Immunopheresis Alone or In Combination With Chemotherapy Versus Chemotherapy Alone in Advanced Triple Negative Breast Cancer (TNBC)
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|ClinicalTrials.gov Identifier: NCT04004910|
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : July 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Advanced Triple Negative Breast Cancer||Other: Plasma soluble TNF receptor pulldown Other: Plasma soluble TNF receptor pulldown + chemotherapy Drug: Chemotherapy Drugs, Cancer||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||170 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A Multicenter, Open-Label, Three-Part Study|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-Label, Three-Part Study to Evaluate the Safety and Effectiveness of Immunopheresis With Immunicom's LW-02 Device in Removal of Soluble Tumor Necrosis Factor Receptors (sTNF-Rs) as Well as Clinical Efficacy in Treatment of Patients With Advanced, Refractory Triple Negative Breast Cancer (TNBC) Alone, or in Combination With Low Dose Weekly Paclitaxel Plus Carboplatin Chemotherapy Versus Low Dose Weekly Paclitaxel Plus Carboplatin Chemotherapy.|
|Actual Study Start Date :||May 31, 2019|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||July 31, 2021|
All patients will receive up to 16 weeks of initial treatment as per study arm assignment, which will include up to 48 LW-02 device-based immunopheresis treatments over a 4-month period (up to 3 procedures per week). Each patient assigned to the treatment with LW-02 device-based immunopheresis will require central vascular access for the procedure. In general, a cuffed,tunneled dual-lumen catheter will be inserted into a central vein and remain in situ throughout the treatment phase or longer if additional treatments are clinically indicated.Immunopheresis will be performed using the LW-02 device used in-line with the Terumo BCT Spectra Optia Apheresis System® (or alternate centrifugal apheresis device) with a secondary plasma processing system such as the Secondary Processing Device [SPD].
Other: Plasma soluble TNF receptor pulldown
Immunoadsorption affinity column, the LW-02 device, uses a proprietary human recombinant protein, single chain TNF-α ligand, covalently linked to a bead resin, that both enhances the capture efficiency of sTNF-Rs while avoiding complications from column leaching. Reduced sTNF-R plasma levels may lead to objective tumor responses.
In combined treatment arm the immunopheresis procedure is combined with low dose chemotherapy enhancing its cytotoxic effect.
Experimental: Immunopheresis combined with weekly chemotherapy
All patients will receive up to 16 weeks of treatment as per study arm assignment, which will include up to 48 LW-02 device-based immunopheresis treatments over a 4-month period (up to 3 procedures per week). Each patient will require central vascular access for the procedure. Immunopheresis will be performed using the LW-02 device used in-line with the Apheresis System with a secondary plasma processing system. Patients will be treated with immunopheresis combined with iv chemotherapy regimen administered iv on a weekly basis (every 7 days) in doses: 80 mg/m2 of paclitaxel and carboplatin AUC2 (Calvert formula). Patients will be administered their chemotherapy following the last LW-02 device-based immunopheresis procedure of each week. Chemotherapy infusion will follow immunopheresis, but will be initiated not earlier than 90 minutes after completion of the procedure in the absence of any immunopheresis-related side effects (i.e. hypotension).
Other: Plasma soluble TNF receptor pulldown + chemotherapy
The LW02 device comprises an immunoadsorption affinity column, employing a proprietary human recombinant protein, single chain TNF-α ligand, covalently linked to a bead resin, that both enhances the capture efficiency of sTNF-Rs while avoiding complications from column leaching. Reduced sTNF-R plasma levels may lead to objective tumor responses.
In combined treatment arm the immunopheresis procedure is combined with low dose chemotherapy to potentially enhancing its cytotoxic effect.
Active Comparator: Chemotherapy
Patients who are assigned chemotherapy arm of the study will be treated with paclitaxel+carboplatin chemotherapy alone. The chemotherapy regimen will be administered intravenously on a weekly basis (every 7 days) in doses: 80 mg/m2 of paclitaxel and carboplatin AUC2 (Calvert formula).
Drug: Chemotherapy Drugs, Cancer
IV chemotherapy with paclitaxel and carboplatin in low doses on a weekly basis.
Other Name: Paclitaxel + carboplatin in low doses
- Soluble Tumor Necrosis Factor Receptor (sTNFR) concentrations in plasma (picogram per mL) [ Time Frame: 16 weeks ]Change in sTNFR plasma concentrations (reduction in levels at 16 weeks from baseline)
- Safety and Tolerability Assessment [ Time Frame: 16 weeks ]Safety and tolerability assessment based on adverse event / serious adverse event (AE / SAE) and adverse device / serious adverse device effects (ADE / SADE) reporting using CTCAE/MedDRA coding terms
- Quality-of-life (QoL) Assessment [ Time Frame: 16 weeks ]QoL measured by EQ-5D-5L index as well as ECOG status
- Tumor burden [ Time Frame: screening (-4-0 weeks), week 8, and week 16, and then every 12 weeks (+/- 1 week) up to one-year follow-up. ]Clinical Efficacy Assessment will be based tumor measurements assessed in accordance to RECIST 1.1 criteria.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04004910
|Contact: Emel Guldogan Director of Clinical Trials, Immunicom Inc||+1 972 358 firstname.lastname@example.org|
|Contact: Amir Jafri CEO, Immunicom Inc||+1 858 353 email@example.com|
|Katedra i Klinika Onkologii UJ CM||Recruiting|
|Kraków, Małopolskie, Poland, 31-531|
|Contact: Prof. Piotr Wysocki, MD, PhD +48(12)4248912 firstname.lastname@example.org ; email@example.com|
|Contact: Alina Wadas +48 782780374|
|Principal Investigator: Prof. Piotr Wysocki, MD, PhD|
|Study Director:||Adam Ostrowski, MD Medical Director||Immunicom Inc|