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Understanding Side Effects of Immunotherapy for Solid Tumors

This study is looking at how different factors like age, gender, and other health conditions might affect whether people with solid tumors develop side effects from immunotherapy. Immunotherapy helps your body's immune system fight cancer. Participants will have blood samples collected and complete questionnaires. The main goal is to understand what causes severe side effects (immune-related adverse events or irAEs) within the first year of immunotherapy. This information could help doctors better predict and manage side effects in the future. You can join if you are 18 or older, have a solid tumor, and are planning to receive immunotherapy according to standard guidelines.

Study design
This is an observational study planning to include 2062 participants. It is not testing a new treatment but rather observing patients receiving standard immunotherapy.
What's involved
You will have blood samples collected and complete questionnaires. These activities will occur over a 12-month period.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for the occurrence of severe side effects for 52 weeks (one year).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04871542

Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors

Recruiting
Not specifiedAges 18+Observational
SWOG Cancer Research Network
~2,062 participants
Updated 2026-05-05 on ClinicalTrials.gov
What's tested:Biospecimen CollectionQuestionnaire Administration

At a glance

Recruiting sites
589 of 849 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurrence of severe or worse non-hematological immune-related adverse event (irAE)
Measured over 52 weeks

Conditions

Malignant Solid Neoplasm

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Solid Neoplasm

NCT04871542

Where you'd take part

This study runs at 849 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesotastudy coordinator listed

    Recruiting

  • Adena Regional Medical Center

    Chillicothe, Ohiostudy coordinator listed

    Recruiting

  • AdventHealth Hendersonville

    Hendersonville, North Carolinastudy coordinator listed

    Recruiting

  • AdventHealth Infusion Center Asheville

    Asheville, North Carolinastudy coordinator listed

    Recruiting

  • AdventHealth Infusion Center Haywood

    Clyde, North Carolinastudy coordinator listed

    Recruiting

  • AdventHealth Infusion Center Weaverville

    Weaverville, North Carolinastudy coordinator listed

    Recruiting

  • Advocate Christ Medical Center

    Oak Lawn, Illinoisstudy coordinator listed

    Recruiting

  • Advocate Good Samaritan Hospital

    Downers Grove, Illinoisstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Krishna S Gunturu · PRINCIPAL_INVESTIGATOR · SWOG Cancer Research Network

Who to contact

Site Public Contact
[email protected]
907-212-6871
Email the study team

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Eligibility criteria

Inclusion

Participants must be planning to receive ICI-based therapy for a solid tumor malignancy. 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 investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines

What this trial measures

  • Occurrence of severe or worse non-hematological immune-related adverse event (irAE)52 weeks

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