NCT05932212

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 6, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

August 25, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

2.3 years

First QC Date

June 27, 2023

Last Update Submit

March 10, 2025

Conditions

Vulvar Cancer

Keywords

PD-1/CTLA-4vulvar cancer

Outcome Measures

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

    Up to approximately 1 years

Secondary Outcomes (8)

  • Progression-free survival (PFS) Assessed by investigator

    Up to approximately 2 years

  • Duration of Response (DOR) Assessed by investigator

    Up to approximately 2 years

  • Disease control rate (DCR) Assessed by investigator

    Up to approximately 1 years

  • Time to Response (TTR) Assessed by investigator

    Up to approximately 1 years

  • Overall survival (OS)

    Up to approximately 2 years

  • +3 more secondary outcomes

Study Arms (2)

Cohort A: AK104

EXPERIMENTAL

AK104 monotherapy

Drug: AK104

Cohort B: AK104+chemotherapy

EXPERIMENTAL

AK104 combined with platinum-based chemotherapy (paclitaxel+ cisplatin or carboplatin)

Drug: AK104+ Paclitaxel+Cisplatin or Carboplatin

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.

Also known as: Cadonilimab
Cohort A: AK104
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.

Cohort B: AK104+chemotherapy

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Clinical oncology school of Fujian Medical University, Fujian Cancer Hospital

Fuzhou, Fujian, 350000, China

RECRUITING

Sun Yant-Sen Memorial Hospital

Guangzhou, Guangdong, 510000, China

RECRUITING

The Fourth Hospital of Hebei Medical University

Shijiangzhuang, Hebei, 050000, China

NOT YET RECRUITING

Liaoning Cancer Hospital & Insitut

Shenyang, Liaoning, 110042, China

RECRUITING

Tianjin medical university Cancer Institut & Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

NOT YET RECRUITING

MeSH Terms

Conditions

Vulvar Neoplasms

Interventions

Carboplatin

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsVulvar DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Central Study Contacts

Ting Liu, MD

CONTACT

+86(0760)89873999clinicaltrials@akesobio.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2023

First Posted

July 6, 2023

Study Start

August 25, 2023

Primary Completion

December 15, 2025

Study Completion

December 15, 2025

Last Updated

March 12, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(6)