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Efficacy and Safety Study of First-line Treatment With SG001 Plus Chemotherapy ± Bevacizumab Versus Placebo Plus Chemotherapy ±Bevacizumab for Recurrent, or Metastatic Cervical Cancer With PD-L1 Positive (CPS≥1)

Primary Purpose

Recurrent, or Metastatic Cervical Cancer With PD-L1 Positive (CPS≥1)

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
SG001 injection
Paclitaxel
Cisplatin
Carboplatin
Bevacizumab injection
SG001 placebo
Sponsored by
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent, or Metastatic Cervical Cancer With PD-L1 Positive (CPS≥1)

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Age ≥ 18 and ≤ 70 on the day of signing informed consent and volunteered to participated in this study. Has histologically documented recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which has not been treated with systemic chemotherapy and is not amenable to curative treatment (such as with surgery and/or radiation). (Safety Lead-in)Has a measurable lesion per RECIST 1.1 via CT or MRI. (Phase 3) Has a assessable lesion per RECIST 1.1 via CT or MRI. Has provided enough archival tumor tissue sample or willing to provide newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for prospective determination of Programmed Cell Death-Ligand 1 (PD-L1) status prior to first dose. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 14 days prior to first dose. Has a predicted survival period ≥ 3 months assessed by investigators. Adverse reactions from the previous anti-tumor treatment have not yet recovered to ≤ level 1 based on CTCAE 5.0. Adequate organ function as defined below: Blood routine tests (No blood transfusions and hematopoietic stimulators have been used, and no drugs have been used to correct blood cell counts ): Absolute neutrophil count (ANC) ≥1.5×10^9/L; Platelets ≥100 ×10^9/L; Hemoglobin (HGB)≥9 g/dL; Serum biochemical indexs: Serum creatinine ≤1.5 × ULN or >1.5 × ULN with creatinine clearance (CCr) ≥ 60 mL/min; Serum total bilirubin (TBIL) ≤ 1.5 × ULN (Patients with Gilbert's syndrome can be up to 3 × ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN or ≤5 X ULN for patients with liver metastases; Coagulation function: Activated partial thromboplastin time (APPT) and International Normalized Ratio (INR)≤1.5 × ULN (No anticoagulants or other drugs affecting clotting function have been used within 14 days prior to the first dose, except for patients requiring long-term anticoagulant therapy). Exclusion Criteria: Active malignancy within 2 years prior to first dose of the investigational drug, except for cervical cancer studied in this trial and any locally curable tumor that has received radical therapy (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, cervical cancer in situ, breast cancer in situ, etc). History of primary immunodeficiency. History of active tuberculosis. Patients with any active autoimmune disease, except for patients with well-controlled type I diabetes, well-controlled hypothyroidism with hormone replacement therapy, skin diseases (such as vitiligo, psoriasis, or hair loss) without systemic treatment, or those who are not expected to relapse without external triggers. Serious cardiovascular disease within 6 months prior to the first dose, including but not limited to: stable angina with functional class III-IV; unstable angina or myocardial infarction; NYHA grade III-IV congestive heart failure; severe arrhythmias requiring drug therapy (congestive heart failure allowed if ventricular rate can be controlled; severe arrhythmias requiring drug therapy (congestive heart failure is allowed if the ventricular rate can be controlled). History of interstitial lung disease, or non-infectious pneumonitis requiring glucocorticoid therapy. Patients with active soft meningeal disease or poorly controlled brain metastasis. Prior therapy with any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways including anti-PD-1, anti-PD-L1, anti-PD-L2, anti CTLA-4, OX40 agonist, and anti-CD137, etc. Has received prior radiotherapy within 14 days prior to the first dose. Has received prior chemosensitizer within 14 days prior to the first dose. Presence of clinically significant hydronephros which cannot be relieved by ventriculostomy or ureteral stent placement assessed by investigator. Patients with un-controlled pleural effusion, pericardial effusion or seroperitoneum requiring repeated drainage. Has any active infection requiring systemic treatment by intravenous infusion within 14 days prior to the first dose. Has received systemic corticosteroids (at doses equivalent to or greater than 10 mg/day of prednisone) or other immunosuppressive drugs within 14 days prior to the first dose. Have received major surgery, open biopsy or traumatism within 28 days before the first dose, or planned to receive elective major surgery during the study period. planned to receive during the study period. Have received Chinese herbal medicine or Chinese patent medicine with anti-tumor activity within14 days prior to the first dose. History of organ transplant or allogenic haemopoietic stem cell transplantation. Patients should be excluded if they have a positive test for human immunodeficiency virus antibody (HIV-Ab) or treponema pallidum antibody (TP-Ab). Patients with positive Hepatitis B virus surface antigen (HBsAg) and/or hepatitis B virus core antibody (HBcAb) as well quantitative HBV-DNA above upper limit of normal value, and patients with positive hepatitis C virus antibody (HCV-Ab) as well quantitative HCV-RNA above upper limit of normal value, should also be excluded. Pregnant or lactating women; Or the blood pregnancy test of women at child-bearing age is positive during screening. History of severe allergic reactions and uncontrolled allergic asthma to all components of the monoclonal antibody formulation. Has a contraindication or hypersensitivity to any component of cisplatin, carboplatin, paclitaxel, or bevacizumab. Have participated other clinical trials and received related investigated drugs within 28 days prior to the first dose (counted from the date of the last treatment in the previous clinical trial, patients participated in the overall survival follow-up of the previous clinical trial can be accepted). Women of child-bearing potential (WOCBP) refuse to take reliable contraceptive methods from signing the informed consent form to 6 months after last dose of investigational drug. Not suitable for this study as determined by the investigator due to other reasons.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    safety run-in Stage(single arm) and Phase 3: SG001+Platinum-based chemotherapy±Bevacizumab

