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14 Trials |
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14 Trials |  |
139 News |  |
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- | Jakafi (ruxolitinib) / Incyte
Journal: ADORE: an open platform study of ruxolitinib in combination with other novel therapies in patients with myelofibrosis. (Pubmed Central) - Sep 12, 2025
P1/2
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.
- | sabatolimab (MBG453) / Novartis, spartalizumab (PDR001) / Novartis
Trial completion date: Trial of Anti-Tim-3 in Combination With Anti-PD-1 and SRS in Recurrent GBM (clinicaltrials.gov) - Sep 10, 2025
P1, N=16, Active, not recruiting, Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
This trial was registered at www.clinicaltrials.gov as #NCT04097821. Trial completion date: Sep 2025 --> Sep 2026
- | sabatolimab (MBG453) / Novartis
Journal: Elevated TIM3 expression on bone marrow T cells drives immune dysfunction in early relapsed blood cancer after allogeneic hematopoietic stem cell transplantation. (Pubmed Central) - Aug 15, 2025
Functional assays demonstrated that TIM3 blockade with sabatolimab restored T cell cytotoxicity, leading to enhanced leukemia cell apoptosis in ER patients. These findings highlight TIM3 as a critical regulator of T cell exhaustion and immune suppression in patients with ER and provide a rationale for the therapeutic use of TIM3 blockade in preventing and treating relapses after allo-HSCT.
- || Review, Journal, PD(L)-1 Biomarker, IO biomarker: Beyond Hypomethylating Agents: Novel Therapies and Targeted Approaches. (Pubmed Central) - Aug 11, 2025
In contrast, exploratory agents such as pevonedistat, magrolimab, and sabatolimab are under further investigation for HR-MDS...Identification of predictive biomarkers for response to targeted therapies and immunotherapies is crucial to optimize patient outcomes. An integrated, patient-centered approach combining genomics, novel therapeutics, and immunomodulation is therefore essential to address the current needs in MDS management.
- ||| Jakafi (ruxolitinib) / Incyte
Trial termination: ADORE: Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients (clinicaltrials.gov) - Aug 7, 2025
P1/2, N=45, Terminated, Sponsor: Novartis Pharmaceuticals
An integrated, patient-centered approach combining genomics, novel therapeutics, and immunomodulation is therefore essential to address the current needs in MDS management. Completed --> Terminated; Sponsor Decision
- ||| sabatolimab (MBG453) / Novartis
Trial termination: STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS (clinicaltrials.gov) - Jul 31, 2025
P2, N=39, Terminated, Sponsor: Novartis Pharmaceuticals
Completed --> Terminated; Sponsor Decision Completed --> Terminated; Lack of efficacy in the program as demonstrated in the earlier CMBG453B12301 (STIMULUS MDS-2) study.
- ||| sabatolimab (MBG453) / Novartis
Trial termination: STIMULUS-AML2: Sabatolimab as a Treatment for Patients With Acute Myeloid Leukemia and Presence of Measurable Residual Disease After Allogeneic Stem Cell Transplantation. (clinicaltrials.gov) - Jun 3, 2025
P1/2, N=24, Terminated, Sponsor: Novartis Pharmaceuticals
Completed --> Terminated; Study was stopped following a strategic decision from the Sponsor. It was not based on any safety findings or safety concerns with sabatolimab.
- EFFICACY AND OUTCOMES OF NOVEL THERAPEUTIC AGENTS AS MONOTHERAPY OR IN COMBINATION WITH CONVENTIONAL THERAPY IN MYELODYSPLASTIC SYNDROME: A SYSTEMATIC REVIEW AND META-ANALYSIS () - May 15, 2025 - Abstract #EHA2025EHA_4118;
This study highlights promising results with the investigational agents for MDS. However, large studies with more power are needed to strengthen our understanding of these investigational agents in MDS patients.
