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Monoclonal Antibodies

Continued Sabatolimab Treatment for Cancer

Phase 2

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant is currently enrolled in a Novartis-sponsored study with sabatolimab, is being treated with sabatolimab, and has fulfilled all requirements in the parent study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial collects safety data from people who continue to benefit from study treatment. It's a chance to detect rare side effects from long-term exposure.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects include reactions related to drug infusion such as discomfort or pain at the injection site; blood-related issues like anemia; gastrointestinal symptoms like nausea or vomiting; fatigue; and possible increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Severity of AEs and SAEs

Secondary outcome measures

Duration of exposure to sabatolimab

Trial Design

6Treatment groups

Experimental Treatment

Group I: sabatolimab + venetoclax + azacitidineExperimental Treatment3 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 + decitabineExperimental Treatment3 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 + decitabineExperimental Treatment2 Interventions

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

Group IV: sabatolimab + azacitidineExperimental Treatment2 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 + HMAExperimental Treatment2 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: sabatolimabExperimental Treatment1 Intervention

Patients will take sabatolimab 800 mg i.v q4w.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

sabatolimab

2021

Completed Phase 2

~20

azacitidine

2005

Completed Phase 3

~1740

venetoclax

2021

Completed Phase 2

~750

decitabine

2007

Completed Phase 2

~860

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,860 Previous Clinical Trials

4,198,239 Total Patients Enrolled

Media Library

Sabatolimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05201066 — Phase 2

Chronic Myelomonocytic Leukemia Research Study Groups: sabatolimab, sabatolimab + azacitidine, sabatolimab + HMA, sabatolimab + spartalizumab + decitabine, sabatolimab + decitabine, sabatolimab + venetoclax + azacitidine

Chronic Myelomonocytic Leukemia Clinical Trial 2023: Sabatolimab Highlights & Side Effects. Trial Name: NCT05201066 — Phase 2

Sabatolimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05201066 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this medical trial currently being sought?

"Affirmative. According to information published on clinicaltrials.gov, enrollment is ongoing for this research project which was first posted on February 13th 2023 and last updated April 19th 2023. Seventy participants are needed from 3 distinct medical locations."

Answered by AI

How many individuals are contributing to the data of this research project?

"Affirmative, per clinicaltrials.gov data, this clinical trial is still enrolling participants. It was first announced on February 13th 2023 and it has been updated most recently on April 19th of the same year; 3 medical centres are looking to recruit a total of 70 patients."

Answered by AI

What have the results been for individuals taking a combination of sabatolimab, venetoclax, and azacitidine?

"The safety of sabatolimab + venetoclax + azacitidine is believed to be an acceptable level, receiving a score of 2 on our team's 1-3 rating system. This assessment was drawn from the available data supporting its safety as it has yet to reach phase 3 trials and gain efficacy validation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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.

2023. "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. https://clinicaltrials.gov/ct2/show/NCT05201066.

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