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Trial Title:
A Phase II, Single-arm, Multicenter, Prospective Study of Cardunolizumab in Recurrent or Metastatic Vulvar and Vaginal Cancer
NCT ID:
NCT06292689
Condition:
Vulvar and Vaginal Cancer
Conditions: Official terms:
Vaginal Neoplasms
Conditions: Keywords:
Cardunolizumab
Vulvar Cancer
Vaginal Cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cardunolizumab
Description:
1. Not systematically treated:
Cardunolizumab (10mg/kg) + Cisplatinum (50mg/m2)/ Carboplatinum (AUC 4-5) +
Paclitaxel (175mg/m2) ± Bevacizumab (15mg/kg) for 6 cycles, every 3 weeks (Q3W), and
then Cardunolizumab ± Bevacizumab Q3W maintenance treatment.
2. Previous systematic treatment:
Cardunolizumab (10mg/kg) + Chemotherapy regimen selected by the investigator ±
Bevacizumab (15mg/kg) for 6 cycles, every 3 weeks (Q3W), and then Cardunolizumab ±
Bevacizumab Q3W maintenance treatment.
Arm group label:
Treatment
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Voluntary enrolment in the study with written informed consent and ability to comply
with protocol requirements visits and related procedures as specified in the
protocol.
2. Age≥18 & ≤75.
3. Recurrent or metastatic vulvar and vaginal carcinoma not amenable to curative
treatment, diagnosed histologically or cytologically, with a pathological type of
squamous, adenocarcinoma or adenosquamous carcinoma.
4. Has at least one measurable lesion based on Response Evaluation Criteria in Solid
Tumors (RECIST) 1.1 assessed by investigator. Lesions located in previously
irradiated areas are considered measurable if they show progression in such lesions.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6. Life expectancy of at least 3 months.
7. Prior immunotherapy, targeted therapies are permitted if treatment has not been
discontinued due to a grade ≥2 adverse event.
8. The end of prior systemic therapy must be ≥ 4 weeks or 5 half-lives, whichever is
shorter, from the first dose of this study. and the treatment-related AE returned to
CTCAE 5.0 ≤ Grade 1 (except alopecia and malaise).
9. All participants must provide an archived tumour tissue sample (formalin-fixed
paraffin-embedded [FFPE] tissue wax block or a minimum of 5 unstained tumour tissue
section samples, preferably newly obtained tumour tissue samples) within 2 years
prior to randomisation.
10. Has adequate organ function.
11. Have agreed to take effective contraception from the date of signing the informed
consent form until 120 days after the last administration.
12. Ability to understand and sign written informed consent and to comply with programme
visits and related procedures.
Exclusion Criteria:
1. Participants who have received prior systemic anticancer therapy (including study
drug) within 4 weeks prior to the first dose of study treatment. Note: If
participants have undergone major surgery, they must have fully recovered from the
toxicity and/or complications of the treatment prior to starting study treatment.
Patients who require elective major surgical treatment during the study period are
not eligible for enrolment.
2. Participants must have recovered to grade ≤1 or baseline level from all AEs
resulting from prior treatment.
3. Received radiotherapy within 2 weeks prior to the first dose. For patients who have
received radiotherapy prior to 2 weeks before the first dose, all of the following
conditions must be met for enrolment: glucocorticosteroids are not required, and
radiation pneumonitis, radiation hepatitis, and radiation enteritis are excluded.
Patients with palliative radiotherapy to bone lesions more than 7 days from the
first dose may be enrolled. Reirradiation of previously treated sites is not
permitted.
4. Received an immunomodulatory drug within 2 weeks prior to randomisation.
5. Active Hepatitis B or Hepatitis C.
6. History of severe bleeding tendency or coagulation disorder.
7. Pregnant or lactating female patients.
8. Has a history or current evidence of any condition, therapy, or laboratory
abnormality that might confound the results of the study, interfere with the
subject's participation for the full duration of the study, or is not in the
best interest of this subject to participate, in the opinion of the treating
investigator.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310005
Country:
China
Contact:
Last name:
Hanmei Lou, MD.
Phone:
+8619817462599
Email:
louhm@zjcc.org.cn
Investigator:
Last name:
Hanmei Lou, MD.
Email:
Principal Investigator
Start date:
March 22, 2024
Completion date:
March 22, 2027
Lead sponsor:
Agency:
Zhejiang Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Akeso
Agency class:
Industry
Collaborator:
Agency:
Innovent Biologics, Inc.
Agency class:
Other
Source:
Zhejiang Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06292689