- sabatolimab (MBG453) / Novartis
PRIMARY RESULTS STIMULUS-AML1: A LARGE, INTERNATIONAL, PHASE II STUDY OF SABATOLIMAB COMBINED WITH AZACITIDINE AND VENETOCLAX AS FRONTLINE THERAPY FOR UNFIT ACUTE MYELOID LEUKEMIA (AML) PATIENTS (PTS) (Poster Hall) - May 15, 2025 - Abstract #EHA2025EHA_2675;
P2
NEJM 2021), STIMULUS-AML1 results did not achieve the predetermined statistical significance over AZA+VEN. The combination of SABA with AZA+VEN is feasible without evidence of increased toxicity.
- ||||| sabatolimab (MBG453) / Novartis
Trial termination: STIMULUS-AML-1: A Study of MBG453 in Combination With Azacitidine and Venetoclax in AML Patients Unfit for Chemotherapy (clinicaltrials.gov) - Apr 10, 2025
P2, N=90, Terminated, Sponsor: Novartis Pharmaceuticals
The combination of SABA with AZA+VEN is feasible without evidence of increased toxicity. Completed --> Terminated; The study was terminated because results from 2 trials in the program were negative (including the main trial) and Novartis decided to terminate the program all together.
- ||||| sabatolimab (MBG453) / Novartis
Trial termination: 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) - Apr 8, 2025
P2, N=127, Terminated, Sponsor: Novartis Pharmaceuticals
Completed --> Terminated; In December 2023, Novartis decided to terminate the sabatolimab clinical development program early after Phase II and III studies failed to meet their primary objectives. The termination was not due to safety concerns.
- || sabatolimab (MBG453) / Novartis
Trial completion: STIMULUS-MDS3: A Study of Sabatolimab in Combination With Azacitidine and Venetoclax in High or Very High Risk MDS Participants (clinicaltrials.gov) - Mar 31, 2025
P2, N=20, Completed, Sponsor: Novartis Pharmaceuticals
The termination was not due to safety concerns. Terminated --> Completed
- ||||||||| sabatolimab (MBG453) / Novartis
Trial termination: 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) - Mar 25, 2025
P3, N=530, Terminated, Sponsor: Novartis Pharmaceuticals
Completed --> Terminated; Despite positive trends identified post unblinding after Overall Survival primary analysis, the study did not show statistical significance in its primary endpoint, overall survival. No new safety findings were detected.
- ||| sabatolimab (MBG453) / Novartis
Trial completion: STIMULUS-AML-1: A Study of MBG453 in Combination With Azacitidine and Venetoclax in AML Patients Unfit for Chemotherapy (clinicaltrials.gov) - Mar 3, 2025
P2, N=90, Completed, Sponsor: Novartis Pharmaceuticals
No new safety findings were detected. Active, not recruiting --> Completed
- | sabatolimab (MBG453) / Novartis
Trial completion date, Trial primary completion date: Roll-over Study for Patients Who Have Completed a Prior Novartis-sponsored Sabatolimab (MBG453) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Sabatolimab. (clinicaltrials.gov) - Feb 27, 2025
P2, N=33, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Active, not recruiting --> Completed Trial completion date: Nov 2025 --> Feb 2028 | Trial primary completion date: Nov 2025 --> Feb 2028
- ||| sabatolimab (MBG453) / Novartis
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: Roll-over Study for Patients Who Have Completed a Prior Novartis-sponsored Sabatolimab (MBG453) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Sabatolimab. (clinicaltrials.gov) - Feb 14, 2025
P2, N=33, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Trial completion date: Nov 2025 --> Feb 2028 | Trial primary completion date: Nov 2025 --> Feb 2028 Recruiting --> Active, not recruiting | N=70 --> 33 | Trial completion date: Feb 2028 --> Nov 2025 | Trial primary completion date: Feb 2028 --> Nov 2025
- | sabatolimab (MBG453) / Novartis
Enrollment open, Trial initiation date: ALLG AMLM26 INTERCEPT (Investigating Novel Therapy to Target Early Relapse and Clonal Evolution as Pre-emptive Therapy in AML): A Multi-arm, Precision-based, Recursive, Platform Trial (clinicaltrials.gov) - Jan 3, 2025
P1/2, N=12, Recruiting, Sponsor: M.D. Anderson Cancer Center
Recruiting --> Active, not recruiting | N=70 --> 33 | Trial completion date: Feb 2028 --> Nov 2025 | Trial primary completion date: Feb 2028 --> Nov 2025 Not yet recruiting --> Recruiting | Initiation date: Apr 2025 --> Dec 2024
- sabatolimab (MBG453) / Novartis
Safety and Activity of the TIM3 Inhibitor Sabatolimab in Patients with Lower-Risk Myelodysplastic Syndromes () - Dec 7, 2024 - Abstract #ASH2024ASH_8763;
Sabatolimab produced hematological responses in this cohort, including two patients with erythroid responses and one with neutrophil recovery. This study suggests clinical activity in blocking the TIM3 axis in lower-risk MDS and supports further evaluation of this target.
- || sabatolimab (MBG453) / Novartis
Trial completion, Trial completion date, Trial primary completion date: STIMULUS-AML2: Sabatolimab as a Treatment for Patients With Acute Myeloid Leukemia and Presence of Measurable Residual Disease After Allogeneic Stem Cell Transplantation. (clinicaltrials.gov) - Nov 12, 2024
P1/2, N=24, Completed, Sponsor: Novartis Pharmaceuticals
This study suggests clinical activity in blocking the TIM3 axis in lower-risk MDS and supports further evaluation of this target. Active, not recruiting --> Completed | Trial completion date: Dec 2024 --> Aug 2024 | Trial primary completion date: Dec 2024 --> Aug 2024
- sabatolimab (MBG453) / Novartis
Clinical Features and Preliminary Investigation of PPM1D-Mutated Myeloproliferative Neoplasms (Halls G-H (San Diego Convention Center)) - Nov 6, 2024 - Abstract #ASH2024ASH_5918;
One patient who had CMML-2 with high-risk features was treated with azacitidine and sabatolimab at diagnosis...Thus, expanded clinical cohorts to further refine the relationship between PPM1D mutations and MPN disease phenotypes coupled with additional mechanistic studies of PPM1D in MPN pathogenesis are required. These findings underscore the complexity of MPNs and highlight avenues for future exploration in precision medicine for patients with PPM1D mutations.
- Talvey (talquetamab-tgvs) / J&J
Combined PD-1 and Tim-3 Blockade Improves the in Vitro Anti-Myeloma Activity of T Cells of Patients on Talquetamab (Pacific Ballroom Salons 18-19 (Marriott Marquis San Diego Marina)) - Nov 6, 2024 - Abstract #ASH2024ASH_2088;
P1, P2
Presence of CD8+ Tem cells at baseline resulted in longer PFS, whereas more CD8+ TEMRA cells predicted shorter PFS. While our in vitro model has limitations, it shows that targeting the checkpoint markers PD-1 and Tim-3 may improve potency of BiAbs.
- | sabatolimab (MBG453) / Novartis
New P1/2 trial: ALLG AMLM26 INTERCEPT (Investigating Novel Therapy to Target Early Relapse and Clonal Evolution as Pre-emptive Therapy in AML): A Multi-arm, Precision-based, Recursive, Platform Trial (clinicaltrials.gov) - Oct 30, 2024
P1/2, N=12, Not yet recruiting, Sponsor: M.D. Anderson Cancer Center
- ||||||| sabatolimab (MBG453) / Novartis
Trial completion: 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) - Oct 27, 2024
P3, N=530, Completed, Sponsor: Novartis Pharmaceuticals
While our in vitro model has limitations, it shows that targeting the checkpoint markers PD-1 and Tim-3 may improve potency of BiAbs. Active, not recruiting --> Completed
- || sabatolimab (MBG453) / Novartis
Trial completion: STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS (clinicaltrials.gov) - Oct 3, 2024
P2, N=39, Completed, Sponsor: Novartis Pharmaceuticals
Active, not recruiting --> Completed Active, not recruiting --> Completed
- || Jakafi (ruxolitinib) / Incyte
Trial completion: ADORE: Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients (clinicaltrials.gov) - Sep 23, 2024
P1/2, N=45, Completed, Sponsor: Novartis Pharmaceuticals
Active, not recruiting --> Completed Active, not recruiting --> Completed
- |||| sabatolimab (MBG453) / Novartis, siremadlin (HDM201) / Novartis
Trial termination: HDM201 in Combination With MBG453 or Venetoclax in Patients With Acute Myeloid Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - Sep 20, 2024
P1, N=52, Terminated, Sponsor: Novartis Pharmaceuticals
Active, not recruiting --> Completed Active, not recruiting --> Terminated; Business decision
- ||| sabatolimab (MBG453) / Novartis
Trial completion: 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) - Sep 4, 2024
P2, N=127, Completed, Sponsor: Novartis Pharmaceuticals
Active, not recruiting --> Terminated; Business decision Active, not recruiting --> Completed
- || sabatolimab (MBG453) / Novartis, spartalizumab (PDR001) / Novartis
P2 data, Journal, Combination therapy, PD(L)-1 Biomarker, IO biomarker: Sabatolimab in combination with spartalizumab in patients with non-small cell lung cancer or melanoma who received prior treatment with anti-PD-1/PD-L1 therapy: a phase 2 multicentre study. (Pubmed Central) - Sep 1, 2024
P1/2
Limited antitumour activity was observed. The tolerability of sabatolimab administration supports the potential to explore treatment with sabatolimab in various combination regimens and across a spectrum of tumour types.
- Investigating the Therapeutic Potential of Immune Checkpoint Inhibitors in Myelodysplastic Syndromes: A Comprehensive Review and Analysis (LEVEL 3, HALL B3) - Aug 30, 2024 - Abstract #SOHO2024SOHO_580;
However, larger studies with longer follow-up are needed to fully understand the effectiveness of these regimens and identify biomarkers for response or resistance. The integration of ICIs into MDS treatment strategies has the potential to improve patient outcomes and advance personalized therapeutic approaches.
- | sabatolimab (MBG453) / Novartis, spartalizumab (PDR001) / Novartis
Phase classification: CPDR001X2105: Study of PDR001 and/or MBG453 in Combination With Decitabine in Patients With AML or High Risk MDS (clinicaltrials.gov) - Aug 28, 2024
P1, N=241, Completed, Sponsor: Novartis Pharmaceuticals
The integration of ICIs into MDS treatment strategies has the potential to improve patient outcomes and advance personalized therapeutic approaches. Phase classification: P1b --> P1
- | sabatolimab (MBG453) / Novartis
Trial completion date, Trial primary completion date: STIMULUS-AML2: Sabatolimab as a Treatment for Patients With Acute Myeloid Leukemia and Presence of Measurable Residual Disease After Allogeneic Stem Cell Transplantation. (clinicaltrials.gov) - Aug 26, 2024
P1/2, N=24, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Phase classification: P1b --> P1 Trial completion date: Aug 2024 --> Dec 2024 | Trial primary completion date: Aug 2024 --> Dec 2024
- || sabatolimab (MBG453) / Novartis
Trial primary completion date: Roll-over Study for Patients Who Have Completed a Prior Novartis-sponsored Sabatolimab (MBG453) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Sabatolimab. (clinicaltrials.gov) - Aug 26, 2024
P2, N=70, Recruiting, Sponsor: Novartis Pharmaceuticals
Trial completion date: Aug 2024 --> Dec 2024 | Trial primary completion date: Aug 2024 --> Dec 2024 Trial primary completion date: Sep 2027 --> Feb 2028
- | sabatolimab (MBG453) / Novartis
Trial completion date: STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS (clinicaltrials.gov) - Aug 21, 2024
P2, N=39, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Trial primary completion date: Sep 2027 --> Feb 2028 Trial completion date: Jun 2024 --> Oct 2024
- || sabatolimab (MBG453) / Novartis
Trial completion date, Trial primary completion date: STIMULUS-AML-1: A Study of MBG453 in Combination With Azacitidine and Venetoclax in AML Patients Unfit for Chemotherapy (clinicaltrials.gov) - Aug 19, 2024
P2, N=90, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Trial completion date: Jun 2024 --> Oct 2024 Trial completion date: Jul 2024 --> Oct 2024 | Trial primary completion date: Jul 2024 --> Oct 2024
- ||| sabatolimab (MBG453) / Novartis
Enrollment closed, Enrollment change: STIMULUS-AML2: Sabatolimab as a Treatment for Patients With Acute Myeloid Leukemia and Presence of Measurable Residual Disease After Allogeneic Stem Cell Transplantation. (clinicaltrials.gov) - Aug 1, 2024
P1/2, N=24, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Trial completion date: Jul 2024 --> Oct 2024 | Trial primary completion date: Jul 2024 --> Oct 2024 Recruiting --> Active, not recruiting | N=59 --> 24
- ||| sabatolimab (MBG453) / Novartis
Trial termination: STIMULUS-MDS3: A Study of Sabatolimab in Combination With Azacitidine and Venetoclax in High or Very High Risk MDS Participants (clinicaltrials.gov) - Jun 11, 2024
P2, N=20, Terminated, Sponsor: Novartis Pharmaceuticals
Recruiting --> Active, not recruiting | N=59 --> 24 Completed --> Terminated
- ||| sabatolimab (MBG453) / Novartis, nisevokitug (NIS793) / Novartis, Ilaris (canakinumab) / Novartis
Trial termination: Phase Ib Study of Select Drug Combinations in Patients With Lower Risk MDS (clinicaltrials.gov) - May 20, 2024
P1, N=33, Terminated, Sponsor: Novartis Pharmaceuticals
Completed --> Terminated Active, not recruiting --> Terminated; Business reasons
- ||| sabatolimab (MBG453) / Novartis
Enrollment closed, Enrollment change: STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS (clinicaltrials.gov) - May 20, 2024
P2, N=39, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Active, not recruiting --> Terminated; Business reasons Recruiting --> Active, not recruiting | N=90 --> 39
- |||| sabatolimab (MBG453) / Novartis
Enrollment open, Enrollment change, Trial completion date, Trial primary completion date: STIMULUS-AML2: Sabatolimab as a Treatment for Patients With Acute Myeloid Leukemia and Presence of Measurable Residual Disease After Allogeneic Stem Cell Transplantation. (clinicaltrials.gov) - May 3, 2024
P1/2, N=59, Recruiting, Sponsor: Novartis Pharmaceuticals
Recruiting --> Active, not recruiting | N=90 --> 39 N=27 --> 59 | Trial completion date: Apr 2027 --> Aug 2024 | Trial primary completion date: Nov 2024 --> Jul 2024 | Active, not recruiting --> Recruiting
- | sabatolimab (MBG453) / Novartis
Trial completion date: Roll-over Study for Patients Who Have Completed a Prior Novartis-sponsored Sabatolimab (MBG453) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Sabatolimab. (clinicaltrials.gov) - May 3, 2024
P2, N=70, Recruiting, Sponsor: Novartis Pharmaceuticals
N=27 --> 59 | Trial completion date: Apr 2027 --> Aug 2024 | Trial primary completion date: Nov 2024 --> Jul 2024 | Active, not recruiting --> Recruiting Trial completion date: Jun 2028 --> Feb 2028
- || sabatolimab (MBG453) / Novartis
Trial completion date, Trial primary completion date: STIMULUS-AML-1: A Study of MBG453 in Combination With Azacitidine and Venetoclax in AML Patients Unfit for Chemotherapy (clinicaltrials.gov) - May 3, 2024
P2, N=90, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Trial completion date: Jun 2028 --> Feb 2028 Trial completion date: Mar 2026 --> Jul 2024 | Trial primary completion date: Mar 2026 --> Jul 2024
- || sabatolimab (MBG453) / Novartis
Trial completion date, Trial primary completion date: STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS (clinicaltrials.gov) - Apr 23, 2024
P2, N=90, Recruiting, Sponsor: Novartis Pharmaceuticals
Trial completion date: Mar 2026 --> Jul 2024 | Trial primary completion date: Mar 2026 --> Jul 2024 Trial completion date: Mar 2025 --> Jun 2024 | Trial primary completion date: Jan 2024 --> Sep 2023
- | sabatolimab (MBG453) / Novartis
Enrollment change, Trial withdrawal: A Study of Sabatolimab and Magrolimab-based Treatment in AML or Higher Risk MDS Participants (clinicaltrials.gov) - Apr 11, 2024
P1/2, N=0, Withdrawn, Sponsor: Novartis Pharmaceuticals
Trial completion date: Mar 2025 --> Jun 2024 | Trial primary completion date: Jan 2024 --> Sep 2023 N=63 --> 0 | Not yet recruiting --> Withdrawn
- ||| sabatolimab (MBG453) / Novartis
Enrollment closed, Enrollment change: STIMULUS-AML2: Sabatolimab as a Treatment for Patients With Acute Myeloid Leukemia and Presence of Measurable Residual Disease After Allogeneic Stem Cell Transplantation. (clinicaltrials.gov) - Mar 14, 2024
P1/2, N=27, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
N=63 --> 0 | Not yet recruiting --> Withdrawn Recruiting --> Active, not recruiting | N=59 --> 27
- || sabatolimab (MBG453) / Novartis
Enrollment open, Trial completion date, Trial primary completion date: MBG453 in Lower Risk MDS (clinicaltrials.gov) - Mar 12, 2024
P2, N=20, Recruiting, Sponsor: Massachusetts General Hospital
Recruiting --> Active, not recruiting | N=59 --> 27 Not yet recruiting --> Recruiting | Trial completion date: Dec 2022 --> Jan 2026 | Trial primary completion date: Jun 2022 --> Jun 2024
- |||| sabatolimab (MBG453) / Novartis
Trial completion date, Trial primary completion date: 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) - Mar 2, 2024
P3, N=530, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Not yet recruiting --> Recruiting | Trial completion date: Dec 2022 --> Jan 2026 | Trial primary completion date: Jun 2022 --> Jun 2024 Trial completion date: Jan 2027 --> Sep 2024 | Trial primary completion date: Jan 2027 --> Sep 2024
- | Jakafi (ruxolitinib) / Incyte
Trial completion date: ADORE: Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients (clinicaltrials.gov) - Feb 15, 2024
P1/2, N=45, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Trial completion date: Jan 2027 --> Sep 2024 | Trial primary completion date: Jan 2027 --> Sep 2024 Trial completion date: Mar 2024 --> Jul 2024
- || sabatolimab (MBG453) / Novartis
P1 data, Journal, Combination therapy: Phase Ib study of sabatolimab (MBG453), a novel immunotherapy targeting TIM-3 antibody, in combination with decitabine or azacitidine in high- or very high-risk myelodysplastic syndromes. (Pubmed Central) - Jan 22, 2024
Sabatolimab + HMA had a safety profile similar to that reported for HMA alone and demonstrated durable clinical responses in patients with HR/vHR-MDS. These results support the ongoing evaluation of sabatolimab-based combination therapy in MDS, CMML, and acute myeloid leukemia.
- | sabatolimab (MBG453) / Novartis, spartalizumab (PDR001) / Novartis
Trial completion date: Trial of Anti-Tim-3 in Combination With Anti-PD-1 and SRS in Recurrent GBM (clinicaltrials.gov) - Dec 31, 2023
P1, N=16, Active, not recruiting, Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- || sabatolimab (MBG453) / Novartis
P2 data, Clinical Trial,Phase III, Journal: Sabatolimab plus hypomethylating agents in previously untreated patients with higher-risk myelodysplastic syndromes (STIMULUS-MDS1): a randomised, double-blind, placebo-controlled, phase 2 trial. (Pubmed Central) - Dec 25, 2023
P2
Sabatolimab had a manageable safety in most patients with higher-risk myelodysplastic syndromes. A randomised phase 3 trial is ongoing to assess the potential benefit of sabatolimab plus azacitidine on overall survival in this setting.