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Triple Negative Breast CancerPhase 2AdvanTIG-211NCT05809895

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

A Phase 2 study testing Ociperlimab, Tislelizumab and Paclitaxel in people with Triple Negative Breast Cancer, run by Novartis Pharmaceuticals.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Triple Negative Breast Cancer
What is being tested?
Ociperlimab, Tislelizumab and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
15 Sep 2023to 18 Jul 2029
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

About this study

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)

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.

Read the 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.

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
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OciperlimabDrug

    Also called WCD118

    900 mg intravenously (IV) every 3 weeks (Q3W)

  • TislelizumabDrug

    Also called VDT482

    200 mg intravenously (IV) Q3W

  • PaclitaxelDrug

    90 mg/m2 intravenously (IV) on Days 1, 8 and 15 every 28 days

  • Nab-paclitaxelDrug

    100 mg/m2 intravenously (IV) on Days 1, 8 and 15 every 28 days

  • CarboplatinDrug

    AUC 2 intravenously (IV) on Days 1 and 8 every 21 days

  • PlaceboDrug

    normal saline intravenously (IV) Q3W

  • PembrolizumabDrug

    Also called MK-3475

    200 mg intravenously (IV) Q3W

  • GemcitabineDrug

    1000 mg/m2 intravenously (IV) on Days 1 and 8 every 21 days

Study groups in NCT05809895
Study groupRoleWhat they receive
Arm A: ociperlimab+tislelizumab+chemotherapy (PD-L1 CPS ≥ 10)ExperimentalParticipants 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.
Receives: Drug: Ociperlimab; Drug: Tislelizumab; Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Carboplatin; Drug: Gemcitabine
Arm B: placebo + pembrolizumab + chemotherapy (PD-L1 CPS ≥ 10)Active comparatorParticipants 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.
Receives: Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Carboplatin; Drug: Placebo; Drug: Pembrolizumab; Drug: Gemcitabine
Arm C: placebo + tislelizumab + chemotherapy (PD-L1 CPS ≥ 10)Active comparatorParticipants 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.
Receives: Drug: Tislelizumab; Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Carboplatin; Drug: Placebo; Drug: Gemcitabine
Arm D: ociperlimab + tislelizumab + chemotherapy (PD-L1 CPS score ≥ 1 to < 10)OtherExploratory 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.
Receives: Drug: Ociperlimab; Drug: Tislelizumab; Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Carboplatin; Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: From randomization to date of disease progression or death, assessed up to approximately 32 months after first randomization

Secondary outcomes (15)

  1. 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.

    Measured: From randomization to death, assessed up to approximately 32 months after first randomization

  2. 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.

    Measured: Up to approximately 32 months after first randomization

  3. 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

    Measured: Approximately 32 months after first randomization

  4. 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

    Measured: From randomization to first documented response, assessed up to approximately 32 months after first randomization

  5. 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.

    Measured: From first documented response to disease progression or death, assessed up to approximately 32 months after first randomization

  6. 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.

    Measured: From randomization to date of disease progression or death, assessed up to approximately 32 months after first randomization

  7. Number of participants with dose modifications

    Number of participants with dose interruption and reductions for each drug component as a measure of tolerability

    Measured: Approximately 32 months after first dose

  8. 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

    Measured: Baseline

  9. 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

    Measured: Baseline

  10. 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

    Measured: From Cycle 1 to Cycle 16, end of treatment and 30 day safety follow-up. Each cycle is 21 days

  11. 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

    Measured: From Cycle 1 to Cycle 16, end of treatment and 30 day safety follow-up. Each cycle is 21 days

  12. 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.

    Measured: Up to approximately 32 months after first dose

  13. 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.

    Measured: Up to approximately 32 months after first dose

  14. Serum concentrations of ociperlimab

    Summary statistics of serum ociperlimab concentrations by time point

    Measured: 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.

  15. Serum concentrations of tislelizumab

    Summary statistics of serum tislelizumab concentrations by time point

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2023
  2. Study start15 Sep 2023 (estimated)
  3. Primary completion17 Jul 2029 (estimated)
  4. Study completion18 Jul 2029 (estimated)

Why it stopped: Business decision, not driven by safety concerns; no new safety signals have been observed in the ociperlimab program.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05809895
Sponsor's protocol ID
CWCD118B12201
Other IDs
2022-503099-99-00
Acronym
AdvanTIG-211
Status last verified
Jul 2023
First submitted
30 Mar 2023
Last updated
24 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ociperlimab, Tislelizumab and Paclitaxel in people with Triple Negative Breast Cancer, run by Novartis Pharmaceuticals.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) based on investigator assessment using RECIST 1.1 criteria 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05809895.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.

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