Clinical trial · Observational
Immune Related Toxicity and Symptom Burden in Chronic Cancer Survivors With Melanoma Receiving Adjuvant Immunotherapy With Immune Checkpoint Inhibitors
NCT04990726CI-TRIAL-00104141active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260919-000001
Summary
Brief summary (as posted)
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
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Clinical Stage III Cutaneous Melanoma AJCC v8 | — | UNRESOLVED | — |
| Melanoma, Stage II | Melanoma | CURATED_BROADER | 0.78 |
| Melanoma Stage IV | Melanoma | CURATED_BROADER | 0.78 |
| Pathologic Stage IIIA Cutaneous Melanoma AJCC v8 | — | UNRESOLVED | — |
| Pathologic Stage IIIB Cutaneous Melanoma AJCC v8 | — | UNRESOLVED | — |
| Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 | — | UNRESOLVED | — |
| Pathologic Stage III Cutaneous Melanoma AJCC v8 | — | UNRESOLVED | — |
| Pathologic Stage IIID Cutaneous Melanoma AJCC v8 | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Assessment | Behavioral | — | UNRESOLVED |
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 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.
- interventionNames
- Behavioral: Assessment
- Procedure: Biospecimen Collection
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- label
- 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.
- interventionNames
- Behavioral: Assessment
- Procedure: Biospecimen Collection
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.