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

NCT06459687 | Recruiting Phase 3 DMC

• 1 other identifier: ZKAB001-LEES-2024-01
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 5

Brief Summary

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).

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival

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

Secondary Outcomes (17)

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

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

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

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

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

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

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

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

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

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

Study Arms (2)

Socazolimab+Chemotherapy±Bevacizumab

EXPERIMENTAL

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.

Drug: Socazolimab+cisplatin/carboplatin+paclitaxel+Bevacizumab

Placebo+Chemotherapy±Bevacizumab

PLACEBO COMPARATOR

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.

Drug: Placebo+cisplatin/carboplatin+paclitaxel+Bevacizumab

Interventions

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.

Socazolimab+Chemotherapy±Bevacizumab

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.

Placebo+Chemotherapy±Bevacizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Able to understand and voluntarily signed written informed consent. Informed consent must be signed prior to specified study procedure.
• \. Age ≥ 18 years and ≤75 years on the date of signing the informed consent, female.
• \. ECOG Physical fitness score was 0 or 1.
• \. Life expectancy ≥ 3 months.
• \. Histologically confirmed cervical cancer that cannot be cured by surgery or radiotherapy/concurrent chemoradiotherapy.
• \. Have at least one measurable tumor lesion examined by CT or MRI according to RECIST v1.1 criteria;
• \. All subjects must provide archived or freshly obtained tumor tissue samples (formalin-fixed paraffin-embedded \[FFPE\] tissue wax blocks or at least 5 unstained tumor tissue section samples, preferably newly obtained tumor tissue samples) within the previous 5 years of randomization.
• \. Laboratory examination results during the screening period indicate that the subject has good organ function.
• \. Effective contraception should be used by fertile female subjects from the signing of informed consent until 180 days after the last administration of the study drug.

You may not qualify if:

• \. Other histopathological types of cervical cancer, such as small cell carcinoma, clear cell carcinoma, sarcoma, etc.
• \. 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.
• \. Active or potentially recurring autoimmune disease.
• \. Patients with other active malignant tumors within 3 years prior to randomization.
• \. Participants who had participated in other clinical studies and used other clinical trial drugs within 4 weeks before randomization.
• \. Major surgery, open biopsy or significant trauma within 4 weeks before randomization; Or an expected major surgical treatment during the study.
• \. Anti-tumor therapy within 4 weeks before randomization.
• \. Severe infection occurring within 4 weeks prior to randomization.
• \. Vaccination within 4 weeks prior to randomization.
• \. Received immune-modulating drugs (such as thymosin, interferon, interleukin-2) within 2 weeks before randomization.
• \. Use of systemic antibacterial, antiviral, or antifungal drugs within 2 weeks prior to randomization.
• \. Subjects requiring systemic treatment with corticosteroids (\> 10 mg/ day of prednisone or equivalent doses of corticosteroids) or other immunosuppressive drugs within 2 weeks prior to randomization.
• \. Clinically significant hydronephrosis that cannot be relieved by nephrostomy or ureteral stenting as determined by the investigator.
• \. Central nervous system metastatic or cancerous meningitis.
• \. Uncontrolled pleural, pericardial, or peritoneal effusions requiring repeated drainage (more frequently than monthly).

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead

Study Sites (5)

Anhui Provincial Cancer Hospital

Hefei, Anhui, 230031, China

RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 14, 2024
• Study Start: November 28, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

CN (5)