Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors

Recruiting now

Conditions studied: Malignant Solid Neoplasm

In brief

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.

Key facts

Study ID

NCT04871542

Run by

SWOG Cancer Research Network

People needed

2062

Starts

2021-09-13

Expected to finish

2028-03-14

Last updated by the study team

2026-05-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 it is running

• Mercy Cancer Center - Elk Grove — Elk Grove, California, United States (enrolling)
• Kaiser Permanente-Fresno — Fresno, California, United States (enrolling)
• Mercy San Juan Medical Center — Carmichael, California, United States (enrolling)
• Kaiser Permanente Dublin — Dublin, California, United States (enrolling)
• Fresno Cancer Center — Fresno, California, United States (enrolling)
• Kaiser Permanente Fresno Orchard Plaza — Fresno, California, United States (enrolling)
• Anchorage Associates in Radiation Medicine — Anchorage, Alaska, United States (enrolling)
• Alaska Oncology and Hematology LLC — Anchorage, Alaska, United States (enrolling)
• Kingman Regional Medical Center — Kingman, Arizona, United States (enrolling)
• Alaska Women's Cancer Care — Anchorage, Alaska, United States (enrolling)
• Kaiser Permanente-Fremont — Fremont, California, United States (enrolling)
• VA Central California Fresno Medical Center — Fresno, California, United States (enrolling)
• Katmai Oncology Group — Anchorage, Alaska, United States (enrolling)
• Mercy Hospital Fort Smith — Fort Smith, Arkansas, United States (enrolling)
• Providence Alaska Medical Center — Anchorage, Alaska, United States (enrolling)
• NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro, Arkansas, United States (enrolling)
• CARTI Cancer Center — Little Rock, Arkansas, United States (enrolling)
• Kaiser Permanente-Deer Valley Medical Center — Antioch, California, United States (enrolling)
• Mission Hope Medical Oncology - Arroyo Grande — Arroyo Grande, California, United States (enrolling)
• PCR Oncology — Arroyo Grande, California, United States (enrolling)
• Cancer Center at Saint Joseph's — Phoenix, Arizona, United States (enrolling)
• Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California, United States (enrolling)
• Alaska Breast Care and Surgery LLC — Anchorage, Alaska, United States (enrolling)
• Mercy Cancer Center - Carmichael — Carmichael, California, United States (enrolling)
• Contra Costa Regional Medical Center — Martinez, California, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.