A Phase II Study of Serplulimab Plus Bevacizumab in Combination With Chemotherapy in 1L Treatment of Untreated Recurrent or Metastatic Cervical Cancer

Sponsor
Sichuan Cancer Hospital and Research Institute
Study ID
NCT05444374
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Serplulimab — DRUG
    Recombinant anti-PD-1 humanized monoclonal antibody injection
  • Bevacizumab — DRUG
    Humanized anti-VEGF monoclonal antibody injection

Study Details

This study is a single-arm, multicenter, Phase II study to evaluate the efficacy and safety of the treatment of Serplulimab plus Bevacizumab in combination with chemotherapy in 1L treatment of patients with untreated recurrent or metastatic cervical cancer. Approximately 48 eligible subjects are planned to be enrolled across all sites. The dosing regimen is: Serplulimab plus Bevacizumab combined with chemotherapy (cisplatin, paclitaxel). Each cycle is 21 days (every 3 weeks). Subjects will receive Cisplatin plus Paclitaxel up to 4-6 cycles. The maximum duration of treatment with Serplulimab is 2 years (up to 35 cycles). During the study treatment period, the subjects will receive imaging examination and response assessments every 6 weeks (± 7 days) in the first 48 weeks, every 9 weeks (± 7 days) in 48-96 weeks, and then every 12 weeks (± 7 days). After the treatment discontinuation visit, the subjects will enter the safety follow-up period and survival follow-up period.

Key Dates

Start date
Oct 1, 2022
Status verified
Jun 2022
Primary completion
Sep 30, 2024
Completion
Dec 31, 2025

Study Design

Enrollment
48 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Serplulimab plus Bevacizumab Combined With Chemotherapy
    Each cycle being 21 days, Cisplatin plus Paclitaxel up to 4-6 cycles, the maximum duration of treatment with Serplulimab is 2 years (up to 35 cycles). * Serplulimab, 300 mg IV, Day1 of each cycle * Bevacizumab, 7.5 mg/kg, IV, Day1 of each cycle * Cisplatin: 50 mg/m2, IV, Day1 of each cycle * Paclitaxel: 175 mg/m2, IV, Day1 of each cycle

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to approximately 2 years ]

Central Contacts

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