- |||||||||| linrodostat (BMS-986205) / BMS, Ono Pharma, Opdivo (nivolumab) / BMS
Enrollment closed, Trial completion date, Trial primary completion date: Nivolumab and BMS986205 in Treating Patients With Stage II-IV Squamous Cell Cancer of the Head and Neck (clinicaltrials.gov) - Feb 4, 2025 P2, N=45, Active, not recruiting, FRACTION-GC represents a novel adaptive protocol for testing multiple combination immunotherapies. Terminated --> Active, not recruiting | Trial completion date: Jun 2024 --> Dec 2025 | Trial primary completion date: Jun 2024 --> Dec 2025
- |||||||||| linrodostat (BMS-986205) / BMS, Ono Pharma, Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
P1/2 data, Journal, PD(L)-1 Biomarker, IO biomarker, Metastases: Phase 1/2 Study of the Indoleamine 2,3-Dioxygenase 1 Inhibitor Linrodostat Mesylate Combined With Nivolumab or Nivolumab and Ipilimumab in Advanced Solid Tumors or Hematologic Malignancies. (Pubmed Central) - Dec 13, 2024 Terminated --> Active, not recruiting | Trial completion date: Jun 2024 --> Dec 2025 | Trial primary completion date: Jun 2024 --> Dec 2025 Linrodostat + nivolumab
- |||||||||| linrodostat (BMS-986205) / BMS, Ono Pharma, Opdivo (nivolumab) / BMS
Trial completion date, Trial primary completion date, Checkpoint inhibition: Nivolumab, BMS-986205, and Radiation Therapy With or Without Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma (clinicaltrials.gov) - Aug 15, 2024 P1, N=18, Active, not recruiting, Trial primary completion date: Apr 2024 --> Nov 2026 Trial completion date: Jun 2025 --> Jun 2027 | Trial primary completion date: Feb 2024 --> Feb 2025
- |||||||||| linrodostat (BMS-986205) / BMS, Ono Pharma, Opdivo (nivolumab) / BMS
Trial completion date, Trial termination, Trial primary completion date: Nivolumab and BMS986205 in Treating Patients With Stage II-IV Squamous Cell Cancer of the Head and Neck (clinicaltrials.gov) - Jul 28, 2024 P2, N=45, Terminated, Trial completion date: Jun 2025 --> Jun 2027 | Trial primary completion date: Feb 2024 --> Feb 2025 Trial completion date: Dec 2025 --> Jun 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2025 --> Jun 2024
- |||||||||| Journal: Camptothesome-based combination nanotherapeutic regimen for improved colorectal cancer immunochemotherapy. (Pubmed Central) - Mar 1, 2024
irAEs can be predicted by concentrations of several circulating cytokines prior to treatment. To mitigate the Camptothesome-induced IDO1 negative feedback mechanism, we had co-encapsulated, indoximod (IND, IDO1 inhibitor) into Camptothesome using doxorubicin-derived IND (DOX-IND)...This optimum DOX-IND/Camptothesome outperformed the combination of Camptothesome, Doxil and IND or other IDO1 inhibitors (BMS-986205 or epacadostat) in treating mice bearing late-stage MC38 tumors, and combination with immune checkpoint blockade (ICB) enabled it to eradicate 60
- |||||||||| linrodostat (BMS-986205) / BMS, Ono Pharma, Opdivo (nivolumab) / BMS
Trial primary completion date: ENERGIZE: A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer (clinicaltrials.gov) - Jan 29, 2024 P3, N=861, Active, not recruiting, To mitigate the Camptothesome-induced IDO1 negative feedback mechanism, we had co-encapsulated, indoximod (IND, IDO1 inhibitor) into Camptothesome using doxorubicin-derived IND (DOX-IND)...This optimum DOX-IND/Camptothesome outperformed the combination of Camptothesome, Doxil and IND or other IDO1 inhibitors (BMS-986205 or epacadostat) in treating mice bearing late-stage MC38 tumors, and combination with immune checkpoint blockade (ICB) enabled it to eradicate 60 Trial primary completion date: Nov 2023 --> Apr 2025
- |||||||||| linrodostat (BMS-986205) / BMS, Ono Pharma, Opdivo (nivolumab) / BMS
