Spartalizumab Safety for Cancer

Not currently recruiting at 57 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Novartis Pharmaceuticals

Must be taking: Spartalizumab

Disqualifiers: Discontinued spartalizumab, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 5 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the safety and tolerability of spartalizumab, a cancer treatment. The goal is to ensure patient safety and allow those already benefiting to continue treatment. It targets individuals currently participating in a Novartis-sponsored study who are experiencing positive results with spartalizumab. Those currently using spartalizumab and finding it effective in managing cancer may find this trial suitable. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to benefit from this innovative therapy.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It seems focused on participants already receiving spartalizumab, so it's best to ask the study team for details.

Is there any evidence suggesting that spartalizumab is likely to be safe for humans?

Research has shown that spartalizumab, when combined with sabatolimab, is generally safe and well-tolerated in patients with advanced cancers. One study demonstrated early signs of tumor reduction with this combination treatment. Patients did not experience unexpected or severe side effects beyond those typical for cancer treatments.

However, spartalizumab remains in the early stages of testing, so researchers continue to closely study its safety. While initial results are reassuring, further research is necessary to fully understand its safety for all patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Spartalizumab is unique because it targets the PD-1 pathway, a mechanism that helps cancer cells evade the immune system. Unlike traditional chemotherapy, which attacks rapidly dividing cells indiscriminately, spartalizumab specifically enhances the body's immune response to recognize and destroy cancer cells. Researchers are excited about this treatment because it offers the potential for more precise targeting of cancer cells, reducing harm to healthy cells and potentially leading to fewer side effects compared to existing therapies.

What evidence suggests that spartalizumab might be an effective treatment for cancer?

Research has shown that spartalizumab, when combined with other treatments, has potential in fighting certain cancers. In one study, some patients with colorectal cancer and non-small cell lung cancer (NSCLC) experienced tumor shrinkage. These improvements lasted between 12 and 27 months, suggesting the treatment might have lasting effects. While the full potential of spartalizumab is still under investigation, these early results offer hope for its effectiveness against advanced solid tumors. Participants in this trial will receive spartalizumab to further evaluate its safety and efficacy. ^{1 2 3 4 6}

Who Is on the Research Team?

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for patients already participating in a Novartis-sponsored study, receiving spartalizumab alone or with other treatments for solid tumors. They must be benefiting from the treatment as judged by their doctor and meet all other ongoing study requirements.

Inclusion Criteria

I am currently in a Novartis study and receiving spartalizumab.

I am benefiting from the current treatment, as confirmed by my doctor.

I am currently in a Novartis study and receiving spartalizumab alone or with other treatments.

Exclusion Criteria

I was taken off spartalizumab for reasons other than joining another study.

Subject does not meet the criteria specified in the parent protocol criteria for continued study treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants continue to receive spartalizumab as a single agent or in combination with other study treatments

5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Spartalizumab

Trial Overview The trial continues to evaluate the safety and tolerability of spartalizumab, an investigational drug, given either alone or alongside other treatments to those who have been taking it and are seeing positive results.

How Is the Trial Designed?

Group I: PDR001 Experimental Treatment 1 Intervention

All subjects in all combination will be entered in one arm

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Published Research Related to This Trial

In a phase 1/2 study involving 58 patients with advanced solid tumors, spartalizumab was found to be well tolerated with no dose-limiting toxicities, indicating a favorable safety profile for this PD-1 blocking antibody.

Although spartalizumab showed limited clinical activity with a response rate of only 3.4% in this heavily pretreated population, there was evidence of immune activation, as indicated by increased CD8+ lymphocyte infiltration in tumor biopsies from patients who experienced clinical benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A first-in-human phase 1 dose escalation study of spartalizumab (PDR001), an anti-PD-1 antibody, in patients with advanced solid tumors. Naing, A., Gainor, JF., Gelderblom, H., et al.[2023]

In a phase I study involving 18 patients with advanced cancers, spartalizumab was found to be safe at doses up to 10 mg/kg every two weeks, with no dose-limiting toxicities reported.

