Serplulimab Plus Chemoradiotherapy for Stage III-IVA Cervical Cancer

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Active, not recruiting; Phase 2

Conditions: Cervical Cancer

Treatments: Drug: Serplulimab; Drug: Carboplatin; Drug: Cisplatin; Radiation: Brachytherapy and External Beam Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06419673

HLX10IIT29

Details and patient eligibility

About

This study is a prospective, multicenter, randomized, open controlled clinical trial aimed at evaluating the effectiveness and safety of serplulimab plus chemoradiotherapy in FIGO 2018 stage III or IVA cervical squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma patients who have not received prior treatment.

Full description

Cervical cancer is the most prevalent malignant tumor of the female reproductive system in China, with an estimated 150,700 new cases and 55,700 new deaths annually. Concurrent chemoradiotherapy (CRT) remains the standard treatment for locally advanced cervical cancer (LACC). However, for high-risk LACC (HR-LACC) patients, the 2-year progression-free survival (PFS) rate is only 57%-62%, and the 5-year overall survival (OS) rate is 52%-64%, which are the leading causes of patient mortality. The KEYNOTE-A18 study demonstrated that the combination of pembrolizumab and CRT reduced the progression risk and death risk by 30% and 27%, respectively, for HR-LACC patients. Following this, the FDA approved pembrolizumab in combination with CRT for the treatment of newly diagnosed stages III-IVA cervical cancer in January 2024. This prospective, multicenter, randomized, controlled clinical trial study aims to evaluate the effectiveness and safety of serplulimab induced and combined chemoradiotherapy in FIGO 2018 stage III or IVA cervical squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma patients who have not received prior treatment.

Enrollment: 240 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

1. Age ≥ 18 years and ≤ 75 years at time of study entry.
2. Has histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix.
3. The International Federation of Gynecology and Obstetrics (FIGO) 2018 Stages III-IVA.
4. Diagnosed with PD-L1-positive (combined positive score ≥1).
5. Has not previously received any definitive surgical, radiation, or systemic therapy for cervical cancer.
6. WHO/ECOG performance status of 0 or 1.
7. Patient must have at least one measurable disease as defined by RECIST 1.1.

Main Exclusion Criteria:

1. Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death receptor ligand 1 (PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent o..
2. Ongoing participation in another clinical study, or planned initiation of treatment in this study less than 28 days from the end of treatment in the previous clinical study.
3. Known history of serious allergy to any active ingredie or any excipients list in monoclonal antibody.
4. The patient has other factors that, in the judgment of the investigator, may lead to forced early termination of the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

240 participants in 2 patient groups

Serplulimab + chemoradiotherapy , Serplulimab maintenance

Experimental group

Description:

Participants receive serplulimab 300 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 3 cycles followed by serplulimab 300 mg IV on Day 1 of each 6-week cycle (Q3W) for an additional 15 cycles. During the Q3W dosing period of serplulimab, participants receive concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV or carboplatin (AUC=2) once per week (QW) for 5 or 6 weeks plus external beam radiotherapy followed by brachytherapy not to exceed 8 weeks.

Treatment:

Drug: Carboplatin

Radiation: Brachytherapy and External Beam Radiotherapy

Drug: Cisplatin

Drug: Serplulimab

Concurrent chemoradiotherapy

Active Comparator group

Description:

Participants receive concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV or carboplatin (AUC=2) once per week (QW) for 5 or 6 weeks plus external beam radiotherapy followed by brachytherapy not to exceed 8 weeks.

Treatment:

Drug: Carboplatin

Radiation: Brachytherapy and External Beam Radiotherapy

Drug: Cisplatin