A Trial of AK104 or AK112 in Combination With Axitinib in Patients With Metastatic Mucosal Melanoma

Launched by PEKING UNIVERSITY CANCER HOSPITAL & INSTITUTE · May 16, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the safety and effectiveness of two experimental treatments, called AK104 and AK112, when used together with a drug named axitinib in patients who have advanced mucosal melanoma, a type of skin cancer that can spread to other parts of the body. The trial is designed to find out how these treatments work in combination, and it will take place in two parts—one part will focus on adjusting the doses of the medications, and the other will expand the number of participants to gather more data.

To be eligible for this trial, participants should be between 18 to 70 years old, have a confirmed diagnosis of metastatic mucosal melanoma, and have a life expectancy of at least three months. They should also have good overall health, meaning they can perform daily activities without major issues. Participants will be required to give their written consent and follow the study guidelines. This trial is not yet recruiting participants, so more information will be available as it progresses. If you or a loved one is considering participating, it's important to discuss it with a healthcare provider to understand the potential benefits and risks.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1、18 to 70 years old (at the time consent is obtained). 2、Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
• • 3、Have histologically- or cytologically-confirmed diagnosis of Metastatic Mucosal Melanoma.
• • 4、Have a life expectancy of at least 3 months 5、Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 6、Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as determined by the site study team 7、Has adequate organ function as defined by:Absolute neutrophil count ≥ 1,500/µL;Platelets ≥ 100,000/µL;Hemoglobin ≥ 9 g/dL;Crcl ≥ 50ml/min creatinine clearance may be calculated using the institutional/laboratory standard method.Serum total bilirubin ≤ 1.5 x ULN ;Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN ;Albumin ≥28g/L;International Normalized Ratio (INR) and aPTT \<1.5 x ULN. Left ventricular ejection fraction ≥50%.
• • 8、Have recovered from the effects of any prior radiotherapy or surgery 9、All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment.
• Exclusion Criteria:
• • 1. Prior treatment with anti-PD-1/PD-L1/PD-L2 antibody and Axitinib
• • 2. Is currently participating in a study of an investigational agent or using an investigational device
• • 3. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy within 2 years prior to the first dose of study treatment
• • 4. Has undergone major surgery within 30 days of Study Day 1
• • 5. Has a known additional malignancy that is progressing or requires systemic treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
• • 6. Has known active central nervous system (CNS) metastases
• • 7. Has carcinomatous meningitis
• • 8. Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment NOTE: Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study
• • 9. Has an active infection requiring systemic therapy
• • 10. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected)
• • 11. History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 12 months prior to day 1 of study treatment