Clinical trial · Interventional
Evaluation of Cytokine Biomarkers in Melanoma Patients During Immunotherapy
Open Prospective Clinical Trial to Develop the Computer Software (Intelligent Prognostic System) for Predicting the Efficacy of Anti-PD-1 Immunotherapy of Melanoma Patients in Routine Practice
NCT04928365CI-TRIAL-00052303unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Open prospective clinical trial to develop the computer software (Intelligent prognostic system) for predicting the efficacy of anti-PD-1 immunotherapy of melanoma patients in routine practice
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-PD-1 monoclonal antibody | Drug | Anti-PD1 Monoclonal Antibody | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Advanced melanoma patients
- interventionNames
- Drug: Anti-PD-1 monoclonal antibody
- type
- OTHER
- label
- Stage III and IV melanoma patients after radical surgery
- interventionNames
- Drug: Anti-PD-1 monoclonal antibody
Primary outcomes (2)
- measure
- Overall survival
- timeFrame
- up to 12 months
- measure
- Progression free survival
- timeFrame
- up to 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Morphological verification of cutaneous melanoma. Verification of metastases is not necessary 2. ECOG 0-1 3. Age of patients - 18 years and older 4. No prior chemotherapy, immunotherapy, radiation or hormonal therapy 5. Adequate contraception for women of childbearing age 6. Written consent of the patient to participate in the study Exclusion Criteria: 1. Non-compliance with the previously listed criteria 2. Pregnancy and breastfeeding 3. Therapy with systemic corticosteroids and/or other immunosuppressants within 4 weeks before the screening or a high probability of the need for their use during the study for the treatment of intercurrent pathology 4. History of another malignancy other than the study indication under this trial within 5 years of study enrollment. Does not apply to subjects who underwent successful definitive resection of basal or squamous cell carcinoma of the skin, in situ cervical cancer, in situ breast cancer, or other in situ cancers.
References
Publications (0)
Data not yet available
No reference posted for this study.