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Phase III Study of Socazolimab as First-Line Treatment in Persistent, Recurrent, or Metastatic Cervical Cancer

ConditionCervical Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorLee's Pharmaceutical Limited

About this trial

The goal of this clinical trial is to evaluate the efficacy and safety of Socazolimab combined with chemotherapy with or without bevacizumab as first-Line treatment in persistent, recurrent, or metastatic cervical cancer. The main question it aims to answer is:

Does Socazolimab combined with chemotherapy with or without bevacizumab better benefit patients with persistent, recurrent, or metastatic cervical cancer as first-line treatment compared with placebo combined with chemotherapy with or without bevacizumab.

Participants will be treated with Socazolimab/placebo + chemotherapy ± bevacizumab) for 6\~8 cycles (Q3w), following maintenance treatment of Socazolimab/placebo (Q3w).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Able to understand and voluntarily signed written informed consent. Informed consent must be signed prior to specified study procedure.

2. Age ≥ 18 years and ≤75 years on the date of signing the informed consent, female.

3. ECOG Physical fitness score was 0 or 1.

4. Life expectancy ≥ 3 months.

Disqualifiers

1. Other histopathological types of cervical cancer, such as small cell carcinoma, clear cell carcinoma, sarcoma, etc.

2. Prior anti-angiogenic therapy (e.g., bevacizumab), immune checkpoint inhibitors (e.g., anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.), or targeting immune costimulators (e.g. antibodies against ICOS, CD40, CD137, GITR, OX40 targets, etc.) and any treatment targeting the immune mechanism of tumor.

3. Active or potentially recurring autoimmune disease.

4. Patients with other active malignant tumors within 3 years prior to randomization.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Socazolimab+cisplatin/carboplatin+paclitaxel+Bevacizumab

    Drug

    6\~8 cycles of Socazolimab (5 mg/kg) + cisplatin (50 mg/m2) /carboplatin (AUC5) + paclitaxel (175 mg/m2) ± Bevacizumab (15 mg/kg), Q3w. Followed with Socazolimab (5 mg/kg), Q3w.

  • Placebo+cisplatin/carboplatin+paclitaxel+Bevacizumab

    Drug

    6\~8 cycles of placebo (5 mg/kg) + cisplatin (50 mg/m2) /carboplatin (AUC5) + paclitaxel (175 mg/m2) ± Bevacizumab (15 mg/kg), Q3w. Followed with placebo (5 mg/kg), Q3w.

Treatment groups

440 Participants
are divided into 2 treatment groups
Group A: Socazolimab+Chemotherapy±BevacizumabExperimental treatment 1 intervention
Group B: Placebo+Chemotherapy±BevacizumabPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall survival

Time frame
From date of randomization to date of death from any cause, assessed up to 100 months.

Secondary outcomes

1

PFS (assessed by BICR, based on RECIST v1.1)

Time frame
From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
2

ORR (assessed by BICR, based on RECIST v1.1)

Time frame
From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
3

DoR (assessed by BICR, based on RECIST v1.1)

Time frame
From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
4

DCR (assessed by BICR, based on RECIST v1.1)

Time frame
From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lee's Pharmaceutical Limited

Lead sponsor

Source ClinicalTrials.gov
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