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PD-1 Inhibitors With or Without Radiation in Advanced Melanoma

NCT05498805 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2022-08-12

No results posted yet for this study

Summary

This trial was a single-center, prospective, randomized controlled phase II trial. The objective was to evaluate the efficacy and safety of PD-1 inhibitors with or without radiotherapy in patients with advanced melanoma. At the same time, tissue and peripheral blood samples of patients were collected for the determination of PD-L1 expression, ctDNA and other biomarkers and results analysis to find prognostic or curative effect predictors. A total of 92 patients were planned to be enrolled in this study.

Patients with advanced melanoma who met the inclusion criteria but did not meet the exclusion criteria were enrolled in the study and received PD-1 inhibitors with or without radiotherapy.

Conditions

  • the Efficacy and Safety of PD-1 Inhibitors With or Without Radiotherapy in Patients With Advanced Melanoma

Interventions

RADIATION

Radiation

According to the lesion sites, SBRT or hyperfractionated radiotherapy was used.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-15
Primary Completion
2024-10-15
Completion
2025-08-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05498805 on ClinicalTrials.gov