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This is a randomized, double-blind, placebo-controlled phase III study to evaluate GLS-010 plus platinum-containing chemotherapy with or without bevacizumab as first-line treatment for persistent, recurrent, or metastatic cervical cancer.
This is a randomized, double-blind, placebo-controlled phase III study,aimed to evaluate the efficacy and safety of GLS-010 plus platinum-containing chemotherapy with or without bevacizumab as first-line treatment for persistent, recurrent, or metastatic cervical cancer.All enrolled patients will be randomly divided into 2 groups and continuously treated until any event that meets the criteria for end of the clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLS-010+chemotherapy± bevacizumab | Experimental | GLS-010 in combination with cisplatin or carboplatin and paclitaxel± bevacizumab |
|
| Placebo+chemotherapy± bevacizumab | Placebo Comparator | Placebo in combination with cisplatin or carboplatin and paclitaxel± bevacizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLS-010 | Drug | IV infusion |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival (OS) | OS is defined as the time from randomization to death due to any cause. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival (PFS) | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1. | Up to 2 years |
| Objective Response Rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Hospital | Shanghai | Shanghai Municipality | China |
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| Drug |
IV infusion |
|
| paclitaxel | Drug | IV infusion |
|
| cisplatin | Drug | IV infusion |
|
| carboplatin | Drug | IV infusion |
|
| bevacizumab | Drug | IV infusion |
|
Proportion of subjects who have a complete or partial response relative to baseline based on RECIST 1.1 criteria.
| Up to 2 years |
| Duration of Response (DOR) | Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria. | Up to 2 years |
| Disease Control Rate (DCR) | DCR defined as the proportion of subjects' response of CR, PR, or SD based on RECIST v1.1 criteria. | Up to 2 years |
| Time to Response(TTR) | TTR defined as the time from the date of randomization to the date when the response criteria are first met, based on RECIST v1.1 criteria. | Up to 2 years |
| Number of subjects with adverse events (AEs) | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment | From the time of signed informed consent to 90 days after end of treatment. |
| Quality of life (QoL) | EORTC QLQ-C30 will be used. | Up to 2 years |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000719848 | zimberelimab |
| D017239 | Paclitaxel |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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