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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

Must not have

Participant not willing to comply with the contraception requirements outlined in the exclusion criteria of the parent protocol

Participant has been permanently discontinued from sabatolimab treatment in the parent study due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Severity of AEs and SAEs

Secondary study objectives

Duration of exposure to sabatolimab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

venetoclax

2014

Completed Phase 2

~740

INQOVI (oral decitabine)

2022