AK104 for Recurrent or Metastatic Vulvar Cancer
ConditionVulvar Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorAkeso
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
AK104
DrugAK104 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 Carboplatin
DrugAK104 (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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Cohort A: AK104Experimental treatment 1 intervention
Group B: Cohort B: AK104+chemotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 yearsSecondary outcomes
1
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 years2
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 years3
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 years4
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 Source ClinicalTrials.gov