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

Sponsor
Fudan University
Study ID
NCT04593485
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Oct 28, 2020
Status verified
Dec 2020
Primary completion
Oct 31, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    patients with postoperative recurrence of malignant melanoma of the female genital tract requiring adjuvant therapy, Camrelizumab for injection
  • Experimental: Cohort 2
    patients with metastatic or unresectable malignant melanoma of the female genital tract, Camrelizumab for injection

Primary Outcome Measure

Relapse-free survival (RFS) [ Time Frame: RFS was defined as the time from surgery to first local, regional, or distant tumor recurrence or death from any cause, whichever came first, assessed up to one year. ]

Central Contacts

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