AK104 for Recurrent or Metastatic Vulvar Cancer

Launched by AKESO · Jun 27, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called AK104 for women with recurrent or metastatic vulvar cancer, which means the cancer has returned or spread and cannot be cured with surgery or radiation. The trial aims to find out how well AK104 works on its own or when combined with chemotherapy to help shrink tumors and improve patient outcomes. It is currently recruiting participants, specifically women aged 18 to 80 who have been diagnosed with certain types of vulvar cancer and have already tried at least one other treatment without success.

To be eligible for this trial, participants should have a life expectancy of at least three months and be in relatively good health, as determined by their doctor. Women who can become pregnant must also take a pregnancy test and agree to use effective birth control during the study. Participants can expect to receive AK104 and may experience side effects, which will be monitored closely by the research team. This study is an important step in exploring new options for women facing challenging cases of vulvar cancer.

Gender

FEMALE

Eligibility criteria

• 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.