The study showed preliminary antitumor activity, with partial responses observed in 11% of patients, indicating potential effectiveness in treating certain types of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I study of the antiprogrammed cell death-1 Ab spartalizumab (PDR001) in Japanese patients with advanced malignancies. Minami, H., Doi, T., Toyoda, M., et al.[2021]

In a phase I/II study involving 219 patients with advanced solid tumors, the combination of sabatolimab and spartalizumab was well tolerated, with fatigue being the most common treatment-related side effect.

While no responses were observed with sabatolimab alone, the combination treatment showed preliminary antitumor activity, with 5 patients achieving partial responses in various cancers, suggesting potential efficacy in specific populations.

NCBI (Pubmed)

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. Curigliano, G., Gelderblom, H., Mach, N., et al.[2023]

Sabatolimab, a humanized monoclonal antibody targeting TIM-3, enhances T-cell killing and boosts inflammatory cytokine production by dendritic cells, indicating its potential to improve immune responses against cancer.

The antibody also facilitates the phagocytosis of TIM-3-expressing target cells and blocks TIM-3 interactions with its ligands, suggesting it has both direct anti-leukemic effects and immune-modulating properties, making it a promising candidate for treating myeloid cell neoplasms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of sabatolimab, a novel immunotherapy with immuno-myeloid activity directed against TIM-3 receptor. Schwartz, S., Patel, N., Longmire, T., et al.[2023]

Sabatolimab, a humanized anti-TIM-3 monoclonal antibody, is being developed for treating myeloproliferative disorders like acute myeloid leukemia, showcasing its potential as a novel immunotherapy.

This therapy works through multiple mechanisms, including blocking TIM-3 and its ligands, modulating leukemic cell self-renewal, and promoting antibody-dependent phagocytosis of TIM-3-expressing leukemic cells, which may enhance the overall antitumor immune response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TIM-3: a tumor-associated antigen beyond checkpoint inhibition? Barth, S., Naran, K.[2023]

In a phase 2 trial involving 127 patients with higher-risk myelodysplastic syndromes, the addition of sabatolimab to hypomethylating agents did not significantly improve complete response rates or progression-free survival compared to placebo.

Despite the lack of significant efficacy, sabatolimab was generally well-tolerated, with manageable safety profiles, although there was one treatment-related death due to pneumonitis.

NCBI (Pubmed)

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. Zeidan, AM., Ando, K., Rauzy, O., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37994196/

Phase Ib study of sabatolimab (MBG453), a novel ... These results support the ongoing evaluation of sabatolimab-based combination therapy in MDS, CMML, and acute myeloid leukemia. © 2023 Wiley Periodicals LLC.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33883177/

Phase I/Ib Clinical Trial of Sabatolimab, an Anti-TIM ... - PubMed This phase I/II study evaluated the safety and efficacy of sabatolimab, with or without spartalizumab, in patients with advanced solid tumors.

3. aacrjournals.org aacrjournals.org/clincancerres/article/doi/10.1158/1078-0432.CCR-20-4746/672142/am/Phase-I-Ib-clinical-trial-of-Sabatolimab-an-Anti

Phase I/Ib clinical trial of Sabatolimab, an Anti-TIM-3 Antibody ... Five patients receiving combination treatment had partial responses (6%; lasting 12-27 months), in colorectal cancer (n=2), non-small cell lung cancer (NSCLC), ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02608268

NCT02608268 | Phase I-Ib/II Study of MBG453 as Single ... The purpose of this first-in-human study of MBG453 was to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity ...

5. aacrjournals.org aacrjournals.org/clincancerres/article/27/13/3620/671520/Phase-I-Ib-Clinical-Trial-of-Sabatolimab-an-Anti

Phase I/Ib Clinical Trial of Sabatolimab, an Anti–TIM-3 ... This phase I/II study evaluated the safety and efficacy of sabatolimab, with or without spartalizumab, in patients with advanced solid tumors.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11367382/

Sabatolimab in combination with spartalizumab in patients ... In a phase 1 dose-escalation study, sabatolimab plus spartalizumab was safe and well tolerated, with preliminary antitumour activity in advanced ...