NCT06455046

Efficacy and Safety of AK104 Combined With Chemotherapy and Recombinant Human Adenovirus 5 Injection in Cervical Cancer

Efficacy and Safety of AK104 Combined With Pemetrexed, Carboplatin and Recombinant Human Adenovirus 5 Injection in Advanced Recurrent Cervical Cancer: a Multicenter, Single-arm, Prospective Phase II Clinical Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

In order to improve the clinical effect and find a new safe and effective treatment model for advanced recurrent cervical cancer, this study explored the efficacy level safety of pemetrexed, carboplatin, recombinant human adenovirus type 5, and AK104 regimen in recurrent and refractory advanced cervical cancer. For some patients with immune-resistant cervical cancer, combination chemotherapy and oncolytic virus therapy can promote the transformation of cold tumors into hot tumors, eliminate and then reverse the suppressor factors of immune resistance, and break the dilemma of immunotherapy drug resistance, which is a new method and strategy under immunotherapy drug resistance.

Detailed description

The Combined Treatment Stage consists of AK104 at a dosage of 10 mg/kg, Pemetrexed at a dosage of 500mg/m2, Cisplatin with an AUC of 4-6 mg/mL/min, and Human Adenovirus 5 Injection. This treatment is administered every 3 weeks for a total of 4 cycles. Upon enrollment, the drugs are given in the following sequence on the first day of each combined treatment cycle: local injection of Human Adenovirus 5 Injection (d1-d5), intravenous infusion of AK104 (d1), intravenous infusion of Pemetrexed (d2), and intravenous infusion of Cisplatin (d2). The Maintenance Treatment Stage involves single-drug AK104 at a dose of 10 mg/kg every 3 weeks for a duration lasting up to two years.

Conditions

• Cervical Cancer Recurrent

Interventions

Type	Name	Description
DRUG	AK104	PD-1/CTLA-4 bispecific antibody
DRUG	Recombinant Human Adenovirus 5 Injection	Recombinant Human Adenovirus 5 Injection

Timeline

• Start date: 2023-10-11
• Primary completion: 2025-10-10
• Completion: 2025-10-10
• First posted: 2024-06-12
• Last updated: 2024-06-12

Locations

1 site across 1 country: China