NCT06062589

AK104 Combined With I-125 Brachytherapy for Recurrent or Metastatic Cervical Cancer

AK104 Combined With Iodine-125 Brachytherapy in the Treatment of Recurrent or Metastatic Cervical Cancer

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 18 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to determine efficacy and safety of AK104 combined with I-125 brachytherapy for recurrent or metastatic cervical cancer. This is an open-label, single-center, observational study of AK104 with Iodine-125 brachytherapy in the treatment of recurrent or metastatic cervical cancer. 18 eligible patients will receive Iodine-125 brachytherapy (single implantation, half-life of 60 days, 99% of total dose given after 90 days), followed by AK104 treatment (6mg/kg Q2W) starting within 1 week of particle implantation, for a total of 6 cycles or until disease progression, intolerable toxicity, investigator decision, withdrawal of informed consent, death, or other reasons as specified in the protocol.

Detailed description

Study Title AK104 combined with Iodine-125 brachytherapy in the Treatment of Recurrent or Metastatic Cervical Cancer Study Objectives Primary Objective To explore the effectiveness of AK104 in combination with Iodine-125 brachytherapy in the treatment of recurrent or metastatic cervical cancer. Secondary Objective To explore the safety of AK104 in combination with Iodine-125 brachytherapy in the treatment of recurrent or metastatic cervical cancer. Study Endpoints Primary Endpoint Objective response rate (ORR) based on RECIST 1.1 evaluation. Secondary Endpoints Disease control rate (DCR), progression-free survival (PFS), and 3-year overall survival rate (OS) based on RECIST 1.1 evaluation. Safety assessment: Incidence and severity of adverse events (AE), clinically significant abnormal laboratory test results. Target Population Patients with unresectable recurrent or metastatic cervical cancer who have undergone radical surgery and/or radical chemoradiotherapy and are suitable for local radiotherapy (non-central pelvic recurrence or oligometastasis in stage IVB). Study Drug and Administration AK104, 6mg/kg Q2W, administered via intravenous infusion over 60 minutes (±10 minutes). For subjects unable to tolerate a 60-minute infusion, the infusion time may be extended up to 120 minutes. Dose adjustments are not allowed during treatment with AK104, but treatment may be delayed for a maximum of 12 weeks from the previous dose. Treatment will be discontinued if AK104 has been withheld for more than 12 weeks due to treatment-related immune-related adverse events (irAE) requiring corticosteroid therapy, or for reasons unrelated or potentially unrelated to AK104, but the investigator determines that the patient would benefit from continued treatment after discussion with the medical monitor.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
RADIATION	Iodine-125 particle brachytherapy	All enrolled patients' relapsed or metastatic lesions underwent image-guided radiation I-125 particle implantation brachytherapy (single implantation, half-life of 60 days, 99% of total dose given after 90 days). The prescribed dose is above 130Gy. Technical process: positioning and preoperative planning design; Template reset and particle implantation under the guidance of image system; Rapid and real-time intraoperative optimization; Postoperative dose validation.
DRUG	AK104	AK104 treatment (6mg/kg Q2W) starting within 1 week of particle implantation, for a total of 6 cycles or until disease progression, intolerable toxicity, investigator decision, withdrawal of informed consent, death, or other reasons as specified in the protocol.

Timeline

• Start date: 2023-10-11
• Primary completion: 2025-01-11
• Completion: 2027-10-11
• First posted: 2023-10-02
• Last updated: 2023-10-02