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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-13274 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2019-0390 | Other Identifier | M D Anderson Cancer Center |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assessment | Behavioral | Undergo medical assessments |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in immune analysis | Will longitudinally evaluate the correlation of changes in immune analysis in peripheral blood samples with timing, severity, and phenotype of irAEs, symptom burden, and quality of life in those patients, compared to patients with similar disease stage who opt for active surveillance. | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
Previous systemic therapy for melanoma
Previous history of other cancers treated with immunotherapy
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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Patients with resected melanoma who are eligible for adjuvant CPI treatment
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| Name | Affiliation | Role |
|---|---|---|
| Maryam Buni | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| M.D. Anderson Cancer Center | View source |
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Blood
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| Biospecimen Collection | Procedure | Undergo collection of blood samples |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Complete questionnaires |
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| Immune-related genetic polymorphisms |
Will determine whether specific immune-related genetic polymorphisms are associated with the development of irAEs and symptom burden in melanoma patients receiving adjuvant CPI therapy. |
| 24 months |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D012149 | Restraint, Physical |
| ID | Term |
|---|---|
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
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