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14 Trials |
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14 Trials |  |
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- ||| New P1 trial: Study of Select Combinations in Adults With Myelofibrosis (clinicaltrials.gov) - Feb 25, 2020
P1, N=195, Not yet recruiting, Sponsor: Novartis Pharmaceuticals
- || sabatolimab (MBG453) / Novartis
Trial completion date, Trial initiation date, Trial primary completion date, Combination therapy: STIMULUS-AML-1: A Study of MBG453 in Combination With Azacitidine and Venetoclax in AML Patients Unfit for Chemotherapy (clinicaltrials.gov) - Feb 23, 2020
P2, N=86, Not yet recruiting, Sponsor: Novartis Pharmaceuticals
Trial completion date: Mar 2025 --> Dec 2025 | Initiation date: Jan 2020 --> May 2020 | Trial primary completion date: Jan 2022 --> Sep 2022
- || Jakafi (ruxolitinib) / Novartis, Incyte
Trial completion date, Trial primary completion date: ADORE: Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients (clinicaltrials.gov) - Feb 12, 2020
P1/2, N=130, Recruiting, Sponsor: Novartis Pharmaceuticals
Trial completion date: Mar 2025 --> Dec 2025 | Initiation date: Jan 2020 --> May 2020 | Trial primary completion date: Jan 2022 --> Sep 2022 Trial completion date: Mar 2024 --> Sep 2024 | Trial primary completion date: Jul 2022 --> Mar 2023
- |||||||||| sabatolimab (MBG453) / Novartis
New P3 trial, Combination therapy: STIMULUS-MDS2: Study of Efficacy and Safety of MBG453 in Combination With Azacitidine in Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2) (clinicaltrials.gov) - Feb 11, 2020
P3, N=500, Not yet recruiting, Sponsor: Novartis Pharmaceuticals
- || sabatolimab (MBG453) / Novartis, spartalizumab (PDR001) / Novartis
Trial completion date, Trial primary completion date, Combination therapy, PD(L)-1 Biomarker, IO biomarker, Metastases: Phase I-Ib/II Study of MBG453 as Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies (clinicaltrials.gov) - Feb 10, 2020
P1/2, N=269, Recruiting, Sponsor: Novartis Pharmaceuticals
Trial completion date: Mar 2024 --> Sep 2024 | Trial primary completion date: Jul 2022 --> Mar 2023 Trial completion date: Nov 2019 --> Oct 2021 | Trial primary completion date: Nov 2019 --> Oct 2021
- ||||| MBG453 / Novartis
Clinical: Combining MBG453 with hypomethylating agents was “extremely well tolerated,” with no high-grade immune-related toxicities. @beatalleukemia discusses the safety and preliminary efficacy data at #ASH19 https://t.co/C2Ewa9fLYZ (Twitter) - Dec 10, 2019
- |||||| MBG453 / Novartis, azacitidine / Generic Mfg.
Clinical, P2 data: Dr Uma Borate @beatalleukemia from Uni of Oregon @uoregon delivered a fantastic presentation of combining anti-#TIM3 #MBG453 with decitabine among myeloid malignancy patients. We have the randomized phase 2 study of this agent with azacitidine in higher risk #MDS at @YaleCancer (Twitter) - Dec 9, 2019
- |||||| MBG453 / Novartis
Monotherapy: @beatalleukemia @OHSUKnight nicely summarized ongoing #MBG453 TIM3 inhibitor + decitabine in #MDS/#AML #ASH19 - here we have some single agent data (little monotherapy activity) - but TIM3 expression predicted response, combination ORR 24-56%, immune AEs uncommon. @LuskinMarlise (Twitter) - Dec 9, 2019
- |||| sabatolimab (MBG453) / Novartis
New P2 trial, Combination therapy: STIMULUS-AML-1: A Study of MBG453 in Combination With Azacitidine and Venetoclax in AML Patients Unfit for Chemotherapy (clinicaltrials.gov) - Nov 15, 2019
P2, N=80, Not yet recruiting, Sponsor: Novartis Pharmaceuticals
- MBG453 / Novartis, azacitidine / Generic mfg., decitabine / Generic mfg.
