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This is A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate AK104 Plus Platinum-containing Chemotherapy With or Without Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK104+chemotherapy± bevacizumab | Experimental | AK104 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 |
|---|---|---|---|---|
| AK104 | Biological | IV infusion |
| |
| paclitaxel |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival (PFS) assessed by blinded independent central review (BICR) per RECIST v1.1 | 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 approximately 2 years |
| overall survival (OS) | OS is defined as the time from randomization to death due to any cause. | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR | Proportion of subjects who have a complete or partial response relative to baseline as assessed by investigator according to RECIST 1.1 criteria | Up to approximately 2 years |
| Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR |
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Inclusion Criteria:
signs the written informed consent form.
Women aged ≥ 18 and ≤ 75 years.
ECOG of 0 or 1.
Life expectancy ≥ 3 months.
Histologically or cytologically confirmed cervical cancer, not amenable to curative surgery or concurrent chemoradiotherapy.
At least one measurable tumor lesion per RECIST v1.1; lesions at sites previously treated with radiotherapy or other loco-regional therapy are not considered as target lesions unless the lesion has unequivocal progression or the biopsy is obtained to confirm maligancy.
All subjects must provide archival tumor tissue samples within 2 years prior to randomization,or fresh tumor tissue samples obtained by biopsy.
Subjects must have adequate organ function as assessed in the laboratory tests.
Female subjects of childbearing potential must have a negative serum pregnancy test prior to the first dose. If a female subject of childbearing potential must use acceptable effective methods of contraception from screening and must agree to continue these precautions until 120 days after the last dose of study drug.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaohua Wu, MD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's Hospital School Of Medicine Zhejiang University | Hangzhou | China | ||||
| Zhejiang Cancer Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39426385 | Derived | Wu X, Sun Y, Yang H, Wang J, Lou H, Li D, Wang K, Zhang H, Wu T, Li Y, Wang C, Li G, Wang Y, Li D, Tang Y, Pan M, Cai H, Wang W, Yang B, Qian H, Tian Q, Yao D, Cheng Y, Wei B, Li X, Wang T, Hao M, Wang X, Wang T, Ran J, Zhu H, Zhu L, Liu X, Li Y, Chen L, Li Q, Yan X, Wang F, Cai H, Zhang Y, Liang Z, Liu F, Huang Y, Xia B, Qu P, Zhu G, Chen Y, Song K, Sun M, Chen Z, Zhou Q, Hu L, Abulizi G, Guo H, Liao S, Ye Y, Yan P, Tang Q, Sun G, Liu T, Lu D, Hu M, Wang ZM, Li B, Xia M. Cadonilimab plus platinum-based chemotherapy with or without bevacizumab as first-line treatment for persistent, recurrent, or metastatic cervical cancer (COMPASSION-16): a randomised, double-blind, placebo-controlled phase 3 trial in China. Lancet. 2024 Oct 26;404(10463):1668-1676. doi: 10.1016/S0140-6736(24)02135-4. Epub 2024 Oct 16. |
| Label | URL |
|---|---|
| Related Info | View source |
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| Drug |
IV infusion |
|
| carboplatin | Drug | iv infusion |
|
| cisplatin | Drug | iv infusion |
|
| bevacizumab | Drug | iv infusion |
|
| Placebo | Drug | iv infusion |
|
Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria. |
| Up to approximately 2 years |
| Time to Response(TTR Per RECIST 1.1 as Assessed by BICR | Up to approximately 2 years |
| AE | 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 | Up to approximately 2 years |
| Observed concentrations of AK104 | The endpoints for assessment of PK of AK104 include serum concentrations of AK104 at different timepoints after AK104 administration | From first dose of AK104 through 90 days after last dose of AK104 |
| Number of subjects who develop detectable anti-drug antibodies (ADAs) | The immunogenicity of AK104 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs) | From first dose of AK104 through 90 days after last dose of AK104 |
| Hangzhou |
| China |
| Anhui Provincial Hospital | Hefei | China |
| The Second Affiliated Hospital,Anhui Medical University | Hefei | China |
| Fudan University Shanghai Cancer Center | Shanghai | 200032 | China |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| 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 |
| D056831 | Coordination Complexes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| 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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