Clinical trial NCT06419673: Serplulimab Plus Chemoradiotherapy for Stage III-IVA Cervical Cancer
Official title: Induced and Concurrent Serplulimab Plus Chemoradiotherapy Followed by Toripalimab Maintenance Therapy for Stage III-IVA Cervical Cancer: a Prospective, Multicenter, Randomized, Open Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Cervical Cancer
Keywords: Serplulimab
Concurrent chemoradiotherapy
Cervical Cancer
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2024-05-17
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Progression-Free Survival(PFS) at Month 36
timeFrame: Up to approximately 46 months.
Secondary outcomes:
measure: Overall Survival (OS) at Month 36
timeFrame: Up to approximately 46 months
measure: Objective Response Rate (ORR)
timeFrame: Baseline up to approximately 36 months
measure: Complete Response Rate（CRR）
timeFrame: Baseline up to approximately 36 months
measure: Time to the first disease progression （TTP）
timeFrame: Up to approximately 24 months
measure: Duration of response (DOR)
timeFrame: Up to approximately 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: LINGYING WU, MD
role: PRINCIPAL_INVESTIGATOR
References: