Back to resultsA Study of SHR-1210± SHR-1020 Versus Chemotherapy in Patients With Recurrent or Metastatic Cervical Cancer
Primary Purpose
Recurrent or Metastatic Cervical Cancer
Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SHR-1210
SHR-1020
Physician's choice chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent or Metastatic Cervical Cancer
Eligibility Criteria
Inclusion Criteria:
- Voluntarily agree to participate by giving written informed consent.
- Histologically or cytologically confirmed diagnosis of squamous-cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix.
- The patients relapsed after a platinum-based treatment regimen for recurrent or metastatic disease.
- Patients must provide a fresh biopsy. If not, sufficient and adequate tumor tissue sample from the most recent biopsy of a tumor lesion will be required for PD-L1 expression.
- Has measurable lesion on imaging based on RECIST version 1.1.
- Have a life expectancy of at least 3 months.
- ECOG performance status 0-1.
- If childbearing potential, female patients must be willing to use at least 1 adequate barrier methods throughout the study, starting with the screening visit through 6 months after the last dose of study treatment.
Exclusion Criteria:
- Has any malignancy <5 years prior to study entry. Except for curative skin basal cell carcinoma, carcinoma in situ or breast cancer >3 years.
- Has received prior therapy with: anti-PD-1, anti-PD-L1, or anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibodies; Famitinib; patient is allergic to monoclonal antibody.
- Known to have autoimmune disease.
- Recived other anticancer therapy 4 weeks before randomization.
- Known to be human immunodeficiency virus positive, active hepatitis B virus, or active hepatitis C virus.
- Untreated and/or uncontrolled brain metastases.
- With high risk of vaginal bleeding or gastrointestinal perforation.
Sites / Locations
- Fudan University Shanghai Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Doublet Arm
Single Arm
Physician's choice chemotherapy
Arm Description
SHR-1210+SHR-1020
SHR-1210
Albumin-bound paclitaxel injection or Pemetrexed disodium for injection or Gemcitabine for injection
Outcomes
Primary Outcome Measures
Objective Response Rate (ORR) assessed by Blinded Independent Central Review in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210)
Defined as the number of subjects with a best overall response (BOR) of CR (Disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) divided by the number of measurable subjects with target lesion at baseline according to RECIST 1.1 criteria.
Secondary Outcome Measures
Progression free survival (PFS) in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210)
PFS is defined as from the time of randomization until the date of first documented progression or date of death from any cause, whichever came first.
Overall survival (OS) in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210)
OS is the time interval from randomization to death due to any reason or lost of follow-up.
Objective Response Rate (ORR) assessed by investigator in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210)
Defined as the number of subjects with a best overall response (BOR) of CR (Disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) divided by the number of measurable subjects with target lesion at baseline according to RECIST 1.1 criteria.
Disease control rate (DCR)，recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210) according to RECIST 1.1 criteria
Defined as the number of subjects with a best overall response (BOR) of CR (Disappearance of all target lesions), PR (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) or SD (Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.) divided by the number of measurable subjects with target lesion at baseline according to RECIST 1.1 criteria.
Duration of response (DoR), in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210) according to RECIST 1.1 criteria.
For participants who demonstrate CR or PR, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death from any cause, whichever came first. The DOR per RECIST 1.1 as assessed by Investigator will be presented.
Time to response (TTR), in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210) according to RECIST 1.1 criteria.
Defined as the time from randomization to the first objective tumor response (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters)) observed for patients who achieved a CR or PR.
Time to treatment failure (TTF)，in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210) according to RECIST 1.1 criteria.
Defined as the time from randomization to the end of treatment or death from any cause, whichever came first.
Adverse Events (AEs)
Tolerance
To calculate the proportion of dose interruption, dose reduction or dose termination because of drug-related toxicity
Characteristic of Anti drug antibody
Defined as ratio of ADAs of SHR-1210 during the treatment compared to baseline.
Peak Serum Concentration of SHR-1210
Defined as peak serum concentration of SHR-1210 during the treatment compared to baseline
Peak Plasma Concentration of famitinib
Defined as peak plasma concentration of famitinib during the treatment compared to baseline
Area under the Serum Concentration versus Time Curve of SHR-1210
Defined as area under the serum concentration versus time curve of SHR-1210 during the treatment compared to baseline
Area under the Plasma Concentration versus Time Curve of famitinib
Defined as area under the plasma concentration versus time curve of famitinib during the treatment compared to baseline
Full Information
NCT ID
NCT04680988
First Posted
December 7, 2020
Last Updated
November 14, 2022
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04680988
Brief Title
A Study of SHR-1210± SHR-1020 Versus Chemotherapy in Patients With Recurrent or Metastatic Cervical Cancer
Official Title
A Randomized,Open-label, Multi-Center, Phase II Clinical Trial to Assess the Efficacy and Safety of SHR-1210± SHR-1020 Versus Physician's Choice Chemotherapy in the Treatment of Recurrent or Metastatic Cervical Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 5, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a randomized, open-label, 3-arm Phase 2 study to evaluate the efficacy and safety of SHR-1210 alone or with SHR-1020 versus physician's choice chemotherapy in recurrent or metastatic cervical cancer patients. All enrolled patients will be randomly divided into 3 groups and receive treatment until disease progression, intolerable toxicity，any criterion for stopping the study drug or SHR-1210 treatment for up to 2 years.
Detailed Description
This is a randomized, open-label, 3-arm Phase 2 study to evaluate the efficacy and safety of SHR-1210 alone or with SHR-1020 versus physician's choice chemotherapy in recurrent or metastatic cervical cancer patients. All enrolled patients will be randomly divided into 3 groups and receive treatment until disease progression, intolerable toxicity，any criterion for stopping the study drug or SHR-1210 treatment for up to 2 years.The primary study hypotheses are that the combination of SHR-1210 plus SHR-1020 is superior to SHR-1210 or physician's choice chemotherapy with respect to: 1) Progression free survival(PFS) in recurrent or metastatic cervical cancer patients(SHR-1210+SHR-1020 versus SHR-1210；2) Overall survival(OS) in recurrent or metastatic cervical cancer patients(SHR-1210+SHR-1020 versus Physician's choice chemotherapy).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent or Metastatic Cervical Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
194 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Doublet Arm
Arm Type
Experimental
Arm Description
SHR-1210+SHR-1020
Arm Title
Single Arm
Arm Type
Experimental
Arm Description
SHR-1210
Arm Title
Physician's choice chemotherapy
Arm Type
Active Comparator
Arm Description
Albumin-bound paclitaxel injection or Pemetrexed disodium for injection or Gemcitabine for injection
Intervention Type
Drug
Intervention Name(s)
SHR-1210
Other Intervention Name(s)
Camrelizumab
Intervention Description
SHR-1210 intravenously every 3 weeks
Intervention Type
Drug
Intervention Name(s)
SHR-1020
Other Intervention Name(s)
Famitinib
Intervention Description
SHR-1020 Orally once daily
Intervention Type
Drug
Intervention Name(s)
Physician's choice chemotherapy
Other Intervention Name(s)
Albumin-bound paclitaxel injection, Pemetrexed disodium for injection, Gemcitabine for injection
Intervention Description
Investigators will declare one of the following regimens:Albumin-bound paclitaxel injection, Pemetrexed disodium for injection, Gemcitabine for injection
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) assessed by Blinded Independent Central Review in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210)
Description
Defined as the number of subjects with a best overall response (BOR) of CR (Disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) divided by the number of measurable subjects with target lesion at baseline according to RECIST 1.1 criteria.
Time Frame
Up to approximately 2 years
Secondary Outcome Measure Information:
Title
Progression free survival (PFS) in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210)
Description
PFS is defined as from the time of randomization until the date of first documented progression or date of death from any cause, whichever came first.
Time Frame
Up to approximately 2 years
Title
Overall survival (OS) in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210)
Description
OS is the time interval from randomization to death due to any reason or lost of follow-up.
Time Frame
Up to approximately 2 years
Title
Objective Response Rate (ORR) assessed by investigator in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210)
Description
Defined as the number of subjects with a best overall response (BOR) of CR (Disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) divided by the number of measurable subjects with target lesion at baseline according to RECIST 1.1 criteria.
Time Frame
Up to approximately 2 years
Title
Disease control rate (DCR)，recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210) according to RECIST 1.1 criteria
Description
Defined as the number of subjects with a best overall response (BOR) of CR (Disappearance of all target lesions), PR (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) or SD (Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.) divided by the number of measurable subjects with target lesion at baseline according to RECIST 1.1 criteria.
Time Frame
Up to approximately 2 years
Title
Duration of response (DoR), in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210) according to RECIST 1.1 criteria.
Description
For participants who demonstrate CR or PR, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death from any cause, whichever came first. The DOR per RECIST 1.1 as assessed by Investigator will be presented.
Time Frame
Up to approximately 2 years
Title
Time to response (TTR), in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210) according to RECIST 1.1 criteria.
Description
Defined as the time from randomization to the first objective tumor response (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters)) observed for patients who achieved a CR or PR.
Time Frame
Up to approximately 2 years
Title
Time to treatment failure (TTF)，in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210) according to RECIST 1.1 criteria.
Description
Defined as the time from randomization to the end of treatment or death from any cause, whichever came first.
Time Frame
Up to approximately 2 years
Title
Adverse Events (AEs)
Time Frame
from the first drug administration to within 90 days for the last treatment dose
Title
Tolerance
Description
To calculate the proportion of dose interruption, dose reduction or dose termination because of drug-related toxicity
Time Frame
from the first drug administration to within 90 days for the last treatment dose
Title
Characteristic of Anti drug antibody
Description
Defined as ratio of ADAs of SHR-1210 during the treatment compared to baseline.
Time Frame
from the first drug administration to within 90 days for the last treatment dose
Title
Peak Serum Concentration of SHR-1210
Description
Defined as peak serum concentration of SHR-1210 during the treatment compared to baseline
Time Frame
from the first drug administration to within 90 days for the last treatment dose
Title
Peak Plasma Concentration of famitinib
Description
Defined as peak plasma concentration of famitinib during the treatment compared to baseline
Time Frame
from the first drug administration to within 90 days for the last treatment dose
Title
Area under the Serum Concentration versus Time Curve of SHR-1210
Description
Defined as area under the serum concentration versus time curve of SHR-1210 during the treatment compared to baseline
Time Frame
from the first drug administration to within 90 days for the last treatment dose
Title
Area under the Plasma Concentration versus Time Curve of famitinib
Description
Defined as area under the plasma concentration versus time curve of famitinib during the treatment compared to baseline
Time Frame
from the first drug administration to within 90 days for the last treatment dose
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Voluntarily agree to participate by giving written informed consent.
Histologically or cytologically confirmed diagnosis of squamous-cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix.
The patients relapsed after a platinum-based treatment regimen for recurrent or metastatic disease.
Patients must provide a fresh biopsy. If not, sufficient and adequate tumor tissue sample from the most recent biopsy of a tumor lesion will be required for PD-L1 expression.
Has measurable lesion on imaging based on RECIST version 1.1.
Have a life expectancy of at least 3 months.
ECOG performance status 0-1.
If childbearing potential, female patients must be willing to use at least 1 adequate barrier methods throughout the study, starting with the screening visit through 6 months after the last dose of study treatment.
Exclusion Criteria:
Has any malignancy <5 years prior to study entry. Except for curative skin basal cell carcinoma, carcinoma in situ or breast cancer >3 years.
Has received prior therapy with: anti-PD-1, anti-PD-L1, or anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibodies; Famitinib; patient is allergic to monoclonal antibody.
Known to have autoimmune disease.
Recived other anticancer therapy 4 weeks before randomization.
Known to be human immunodeficiency virus positive, active hepatitis B virus, or active hepatitis C virus.
Untreated and/or uncontrolled brain metastases.
With high risk of vaginal bleeding or gastrointestinal perforation.
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Study of SHR-1210± SHR-1020 Versus Chemotherapy in Patients With Recurrent or Metastatic Cervical Cancer
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