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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Advanced Cervical Cancer

Intervention / Treatment
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* Drug: IBI310
* Drug: Placebo
* Drug: Sintilimab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IBI310+Sintilimab<br>IBI310+Sintilimab | Drug: IBI310<br>* IBI310 3 mg/kg,Q3W, for a total of 4 cycles<br>Drug: Sintilimab<br>* Sintilimab 200mg,Q3W<br>* Other names: IBI308;|
| Active Comparator: Placebo+Sintilimab<br>Placebo+Sintilimab | Drug: Placebo<br>* Placebo Q3W, for a total of 4 cycles<br>Drug: Sintilimab<br>* Sintilimab 200mg,Q3W<br>* Other names: IBI308;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | Objective response rate (ORR) assessed by the Independent Radiological Review Committee (IRRC) according to the Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 | 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. | 
| Objective response rate (ORR) | ORR assessed by the investigator according to the RECIST V1.1 | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Control Rate（DCR） | DCR assessed by the investigator and IRRC according to the RECIST V1.1 | 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. |