Actively Recruiting
A Phase II, Single-arm, Multicenter Study of Cardunolizumab with Chemotherapy and Bevacizumab in Recurrent or Metastatic Vulvar and Vaginal Cancer
Led by Zhejiang Cancer Hospital · Updated on 2024-11-21
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang Cancer Hospital
Lead Sponsor
A
Akeso
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of cardunolizumab combined with or without chemotherapy and bevacizumab in treating recurrent or metastatic vulvar and vaginal cancers that cannot be cured with radical treatment. This phase II, single-arm, multicenter prospective study aims to see how this treatment works in women with these cancers. Participants who have not received systematic treatment will receive cardunolizumab with platinum-based doublet chemotherapy, with or without bevacizumab, every three weeks for six cycles followed by maintenance treatment with cardunolizumab with or without bevacizumab every three weeks. Those previously treated with systemic therapy will receive cardunolizumab with chemotherapy chosen by the investigator and with or without bevacizumab following the same schedule. During the study, participants will undergo assessments to measure tumor response using RECIST 1.1 criteria and will be monitored for progression-free survival, overall survival, disease control rate, and duration of response up to 2 years. Adverse events will be tracked from the first dose until 90 days after the last dose. Women must provide tumor tissue samples before enrollment and will be followed for safety and treatment effects over the course of the trial, which starts in March 2024 and ends in March 2027.
CONDITIONS
Brief Title
A Phase II, Single-arm, Multicenter, Prospective Study of Cardunolizumab in Recurrent or Metastatic Vulvar and Vaginal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to join the study and comply with all visits and procedures
- Female, aged 18 to 75 years
- Diagnosed with recurrent or metastatic vulvar or vaginal carcinoma not suitable for curative treatment
- Have at least one measurable tumor lesion based on RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 3 months
- Prior immunotherapy or targeted therapy allowed if no severe adverse events occurred
- Completed prior systemic therapy at least 4 weeks or 5 half-lives before starting this study with related adverse events resolved to Grade 1 or less
- Provide archived tumor tissue samples within 2 years before randomization
- Have adequate organ function
- Agree to use effective contraception from consent until 120 days after last study drug dose
- Understand and sign informed consent and follow study procedures
You will not qualify if you...
- Received systemic anticancer therapy within 4 weeks before first study dose
- Not fully recovered to baseline or Grade 1 or less from adverse events of prior treatments
- Received radiotherapy within 2 weeks before first study dose unless meeting specific conditions
- Received immunomodulatory drugs within 2 weeks before randomization
- Have active Hepatitis B or C infection
- History of severe bleeding or clotting disorders
- Pregnant or breastfeeding
- Have any other medical condition or abnormal lab result that may interfere with study participation or results as judged by the investigator
- Require major surgery during the study period or not fully recovered from prior major surgery complications before starting study treatment
- Reirradiation of previously treated sites is not allowed
- Palliative radiotherapy to bone lesions must be more than 7 days before first dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 18 weeks for initial 6 cycles, followed by ongoing maintenance treatment
Participants receive Cardunolizumab combined with chemotherapy and optionally Bevacizumab for 6 cycles every 3 weeks, followed by maintenance treatment with Cardunolizumab ± Bevacizumab every 3 weeks.
Visits every 3 weeks during treatment cycles and maintenance
Duration - Up to 2 years
Participants are monitored for safety and treatment outcomes for up to 2 years after starting treatment.
Periodic visits for assessments up to 2 years
Trial Site Locations
Total: 1 location
1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310005
Actively Recruiting
Research Team
H
Hanmei Lou, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Frequently Asked Questions
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