    Phase 3: Placebo+Platinum-based chemotherapy±Bevacizumab

    Arm Description

    SG001 360 mg, Intravenous infusion, D1, Q3W, up to approximately 2 years ; paclitaxel 175 mg/m^2, Intravenous infusion, D1, Q3W, up to 6 cycles; cisplatin 50 mg/m^2 or carboplatin(AUC=5) , Intravenous infusion, D1, Q3W, up to 6 cycles; with or without bevacizumab 15 mg/kg, Intravenous infusion, D1, Q3W, up to approximately 2 years All treatments will be administered until disease progression or toxicity

    Placebo, Intravenous infusion, D1, Q3W, up to approximately 2 years ; paclitaxel 175 mg/m^2, Intravenous infusion, D1, Q3W, up to 6 cycles; cisplatin 50 mg/m^2 or carboplatin(AUC=5) , Intravenous infusion, D1, Q3W, up to 6 cycles; with or without bevacizumab 15 mg/kg, Intravenous infusion, D1, Q3W, up to approximately 2 years All treatments will be administered until disease progression or toxicity

    Outcomes

    Primary Outcome Measures

    Safety Lead-in
    Incidence and grade of the TRAE、SAE and irAE
    PFS per RECIST 1.1
    Phase 3
    Overall survival (OS)
    Phase 3

    Secondary Outcome Measures

    Safety Lead-in and phase 3
    ORR per RECIST 1.1
    Peak Plasma Concentration(Cmax)
    Safety Lead-in and phase 3
    DOR per RECIST 1.1
    Safety Lead-in and phase 3
    DCR per RECIST 1.1
    Safety Lead-in and phase 3
    TTR per RECIST 1.1
    Safety Lead-in and phase 3
    Area under the plasma concentration versus time curve (AUC)
    Safety Lead-in and phase 3
    half-time(t1/2)
    Safety Lead-in and phase 3
    Plasma clearance(CL)
    Safety Lead-in and phase 3
    Volume of Distribution at Steady State(Vss)
    Safety Lead-in and phase 3
    PFS per iRECIST 1.1
    phase 3
    Incidence and grade of the TRAE、SAE and irAE
    phase 3

