Trials / Completed
CompletedNCT04590599
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
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 205 (actual)
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd. · Industry
- Sex
- Female
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IBI310 | IBI310 3 mg/kg,Q3W, for a total of 4 cycles |
| DRUG | Placebo | Placebo Q3W, for a total of 4 cycles |
| DRUG | Sintilimab | Sintilimab 200mg,Q3W |
Timeline
- Start date
- 2020-12-08
- Primary completion
- 2023-11-20
- Completion
- 2023-11-20
- First posted
- 2020-10-19
- Last updated
- 2023-12-18
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04590599. Inclusion in this directory is not an endorsement.