NCT04593485

Anti-PD-1 Antibody in the Treatment of Patients With Malignant Melanoma of the Female Genital Tract

Single-center, Open-label, Single-arm Phase II Clinical Trial of Anti-PD-1 Antibody (Camrelizumab for Injection) in the Treatment of Patients With Malignant Melanoma of the Female Genital Tract

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, open-label, single-arm phase II clinical study to exploratory observe and evaluate the efficacy and safety of anti-PD-1 antibody (Camrelizumab for Injection) in patients with malignant melanoma of the female genital tract. Subjects were to have a safety visit 3 days prior to dosing in each treatment cycle after the study. Imaging was performed every 8 weeks to assess efficacy until radiographic progression, initiation of new antineoplastic therapy, withdrawal of consent, or subject lost to follow-up/death. After the end of treatment, an end-of-treatment visit and a post-treatment safety visit will also be performed. After the end of treatment, subjects will also be followed up for survival (every 3 months for years 1 to 2, every 4 months for years 3, every 6 months for years 4 to 5, and annually from year 6) to collect and record the survival status of subjects and subsequent anti-tumor treatment.

Detailed description

This is a single-center, open-label, single-arm phase II clinical study to exploratory observe and evaluate the efficacy and safety of anti-PD-1 antibody (Camrelizumab for Injection) in patients with malignant melanoma of the female genital tract. The patients were divided into two cohorts according to their conditions: Cohort 1: patients with postoperative recurrence of malignant melanoma of the female genital tract requiring adjuvant therapy；Cohort 2: patients with metastatic or unresectable malignant melanoma of the female genital tract who were screened eligible and received study treatment after being fully informed and signing the informed consent form. Camrelizumab will be administered at a fixed dose of 200 mg intravenously (iv) on D1 in a 14-day cycle. All subjects will be administered until they reach the end of treatment standard specified in the protocol. Subjects were to have a safety visit 3 days prior to dosing in each treatment cycle after the study. Imaging was performed every 8 weeks to assess efficacy until radiographic progression, initiation of new antineoplastic therapy, withdrawal of consent, or subject lost to follow-up/death. After the end of treatment, an end-of-treatment visit and a post-treatment safety visit will also be performed. Subjects who have concluded the study treatment for reasons other than disease progression will receive imaging assessment at the end of treatment (if imaging evaluation is not performed at 4 months) and imaging assessment every 3 months after the end of treatment to assess the time to disease progression. After the end of treatment, subjects will also be followed up for survival (every 3 months for years 1 to 2, every 4 months for years 3, every 6 months for years 4 to 5, and annually from year 6) to collect and record the survival status of subjects and subsequent anti-tumor treatment. Tumor tissue samples, sections, paraffin blocks or biopsy blocks, and biomarkers, including but not limited to PD-L1 expression level and the proportion of positive cells, TMB level and MMR status, will be collected from subjects during the screening period after the most recent previous treatment.

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
DRUG	Camrelizumab for injection	Carrelizumab will be administered at a fixed dose

Timeline

• Start date: 2020-10-28
• Primary completion: 2023-10-01
• Completion: 2023-12-01
• First posted: 2020-10-20
• Last updated: 2020-12-23

Locations

2 sites across 1 country: China