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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.

Primary Purpose

Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic

Status

Recruiting

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

decitabine

Spartalizumab

Sabatolimab

Azacitidine

Venetoclax

INQOVI (oral decitabine)

About this trial

This is an interventional treatment trial for Myelodysplastic Syndromes focused on measuring roll-over study, MBG453, sabatolimab, azacitidine, decitabine, venetoclax, spartalizumab, HMA, INQOVI (oral decitabine)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
Participant is currently benefiting from the treatment with sabatolimab as determined by guidelines of the parent protocol and investigator's judgment.
Participant has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.
Willingness and ability to comply with scheduled visits, treatment plan and any other study procedures.
Written informed consent obtained prior to enrolling in the roll-over study.

Exclusion Criteria:

Participants in cohorts or treatment groups not receiving sabatolimab in 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.
Participant currently has unresolved toxicities for which sabatolimab dosing has been interrupted in the parent study (participants meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow sabatolimab dosing to resume).
Pregnant or nursing (lactating) women. Where pregnancy is defined as the state of a female after conception confirmed by a positive serum hCG laboratory test and until the termination of gestation.
Participant not willing to comply with the contraception requirements outlined in the exclusion criteria of the parent protocol.
Local access to commercially available sabatolimab for parent protocol indications.

Sites / Locations

Massachusetts General Hospital .Recruiting
Oregon Health and Science UniRecruiting
Novartis Investigative SiteRecruiting
Novartis Investigative SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Sabatolimab + azacitidine

sabatolimab + decitabine

sabatolimab + venetoclax + azacitidine

sabatolimab + spartalizumab + decitabine

sabatolimab + HMA

Arm Description

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

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

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

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.

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.

Outcomes

Primary Outcome Measures

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

An AE is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. An AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product. An SAE is defined as any adverse event [appearance of (or worsening of any pre-existing)] undesirable sign(s), symptom(s), or medical conditions(s) which meets any one of the following criteria: fatal, life-threatening, results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, may have caused a congenital anomaly/birth defect, requires intervention to prevent permanent impairment or damage.

Severity of AEs and SAEs

Severity of AEs and SAEs will be measured according to the CTCAE v5.0

Secondary Outcome Measures

Duration of exposure to sabatolimab

The length of time patients will be exposed to sabatolimab and will be reported by treatment groups.

Full Information

NCT ID

NCT05201066

First Posted

January 3, 2022

Last Updated

June 22, 2023

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT05201066

Brief Title

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.

Official Title

An Open-label, Multicenter, 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.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 13, 2023 (Actual)

Primary Completion Date

December 2, 2027 (Anticipated)

Study Completion Date

June 13, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

The purpose of the roll-over study is to provide access and to collect and assess safety of sabatolimab in participants who are currently receiving treatment with sabatolimab in a Novartis-sponsored study (parent study), that has fulfilled the requirements of the primary objective or was terminated for any reason. Eligible participants from those studies who were receiving sabatolimab and who, in the opinion of the investigator, would benefit from continued study treatment, may enroll in the study. The primary objective is to evaluate safety, including serious adverse events (SAE) and adverse events (AE). The secondary objective is to collect exposure to study treatment (sabatolimab and individual combination agents). his is a multicenter, open label, roll-over study to collect and assess safety of sabatolimab in participants who are treated in current Novartis-sponsored parent studies and who are benefitting from continued study treatment including sabatolimab as judged by the investigator. The treatment with sabatolimab and combination agent(s), as applicable, is continued according to the schedule in the parent study. Adverse events will be collected continuously throughout the study and participants will be questioned about adverse events at each visit. