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

M.D. Anderson Cancer Center

Status: Active, not recruiting

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

Treatments: Procedure: Biospecimen Collection; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Behavioral: Assessment

Study type: Observational

Funder types: Other

Identifiers

NCT04990726

2019-0390 (Other Identifier)

NCI-2020-13274 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

126 participants in 2 patient groups

Observational (assessment, blood collection, questionnaire)

Description:

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

Treatment:

Behavioral: Assessment

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Procedure: Biospecimen Collection

Treatment (assessment, blood collection, questionnaire)

Description:

Patients undergo medical assessments and blood sample collection and complete questionnaires at baseline (prior to C1 infusion), 2, 4, 7 infusion, at end of treatment, and 18 and 24 months after completion of treatment.

Treatment:

Behavioral: Assessment

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Procedure: Biospecimen Collection