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nisevokitug (NIS793)
i
Other names: XOMA089, NIS 793, NIS793, XOMA-089, NIS-793, XOMA 089
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Company:
Novartis, Xoma
Drug class:
TGF-β1 inhibitor
Related drugs:
4ms
ADORE: Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients (clinicaltrials.gov)
P1/2, N=45, Terminated, Novartis Pharmaceuticals | Completed --> Terminated; Sponsor Decision
Trial termination
|
Jakafi (ruxolitinib) • sabatolimab (MBG453) • rineterkib (LTT462) • siremadlin (HDM201) • Adakveo (crizanlizumab-tmca) • nisevokitug (NIS793)
7ms
ADORE: an open platform study of ruxolitinib in combination with other novel therapies in patients with myelofibrosis. (PubMed, Blood Adv)
Forty-four patients were enrolled in Part 1 of the study of ruxolitinib in combination with siremadlin, rineterkib, sabatolimab, crizanlizumab, or NIS793. Overall, available data from ADORE suggest the feasibility and benefits of combining novel agents with ruxolitinib in patients with suboptimal response to ruxolitinib alone. This trial was registered at www.clinicaltrials.gov as #NCT04097821.
Journal
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GDF15 (Growth differentiation factor 15)
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Jakafi (ruxolitinib) • sabatolimab (MBG453) • rineterkib (LTT462) • siremadlin (HDM201) • Adakveo (crizanlizumab-tmca) • nisevokitug (NIS793)
8ms
daNIS-3: Study of NIS793 and Other Novel Investigational Combinations With SOC Anti-cancer Therapy for the 2L Treatment of mCRC (clinicaltrials.gov)
P2, N=204, Terminated, Novartis Pharmaceuticals | Completed --> Terminated; The study was terminated early due to the halt of NIS793 treatment and urgent safety measures issued in July and August 2023, respectively, as continued evaluation of Standard of Care alone will not support the trial's purpose.
Trial termination
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Avastin (bevacizumab) • 5-fluorouracil • Tevimbra (tislelizumab-jsgr) • oxaliplatin • irinotecan • leucovorin calcium • nisevokitug (NIS793)
10ms
daNIS-3: Study of NIS793 and Other Novel Investigational Combinations With SOC Anti-cancer Therapy for the 2L Treatment of mCRC (clinicaltrials.gov)
P2, N=204, Completed, Novartis Pharmaceuticals | Active, not recruiting --> Completed
Trial completion
|
Avastin (bevacizumab) • 5-fluorouracil • Tevimbra (tislelizumab-jsgr) • oxaliplatin • irinotecan • leucovorin calcium • nisevokitug (NIS793)
1year
ADORE: Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients (clinicaltrials.gov)
P1/2, N=45, Completed, Novartis Pharmaceuticals | Active, not recruiting --> Completed
Trial completion
|
Jakafi (ruxolitinib) • sabatolimab (MBG453) • rineterkib (LTT462) • siremadlin (HDM201) • Adakveo (crizanlizumab-tmca) • nisevokitug (NIS793)
1year
Study of Efficacy and Safety of NIS793 in Combination With Standard of Care (SOC) Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2 (clinicaltrials.gov)
P3, N=511, Completed, Novartis Pharmaceuticals | Active, not recruiting --> Completed
Trial completion • Combination therapy • Metastases
|
gemcitabine • albumin-bound paclitaxel • nisevokitug (NIS793)
over1year
FOLFIRINOX + NIS793 in Pancreatic Cancer (clinicaltrials.gov)
P1, N=4, Terminated, Colin D. Weekes, M.D., PhD | N=50 --> 4 | Trial completion date: May 2025 --> Jul 2023 | Recruiting --> Terminated | Trial primary completion date: Dec 2024 --> Jul 2023; NIS793 is no longer being developed
Enrollment change • Trial completion date • Trial termination • Trial primary completion date
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5-fluorouracil • capecitabine • oxaliplatin • irinotecan • leucovorin calcium • nisevokitug (NIS793)
over1year
daNIS-3: Study of NIS793 and Other Novel Investigational Combinations With SOC Anti-cancer Therapy for the 2L Treatment of mCRC (clinicaltrials.gov)
P2, N=204, Active, not recruiting, Novartis Pharmaceuticals | Trial primary completion date: May 2024 --> Sep 2024
Trial primary completion date • Metastases
|
Avastin (bevacizumab) • 5-fluorouracil • Tevimbra (tislelizumab-jsgr) • oxaliplatin • irinotecan • leucovorin calcium • nisevokitug (NIS793)
over1year
Phase Ib Study of Select Drug Combinations in Patients With Lower Risk MDS (clinicaltrials.gov)
P1, N=33, Terminated, Novartis Pharmaceuticals | Active, not recruiting --> Terminated; Business reasons
Trial termination
|
sabatolimab (MBG453) • Ilaris (canakinumab) • nisevokitug (NIS793)
over1year
daNIS-1: Study of Efficacy and Safety of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) (clinicaltrials.gov)
P2, N=164, Terminated, Novartis Pharmaceuticals | Active, not recruiting --> Terminated; The study was early terminated following the NIS793 treatment halt and urgent safety measure issued in July 2023, as the continued evaluation of Standard of Care alone will not support the original purpose of this phase 2 clinical trial.
Trial termination • Combination therapy • Metastases
|
gemcitabine • albumin-bound paclitaxel • spartalizumab (PDR001) • nisevokitug (NIS793)
over1year
daNIS-3: Study of NIS793 and Other Novel Investigational Combinations With SOC Anti-cancer Therapy for the 2L Treatment of mCRC (clinicaltrials.gov)
P2, N=204, Active, not recruiting, Novartis Pharmaceuticals | Trial primary completion date: Sep 2024 --> May 2024
Trial primary completion date • Metastases
|
Avastin (bevacizumab) • 5-fluorouracil • Tevimbra (tislelizumab-jsgr) • oxaliplatin • irinotecan • leucovorin calcium • nisevokitug (NIS793)
over1year
daNIS-3: Study of NIS793 and Other Novel Investigational Combinations With SOC Anti-cancer Therapy for the 2L Treatment of mCRC (clinicaltrials.gov)
P2, N=205, Active, not recruiting, Novartis Pharmaceuticals | Trial primary completion date: May 2024 --> Sep 2024
Trial primary completion date • Metastases
|
Avastin (bevacizumab) • 5-fluorouracil • Tevimbra (tislelizumab-jsgr) • oxaliplatin • irinotecan • leucovorin calcium • nisevokitug (NIS793)
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