    Full Information

    First Posted
    January 16, 2023
    Last Updated
    January 27, 2023
    Sponsor
    CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05715840
    Brief Title
    Efficacy and Safety Study of First-line Treatment With SG001 Plus Chemotherapy ± Bevacizumab Versus Placebo Plus Chemotherapy ±Bevacizumab for Recurrent, or Metastatic Cervical Cancer With PD-L1 Positive (CPS≥1)
    Official Title
    A Randomised, Double-blind, Placebo-controlled, Multicentre Phase Ш Clinical Study to Evaluate the Efficacy and Safety of First-line Treatment With SG001 Plus Chemotherapy±Bevacizumab Versus Placebo Plus Chemotherapy±Bevacizumab for PD-L1 Positive (CPS≥1) Women With Recurrent, or Metastatic Cervical Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 31, 2023 (Anticipated)
    Primary Completion Date
    July 31, 2024 (Anticipated)
    Study Completion Date
    May 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study is a randomised, double-blind, placebo-controlled, multicentre phase 3 clinical study to evaluate the efficacy and safety of SG001 plus chemotherapy±bevacizumab versus placebo plus chemotherapy±bevacizumab, as first-line treatment, in patients with PD-L1 positive (CPS≥1), Recurrent or Metastatic Cervical Cancer. The study contains a Safety Lead-in Phase in which the safety and tolerability of SG001+Chemotherapy±Bevacizumab will be assessed prior to the Phase 3 portion of the study.
    Detailed Description
    The purpose of this study is to assess the efficacy and safety of SG001 plus one of four platinum-based chemotherapy regimens compared to the placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult PD-L1 positive (CPS≥1) women with recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab. The study include two stages: the safety run-in phase and phase Ⅲ trail. Upon completion of the first stage study, the Safety Monitoring Committee (SMC) will decide whether to proceed directly to Phase Ⅲ study. The primary study hypotheses are that the combination of SG001 plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1), 2) Overall Survival (OS).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Recurrent, or Metastatic Cervical Cancer With PD-L1 Positive (CPS≥1)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    368 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    safety run-in Stage(single arm) and Phase 3: SG001+Platinum-based chemotherapy±Bevacizumab
    Arm Type
    Experimental
    Arm Description
    SG001 360 mg, Intravenous infusion, D1, Q3W, up to approximately 2 years ; paclitaxel 175 mg/m^2, Intravenous infusion, D1, Q3W, up to 6 cycles; cisplatin 50 mg/m^2 or carboplatin(AUC=5) , Intravenous infusion, D1, Q3W, up to 6 cycles; with or without bevacizumab 15 mg/kg, Intravenous infusion, D1, Q3W, up to approximately 2 years All treatments will be administered until disease progression or toxicity
    Arm Title
    Phase 3: Placebo+Platinum-based chemotherapy±Bevacizumab
