  • Started Sep 2021; still recruiting 5 years 1 month later.
Updated Nov 6, 2026Primary completion movedStudy completion moved+2 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,062
Ages
18 Years and older
Sex
All
01

Study summary

This study examines how certain risk factors (such as age, gender, other medical conditions, and the type of immunotherapy used to treat the cancer) affect whether a patient with a malignant solid tumor will develop mild or serious side effects from the immunotherapy medications. Immunotherapy is the type of treatment that helps the body's immune system fight cancer. In the future, this information may help doctors make better decisions about cancer treatments.

Read the detailed description

PRIMARY OBJECTIVE:

I. To both develop and independently validate a risk prediction model for Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher non-hematological immune-related adverse events (irAEs) in the first year of immune checkpoint inhibitor (ICI)-based therapy for the treatment of solid tumors.

SECONDARY OBJECTIVES:

I. To prospectively assess the incidence of any grade of non-hematological irAEs and grade 4 hematological irAEs on ICI-based therapy.

II. To observe the trajectory of patient-reported quality of life and health preferences over 12 months.

III. To observe the trajectory of patient-reported adverse events over 12 months using serial assessment with select Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measures.

IV. To measure the burden of chronic, grade 1 and 2 toxicities using methods such as toxicity over time (ToxT).

V. To track patterns of treatment of irAEs and patterns of toxicity resolution.

TRANSLATIONAL MEDICINE OBJECTIVES:

I. To evaluate the cytokine toxicity (CYTOX) score, a composite measure derived from 11 different cytokine levels, both prior to ICI-based therapy and after 1 cycle of ICI-based therapy as a predictive signature for the development of irAEs.

II. To establish a repository of archival tissue and blood/serum specimens for potential predictive and/or prognostic markers of irAE risk.

ADDITIONAL OBJECTIVE:

I. To assess the feasibility of using electronic (e)PRO in a multi-center clinical trial setting.

OUTLINE:

Patients undergo collection of a tissue sample at the start of their routine cancer treatment. Patients complete questionnaires at the start of cancer treatment, weeks 4, 12, 24, and 52. Patients will have the option of providing blood samples at several time points during the study.

02

Conditions studied

  • Malignant Solid Neoplasm
03

In context

Lead sponsor

SWOG Cancer Research Network is the lead sponsor of 339 studies on the registry; 37 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.

Browse SWOG Cancer Research Network studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients planning to receive ICI-based therapy for a solid tumor malignancy.

Eligibility criteria

Inclusion Criteria:

  • Participants must be planning to receive ICI-based therapy for a solid tumor . This therapy must be given according to Food and Drug Administration (FDA) label or National Comprehensive Cancer Network (NCCN) guidelines at Category 1 or 2A and not in the context of a clinical trial
  • Participants who have received prior ICI-based therapy must have completed ICI based therapy at least 180 days prior to registration
  • Participants must not have discontinued any prior ICI-based therapy (if applicable) because of irAE
  • Participants must not have received chemotherapy, biologic, or targeted-therapy within 21 days prior to registration

  • Participants must have recovered from side effects of prior therapy to the following standards per treating physician's discretion:

    • =\< Grade 1 for any non-hematologic side effects (excluding neuropathy and alopecia); lab-related parameters of liver and renal function will be considered at the discretion of the treating physician)
    • =\< Grade 2 for neuropathy and/or alopecia
    • Grade 3 or less for any hematologic side effects
  • Participants must be planning to begin standard of care ICI-based therapy within 3 calendar days after registration
  • Participants must not be planning to receive ICI-based therapy in combination with chemotherapy or any other non-ICI therapy for treatment of their cancer
  • Participants must be at least 18 years of age
  • Participants must complete their history and physical examination within 28 days prior to registration
  • Participants who can complete the S2013 Feasibility Questionnaire in English or Spanish must participate at the scheduled assessments
  • Participants must be able to complete Patient-Reported Outcome (PRO) instruments in English, Spanish, or French and must be planning to complete PROs at all scheduled assessments
  • Participants must complete the pre-registration (baseline) PRO forms within 14 days prior to registration

  • Participants must be willing to participate in PRO data collection

    • Note: Prior to registration, participants must decide on their method (paper or electronic) of completing their follow-up questionnaires. Participants who elect electronic (ePRO) completion must have an iPhone, Android phone, or tablet with cellular or WiFi connectivity in order to download the Patient Cloud mobile applications onto the device (personal device or a site provisioned device for multi-users)
  • Participants must be offered the opportunity to participate in the optional specimen banking

  • Note: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.

    • Participants must be informed of the nature of this study and must sign and give in accordance with institutional and federal guidelines
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,062 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Observational (biospecimen collection, questionnaire)

    Patients undergo collection of a tissue sample at the start of their routine cancer treatment. Patients complete questionnaires at the start of cancer treatment, weeks 4, 12, 24, and 52. Patients will have the option of providing blood samples at several time points during the study.

    Procedure: Biospecimen Collection · Other: Questionnaire Administration

Interventions

  • ProcedureBiospecimen Collection

    Undergo collection of blood sample

    Also known as: Biological Sample Collection

  • OtherQuestionnaire Administration

    Complete questionnaires

06

What researchers measure

Primary outcomes

  1. Occurrence of severe or worse non-hematological immune-related adverse event (irAE)

    Adverse events will be recorded according to the physician rated Common Terminology Criteria for Adverse Events (CTCAE) scoring system.

    Time frame: 52 weeks

Secondary outcomes

  1. Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29

    PROMIS-29 Includes 4 questions to evaluate each of 7 domains (physical function, anxiety, depression, fatigue, sleep disturbance, social functioning, and pain interference) using a 5- point Likert scale, as well as a single item to assess pain severity on a 0-10 scale. The PROMIS-29 assesses severity levels of symptoms and their effect on the patient's functioning, assessed over the preceding 7-day period.

    Time frame: Baseline to 52 weeks

  2. Change in PRO-CTCAE scores

    Patients report severity, frequency, and/or interference of toxicities. For this protocol the following 11 items will be assessed: fatigue interference, neuropathy severity and interference, nausea frequency and severity, shortness of breath severity and interference, presence of rash, itching severity, and diarrhea severity and interference over the preceding 7 days.

    Time frame: Baseline to 52 weeks

  3. Change in PROMIS Cognitive Function- Short Form 4a version 2.0 scores

    Assesses patient-perceived cognitive deficits over the past 7 days. Facets include mental acuity, concentration, verbal and nonverbal memory, verbal fluency, and perceived changes in these cognitive functions. The extent to which cognitive impairments interfere with daily functioning, whether other people observe cognitive impairments, and the impact of cognitive dysfunction on quality of life are also assessed. The PROMIS Short Form Cognitive Function 4a is a questionnaire composed of 4 items rated on a 5 level scale, ranging from Never to Very often (Several times a day), with raw scores ranging from 5 to 20, with higher scores representing better cognitive function. In combination with the PROMIS-29, the use of this questionnaire allows the calculation of the PROMIS-Preference score, which quantifies the value participants place on different health states.

    Time frame: Baseline to 52 weeks

  4. Change in toxicity over time (ToxT)

    ToxT is a collection of statistical codes in Statistical Analysis Software that generate plots depicting summary statistics or individual patient data over discrete timepoints, combined with longitudinal statistical analyses (repeated measures modelling, and time-to-event and AUC analyses).

    Time frame: Baseline to 52 weeks

  5. Change in cytokine toxicity (CYTOX) score

    The relationship between the CYTOX score and the occurrence of irAE will be evaluated using area under the curve (AUC). Separate evaluations will be conducted using both cytokine levels determined both prior to ICI-based therapy and after 1 cycle of ICI-based therapy.

    Time frame: Baseline to 1 cycle after ICI-therapy

Other outcomes

  1. Feasibility of the Patient Cloud electronic (e)PRO app

    Will be assessed by comparing the extent of missing data at each assessment time between participants choosing the Patient Cloud ePRO application (app) versus the use of paper forms. The participant experience of using the Patient Cloud ePRO app will also be assessed using a one-time questionnaire at the end of the participant's participation in the study

    Time frame: Up to 52 weeks

07

Study locations

589 of 849 sites recruiting

Showing the first 100 of 849 sites across 5 countries. Choose a country and city above to see the rest.

08

Updates

1 registry update since Sep 25, 2026
Sites
1 site added, 1 site removed
Show site
  • Henry Ford River District Hospital · East China, United States
Show 1 removed
  • Henry Ford River District Hospital · East China Township, United States
Nov 6, 2026
Primary completion
Sep 30, 2026→May 15, 2030
Nov 6, 2026
Study completion
Mar 14, 2028→Dec 15, 2030
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    1 site added, 1 site removed
    Show site
    • Henry Ford River District Hospital · East China, United States
    Show 1 removed
    • Henry Ford River District Hospital · East China Township, United States
    Primary completion Sep 30, 2026→May 15, 2030
    Study completion Mar 14, 2028→Dec 15, 2030
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT04871542
Lead sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
May 4, 2021
Start date
Sep 13, 2021
Primary completion
May 15, 2030 (estimated)
Completion
Dec 15, 2030 (estimated)
Last update
Nov 6, 2026

Study contacts

Krishna S Gunturu
principal investigator · SWOG Cancer Research Network

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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