Advanced Cervical Cancer
Conditions
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
Interventions
DRUGIBI310
IBI310 3 mg/kg,Q3W, for a total of 4 cycles
DRUGPlacebo
Placebo Q3W, for a total of 4 cycles
DRUGSintilimab
Sintilimab 200mg,Q3W
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. The subject must sign the written informed consent form, and can comply with the visits 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 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). 5. 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
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 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). 3. Patients who are planning to undergo or have previously received organ or bone marrow transplantation. 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 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. 5. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | 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) assessed by the Independent Radiological Review Committee (IRRC) according to the Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | DCR assessed by the investigator and IRRC according to the RECIST V1.1 |
Countries
China
Outcome results
None listed