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Phase II Study Evaluating the Efficacy and Safety of Ociperlimab in Combination With Tislelizumab and Chemotherapy as First-line Treatment for Participants With Advanced Triple Negative Breast Cancer (AdvanTIG-211)

Primary Purpose

Triple Negative Breast Cancer

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ociperlimab
Tislelizumab
Paclitaxel
Nab-paclitaxel
Carboplatin
Placebo
Pembrolizumab
Gemcitabine
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Triple Negative Breast Cancer focused on measuring TNBC, Triple Negative Breast Cancer, PD-L1, Ociperlimab, Tislelizumab, WCD118 (BGB-A1217), VDT482 (BGB-A317), Pembrolizumab, Carboplatin, Gemcitabine, Paclitaxel, Nab-paclitaxel, TIGIT, Combination immunotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria: Participant has histologically confirmed diagnosis of advanced (loco-regionally recurrent and not amenable to curative therapy, or metastatic (stage IV)) TNBC Participant has completed systemic treatment for Stage I-III breast cancer, if indicated, and ≥ 6 months have elapsed between the completion of systemic treatment with curative intent and disease recurrence A recently or newly obtained tumor biopsy from a metastatic site must be provided for determination of PD-L1 expression using the PD-L1 IHC 22C3 assay by a Novartis designated central laboratory, prior to study randomization. If a result of PD-L1 expression assessed by a PD-L1 IHC 22C3 pharmDx test in a local laboratory is available, this can serve as PD-L1 status confirmation. For Arms A, B and C participants must have PD-L1 positive tumors with CPS≥ 10. For Arm D, participants must have PD-L1 positive tumors with CPS ≥ 1 to < 10. Participant has measurable disease, i.e., at least one measurable lesion per RECIST 1.1 criteria (a lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation) Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Participant has life expectancy ≥ 12 weeks from the start of study treatment Key Exclusion Criteria: Participant has received prior treatment with immunotherapy in the metastatic setting, or anti-T cell immunoreceptor with Ig and ITIM domains (TIGIT) therapy in any setting History of severe hypersensitivity to any of the study drugs (i.e. monoclonal antibodies, gemcitabine, carboplatin, nab-paclitaxel, paclitaxel) or its excipients or to drugs of similar chemical classes Participant with inflammatory breast cancer at screening Participant has central nervous system (CNS) involvement which was not previously treated and/or was newly detected at screening. Previously treated CNS involvement must fulfill the following criteria to be eligible for the trial: Completed prior therapy (including radiation and/or surgery) for CNS metastases ≥ 28 days prior to the start of the study and CNS tumor is clinically stable at the time of screening, and Participant is not receiving steroids and/or enzyme inducing anti-epileptic medications for brain metastases Participant has an active autoimmune diseases or history of autoimmune diseases that may relapse Participant has not recovered from all toxicities related to prior anticancer therapies to National Cancer Institute (NCI) CTCAE version 5.0 Grade ≤1. Exception to this criterion: participants with any grade of alopecia are allowed to enter the study Other inclusion/exclusion criteria may apply

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Other

    Arm Label

    Arm A: ociperlimab+tislelizumab+chemotherapy (PD-L1 CPS ≥ 10)

    Arm B: placebo + pembrolizumab + chemotherapy (PD-L1 CPS ≥ 10)

    Arm C: placebo + tislelizumab + chemotherapy (PD-L1 CPS ≥ 10)

    Arm D: ociperlimab + tislelizumab + chemotherapy (PD-L1 CPS score ≥ 1 to < 10)

    Arm Description

    Participants with a PD-L1 CPS ≥ 10 will receive after randomization ociperlimab + tislelizumab + chemotherapy. The choice of one of three chemotherapy options is at the discretion of the investigator provided that it is either: (1) paclitaxel, (2) nab-paclitaxel, or (3) gemcitabine plus carboplatin.

    Participants with a PD-L1 CPS ≥ 10 will receive after randomization placebo + pembrolizumab + chemotherapy. The choice of one of three chemotherapy options is at the discretion of the investigator provided that it is either: (1) paclitaxel, (2) nab-paclitaxel, or (3) gemcitabine plus carboplatin.

    Participants with a PD-L1 CPS ≥ 10 will receive after randomization placebo + tislelizumab + chemotherapy. The choice of one of three chemotherapy options is at the discretion of the investigator provided that it is either: (1) paclitaxel, (2) nab-paclitaxel, or (3) gemcitabine plus carboplatin.

    Exploratory arm: Participants with a PD-L1 CPS ≥ 1 to < 10 will receive ociperlimab + tislelizumab + chemotherapy. The choice of one of three chemotherapy options is at the discretion of the investigator provided that it is either: (1) paclitaxel, (2) nab-paclitaxel, or (3) gemcitabine plus carboplatin.

    Outcomes

    Primary Outcome Measures

    Progression-free Survival (PFS) based on investigator assessment using RECIST 1.1 criteria in Arm A and B
    PFS is defined as the time from the date of randomization to the date of first documented progression or death due to any cause. The comparison of PFS between Arm A and Arm B will be provided

    Secondary Outcome Measures

    Overall Survival (OS) based on investigator assessment using RECIST 1.1 criteria in Arm A, B and C
    OS is defined as the time from date of randomization to date of death due to any cause. The comparison of OS between Arm A and Arm B, Arm B and Arm C, and Arm A and Arm C will be provided.
    Overall Response Rate (ORR) based on investigator assessment using RECIST 1.1 criteria in Arm A, B and C
    ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) as per local assessment according to RECIST 1.1.
    Clinical benefit rate (CBR) with confirmed response in Arm A, B and C
    CBR is defined as the percentage of participants with a BOR of confirmed CR, PR or stable disease (SD) lasting for a duration of 24 weeks. CR, PR and SD are defined as per local investigator assessment according to RECIST 1.1
    Time to response (TTR) based on investigator assessment using RECIST 1.1 criteria in Arm A, B and C
    TTR is defined as the time from date of randomization to the first documented response of either CR or PR, as per local investigator assessment according to RECIST 1.1
    Duration of Response (DOR) based on investigator assessment using RECIST 1.1 criteria in Arm A, B and C
    DOR is defined as the duration of time between the date of first documented response (CR or PR as per local investigator assessment according to RECIST 1.1) and the date of first documented progression or death due to any cause.
    Progression-free Survival (PFS) based on investigator assessment using RECIST 1.1 criteria in Arm A, B and C
    PFS is defined as the time from the date of randomization to the date of first documented progression or death due to any cause. PFS for participants in Arm C will be compared to PFS for participants in Arm A and B.
    Number of participants with dose modifications
    Number of participants with dose interruption and reductions for each drug component as a measure of tolerability
    Anti-drug Antibodies (ADA) prevalence at Baseline for ociperlimab
    prevalence at baseline is calculated as the percentage of participants who had an ADA positive result at baseline for ociperlimab
    Anti-drug Antibodies (ADA) prevalence at Baseline for tislelizumab
    prevalence at baseline is calculated as the percentage of participants who had an ADA positive result at baseline for tislelizumab
    Anti-drug Antibodies (ADA) incidence on treatment for ociperlimab
    ADA incidence on treatment will be calculated as the percentage of participants who are treatment-induced ADA positive for ociperlimab
    Anti-drug Antibodies (ADA) incidence on treatment for tislelizumab
    ADA incidence on treatment will be calculated as the percentage of participants who are treatment-induced ADA positive for tislelizumab
    Change from baseline in the Functional Assessment of Cancer Therapy-Breast (FACT-B) Trial Outcomes Index (TOI) score
    Change from baseline in the FACT-B TOI score for participants in Arms A, B and C. The FACT-B is a questionnaire that consists of 37 items with items from FACT-General (FACT-G) questionnaire (27 items) and from the Breast Cancer Subscale (BCS, 10 items). FACT-B consists of five subscales that address different aspects of the participant's quality of life: physical well-being (PWB), social/family well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and BCS. The FACT-B TOI is a composite of PWB, FWB and BCS, and ranges from 0 to 96, with higher scores indicating better quality of life.
    Time to 5-point definitive deterioration in FACT-B TOI score
    Time to 5-point definitive deterioration in the FACT-B TOI in Arms A, B and C. The FACT-B is a questionnaire that consists of 37 items with items from FACT-General (FACT-G) questionnaire (27 items) and from the Breast Cancer Subscale (BCS, 10 items). FACT-B consists of five subscales that address different aspects of the participant's quality of life: physical well-being (PWB), social/family well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and BCS. The FACT-B TOI is a composite of PWB, FWB and BCS, and ranges from 0 to 96, with higher scores indicating better quality of life. Definitive deterioration is defined as the time from the date of randomization to the date of event defined at least 5-point worsening from baseline with no later improvement above this threshold during the course of treatment or until death due to any cause, in the FACT-B TOI score.
    Serum concentrations of ociperlimab
    Summary statistics of serum ociperlimab concentrations by time point
    Serum concentrations of tislelizumab
    Summary statistics of serum tislelizumab concentrations by time point

    Full Information

    First Posted
    March 30, 2023
    Last Updated
    July 21, 2023
    Sponsor
    Novartis Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05809895
    Brief Title
    Phase II Study Evaluating the Efficacy and Safety of Ociperlimab in Combination With Tislelizumab and Chemotherapy as First-line Treatment for Participants With Advanced Triple Negative Breast Cancer
    Acronym
    AdvanTIG-211
    Official Title
    AdvanTIG-211: A Randomized, Double-blind, Placebo-controlled, Phase II Study Evaluating the Efficacy and Safety of Ociperlimab (WCD118) Combined With Tislelizumab (VDT482) Plus Chemotherapy Versus Placebo Combined With Pembrolizumab Plus Chemotherapy as First-line Therapy for Participants With Advanced Triple Negative Breast Cancer (TNBC)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Business decision, not driven by safety concerns; no new safety signals have been observed in the ociperlimab program.
    Study Start Date
    September 15, 2023 (Anticipated)
    Primary Completion Date
    July 17, 2029 (Anticipated)
    Study Completion Date
    July 18, 2029 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Novartis Pharmaceuticals

    4. Oversight

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

    5. Study Description

    Brief Summary
    The primary scientific question of interest of this study is whether the combination of ociperlimab, tislelizumab and chemotherapy improves progression-free survival (PFS) compared to the combination of placebo, pembrolizumab and chemotherapy as first-line therapy for adult men and women with advanced triple negative breast cancer (TNBC) whose tumors express programmed death ligand 1 (PD - L1) [combined positive score (CPS) ≥10], regardless of study treatment discontinuation or start of new anti-neoplastic therapy.
    Detailed Description
    This is a randomized, double-blind, placebo-controlled, multicenter, Phase II study evaluating the efficacy and safety of ociperlimab in combination with tislelizumab and chemotherapy as first-line treatment for participants with advanced TNBC whose tumors express PD-L1 (CPS ≥ 10). Additionally, the efficacy and safety of the triple combination (ociperlimab + tislelizumab + chemotherapy) will be assessed in Arm D (a separate single-arm, open-label cohort) in 30 participants with advanced TNBC whose tumors express PD-L1 (CPS ≥ 1 to < 10). Study treatment will continue until the participant experiences one of the following: disease progression per investigator's assessment by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, unacceptable toxicity, pregnancy, treatment is discontinued at the discretion of the investigator or participant, start of a new antineoplastic therapy, withdrawal of consent, lost to follow-up, death, or study is terminated by the sponsor.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Triple Negative Breast Cancer
    Keywords
    TNBC, Triple Negative Breast Cancer, PD-L1, Ociperlimab, Tislelizumab, WCD118 (BGB-A1217), VDT482 (BGB-A317), Pembrolizumab, Carboplatin, Gemcitabine, Paclitaxel, Nab-paclitaxel, TIGIT, Combination immunotherapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Masking Description
    Participants will be randomized to Arms A, B and C in a double-blind manner Participants will be enrolled in Arm D in an open-label manner
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm A: ociperlimab+tislelizumab+chemotherapy (PD-L1 CPS ≥ 10)
    Arm Type
    Experimental
    Arm Description
    Participants with a PD-L1 CPS ≥ 10 will receive after randomization ociperlimab + tislelizumab + chemotherapy. The choice of one of three chemotherapy options is at the discretion of the investigator provided that it is either: (1) paclitaxel, (2) nab-paclitaxel, or (3) gemcitabine plus carboplatin.
    Arm Title
    Arm B: placebo + pembrolizumab + chemotherapy (PD-L1 CPS ≥ 10)
    Arm Type
    Active Comparator
    Arm Description
    Participants with a PD-L1 CPS ≥ 10 will receive after randomization placebo + pembrolizumab + chemotherapy. The choice of one of three chemotherapy options is at the discretion of the investigator provided that it is either: (1) paclitaxel, (2) nab-paclitaxel, or (3) gemcitabine plus carboplatin.
    Arm Title
    Arm C: placebo + tislelizumab + chemotherapy (PD-L1 CPS ≥ 10)
    Arm Type
    Active Comparator
    Arm Description
    Participants with a PD-L1 CPS ≥ 10 will receive after randomization placebo + tislelizumab + chemotherapy. The choice of one of three chemotherapy options is at the discretion of the investigator provided that it is either: (1) paclitaxel, (2) nab-paclitaxel, or (3) gemcitabine plus carboplatin.
    Arm Title
    Arm D: ociperlimab + tislelizumab + chemotherapy (PD-L1 CPS score ≥ 1 to < 10)
    Arm Type
    Other
    Arm Description
    Exploratory arm: Participants with a PD-L1 CPS ≥ 1 to < 10 will receive ociperlimab + tislelizumab + chemotherapy. The choice of one of three chemotherapy options is at the discretion of the investigator provided that it is either: (1) paclitaxel, (2) nab-paclitaxel, or (3) gemcitabine plus carboplatin.
    Intervention Type
    Drug
    Intervention Name(s)
    Ociperlimab
    Other Intervention Name(s)
    WCD118
    Intervention Description
    900 mg intravenously (IV) every 3 weeks (Q3W)
    Intervention Type
    Drug
    Intervention Name(s)
    Tislelizumab
    Other Intervention Name(s)
    VDT482
    Intervention Description
    200 mg intravenously (IV) Q3W
    Intervention Type
    Drug
    Intervention Name(s)
    Paclitaxel
    Intervention Description
    90 mg/m2 intravenously (IV) on Days 1, 8 and 15 every 28 days
    Intervention Type
    Drug
    Intervention Name(s)
    Nab-paclitaxel
    Intervention Description
    100 mg/m2 intravenously (IV) on Days 1, 8 and 15 every 28 days
    Intervention Type
    Drug
    Intervention Name(s)
    Carboplatin
    Intervention Description
    AUC 2 intravenously (IV) on Days 1 and 8 every 21 days
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    normal saline intravenously (IV) Q3W
    Intervention Type
    Drug
    Intervention Name(s)
    Pembrolizumab
    Other Intervention Name(s)
    MK-3475
    Intervention Description
    200 mg intravenously (IV) Q3W
    Intervention Type
    Drug
    Intervention Name(s)
    Gemcitabine
    Intervention Description
    1000 mg/m2 intravenously (IV) on Days 1 and 8 every 21 days
    Primary Outcome Measure Information:
    Title
    Progression-free Survival (PFS) based on investigator assessment using RECIST 1.1 criteria in Arm A and B
    Description
    PFS is defined as the time from the date of randomization to the date of first documented progression or death due to any cause. The comparison of PFS between Arm A and Arm B will be provided
    Time Frame
    From randomization to date of disease progression or death, assessed up to approximately 32 months after first randomization
    Secondary Outcome Measure Information:
    Title
    Overall Survival (OS) based on investigator assessment using RECIST 1.1 criteria in Arm A, B and C
    Description
    OS is defined as the time from date of randomization to date of death due to any cause. The comparison of OS between Arm A and Arm B, Arm B and Arm C, and Arm A and Arm C will be provided.
    Time Frame
    From randomization to death, assessed up to approximately 32 months after first randomization
    Title
    Overall Response Rate (ORR) based on investigator assessment using RECIST 1.1 criteria in Arm A, B and C
    Description
    ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) as per local assessment according to RECIST 1.1.
    Time Frame
    Up to approximately 32 months after first randomization
    Title
    Clinical benefit rate (CBR) with confirmed response in Arm A, B and C
    Description
    CBR is defined as the percentage of participants with a BOR of confirmed CR, PR or stable disease (SD) lasting for a duration of 24 weeks. CR, PR and SD are defined as per local investigator assessment according to RECIST 1.1
    Time Frame
    Approximately 32 months after first randomization
    Title
    Time to response (TTR) based on investigator assessment using RECIST 1.1 criteria in Arm A, B and C
    Description
    TTR is defined as the time from date of randomization to the first documented response of either CR or PR, as per local investigator assessment according to RECIST 1.1
    Time Frame
    From randomization to first documented response, assessed up to approximately 32 months after first randomization
    Title
    Duration of Response (DOR) based on investigator assessment using RECIST 1.1 criteria in Arm A, B and C
    Description
    DOR is defined as the duration of time between the date of first documented response (CR or PR as per local investigator assessment according to RECIST 1.1) and the date of first documented progression or death due to any cause.
    Time Frame
    From first documented response to disease progression or death, assessed up to approximately 32 months after first randomization
    Title
    Progression-free Survival (PFS) based on investigator assessment using RECIST 1.1 criteria in Arm A, B and C
    Description
    PFS is defined as the time from the date of randomization to the date of first documented progression or death due to any cause. PFS for participants in Arm C will be compared to PFS for participants in Arm A and B.
    Time Frame
    From randomization to date of disease progression or death, assessed up to approximately 32 months after first randomization
    Title
    Number of participants with dose modifications
    Description
    Number of participants with dose interruption and reductions for each drug component as a measure of tolerability
    Time Frame
    Approximately 32 months after first dose
    Title
    Anti-drug Antibodies (ADA) prevalence at Baseline for ociperlimab
    Description
    prevalence at baseline is calculated as the percentage of participants who had an ADA positive result at baseline for ociperlimab
    Time Frame
    Baseline
    Title
    Anti-drug Antibodies (ADA) prevalence at Baseline for tislelizumab
    Description
    prevalence at baseline is calculated as the percentage of participants who had an ADA positive result at baseline for tislelizumab
    Time Frame
    Baseline
    Title
    Anti-drug Antibodies (ADA) incidence on treatment for ociperlimab
    Description
    ADA incidence on treatment will be calculated as the percentage of participants who are treatment-induced ADA positive for ociperlimab
    Time Frame
    From Cycle 1 to Cycle 16, end of treatment and 30 day safety follow-up. Each cycle is 21 days
    Title
    Anti-drug Antibodies (ADA) incidence on treatment for tislelizumab
    Description
    ADA incidence on treatment will be calculated as the percentage of participants who are treatment-induced ADA positive for tislelizumab
    Time Frame
    From Cycle 1 to Cycle 16, end of treatment and 30 day safety follow-up. Each cycle is 21 days
    Title
    Change from baseline in the Functional Assessment of Cancer Therapy-Breast (FACT-B) Trial Outcomes Index (TOI) score
    Description
    Change from baseline in the FACT-B TOI score for participants in Arms A, B and C. The FACT-B is a questionnaire that consists of 37 items with items from FACT-General (FACT-G) questionnaire (27 items) and from the Breast Cancer Subscale (BCS, 10 items). FACT-B consists of five subscales that address different aspects of the participant's quality of life: physical well-being (PWB), social/family well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and BCS. The FACT-B TOI is a composite of PWB, FWB and BCS, and ranges from 0 to 96, with higher scores indicating better quality of life.
    Time Frame
    Up to approximately 32 months after first dose
    Title
    Time to 5-point definitive deterioration in FACT-B TOI score
    Description
    Time to 5-point definitive deterioration in the FACT-B TOI in Arms A, B and C. The FACT-B is a questionnaire that consists of 37 items with items from FACT-General (FACT-G) questionnaire (27 items) and from the Breast Cancer Subscale (BCS, 10 items). FACT-B consists of five subscales that address different aspects of the participant's quality of life: physical well-being (PWB), social/family well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and BCS. The FACT-B TOI is a composite of PWB, FWB and BCS, and ranges from 0 to 96, with higher scores indicating better quality of life. Definitive deterioration is defined as the time from the date of randomization to the date of event defined at least 5-point worsening from baseline with no later improvement above this threshold during the course of treatment or until death due to any cause, in the FACT-B TOI score.
