NCT05522894

AK104 Alone or in Combination With Chemotherapy in the First-line Treatment of ESCC

A Multicenter, Phase II Clinical Study of AK104 (Anti-PD-1/CTLA-4 Bispecific Antibody) Alone or in Combination With Chemotherapy in the First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a two-arm, open, multicenter clinical study to evaluate the efficacy and safety of AK104 alone or in combination with cisplatin and paclitaxel in the treatment of advanced esophageal squamous carcinoma without systemic therapy.

Detailed description

During the treatment, eligible patients in cohort A with PD-L1 CPS ≥5 will receive AK104 10 mg/kg, intravenously, every 3 weeks (maximum 24 months of dosing); in cohort B, regardless of PD-L1 expression, eligible patients will receive AK104 10 mg/kg, intravenously, every 3 weeks (maximum 24 months of dosing), in combination with cisplatin (75 mg/m2) and paclitaxel (175 mg/m2), Q3W (up to 6 cycles, the specific cycles will be determined by the investigator). Thereafter, AK104 maintenance therapy will be continued until disease progression, intolerable toxicity, withdrawal of informed consent, death, or end of the study, whichever occurred first (maximum duration of treatment with AK104 should be less than 12 months). When patients with initially unresectable disease transformed into resectable, an operation can be considered and the original regimen may be used after surgery.

Conditions

• Unresectable Esophageal Squamous Cell Carcinoma
• Locally Advanced Esophageal Squamous Cell Carcinoma
• Metastatic Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	AK104	10mg/kg IV every 3 weeks (Q3W)
DRUG	Cisplatin	75mg/m2 IV every 3 weeks (Q3W)
DRUG	Paclitaxel	175mg/m2 IV every 3 weeks (Q3W)

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-04-01
• Completion: 2024-10-01
• First posted: 2022-08-31
• Last updated: 2022-08-31