Enrollment change, Trial primary completion date, Checkpoint inhibition: Nivolumab, BMS-986205, and Radiation Therapy With or Without Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma (clinicaltrials.gov) - Jul 27, 2023 P1, N=18, Active, not recruiting, Active, not recruiting --> Terminated; Funding source decision to terminate study. N=30 --> 18 | Trial primary completion date: Feb 2022 --> Feb 2024
- |||||||||| linrodostat (BMS-986205) / BMS, Ono Pharma
Journal: Development of tandem-column liquid chromatographic methods for pharmaceutical compounds using simulations based on hydrophobic subtraction model parameters. (Pubmed Central) - Apr 11, 2023 In this study, HSM solute parameters were experimentally determined for a small molecule pharmaceutical (Linrodostat) and ten of its related impurities using multiple linear regression of their retentions on 16 selected RPLC columns against in-house determined HSM column parameters...The proposed workflow can be used to prioritize a small number of column combinations by computational means before any experiments are conducted. This is highly attractive from the point of view of time and resource savings considering over 200,000 different tandem column pairings are possible using columns for which there are data in the HSM database.
- |||||||||| linrodostat (BMS-986205) / BMS, Ono Pharma, Opdivo (nivolumab) / BMS
Enrollment closed, Trial completion date, Checkpoint inhibition: Nivolumab, BMS-986205, and Radiation Therapy With or Without Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma (clinicaltrials.gov) - Mar 22, 2023 P1, N=30, Active, not recruiting, This is highly attractive from the point of view of time and resource savings considering over 200,000 different tandem column pairings are possible using columns for which there are data in the HSM database. Recruiting --> Active, not recruiting | Trial completion date: Jun 2023 --> Jun 2025
- |||||||||| linrodostat (BMS-986205) / BMS, Ono Pharma, Opdivo (nivolumab) / BMS
Enrollment closed: ENERGIZE: A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer (clinicaltrials.gov) - Jan 26, 2023 P3, N=861, Active, not recruiting, Recruiting --> Active, not recruiting | Trial completion date: Jul 2024 --> Nov 2026 | Trial primary completion date: Jan 2023 --> Apr 2024 Recruiting --> Active, not recruiting
- |||||||||| linrodostat (BMS-986205) / BMS, Ono Pharma, Opdivo (nivolumab) / BMS
Enrollment closed, IO biomarker: Nivolumab and BMS986205 in Treating Patients With Stage II-IV Squamous Cell Cancer of the Head and Neck (clinicaltrials.gov) - Nov 17, 2022 P2, N=45, Active, not recruiting, Ultimately, YH29407 overcame the limitations of the competing drugs and displayed potential as an immunotherapy strategy in combination with aPD-1. Recruiting --> Active, not recruiting
- |||||||||| linrodostat (BMS-986205) / BMS, Ono Pharma
Journal: GSH-Responsive Metal-Organic Framework for Intratumoral Release of NO and IDO Inhibitor to Enhance Antitumor Immunotherapy. (Pubmed Central) - Apr 19, 2022 Here, a nanodrug (BMS-SNAP-MOF) is prepared using glutathione (GSH)-sensitive metal-organic framework (MOF) to encapsulate an immunosuppressive enzyme indoleamine 2,3-dioxygenase (IDO) inhibitor BMS-986205, and the nitric oxide (NO) donor s-nitrosothiol groups...Consequently, the IDO inhibitor and NO synergistically modulate the immunosuppressive tumor microenvironment with increase CD8 T cells and reduce Treg cells to result in highly effective immunotherapy. In an animal study, treatment using this theranostic nanodrug achieves obvious regressions of both primary and distant 4T1 tumors, highlighting its application potential in advanced tumor immunotherapy.