    Time Frame
    Up to approximately 32 months after first dose
    Title
    Serum concentrations of ociperlimab
    Description
    Summary statistics of serum ociperlimab concentrations by time point
    Time Frame
    Cycle (C) 1 Day (D) 1, C1D2, C1D4, C1D8, C1D15, D1 of C2, C3, C4 and C5, C5D8, D1 of C6, C8, C12 and C16, end of treatment and 30 day post-treatment. Each cycle is 21 days.
    Title
    Serum concentrations of tislelizumab
    Description
    Summary statistics of serum tislelizumab concentrations by time point
    Time Frame
    Cycle (C) 1 Day (D) 1, C1D2, C1D4, C1D8, C1D15, D1 of C2, C3, C4 and C5, C5D8, D1 of C6, C8, C12 and C16, end of treatment and 30 day post-treatment. Each cycle is 21 days.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Key Inclusion Criteria: Participant has histologically confirmed diagnosis of advanced (loco-regionally recurrent and not amenable to curative therapy, or metastatic (stage IV)) TNBC Participant has completed systemic treatment for Stage I-III breast cancer, if indicated, and ≥ 6 months have elapsed between the completion of systemic treatment with curative intent and disease recurrence A recently or newly obtained tumor biopsy from a metastatic site must be provided for determination of PD-L1 expression using the PD-L1 IHC 22C3 assay by a Novartis designated central laboratory, prior to study randomization. If a result of PD-L1 expression assessed by a PD-L1 IHC 22C3 pharmDx test in a local laboratory is available, this can serve as PD-L1 status confirmation. For Arms A, B and C participants must have PD-L1 positive tumors with CPS≥ 10. For Arm D, participants must have PD-L1 positive tumors with CPS ≥ 1 to < 10. Participant has measurable disease, i.e., at least one measurable lesion per RECIST 1.1 criteria (a lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation) Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Participant has life expectancy ≥ 12 weeks from the start of study treatment Key Exclusion Criteria: Participant has received prior treatment with immunotherapy in the metastatic setting, or anti-T cell immunoreceptor with Ig and ITIM domains (TIGIT) therapy in any setting History of severe hypersensitivity to any of the study drugs (i.e. monoclonal antibodies, gemcitabine, carboplatin, nab-paclitaxel, paclitaxel) or its excipients or to drugs of similar chemical classes Participant with inflammatory breast cancer at screening Participant has central nervous system (CNS) involvement which was not previously treated and/or was newly detected at screening. Previously treated CNS involvement must fulfill the following criteria to be eligible for the trial: Completed prior therapy (including radiation and/or surgery) for CNS metastases ≥ 28 days prior to the start of the study and CNS tumor is clinically stable at the time of screening, and Participant is not receiving steroids and/or enzyme inducing anti-epileptic medications for brain metastases Participant has an active autoimmune diseases or history of autoimmune diseases that may relapse Participant has not recovered from all toxicities related to prior anticancer therapies to National Cancer Institute (NCI) CTCAE version 5.0 Grade ≤1. Exception to this criterion: participants with any grade of alopecia are allowed to enter the study Other inclusion/exclusion criteria may apply
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Novartis Pharmaceuticals
    Organizational Affiliation
    Novartis Pharmaceuticals
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

    Learn more about this trial

    Phase II Study Evaluating the Efficacy and Safety of Ociperlimab in Combination With Tislelizumab and Chemotherapy as First-line Treatment for Participants With Advanced Triple Negative Breast Cancer

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