Vulvar CancerPhase 2NCT05932212
AK104 for Recurrent or Metastatic Vulvar Cancer
A Phase 2 study testing AK104 and AK104+ Paclitaxel+Cisplatin or Carboplatin in people with Vulvar Cancer, run by Akeso at 6 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Vulvar Cancer
- What is being tested?
- AK104 and AK104+ Paclitaxel+Cisplatin or Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 6 sitesChina
- Study dates
- 25 Aug 2023to 31 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Clinical oncology school of Fujian Medical University, Fujian Cancer Hospital
Fuzhou, Fujian, 350000
Sun Yant-Sen Memorial Hospital
Guangzhou, Guangdong, 510000
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Liaoning Cancer Hospital & Insitut
Shenyang, Liaoning, 110042
The Fourth Hospital of Hebei Medical University
Shijiangzhuang, Hebei, 050000
Tianjin medical university Cancer Institut & Hospital
Tianjin, Tianjin Municipality, 300000
About this study
Official title: A Multicenter, Open-label, Phase II Study of AK104 in the Treatment of Recurrent or Metastatic Vulvar Cancer
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.
- Conditions
- Vulvar Cancer
- Being tested
- AK104, AK104+ Paclitaxel+Cisplatin or Carboplatin
- Keywords
- PD-1/CTLA-4, vulvar cancer
- Medical subject headings
- Vulvar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK104Drug
Also called Cadonilimab
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: AK104 | Experimental | AK104 monotherapy Receives: Drug: AK104 |
| Cohort B: AK104+chemotherapy | Experimental | AK104 combined with platinum-based chemotherapy (paclitaxel+ cisplatin or carboplatin) Receives: Drug: AK104+ Paclitaxel+Cisplatin or Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to approximately 1 years
Secondary outcomes (8)
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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to approximately 1 years
Overall survival (OS)
The time from the first administration to death due to any cause
Measured: Up to approximately 2 years
Adverse Events (AEs)
Characterization of incidence, severity and abnormal clinically significant manifestation or laboratory findings.
Measured: Up to approximately 2 years
serum concentrations of AK104
assessment of PK include serum concentrations of AK104 at different timepoints after study drug administration
Measured: Up to approximately 2 years
Antidrug antibodies (ADA) of AK104
Proportion of subjects who develop detectable anti-drug antibodies (ADAs)
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start25 Aug 2023
- Primary completion31 May 2026
- Study completion31 May 2026
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvar CancerStudies of the same condition, open and under way.
- More trials run by AkesoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932212
- Sponsor's protocol ID
- AK104-218
- Status last verified
- Sep 2026
- First submitted
- 27 Jun 2023
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Phase II Study of AK104 in the Treatment of Recurrent or Metastatic Vulvar Cancer
- ClinicalTrials.gov ID
- NCT05932212
- Acronym / sponsor ID
- AK104-218
- Conditions
- Vulvar Cancer
- Keywords
- PD-1/CTLA-4, vulvar cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 20 participants (actual)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2023 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A: AK104 | Experimental | Drug: AK104AK104 monotherapy |
| Cohort B: AK104+chemotherapy | Experimental | Drug: AK104+ Paclitaxel+Cisplatin or CarboplatinAK104 combined with platinum-based chemotherapy (paclitaxel+ cisplatin or carboplatin) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AK104Also: CadonilimabAK104 15mg/kg intravenously(IV) every 3 weeks (Q3W), until progressive disease, unacceptable toxicity, completion of 2 years treatment or withdrawal of consent. | Drug | Cohort A: AK104 |
| AK104+ Paclitaxel+Cisplatin or CarboplatinAK104 (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. | Drug | Cohort B: AK104+chemotherapy |
Primary outcome
Objective response rate (ORR) assessed by investigator.
Time frame: Up to approximately 1 years
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR per RECIST v1.1
8 secondary outcomes
Progression-free survival (PFS) Assessed by investigator
Time frame: Up to approximately 2 years
Duration of Response (DOR) Assessed by investigator
Time frame: Up to approximately 2 years
Disease control rate (DCR) Assessed by investigator
Time frame: Up to approximately 1 years
Time to Response (TTR) Assessed by investigator
Time frame: Up to approximately 1 years
Overall survival (OS)
Time frame: Up to approximately 2 years
Adverse Events (AEs)
Time frame: Up to approximately 2 years
serum concentrations of AK104
Time frame: Up to approximately 2 years
Antidrug antibodies (ADA) of AK104
Time frame: Up to approximately 2 years
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AK104 and AK104+ Paclitaxel+Cisplatin or Carboplatin in people with Vulvar Cancer, run by Akeso at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) assessed by investigator. (time frame: Up to approximately 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.