Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
ConditionMalignant Solid Neoplasm
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSWOG Cancer Research Network
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial population
Patients planning to receive ICI-based therapy for a solid tumor malignancy.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryUndergo collection of blood sample
Questionnaire Administration
Other interventionComplete questionnaires
Treatment groups
2,062 Participants
are divided into 1 treatment groupGroup A: Observational (biospecimen collection, questionnaire)2 interventions
Trial outcomes
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 weeksSecondary 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 weeks2
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 weeks3
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 weeks4
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 weeksOther 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 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
SWOG Cancer Research Network
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov