Actively Recruiting
A Phase II, Single-arm, Multicenter, Prospective Study of Cardunolizumab in Recurrent or Metastatic Vulvar and Vaginal Cancer
Led by Zhejiang Cancer Hospital · Updated on 2024-11-21
40
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang Cancer Hospital
Lead Sponsor
A
Akeso
Collaborating Sponsor
AI-Summary
What this Trial Is About
To evaluate the efficacy and safety of cardunolizumab in combination with/without chemotherapy ± bevacizumab for recurrent or metastatic vulvar and vaginal cancers that are not amenable to radical treatment.
CONDITIONS
Official 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 participate with written informed consent and ability to follow study requirements
- Age between 18 and 75 years
- Have recurrent or metastatic vulvar or vaginal carcinoma not suitable for cure, confirmed by biopsy
- Have at least one measurable tumor lesion per RECIST 1.1 criteria
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Life expectancy of at least 3 months
- Prior immunotherapy or targeted therapy allowed if stopped without serious side effects
- Completed prior systemic therapy at least 4 weeks or 5 half-lives before study start, with side effects reduced to mild or less (except hair loss and fatigue)
- Provide archived or recent tumor tissue samples collected within 2 years before randomization
- Have adequate organ function
- Agree to use effective contraception from consent until 120 days after last study treatment
- Ability to understand and sign informed consent and comply with visits and procedures
You will not qualify if you...
- Received systemic anticancer therapy within 4 weeks before starting study treatment
- Not fully recovered from previous treatment side effects to mild or baseline levels
- Received radiotherapy within 2 weeks prior to study start, except palliative radiotherapy to bone lesions given more than 7 days before
- Received immunomodulatory drugs within 2 weeks before randomization
- Active hepatitis B or C infection
- History of severe bleeding or clotting disorders
- Pregnant or breastfeeding
- Any condition or abnormal test that could affect study results or participation, as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310005
Actively Recruiting
Research Team
H
Hanmei Lou, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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