A Randomized, Double-Blind, Placebo-Controlled, Phase II Study of MBG453 Added to Hypomethylating Agents (HMAs) in Patients (pts) with Intermediate, High, or Very High Risk Myelodysplastic Syndrome (MDS): Stimulus-MDS1 (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_6002;
P2
All pts who discontinue study treatment will be followed for efficacy (if they have not progressed/relapsed) and survival status until approximately 108 PFS events have been observed or for up to 4 yr after the last pt is randomized. This study is ongoing and will enroll pts in several countries, including the United States.
- MBG453 / Novartis, decitabine / Generic mfg.
Phase Ib Study of the Anti-TIM-3 Antibody MBG453 in Combination with Decitabine in Patients with High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) (W311EFGH, Level 3 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_4776;
P1b
In this ongoing study in patients with HR-MDS and AML, the combination of MBG453 and decitabine was safe and well tolerated, and exhibited evidence of anti-leukemic activity with encouraging preliminary response rates occurring at a median of 2 cycles, with durability in both HR-MDS and AML. These findings validate TIM-3 as a promising therapeutic target in MDS and AML and support further clinical development of MBG453 in combination with HMAs in patients with MDS and AML.
- Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
Rheumatic Immune-Related Adverse Events Associated with Treatment with Immune Checkpoint Inhibitors: A Multicenter Study of 38 Cases (Hall B5) - Oct 7, 2019 - Abstract #ACRARHP2019ACR_3103;
Our results were in line with previous studies showing that MSK-irAEs associated with ICI may present as a flare of a previous known rheumatic disease or as a de novo symptom. Most patients presented with asymmetric mono or oligoarthritis and responded to GC and NSAID with only a few requiring DMARD or ICI withdrawal
- | Jakafi (ruxolitinib) / Novartis, Incyte
Enrollment open: ADORE: Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients (clinicaltrials.gov) - Sep 25, 2019
P1/2, N=130, Recruiting, Sponsor: Novartis Pharmaceuticals
Most patients presented with asymmetric mono or oligoarthritis and responded to GC and NSAID with only a few requiring DMARD or ICI withdrawal Not yet recruiting --> Recruiting
- | Jakafi (ruxolitinib) / Novartis, Incyte
New P1/2 trial: ADORE: Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients (clinicaltrials.gov) - Sep 19, 2019
P1/2, N=130, Not yet recruiting, Sponsor: Novartis Pharmaceuticals
- | sabatolimab (MBG453) / Novartis, spartalizumab (PDR001) / Novartis
Trial initiation date, Combination therapy: Trial of Anti-Tim-3 in Combination With Anti-PD-1 and SRS in Recurrent GBM (clinicaltrials.gov) - Sep 16, 2019
P1, N=15, Not yet recruiting, Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Not yet recruiting --> Recruiting Initiation date: Aug 2019 --> Nov 2019
- MBG453 / Novartis, spartalizumab (PDR001) / Novartis
Phase (Ph) II study of MBG453 + spartalizumab in patients (pts) with non-small cell lung cancer (NSCLC) and melanoma pretreated with anti–PD-1/L1 therapy (Poster Area (Hall 4)) - Sep 11, 2019 - Abstract #ESMO2019ESMO_2739;
P1/2
MBG453 (800 mg, Q4W) + spartalizumab (400 mg, Q4W) was well tolerated but with limited efficacy in pts with melanoma and NSCLC who had PD on/after prior anti–PD-1/L1 therapy. Further evaluation of MBG453 in other indications/combinations is needed to assess the clinical relevance of TIM-3 inhibition.
- | sabatolimab (MBG453) / Novartis, spartalizumab (PDR001) / Novartis
Trial completion date, Trial primary completion date, Combination therapy, PD(L)-1 Biomarker, IO biomarker, Metastases: Phase I-Ib/II Study of MBG453 as Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies (clinicaltrials.gov) - Jul 26, 2019
P1/2, N=250, Recruiting, Sponsor: Novartis Pharmaceuticals
Further evaluation of MBG453 in other indications/combinations is needed to assess the clinical relevance of TIM-3 inhibition. Trial completion date: Mar 2019 --> Nov 2019 | Trial primary completion date: Mar 2019 --> Nov 2019
- | sabatolimab (MBG453) / Novartis, spartalizumab (PDR001) / Novartis
Enrollment change, Trial completion date, Combination therapy: Study of PDR001 and/or MBG453 in Combination With Decitabine in Patients With AML or High Risk MDS (clinicaltrials.gov) - Jul 16, 2019
P1b, N=235, Recruiting, Sponsor: Novartis Pharmaceuticals
Trial completion date: Mar 2019 --> Nov 2019 | Trial primary completion date: Mar 2019 --> Nov 2019 N=175 --> 235 | Trial completion date: Apr 2020 --> Apr 2021
- | sabatolimab (MBG453) / Novartis, siremadlin (HDM201) / Novartis
Enrollment open, Combination therapy: HDM201 in Combination With MBG453 or Venetoclax in Patients With Acute Myeloid Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - Jul 14, 2019
P1, N=80, Recruiting, Sponsor: Novartis Pharmaceuticals
N=175 --> 235 | Trial completion date: Apr 2020 --> Apr 2021 Not yet recruiting --> Recruiting
- || sabatolimab (MBG453) / Novartis, spartalizumab (PDR001) / Novartis
New P1 trial, Combination therapy: Trial of Anti-Tim-3 in Combination With Anti-PD-1 and SRS in Recurrent GBM (clinicaltrials.gov) - May 22, 2019
P1, N=15, Not yet recruiting, Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- ||| sabatolimab (MBG453) / Novartis
Enrollment open, Combination therapy: STIMULUS-MDS1: A Study of MBG453 in Combination With Hypomethylating Agents in Subjects With IPSS-R Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS). (clinicaltrials.gov) - May 14, 2019
P2, N=120, Recruiting, Sponsor: Novartis Pharmaceuticals
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- |||| sabatolimab (MBG453) / Novartis
New P2 trial, Combination therapy: STIMULUS-MDS1: A Study of MBG453 in Combination With Hypomethylating Agents in Subjects With IPSS-R Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS). (clinicaltrials.gov) - May 12, 2019
P2, N=120, Not yet recruiting, Sponsor: Novartis Pharmaceuticals
- ||| sabatolimab (MBG453) / Novartis, siremadlin (HDM201) / Novartis
New P1 trial, Combination therapy: HDM201 in Combination With MBG453 or Venetoclax in Patients With Acute Myeloid Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - May 6, 2019
P1, N=80, Not yet recruiting, Sponsor: Novartis Pharmaceuticals
- | sabatolimab (MBG453) / Novartis, spartalizumab (PDR001) / Novartis
Trial primary completion date, Combination therapy, PD(L)-1 Biomarker, IO biomarker, Metastases: Phase I-Ib/II Study of MBG453 as Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies (clinicaltrials.gov) - Aug 6, 2018
P1/2, N=250, Recruiting, Sponsor: Novartis Pharmaceuticals
Not yet recruiting --> Recruiting Trial primary completion date: Oct 2018 --> Mar 2019
- || sabatolimab (MBG453) / Novartis, spartalizumab (PDR001) / Novartis
Enrollment change, Trial completion date, Trial primary completion date, Combination therapy: Study of PDR001 and/or MBG453 in Combination With Decitabine in Patients With AML or High Risk MDS (clinicaltrials.gov) - Jun 20, 2018
P1b, N=175, Recruiting, Sponsor: Novartis Pharmaceuticals
Trial primary completion date: Oct 2018 --> Mar 2019 N=70 --> 175 | Trial completion date: Aug 2019 --> Apr 2020 | Trial primary completion date: Aug 2019 --> Apr 2020
- || sabatolimab (MBG453) / Novartis, spartalizumab (PDR001) / Novartis
Trial completion date, Trial primary completion date, Combination therapy: Study of PDR001 and/or MBG453 in Combination With Decitabine in Patients With AML or High Risk MDS (clinicaltrials.gov) - Mar 3, 2018
P1b, N=70, Recruiting, Sponsor: Novartis Pharmaceuticals
N=70 --> 175 | Trial completion date: Aug 2019 --> Apr 2020 | Trial primary completion date: Aug 2019 --> Apr 2020 Trial completion date: Jun 2019 --> Aug 2019 | Trial primary completion date: Jun 2019 --> Aug 2019
- ||| sabatolimab (MBG453) / Novartis, spartalizumab (PDR001) / Novartis
Trial completion date, Trial initiation date, Combination therapy, PD(L)-1 Biomarker, IO biomarker, Metastases: Phase I-Ib/II Study of MBG453 as Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies (clinicaltrials.gov) - Mar 3, 2018
P1/2, N=250, Recruiting, Sponsor: Novartis Pharmaceuticals
Trial completion date: Jun 2019 --> Aug 2019 | Trial primary completion date: Jun 2019 --> Aug 2019 Trial completion date: Oct 2019 --> Jan 2019 | Initiation date: Nov 2015 --> Sep 2015
- ||||| sabatolimab (MBG453) / Novartis, spartalizumab (PDR001) / Novartis
New P1/2 trial, Combination therapy, PD(L)-1 Biomarker, IO biomarker, Metastases: Phase I-Ib/II Study of MBG453 as Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies (clinicaltrials.gov) - Dec 29, 2017
P1/2, N=250, Not yet recruiting, Sponsor: Novartis Pharmaceuticals
- ||| sabatolimab (MBG453) / Novartis, spartalizumab (PDR001) / Novartis
Enrollment open, Combination therapy: Study of PDR001 and/or MBG453 in Combination With Decitabine in Patients With AML or High Risk MDS (clinicaltrials.gov) - Jul 2, 2017
P1b, N=70, Recruiting, Sponsor: Novartis Pharmaceuticals
Trial completion date: Oct 2019 --> Jan 2019 | Initiation date: Nov 2015 --> Sep 2015 Not yet recruiting --> Recruiting
- ||| sabatolimab (MBG453) / Novartis, spartalizumab (PDR001) / Novartis
New P1 trial, Combination therapy: Study of PDR001 and/or MBG453 in Combination With Decitabine in Patients With AML or High Risk MDS (clinicaltrials.gov) - Feb 27, 2017
P1b, N=70, Not yet recruiting, Sponsor: Novartis Pharmaceuticals
- || sabatolimab (MBG453) / Novartis, spartalizumab (PDR001) / Novartis
Combination therapy, PD(L)-1 Biomarker, IO biomarker, Metastases: Phase I-Ib/II Study of MBG453 as Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies (clinicaltrials.gov) - Jan 11, 2017
P1/2, N=250, Recruiting, Sponsor: Novartis Pharmaceuticals
Not yet recruiting --> Recruiting Trial primary completion date: Oct 2016 --> Oct 2018
- || sabatolimab (MBG453) / Novartis, spartalizumab (PDR001) / Novartis
Combination therapy, PD(L)-1 Biomarker, IO biomarker, Metastases: Phase I-Ib/II Study of MBG453 as Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies (clinicaltrials.gov) - Oct 14, 2016
P1/2, N=250, Recruiting, Sponsor: Novartis Pharmaceuticals
Trial primary completion date: Oct 2016 --> Oct 2018 Trial primary completion date: Jun 2018 --> Oct 2016
- |||| sabatolimab (MBG453) / Novartis, spartalizumab (PDR001) / Novartis
Enrollment open, Combination therapy, PD(L)-1 Biomarker, IO biomarker, Metastases: Phase I-Ib/II Study of MBG453 as Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies (clinicaltrials.gov) - Dec 18, 2015
P1/2, N=250, Recruiting, Sponsor: Novartis Pharmaceuticals
Trial primary completion date: Jun 2018 --> Oct 2016 Not yet recruiting --> Recruiting | Trial primary completion date: Nov 2018 --> Jun 2018 | Not yet recruiting --> Recruiting