- |||||||||| P1 data, Journal, Checkpoint inhibition: Safety of combined ablative radiotherapy and immune checkpoint inhibitors in three phase I trials. (Pubmed Central) - Aug 24, 2024
This analysis features the largest prospectively evaluated cohort of patients treated with combination ablative SBRT and ICI to date and provides context for future trial design. We conclude that multi-site SBRT and ICI can be safely co-administered when SBRT is delivered with prioritization of normal tissue constraints.
- |||||||||| cabiralizumab (BMS-986227) / Ono Pharma, BMS, sotigalimab (APX005M) / Pyxis Oncology, Opdivo (nivolumab) / Ono Pharma, BMS
Journal, PD(L)-1 Biomarker, IO biomarker: A bedside to bench study of anti-PD-1, anti-CD40, and anti-CSF1R indicates that more is not necessarily better. (Pubmed Central) - Nov 19, 2023 P1 While it is impossible to directly infer human doses from murine studies, careful intra-species evaluation can provide important insight. Cabiralizumab dose optimization is necessary for this patient population with limited treatment options.
- |||||||||| Review, Journal: Updates on the Treatment of Tenosynovial Giant Cell Tumor. (Pubmed Central) - Jun 30, 2023
Pexidartinib is the first CSF-1 receptor inhibitor approved for the treatment of TGCT. Here, we discuss various available treatment strategies and ongoing investigations and trials targeting diffuse TGCT, which include nilotinib, lacnotuzumab, cabiralizumab, vimseltinib, and emactuzumab.
- |||||||||| cabiralizumab (BMS-986227) / Ono Pharma, BMS, Opdivo (nivolumab) / BMS
Trial completion date, Trial primary completion date: Nivolumab + Cabiralizumab + Gemcitabine in Patients With Stage IV Pancreatic Cancer Achieving Disease Control in Response to First-line Chemotherapy (GemCaN Trial). (clinicaltrials.gov) - Apr 28, 2023 P2, N=40, Suspended, Here, we discuss various available treatment strategies and ongoing investigations and trials targeting diffuse TGCT, which include nilotinib, lacnotuzumab, cabiralizumab, vimseltinib, and emactuzumab. Trial completion date: Dec 2021 --> Dec 2023 | Trial primary completion date: Dec 2021 --> Dec 2023
- |||||||||| Opdivo (nivolumab) / BMS
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: Neoadjuvant Nivolumab and Chemotherapy in Patients With Localized Triple-negative Breast Cancer (clinicaltrials.gov) - Mar 23, 2023 P1/2, N=15, Active, not recruiting, Trial completion date: Dec 2021 --> Dec 2023 | Trial primary completion date: Dec 2021 --> Dec 2023 Recruiting --> Active, not recruiting | N=31 --> 15 | Trial completion date: Jun 2027 --> May 2026 | Trial primary completion date: Apr 2024 --> Mar 2023
- |||||||||| cabiralizumab (BMS-986227) / Ono Pharma, BMS, sotigalimab (APX005M) / Apexigen, Opdivo (nivolumab) / Ono Pharma, BMS
A bedside to bench study of anti-PD-1, anti-CD40, and anti-CSF1R indicates that more is not necessarily better (Section 40; Poster Board #28) - Mar 14, 2023 - Abstract #AACR2023AACR_4683; Our study suggests that more anti-CSF1R might not be better. Further optimization of cabiralizumab dosing is necessary to evaluate the clinical potential in combination with anti-PD-1 and anti-CD40 in a difficult-to treat patient population whose therapeutic options are limited.
- |||||||||| cabiralizumab (BMS-986227) / Ono Pharma, BMS, Opdivo (nivolumab) / BMS, urelumab (BMS-663513) / BMS, Ono Pharma
Trial completion: C4-MOSART: Stereotactic Body Radiotherapy (SBRT) Plus Immunotherapy for Cancer (clinicaltrials.gov) - Feb 16, 2023 P1, N=60, Completed, Further optimization of cabiralizumab dosing is necessary to evaluate the clinical potential in combination with anti-PD-1 and anti-CD40 in a difficult-to treat patient population whose therapeutic options are limited. Active, not recruiting --> Completed
- |||||||||| cabiralizumab (BMS-986227) / Ono Pharma, BMS, Opdivo (nivolumab) / Ono Pharma, BMS, Turalio (pexidartinib) / Daiichi Sankyo
Journal, Checkpoint inhibition: Cancer therapy with immune checkpoint inhibitor and CSF-1 blockade: A mathematical model. (Pubmed Central) - Nov 9, 2022 The model can be used to assess treatments of combination therapy of anti-PD-1 with anti-CSF-1. Examples are given in comparing the efficacy among different strategies for anti-CSF-1 dosing in a setup of clinical trials.
- |||||||||| BMS-986253 / BMS, Opdivo (nivolumab) / BMS
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: Nivolumab Combined With BMS-986253 in HCC Patients (clinicaltrials.gov) - Sep 30, 2022 P2, N=23, Active, not recruiting, 2 of 6 patients in the nivolumab arm experienced grade 3 severe toxicity, including 1 patient who developed sepsis and 1 who developed peripheral neuropathy. Recruiting --> Active, not recruiting | N=74 --> 23 | Trial completion date: Aug 2024 --> Dec 2025 | Trial primary completion date: Aug 2022 --> Dec 2024
- |||||||||| sotigalimab (PYX-107) / Pyxis Oncology
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, IO biomarker: APX005M With Nivolumab and Cabiralizumab in Advanced Melanoma, Non-small Cell Lung Cancer or Renal Cell Carcinoma (clinicaltrials.gov) - Jul 26, 2022 P1, N=42, Active, not recruiting, We observed no significant association between AEs and survival in our cohort, possibly due to heterogeneity in histologies and IO agents. Recruiting --> Active, not recruiting | N=120 --> 42 | Trial completion date: Oct 2024 --> Oct 2027 | Trial primary completion date: May 2022 --> Nov 2022
- |||||||||| 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, Recruiting --> Active, not recruiting | N=120 --> 42 | Trial completion date: Oct 2024 --> Oct 2027 | Trial primary completion date: May 2022 --> Nov 2022 Recruiting --> Active, not recruiting | Trial completion date: Apr 2022 --> Apr 2024 | Trial primary completion date: Mar 2022 --> Apr 2024
- |||||||||| Opdivo (nivolumab) / BMS
Trial completion date, Trial primary completion date: Neoadjuvant Nivolumab and Chemotherapy in Patients With Localized Triple-negative Breast Cancer (clinicaltrials.gov) - Apr 11, 2022 P1/2, N=50, Recruiting, Recruiting --> Active, not recruiting | Trial completion date: Apr 2022 --> Apr 2024 | Trial primary completion date: Mar 2022 --> Apr 2024 Trial completion date: Feb 2024 --> Jun 2029 | Trial primary completion date: Dec 2022 --> Apr 2024
- |||||||||| cabiralizumab (BMS-986227) / Ono Pharma, BMS, Opdivo (nivolumab) / BMS, urelumab (BMS-663513) / BMS, Ono Pharma
Trial completion date: C4-MOSART: Stereotactic Body Radiotherapy (SBRT) Plus Immunotherapy for Cancer (clinicaltrials.gov) - Mar 15, 2022 P1, N=60, Active, not recruiting, SBRT to {less than or equal to}4 sites with nivolumab+urelumab or nivolumab+cabiralizumab for treating advanced solid tumors is feasible with acceptable toxicity and modest anti-tumor activity. Trial completion date: Feb 2022 --> Jul 2022
- |||||||||| BMS-986253 / BMS, cabiralizumab (BMS-986227) / Ono Pharma, BMS
ROLE OF PORTAL BLOOD CSF1R/IL-8 SIGNALING IN PANCREATIC CANCER CIRCULATING TUMOR CELL SURVIVAL ([VIRTUAL]) - Dec 17, 2021 - Abstract #APCM2021APCM_11; Without myeloid cell attraction and differentiation, clusters don’t form, leaving CTC unaided by M-FB, and myeloid cells differentiating away from immunosuppressive, pro-tumor phenotypes. Such treatments could lead to enhanced anti-tumor myeloid cell responses and suppression of CTC survival.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
Journal: Stereotactic Body Radiation Therapy and Immunotherapy in Abdominal and Pelvic Lymph Node Metastases. (Pubmed Central) - Oct 29, 2021 In this pooled analysis of three prospective trials, SBRT to abdominal or pelvic lymph node metastases with immunotherapy is associated with acceptable toxicity and high rates of LC, even with target undercoverage to meet OAR constraints. This suggests a potential for this approach in clinical practice and study in future trials.
- |||||||||| cabiralizumab (BMS-986227) / Ono Pharma, BMS
Trial completion, Trial completion date, PD(L)-1 Biomarker: FPA008-003: Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers (clinicaltrials.gov) - Aug 9, 2020 P1a/1b, N=295, Completed, SBRT with nivo+ure or nivo+cab is associated with acceptable toxicity and early anti-tumor activity for patients with advanced solid tumors that have progressed on standard therapy. Active, not recruiting --> Completed | Trial completion date: Mar 2020 --> Nov 2019
- |||||||||| BMS-986253 / BMS, Opdivo (nivolumab) / BMS
Enrollment open, Trial completion date, Trial primary completion date: Nivolumab Combined With BMS-986253 in HCC Patients (clinicaltrials.gov) - Aug 7, 2020 P2, N=74, Recruiting, Active, not recruiting --> Completed | Trial completion date: Apr 2020 --> Dec 2019 | Trial primary completion date: Apr 2020 --> Dec 2019 Not yet recruiting --> Recruiting | Trial completion date: Aug 2020 --> Aug 2024 | Trial primary completion date: Aug 2020 --> Aug 2022
- |||||||||| Opdivo (nivolumab) / BMS
Trial completion date, Trial initiation date, Trial primary completion date: Neoadjuvant Nivolumab and Chemotherapy in Patients With Localized Triple-negative Breast Cancer (clinicaltrials.gov) - Aug 7, 2020 P1/2, N=50, Not yet recruiting, Not yet recruiting --> Recruiting | Trial completion date: Aug 2020 --> Aug 2024 | Trial primary completion date: Aug 2020 --> Aug 2022 Trial completion date: Sep 2023 --> Jan 2024 | Initiation date: Jun 2020 --> Oct 2020 | Trial primary completion date: Jul 2022 --> Nov 2022
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