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo, Intravenous infusion, D1, Q3W, up to approximately 2 years ; paclitaxel 175 mg/m^2, Intravenous infusion, D1, Q3W, up to 6 cycles; cisplatin 50 mg/m^2 or carboplatin(AUC=5) , Intravenous infusion, D1, Q3W, up to 6 cycles; with or without bevacizumab 15 mg/kg, Intravenous infusion, D1, Q3W, up to approximately 2 years All treatments will be administered until disease progression or toxicity
    Intervention Type
    Drug
    Intervention Name(s)
    SG001 injection
    Intervention Description
    360 mg,Q3W,IV infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Paclitaxel
    Intervention Description
    175 mg/m^2,Q3W,IV infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Cisplatin
    Intervention Description
    50 mg/m^2,Q3W,IV infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Carboplatin
    Intervention Description
    AUC=5,Q3W,IV infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Bevacizumab injection
    Intervention Description
    15 mg/kg,Q3W,IV infusion
    Intervention Type
    Drug
    Intervention Name(s)
    SG001 placebo
    Intervention Description
    Q3W,IV infusion
    Primary Outcome Measure Information:
    Title
    Safety Lead-in
    Description
    Incidence and grade of the TRAE、SAE and irAE
    Time Frame
    Up to 42 days after the last patient of the lead-in phase
    Title
    PFS per RECIST 1.1
    Description
    Phase 3
    Time Frame
    Up to approximately 3 years
    Title
    Overall survival (OS)
    Description
    Phase 3
    Time Frame
    Up to approximately 3 years
    Secondary Outcome Measure Information:
    Title
    Safety Lead-in and phase 3
    Description
    ORR per RECIST 1.1
    Time Frame
    Up to approximately 3 years
    Title
    Peak Plasma Concentration(Cmax)
    Description
    Safety Lead-in and phase 3
    Time Frame
    Up to approximately 2 years
    Title
    DOR per RECIST 1.1
    Description
    Safety Lead-in and phase 3
    Time Frame
    Up to approximately 3 years
    Title
    DCR per RECIST 1.1
    Description
    Safety Lead-in and phase 3
    Time Frame
    Up to approximately 3 years
    Title
    TTR per RECIST 1.1
    Description
    Safety Lead-in and phase 3
    Time Frame
    Up to approximately 3 years
    Title
    Area under the plasma concentration versus time curve (AUC)
    Description
    Safety Lead-in and phase 3
    Time Frame
    Up to approximately 2 years
    Title
    half-time(t1/2)
    Description
    Safety Lead-in and phase 3
    Time Frame
    Up to approximately 2 years
    Title
    Plasma clearance(CL)
    Description
    Safety Lead-in and phase 3
    Time Frame
    Up to approximately 2 years
    Title
    Volume of Distribution at Steady State(Vss)
    Description
    Safety Lead-in and phase 3
    Time Frame
    Up to approximately 2 years
    Title
    PFS per iRECIST 1.1
    Description
    phase 3
    Time Frame
    Up to approximately 3 years
    Title
    Incidence and grade of the TRAE、SAE and irAE
    Description
    phase 3
    Time Frame
    Up to approximately 3 years

