Serplulimab Plus Chemoradiotherapy for Stage III-IVA Cervical Cancer

NCT06419673 | Active Not Recruiting Phase 2

• 1 other identifier: HLX10IIT29
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Keywords

Serplulimab; Concurrent chemoradiotherapy; Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival(PFS) at Month 36

  PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, or by histopathologic confirmation of suspected disease progression, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD. PFS data will be cumulated to a certain cut-off date and the analysis will be performed via Kaplan-Meier approach to estimate the PFS rate at Month 36 using the entire PFS data up to the cut-off date.

  Up to approximately 46 months.

Secondary Outcomes (5)

• Overall Survival (OS) at Month 36

  Up to approximately 46 months

• Objective Response Rate (ORR)

  Baseline up to approximately 36 months

• Complete Response Rate（CRR）

  Baseline up to approximately 36 months

• Time to the first disease progression （TTP）

  Up to approximately 24 months

• Duration of response (DOR)

  Up to approximately 24 months

Study Arms (2)

Serplulimab + chemoradiotherapy , Serplulimab maintenance

EXPERIMENTAL

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.

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

Concurrent chemoradiotherapy

ACTIVE COMPARATOR

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.

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

Interventions

Serplulimab DRUG

Serplulimab will be administered by intravenous infusion at a dose of 300mg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Serplulimab + chemoradiotherapy , Serplulimab maintenance

Cisplatin DRUG

IV infusion

Concurrent chemoradiotherapy; Serplulimab + chemoradiotherapy , Serplulimab maintenance

Carboplatin DRUG

IV infusion

Concurrent chemoradiotherapy; Serplulimab + chemoradiotherapy , Serplulimab maintenance

Brachytherapy and External Beam Radiotherapy RADIATION

Brachytherapy and External Beam Radiotherapy

Concurrent chemoradiotherapy; Serplulimab + chemoradiotherapy , Serplulimab maintenance

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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..
• 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.
• Known history of serious allergy to any active ingredie or any excipients list in monoclonal antibody.
• The patient has other factors that, in the judgment of the investigator, may lead to forced early termination of the study.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Cisplatin; Carboplatin; Brachytherapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Radiotherapy; Therapeutics

Study Officials

• LINGYING WU, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 17, 2024
• Study Start: May 1, 2024
• Primary Completion: May 31, 2025
• Study Completion (Estimated): May 31, 2028
• Last Updated: May 17, 2024

Record last verified: 2024-05

Locations

CN (1)