Continued Sabatolimab Treatment for Cancer

Recruiting in Palo Alto (17 mi)

+30 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Novartis Pharmaceuticals

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This study is intended to collect safety data from participants who completed the parent protocols but are still benefiting from study treatment. The study population consists of participants who tolerate study treatment of the parent studies. Collecting safety information from long-term exposure might offer the unique opportunity to detect rare Adverse Events.

Do I have to stop taking my current medications for this trial?

The protocol does not specify whether you need to stop taking your current medications. However, since this trial is for participants already on sabatolimab, it seems likely that you can continue your current medications unless otherwise advised by the study team.

What data supports the idea that Continued Sabatolimab Treatment for Cancer is an effective treatment?

The available research shows that Sabatolimab, when used with other treatments, has shown promise in treating certain types of cancer. For example, in a study involving patients with higher-risk myelodysplastic syndromes, Sabatolimab combined with another drug improved outcomes compared to a placebo. This suggests that Sabatolimab can be effective in enhancing the body's immune response to fight cancer. Additionally, it has been tested in combination with another antibody in patients with advanced solid tumors, indicating its potential in treating various cancer types. ^{1 2 3 4 5}

What safety data is available for sabatolimab treatment?

Sabatolimab has been evaluated in several clinical trials for its safety and efficacy. A Phase I/Ib trial assessed sabatolimab alone and in combination with spartalizumab in patients with advanced solid tumors, focusing on safety and efficacy. Additionally, a Phase 2 trial (STIMULUS-MDS1) investigated the safety of sabatolimab combined with hypomethylating agents in patients with higher-risk myelodysplastic syndromes. These studies provide initial safety data for sabatolimab in different cancer types. ^{1 2 3 4 6}

Is the drug Sabatolimab a promising treatment for cancer?

Yes, Sabatolimab is a promising drug for cancer treatment. It is an immunotherapy that targets the TIM-3 receptor, which is involved in regulating immune responses. By blocking this receptor, Sabatolimab can enhance the body's ability to fight cancer. It has shown potential in treating advanced solid tumors and blood-related cancers like acute myeloid leukemia and myelodysplastic syndromes. This drug works by boosting the immune system's attack on cancer cells, making it a valuable addition to cancer therapies. ^{1 2 3 4 7}

Eligibility Criteria

This trial is for patients with Chronic Myelomonocytic Leukemia or Myelodysplastic Syndrome who have completed a prior Novartis-sponsored study and are still benefiting from Sabatolimab. They must be compliant with the previous study's protocol, not pregnant, willing to follow contraception guidelines, and without unresolved toxicities from Sabatolimab.

Inclusion Criteria

I am currently in a Novartis study for sabatolimab and meet all its requirements.

Participant is currently benefiting from the treatment with sabatolimab as determined by guidelines of the parent protocol and investigator's judgment

Written informed consent obtained prior to enrolling in the roll-over study

Exclusion Criteria

I was taken off sabatolimab in a previous study due to side effects or other reasons.

I am unwilling or unable to follow the study's birth control requirements.

I had side effects from sabatolimab that stopped my treatment, but they're resolved now.

Treatment Details

Interventions

• Sabatolimab (Monoclonal Antibodies)
• Spartalizumab (Monoclonal Antibodies)

Trial Overview The trial continues treatment with drugs like decitabine, Spartalizumab, Sabatolimab, Azacitidine, Venetoclax, and oral decitabine (INQOVI) for those previously responding well. It aims to collect long-term safety data on these treatments to identify any rare adverse events.

Participant Groups

Group I: sabatolimab + venetoclax + azacitidine Experimental Treatment 3 Interventions

Patients will take sabatolimab 200 mg i.v./q2w and venetoclax 400 mg p.o. d1-14/q4wk and azacitidine 75 mg/m2/d d1-7/q4w.

Group II: sabatolimab + spartalizumab + decitabine Experimental Treatment 3 Interventions

Patients will take sabatolimab 400 mg i.v./q2w and decitabine 20 mg/m2/d d1-5 i.v. and spartalizumab 100 mg i.v/q2w.

Group III: sabatolimab + decitabine Experimental Treatment 2 Interventions

Patients will take Sabatolimab 400 mg i.v/q2w and decitabine 20 mg/m2/d d1-5 i.v.

Group IV: sabatolimab + azacitidine Experimental Treatment 2 Interventions

Patients will take sabatolimab 800 mg i.v and azacitidine 75 mg/m2/d d1-7 s.c. or i.v./q4w or sabatolimab 400 mg i.v/q2w and azacitidine 75 mg/m2/d d1-7 s.c. or i.v./q4w.

Group V: sabatolimab + HMA Experimental Treatment 2 Interventions

Patients will take sabatolimab 800 mg and azacitidine 75 mg/m2/d d1-7 or decitabine 20 mg/m2/d d1-5/ all q4w HMA means hypomethylating agents. Hypomethylating agents are azacitidine and decitabine.

Group VI: sabatolimab Experimental Treatment 1 Intervention

Patients will take sabatolimab 800 mg i.v q4w.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Mayo Clinic Jacksonville . Jacksonville, FL

Huntsman Cancer Institute Univ of Utah . Salt Lake City, UT

Mayo Clinic Jacksonville Jacksonville, FL

Massachusetts General Hospital Boston, MA

More Trial Locations

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Phase I/Ib Clinical Trial of Sabatolimab, an Anti-TIM-3 Antibody, Alone and in Combination with Spartalizumab, an Anti-PD-1 Antibody, in Advanced Solid Tumors. [2023] Sabatolimab (MBG453) and spartalizumab are mAbs that bind T-cell immunoglobulin domain and mucin domain-3 (TIM-3) and programmed death-1 (PD-1), respectively. This phase I/II study evaluated the safety and efficacy of sabatolimab, with or without spartalizumab, in patients with advanced solid tumors.

