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

NCT04990726 | Active Not Recruiting

• 2 other identifiers: 2019-0390NCI-2020-13274
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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 IV; Clinical Stage III Cutaneous Melanoma AJCC v8; Pathologic Stage III Cutaneous Melanoma AJCC v8; Melanoma, Stage II

Outcome Measures

Primary Outcomes (2)

• Detailed clinical characterization

  Will 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 inhibitor (CPI) therapy through 24 months of follow-up. The primary end point will be at 12 months, but patients will be followed for up to 24 months. Will estimate the incidence rates of any de novo grade 2 or higher irAEs at 12 months post treatment initiation along with 95% confidence interval within the case group. Will also summary irAEs by their onset time in relation to treatment initiation (acute irAE vs late irAE) and by CPI type. Descriptive statistics will be used to summarize results.

  24 months

• Patients-reported outcomes (PROs)

  Will compare PROs at 12 months between the case (with and without irAEs) and control groups. To compare differences between cases and controls, will use logistic regression to adjust for age, gender, ethnicity, tumor stage and type of CPI therapy. The primary outcome measures include quality of life, depression, and fatigue. Will compare each of the three primary outcomes at a significant level of 0.017 (0.05/3) using Bonferroni multiple comparison adjustment. Will use linear mixed effect models to fit the longitudinal PRO assessments to study the change of PROs over time taking the intra-patient correlation into account and to determine the effect of each of the covariates (relevant patient's demographic, irAEs, clinical and treatment characteristics) on the outcomes.

  24 months

Secondary Outcomes (2)

• Changes in immune analysis

  24 months

• Immune-related genetic polymorphisms

  24 months

Study Arms (2)

Observational (assessment, blood collection, questionnaire)

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

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

Treatment (assessment, blood collection, questionnaire)

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.

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

Interventions

Questionnaire Administration OTHER

Complete questionnaires

Observational (assessment, blood collection, questionnaire); Treatment (assessment, blood collection, questionnaire)

Assessment BEHAVIORAL

Undergo medical assessments

Also known as: Assess

Observational (assessment, blood collection, questionnaire); Treatment (assessment, blood collection, questionnaire)

Biospecimen Collection PROCEDURE

Undergo collection of blood samples

Observational (assessment, blood collection, questionnaire); Treatment (assessment, blood collection, questionnaire)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Observational (assessment, blood collection, questionnaire); Treatment (assessment, blood collection, questionnaire)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with resected melanoma who are eligible for adjuvant CPI treatment

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M.D. Anderson Cancer Center

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Melanoma

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Maryam Buni

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: August 4, 2021
• Study Start: December 5, 2019
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)