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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    275
  • sponsor
    M.D. Anderson Cancer Center
Updated on 14 June 2022

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.

Description

PRIMARY OBJECTIVES:

I. Determine the detailed clinical characterization including timing, severity, and phenotype of immune related adverse events (irAEs) in chronic survivors with melanoma from initiation of adjuvant checkpoint inhibitors (CPI) therapy through 24 months of follow-up.

II. Longitudinally assess patients-reported outcomes (PROs) that measure symptom burden (such as fatigue, depression, sleep disturbance) and quality of life (QOL) in those patients, compared to patients with similar disease stage who opt for active surveillance.

SECONDARY OBJECTIVES:

I. Longitudinally evaluate the correlation of changes in immune analysis (immune cells and cytokines) in peripheral blood samples with timing, severity, and phenotype of irAEs, symptom burden, and QOL in those patients, compared to patients with similar disease stage who opt for active surveillance.

II. Determine whether specific immune-related genetic polymorphisms are associated with the development of irAEs and symptom burden in melanoma patients receiving adjuvant CPI therapy.

OUTLINE

Patients undergo medical assessments and blood sample collection, and complete questionnaires at baseline, 1 (optional), 3, 6, 12, 18, and 24 months.

Details
Condition 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
Treatment questionnaire administration, quality-of-life assessment, biospecimen collection, assessment
Clinical Study IdentifierNCT04990726
SponsorM.D. Anderson Cancer Center
Last Modified on14 June 2022

Eligibility

Yes No Not Sure

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
Other concurrent malignancies that require active therapy
Previous history of inflammatory or autoimmune diseases. This include but not limited
Participants < 18 years of age and pregnant women are not eligible to participate in this study
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
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