A Phase II, Single-arm, Multicenter, Prospective Study of Cardunolizumab in Recurrent or Metastatic Vulvar and Vaginal Cancer

NCT ID: NCT06292689

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-22
• Study Completion Date: 2027-03-22

Brief 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.

Conditions

Vulvar and Vaginal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

1.Not systematically treated: 20 patients with recurrent or metastatic vulvar and vaginal cancers enrolled without systemic treatment (platinum-based doublet chemotherapy) will be treated with cardunolizumab + platinum-based doublet chemotherapy ± bevacizumab.

2.Previous systematic treatment: Twenty patients with recurrent or metastatic vulvar and vaginal cancers previously treated with systemic therapy (platinum-based doublet chemotherapy) will be enrolled as subjects receiving cardunolizumab ± investigator's choice of chemotherapy ± bevacizumab.

Group Type: EXPERIMENTAL

Cardunolizumab

Intervention Type: DRUG

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.

Interventions

Cardunolizumab

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Akeso

INDUSTRY

Sponsor Role: collaborator

Innovent Biologics, Inc.

OTHER

Sponsor Role: collaborator

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hanmei Lou

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hanmei Lou, MD

Role: CONTACT

louhm@zjcc.org.cn

+8619817462599

Facility Contacts

Hanmei Lou, MD.

Role: primary

louhm@zjcc.org.cn

+8619817462599

Other Identifiers

IRB-2024-5(IIT)

Identifier Type: -

Identifier Source: org_study_id