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Active Not Recruiting NCT04990726

Immune Related Toxicity and Symptom Burden in Chronic Cancer Survivors With Melanoma Receiving Adjuvant Immunotherapy With Immune Checkpoint Inhibitors

Conditions: Clinical Stage III Cutaneous Melanoma AJCC v8, Pathologic Stage III Cutaneous Melanoma AJCC v8, Pathologic Stage IIIA Cutaneous Melanoma AJCC v8, Pathologic Stage IIIB Cutaneous Melanoma AJCC v8, Pathologic Stage IIIC Cutaneous Melanoma AJCC v8, Pathologic Stage IIID Cutaneous Melanoma AJCC v8, Melanoma, Stage II, Melanoma Stage IV

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 126
Sponsor: M.D. Anderson Cancer Center

Location: M D Anderson Cancer Center Houston Texas

Summary

This study evaluates the immune related toxicity and symptom burden in chronic cancer survivors with melanoma who are receiving adjuvant immunotherapy with immune checkpoint inhibitors. Information collected in this study may help doctors to learn more about the side effects caused by immunotherapy, and to learn if there are any relationships between these side effects and immune and genetic biomarkers found in the blood that may be related to patient's reaction to immunotherapy.

Eligibility Criteria

Inclusion Criteria: * Age \>= 18 years of age * Surgically resected stage II, III, or IV melanoma with no evidence of disease according to the American Joint Committee on Cancer (AJCC) classification criteria * Eligible for adjuvant CPI treatment per treating physician discretion * Plan to continue care at MD Anderson Cancer Center (MDACC) * Ability to communicate and read in English language Exclusion Criteria: * Previous systemic therapy for melanoma * Previous history of other cancers treated with immunotherapy * Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded * Previous cancer that has been resected two or more years ago are not excluded. * Previous history of inflammatory or autoimmune diseases. This include but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or psoriasis. Patients with autoimmune thyroid disease, vitiligo, and type I diabetes mellitus are not excluded. * Other concurrent malignancies that require active therapy * Participants \< 18 years of age and pregnant women are not eligible to participate in this study

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04990726). StuddyBuddy aggregates publicly available trial information.