AK104 for Recurrent or Metastatic Vulvar Cancer

Phase 2RecruitingNCT05932212

Akeso20 enrolled

Overview

This is a multicenter, open-label, phase II clinical study, aiming to the evaluate the efficacy and safety of AK104 (an anti- PD-1 and CTLA-4 bispecific antibody), alone or combined with chemotherapy, in subjects with recurrent or metastatic vulvar cancer not amenable to curative surgery or radiotherapy.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Vulvar Cancer

Interventions

AK104DRUG

AK104 15mg/kg intravenously(IV) every 3 weeks (Q3W), until progressive disease, unacceptable toxicity, completion of 2 years treatment or withdrawal of consent.

AK104+ Paclitaxel+Cisplatin or CarboplatinDRUG

AK104 (10 mg/kg) + paclitaxel (175 mg/m2)+ cisplatin (50 mg/m2) or carboplatin (AUC 4-5) , IV, Q3W, for up to 6 cycles, followed by maintenance therapy of AK104 10 mg/kg Q3W until disease progression, intolerable toxicity, withdrawal of consent, or completion of 2 years treatment.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: Age \>=18 and \<=80. ECOG of 0 or 2. Life expectancy ≥ 3 months. Histologically confirmed vulvar cancer (squamous cell carcinoma or adenosquamous carcinoma), not amenable to curative surgery or radical radiotherapy. For Cohort A, subjects should have experienced failure on at least one previous systemic therapy, or intolerance to standard therapy. At least one measurable tumor lesion per RECIST v1.1. Adequate organ function as assessed in the laboratory tests. Female subjects of childbearing potential must have a negative serum pregnancy test prior to the the first administration and agree to use effective methods of contraception Exclusion Criteria: Subjects with other histopathological types of vulvar cancer, such as melanoma, sarcoma, etc. Systemic or curative (surgery or radiotherapy) anti-tumor therapy within 4 weeks prior to the first administration. Previous treatment with immune checkpoint inhibitors (e.g., anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.). Active or potentially recurrent autoimmune disease.

Locations (6)

Clinical oncology school of Fujian Medical University, Fujian Cancer Hospital

Fuzhou, Fujian, China

RECRUITING

Sun Yant-Sen Memorial Hospital

Guangzhou, Guangdong, China

RECRUITING

The Fourth Hospital of Hebei Medical University

Shijiangzhuang, Hebei, China

Outcomes

Primary Outcomes

Objective response rate (ORR) assessed by investigator.

The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR per RECIST v1.1

Time frame: Up to approximately 1 years

Secondary Outcomes

Progression-free survival (PFS) Assessed by investigator

The time from the first administration to the first documented progressive disease (PD) or death due to any cause, whichever occurs first

Time frame: Up to approximately 2 years

Duration of Response (DOR) Assessed by investigator

Measured from the date of partial or complete response to therapy until the disease progression per RECIST v1.1 criteria

Time frame: Up to approximately 2 years

Disease control rate (DCR) Assessed by investigator

The proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥6 weeks) based on RECIST

Time frame: Up to approximately 1 years

Time to Response (TTR) Assessed by investigator

The time from the first administration to the date of documented CR or PR

Time frame: Up to approximately 1 years

Overall survival (OS)

The time from the first administration to death due to any cause

Time frame: Up to approximately 2 years

Adverse Events (AEs)

Characterization of incidence, severity and abnormal clinically significant manifestation or laboratory findings.

Central Contacts

Ting Liu, MD

CONTACT

+86(0760)89873999 clinicaltrials@akesobio.com

Data from ClinicalTrials.gov

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