- |||||||||| Biomarker, Enrollment closed, Trial completion date, Trial primary completion date: ADVISE: An Adaptive Study to Match Patients With Solid Tumors to Various Immunotherapy Combinations Based Upon a Broad Biomarker Assessment (clinicaltrials.gov) - Apr 13, 2022
P1, N=50, Active, not recruiting, In an animal study, treatment using this theranostic nanodrug achieves obvious regressions of both primary and distant 4T1 tumors, highlighting its application potential in advanced tumor immunotherapy. Recruiting --> Active, not recruiting | Trial completion date: Apr 2022 --> Apr 2024 | Trial primary completion date: Mar 2022 --> Apr 2024
- |||||||||| linrodostat (BMS-986205) / BMS, Ono Pharma, Opdivo (nivolumab) / Ono Pharma, BMS, epacadostat (INCB024360) / Incyte
IDO: Going beyond enzyme activity to eradicate glioblastoma (Room 208-210, Convention Center) - Feb 21, 2022 - Abstract #AACR2022AACR_1420; P1 epacadostat, BMS-986205, etc.) both demonstrate therapeutic activity in young mouse models of cancer [Zhai⋯Wainwright, 2015; Clinical Cancer Research, 21(24):5427-33]...This preclinical investigation led to the opening of a phase I clinical trial at our medical center that’s combining stereotactic radiation (RT), nivolumab (anti-PD-1 mAb), and BMS-986205 (IDO enzyme inhibitor) treatment in newly-diagnosed human patients with wild-type IDH (wtIDH) GBM [NCT04047706]...Since older adults comprise the largest population of patients with cancer, and because the relationship between subject age and increased IDO levels has never been studied, this result is in-line with potentially contributing to the explanation of why IDO enzyme inhibition has failed to improve the overall survival of human GBM patients to-date. In addition to providing insights from these previous observations, this presentation will highlight our group’s current objectives to: (i) develop IDO-PROTACs that aim to therapeutically degrade IDO protein rather than only inhibiting IDO enzyme activity, (ii) define how IDO suppresses the anti-cancer immune response independent of its normal association with tryptophan metabolism, (iii) discuss targeting IDO as a maladaptive aging factor, and (iv) discuss the ongoing clinical trial results of GBM patients treated with RT, anti-PD-1 mAb, and IDO enzyme inhibitor at our medical center.
- |||||||||| Biomarker, Trial primary completion date: ADVISE: An Adaptive Study to Match Patients With Solid Tumors to Various Immunotherapy Combinations Based Upon a Broad Biomarker Assessment (clinicaltrials.gov) - Feb 7, 2022
P1, N=50, Recruiting, In addition to providing insights from these previous observations, this presentation will highlight our group’s current objectives to: (i) develop IDO-PROTACs that aim to therapeutically degrade IDO protein rather than only inhibiting IDO enzyme activity, (ii) define how IDO suppresses the anti-cancer immune response independent of its normal association with tryptophan metabolism, (iii) discuss targeting IDO as a maladaptive aging factor, and (iv) discuss the ongoing clinical trial results of GBM patients treated with RT, anti-PD-1 mAb, and IDO enzyme inhibitor at our medical center. Trial primary completion date: Mar 2021 --> Mar 2022
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
Treatment Implications for Complete Pathologic Responders to Neoadjuvant Immunotherapy (JW Marriott Phoenix Desert Ridge Resort and Spa - Grand Canyon 6-8) - Feb 6, 2022 - Abstract #MHNCS2022MHNCS_140; P2 While this is a small case series, it highlights the potential for neoadjuvant strategies to modify adjuvant treatment algorithms. Longitudinal tracking and collating this unique patient group will help us guide our patients as they make treatment decisions.
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