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Predicting side effects from immune therapy in cancer patients

Immune Checkpoint Inhibitor Toxicity (I-CHECKIT): A Prospective Observational Study

Observational SWOG Cancer Research Network · NCT04871542

This study is trying to see if certain factors like age and medical history can help predict serious side effects in cancer patients receiving immune therapy, so doctors can make better treatment choices.

Quick facts

Study typeObservational
Enrollment2062 (estimated)
Ages18 Years and up
SexAll
SponsorSWOG Cancer Research Network Research network
Drugs / interventionschemotherapy, immunotherapy
Locations849 sites (Anchorage, Alaska and 848 other locations)
Trial IDNCT04871542 on ClinicalTrials.gov

What this trial studies

This observational study aims to develop and validate a risk prediction model for serious non-hematological side effects in patients undergoing immune checkpoint inhibitor therapy for solid tumors. It will assess various risk factors, including age, gender, and medical history, to determine their impact on the likelihood of developing adverse events. Additionally, the study will track patient-reported quality of life and adverse events over a 12-month period, while also evaluating cytokine levels as potential predictors of toxicity. The findings may help clinicians make more informed treatment decisions in the future.

Who should consider this trial

Good fit: Ideal candidates are patients planning to receive immune checkpoint inhibitor therapy for a solid tumor malignancy.

Not a fit: Patients who have previously discontinued immune checkpoint inhibitor therapy due to adverse events may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better prediction and management of side effects from immunotherapy, improving patient outcomes.

How similar studies have performed: Other studies have shown promise in predicting adverse events from immunotherapy, but this approach may provide novel insights into specific risk factors.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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

Where this trial is running

Anchorage, Alaska and 848 other locations

+799 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Malignant Solid Neoplasm
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.