2. England pubmed.ncbi.nlm.nih.gov

Characterization of sabatolimab, a novel immunotherapy with immuno-myeloid activity directed against TIM-3 receptor. [2023] Sabatolimab is a humanized monoclonal antibody (hIgG4, S228P) directed against human T-cell immunoglobulin domain and mucin domain-3 (TIM-3). Herein, we describe the development and characterization of sabatolimab.

3. England pubmed.ncbi.nlm.nih.gov

TIM-3: a tumor-associated antigen beyond checkpoint inhibition? [2023] Immune checkpoint inhibitors are one of the most remarkable immunomodulatory therapies of current times. Sabatolimab is a high-affinity, humanized anti-TIM-3 monoclonal antibody currently in development for patients with myeloproliferative disorders, including acute myeloid leukemia and myelodysplastic syndromes. By targeting TIM-3, a receptor expressed on various immune effector cells as well as myeloid cells, multiple mechanisms of action that are distinct from canonical immune checkpoint inhibitors are in play - (i) blockade of TIM-3 and its ligands PtdSer/galectin-9, (ii) modulation of leukemic cell self-renewal as well as (iii) antibody-dependent phagocytosis of TIM-3-expressing leukemic cells. Novel immunotherapies such as sabatolimab which enhance the antitumor immune response on converging fronts represent the promise of a continuously replenished armoury for the treatment of cancer.

4. England pubmed.ncbi.nlm.nih.gov

Sabatolimab plus hypomethylating agents in previously untreated patients with higher-risk myelodysplastic syndromes (STIMULUS-MDS1): a randomised, double-blind, placebo-controlled, phase 2 trial. [2023] Sabatolimab is an immunotherapy targeting T-cell immunoglobulin domain and mucin domain-3 (TIM-3), an immuno-myeloid regulator expressed on immune cells and leukaemic stem cells. In this trial, we compared the efficacy and safety of sabatolimab plus hypomethylating agent with placebo plus hypomethylating agents in previously untreated patients with higher-risk myelodysplastic syndromes.

5. England pubmed.ncbi.nlm.nih.gov

STIMULUS-MDS2 design and rationale: a phase III trial with the anti-TIM-3 sabatolimab (MBG453) + azacitidine in higher risk MDS and CMML-2. [2023] Patients with higher-risk myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML) unfit for hematopoietic stem cell transplantation have poor outcomes. Novel therapies that provide durable benefit with favorable tolerability and clinically meaningful improvement in survival are needed. T-cell immunoglobulin domain and mucin domain-3 (TIM-3) is an immuno-myeloid regulator expressed on immune and leukemic stem cells in myeloid malignancies. Sabatolimab is a novel immunotherapy targeting TIM-3 with a potential dual mechanism of reactivating the immune system and directly targeting TIM-3+ leukemic blasts suppressing the growth of cancer cells. Here, we describe the aims and design of the phase III STIMULUS-MDS2 trial, which aims to demonstrate the potential for sabatolimab plus azacitidine to improve survival for patients with higher-risk MDS and CMML-2 (NCT04266301). Clinical Trial Registration: NCT04266301 (ClinicalTrials.gov).

6. England pubmed.ncbi.nlm.nih.gov

First-in-human phase 1 study of the anti-TIGIT antibody vibostolimab as monotherapy or with pembrolizumab for advanced solid tumors, including non-small-cell lung cancer☆. [2022] In this first-in-human phase 1 study (NCT02964013; MK-7684-001), we investigated the safety and efficacy of the anti-TIGIT (T cell immunoglobulin and ITIM domain) antibody vibostolimab as monotherapy or in combination with pembrolizumab.

7. United States pubmed.ncbi.nlm.nih.gov

Trial Watch: Immunostimulatory monoclonal antibodies in cancer therapy. [2021] Immunostimulatory monoclonal antibodies (mAbs) exert antineoplastic effects by eliciting a novel or reinstating a pre-existing antitumor immune response. Most often, immunostimulatory mAbs activate T lymphocytes or natural killer (NK) cells by inhibiting immunosuppressive receptors, such as cytotoxic T lymphocyte-associated protein 4 (CTLA4) or programmed cell death 1 (PDCD1, best known as PD-1), or by engaging co-stimulatory receptors, like CD40, tumor necrosis factor receptor superfamily, member 4 (TNFRSF4, best known as OX40) or TNFRSF18 (best known as GITR). The CTLA4-targeting mAb ipilimumab has been approved by the US Food and Drug Administration for use in patients with unresectable or metastatic melanoma in 2011. The therapeutic profile of ipilimumab other CTLA4-blocking mAbs, such as tremelimumab, is currently being assessed in subjects affected by a large panel of solid neoplasms. In the last few years, promising clinical results have also been obtained with nivolumab, a PD-1-targeting mAb formerly known as BMS-936558. Accordingly, the safety and efficacy of nivolumab and other PD-1-blocking molecules are being actively investigated. Finally, various clinical trials are underway to test the therapeutic potential of OX40- and GITR-activating mAbs. Here, we summarize recent findings on the therapeutic profile of immunostimulatory mAbs and discuss clinical trials that have been launched in the last 14 months to assess the therapeutic profile of these immunotherapeutic agents.