A Phase II Clinical Study to Assess the Efficacy and Safety of IBI310 or Placebo Combined With Sintilimab for Advanced Cervical Cancer Subjects Who Have Failed or Cannot Tolerate First-line or Above Platinum-based Chemotherapy

Last updated: December 10, 2023
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Overall Status: Completed

Phase

2

Condition

Cervical Cancer

Uterine Disorders

Treatment

Placebo

Sintilimab

IBI310

Clinical Study ID

NCT04590599
CIBI310E201
  • Ages 18-75
  • Female

Study Summary

This is a randomized, double-blind, controlled, parallel-cohort Phase II clinical study, which is planned to enroll 220 subjects with advanced cervical cancer who have failed or cannot tolerate first-line or above platinum-based chemotherapy

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. The subject must sign the written informed consent form, and can comply with thevisits and related procedures specified in the protocol.
  2. Aged ≥18 years and ≤75 years.
  3. Diagnosed with cervical cancer by histology/cytology.
  4. Patients with relapsed or metastatic cervical cancer who have had progressed orrelapsed after receiving at least first-line of platinum-based chemotherapy (if apatient has progressed or relapsed during or within 6 months after receivingplatinum-based neoadjuvant or adjuvant chemotherapy, she will be deemed to havereceived first-line treatment).
  5. The subject's previous systemic treatment must have ended ≥4 weeks before the firststudy administration, and the treatment-related AEs have recovered to CommonTerminology Criteria for Adverse Events (CTCAE) V5.0 grade ≤1 (except for alopecia andfatigue).

Exclusion

Exclusion Criteria:

  1. Diagnosis of other malignant tumors within 5 years before the first administration,excluding radically cured skin basal cell carcinoma, skin squamous cell carcinoma,radically resected carcinoma in situ and/or thyroid papillary carcinoma.
  2. Pleural effusion, ascites, and pericardial effusion with clinical symptoms orrequiring drainage (patients with effusion that does not require drainage or patientswith no significant increase in the effusion within 3 days after stopping drainage canbe selected).
  3. Patients who are planning to undergo or have previously received organ or bone marrowtransplantation.
  4. Patients with acute or chronic active hepatitis B or C infection, hepatitis B virus (HBV) DNA> 200 IU/ml or 103 copies/ml; hepatitis C virus (HCV) antibody positive andHCV-RNA level higher than the lower limit of detection. Patients with acute or chronicactive hepatitis B or C infection who have received nucleotide antiviral therapy andare below the above standards can be selected.
  5. Meningeal metastases or symptomatic central nervous system (CNS) metastases. Patientswith asymptomatic brain metastases who do not need treatment with glucocorticoids,anticonvulsants or mannitol after radiotherapy can be enrolled.

Study Design

Total Participants: 205
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 2
Study Start date:
December 08, 2020
Estimated Completion Date:
November 20, 2023

Connect with a study center

  • Innovent Biologics, Inc.

    Suzhou, Jiangsu 215123
    China

    Site Not Available

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

    Wuhan,
    China

    Site Not Available

  • Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)

    Zhenjiang,
    China

    Site Not Available

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