- |||||||||| sabatolimab (MBG453) / Novartis, spartalizumab (PDR001) / Novartis
Trial completion date, Trial primary completion date, Combination therapy, 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) - Apr 28, 2021 P1/2, N=252, Active, not recruiting, Not yet recruiting --> Recruiting Trial completion date: Dec 2021 --> May 2021 | Trial primary completion date: Dec 2021 --> May 2021
- |||||||||| sabatolimab (MBG453) / Novartis
New P2 trial: MBG453 in Lower Risk MDS (clinicaltrials.gov) - Apr 1, 2021 P2, N=20, Not yet recruiting,
- |||||||||| Enrollment open: Study of Select Combinations in Adults With Myelofibrosis (clinicaltrials.gov) - Nov 4, 2020
P1, N=195, Recruiting, If this triple combination is assessed to be safe, part 2 (expansion) will open and enroll approximately 68 additional pts who will receive sabatolimab 800 mg Q4W in combination with Aza and venetoclax. Not yet recruiting --> Recruiting
- |||||||||| sabatolimab (MBG453) / Novartis, spartalizumab (PDR001) / Novartis
Enrollment closed, 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) - Nov 3, 2020 P1/2, N=252, Active, not recruiting, Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- |||||||||| sabatolimab (MBG453) / Novartis, spartalizumab (PDR001) / Novartis
Enrollment open, Combination therapy: Trial of Anti-Tim-3 in Combination With Anti-PD-1 and SRS in Recurrent GBM (clinicaltrials.gov) - Aug 7, 2020 P1, N=15, Recruiting, If the triplet is assessed to be safe, Part 2 (expansion; n≈68) will investigate MBG453 at 800 mg Q4W in combination with AZA+venetoclax. Active, not recruiting --> Recruiting
- |||||||||| azacitidine / Generic mfg.
[VIRTUAL] The Problem of TP53-Mutant MDS/AML () - Jul 14, 2020 - Abstract #SOHO2020SOHO_124; P1, P1b, P In TP53 mutant AML, azacitidine in combination with venetoclax did achieve an increased CR/CRi rate of 47%, although these patients had a short median duration of CR/CRi of 5.6 months and a median OS of 7.2 months, similar to survival outcome data with single agent HMA, with recent data showing TP53 as a major driver of resistance to venetoclax.12, 13 This combination is ongoing in MDS patients (NCT02942290)...Other novel HMA combinations have recently had high ORR/CR rates as frontline therapy, which include MBG453 and pevonedistat, although molecular subset data in TP53 mutant patients are unclear...The treatment landscape of these patients is encouraging, as the combination of azacitidine with APR-246 or magrolimab have been well tolerated and produced significantly improved response rates. Ideally, future translational data will further elucidate the underpinnings driving the poor outcomes for this molecular subgroup to lead to additional novel therapeutic strategies.
- |||||||||| Jakafi (ruxolitinib) / Novartis, Incyte
Trial completion date, Trial primary completion date: ADORE: Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients (clinicaltrials.gov) - Jul 7, 2020 P1/2, N=130, Recruiting, Ideally, future translational data will further elucidate the underpinnings driving the poor outcomes for this molecular subgroup to lead to additional novel therapeutic strategies. Trial completion date: Sep 2024 --> Jun 2025 | Trial primary completion date: Mar 2023 --> Jan 2024
- |||||||||| MBG453 / Novartis, azacitidine / Generic mfg., decitabine / Generic mfg.
[VIRTUAL] POST-TRANSPLANT OUTCOMES OF PATIENTS WITH MDS AND AML AFTER RECEIVING HYPOMETHYLATING AGENT THERAPY COMBINED WITH THE TIM-3 INHIBITOR, MBG453 () - May 16, 2020 - Abstract #EHA2020EHA_1444; P1b Escalating doses of MBG453 were administered i.v. every 2 weeks (Q2W; days 8, 22) or every four weeks (Q4W; day 8) in combination with decitabine (20 mg/m2; i.v. days 1–5) or azacitidine (75 mg/m2; i.v. days 1-7)...9 patients received decitabine+MBG453, one also received the anti-PD1 antibody spartalizumab...One patient with therapy-related TP53 mutated MDS harboring a complex karyotype relapsed at day +134; this patient died from sepsis during salvage chemotherapy. Conclusion Patients treated with the anti-TIM3 antibody MBG453 in combination with HMA for MDS and AML can successfully proceed to allogeneic transplant; to date there are limited toxicities related to GVHD.
- |||||||||| sabatolimab (MBG453) / Novartis, spartalizumab (PDR001) / Novartis
Enrollment closed, Combination therapy: Trial of Anti-Tim-3 in Combination With Anti-PD-1 and SRS in Recurrent GBM (clinicaltrials.gov) - Apr 2, 2020 P1, N=15, Active, not recruiting, Trial completion date: Apr 2021 --> Nov 2021 | Trial primary completion date: Apr 2020 --> Nov 2021 Recruiting --> Active, not recruiting
- |||||||||| sabatolimab (MBG453) / Novartis, spartalizumab (PDR001) / Novartis
Enrollment open, Trial completion date, Trial primary completion date, Combination therapy: Trial of Anti-Tim-3 in Combination With Anti-PD-1 and SRS in Recurrent GBM (clinicaltrials.gov) - Mar 6, 2020 P1, N=15, Recruiting, Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting | Trial completion date: Jun 2023 --> Feb 2024 | Trial primary completion date: Jun 2021 --> Feb 2022
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