A Randomized, Double-blind, Controlled, Parallel-cohort 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

Innovent Biologics (Suzhou) Co. Ltd.2 sites in 1 country205 target enrollmentDecember 8, 2020

ConditionsAdvanced Cervical Cancer

InterventionsIBI310 Sintilimab Placebo

DrugsIBI310 Placebo Sintilimab

Overview

Phase: Phase 2
Intervention: IBI310
Conditions: Advanced Cervical Cancer
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Enrollment: 205
Locations: 2
Primary Endpoint: Objective response rate (ORR)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

December 8, 2020

End Date

November 20, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•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.
•Pleural effusion, ascites, and pericardial effusion with clinical symptoms or requiring drainage (patients with effusion that does not require drainage or patients with no significant increase in the effusion within 3 days after stopping drainage can be selected).
•Patients who are planning to undergo or have previously received organ or bone marrow transplantation.
•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 and HCV-RNA level higher than the lower limit of detection. Patients with acute or chronic active hepatitis B or C infection who have received nucleotide antiviral therapy and are below the above standards can be selected.
•Meningeal metastases or symptomatic central nervous system (CNS) metastases. Patients with asymptomatic brain metastases who do not need treatment with glucocorticoids, anticonvulsants or mannitol after radiotherapy can be enrolled.

Arms & Interventions

IBI310+Sintilimab

Intervention: IBI310

IBI310+Sintilimab

Intervention: Sintilimab

Placebo+Sintilimab

Intervention: Placebo

Placebo+Sintilimab

Intervention: Sintilimab

Outcomes

Primary Outcomes

Objective response rate (ORR)

Time Frame: Assessed week 6,week 12,week 18 ,and every 9 weeks (or every 12 weeks after 54 weeks of treatment) for duration of study participation which is estimated to be 24 months.

ORR assessed by the investigator according to the RECIST V1.1

Secondary Outcomes

Disease Control Rate（DCR）(Assessed week 6,week 12,week 18 ,and every 9 weeks (or every 12 weeks after 54 weeks of treatment) for duration of study participation which is estimated to be 24 months.)