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥ 18 and ≤ 70 on the day of signing informed consent and volunteered to participated in this study. Has histologically documented recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which has not been treated with systemic chemotherapy and is not amenable to curative treatment (such as with surgery and/or radiation). (Safety Lead-in)Has a measurable lesion per RECIST 1.1 via CT or MRI. (Phase 3) Has a assessable lesion per RECIST 1.1 via CT or MRI. Has provided enough archival tumor tissue sample or willing to provide newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for prospective determination of Programmed Cell Death-Ligand 1 (PD-L1) status prior to first dose. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 14 days prior to first dose. Has a predicted survival period ≥ 3 months assessed by investigators. Adverse reactions from the previous anti-tumor treatment have not yet recovered to ≤ level 1 based on CTCAE 5.0. Adequate organ function as defined below: Blood routine tests (No blood transfusions and hematopoietic stimulators have been used, and no drugs have been used to correct blood cell counts ): Absolute neutrophil count (ANC) ≥1.5×10^9/L; Platelets ≥100 ×10^9/L; Hemoglobin (HGB)≥9 g/dL; Serum biochemical indexs: Serum creatinine ≤1.5 × ULN or >1.5 × ULN with creatinine clearance (CCr) ≥ 60 mL/min; Serum total bilirubin (TBIL) ≤ 1.5 × ULN (Patients with Gilbert's syndrome can be up to 3 × ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN or ≤5 X ULN for patients with liver metastases; Coagulation function: Activated partial thromboplastin time (APPT) and International Normalized Ratio (INR)≤1.5 × ULN (No anticoagulants or other drugs affecting clotting function have been used within 14 days prior to the first dose, except for patients requiring long-term anticoagulant therapy). Exclusion Criteria: Active malignancy within 2 years prior to first dose of the investigational drug, except for cervical cancer studied in this trial and any locally curable tumor that has received radical therapy (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, cervical cancer in situ, breast cancer in situ, etc). History of primary immunodeficiency. History of active tuberculosis. Patients with any active autoimmune disease, except for patients with well-controlled type I diabetes, well-controlled hypothyroidism with hormone replacement therapy, skin diseases (such as vitiligo, psoriasis, or hair loss) without systemic treatment, or those who are not expected to relapse without external triggers. Serious cardiovascular disease within 6 months prior to the first dose, including but not limited to: stable angina with functional class III-IV; unstable angina or myocardial infarction; NYHA grade III-IV congestive heart failure; severe arrhythmias requiring drug therapy (congestive heart failure allowed if ventricular rate can be controlled; severe arrhythmias requiring drug therapy (congestive heart failure is allowed if the ventricular rate can be controlled). History of interstitial lung disease, or non-infectious pneumonitis requiring glucocorticoid therapy. Patients with active soft meningeal disease or poorly controlled brain metastasis. Prior therapy with any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways including anti-PD-1, anti-PD-L1, anti-PD-L2, anti CTLA-4, OX40 agonist, and anti-CD137, etc. Has received prior radiotherapy within 14 days prior to the first dose. Has received prior chemosensitizer within 14 days prior to the first dose. Presence of clinically significant hydronephros which cannot be relieved by ventriculostomy or ureteral stent placement assessed by investigator. Patients with un-controlled pleural effusion, pericardial effusion or seroperitoneum requiring repeated drainage. Has any active infection requiring systemic treatment by intravenous infusion within 14 days prior to the first dose. Has received systemic corticosteroids (at doses equivalent to or greater than 10 mg/day of prednisone) or other immunosuppressive drugs within 14 days prior to the first dose. Have received major surgery, open biopsy or traumatism within 28 days before the first dose, or planned to receive elective major surgery during the study period. planned to receive during the study period. Have received Chinese herbal medicine or Chinese patent medicine with anti-tumor activity within14 days prior to the first dose. History of organ transplant or allogenic haemopoietic stem cell transplantation. Patients should be excluded if they have a positive test for human immunodeficiency virus antibody (HIV-Ab) or treponema pallidum antibody (TP-Ab). Patients with positive Hepatitis B virus surface antigen (HBsAg) and/or hepatitis B virus core antibody (HBcAb) as well quantitative HBV-DNA above upper limit of normal value, and patients with positive hepatitis C virus antibody (HCV-Ab) as well quantitative HCV-RNA above upper limit of normal value, should also be excluded. Pregnant or lactating women; Or the blood pregnancy test of women at child-bearing age is positive during screening. History of severe allergic reactions and uncontrolled allergic asthma to all components of the monoclonal antibody formulation. Has a contraindication or hypersensitivity to any component of cisplatin, carboplatin, paclitaxel, or bevacizumab. Have participated other clinical trials and received related investigated drugs within 28 days prior to the first dose (counted from the date of the last treatment in the previous clinical trial, patients participated in the overall survival follow-up of the previous clinical trial can be accepted). Women of child-bearing potential (WOCBP) refuse to take reliable contraceptive methods from signing the informed consent form to 6 months after last dose of investigational drug. Not suitable for this study as determined by the investigator due to other reasons.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fenglin She, MSc
    Phone
    010-63942533
    Email
    shefenglin@mail.ecspc.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lingying Wu, M.D
    Organizational Affiliation
    National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy and Safety Study of First-line Treatment With SG001 Plus Chemotherapy ± Bevacizumab Versus Placebo Plus Chemotherapy ±Bevacizumab for Recurrent, or Metastatic Cervical Cancer With PD-L1 Positive (CPS≥1)

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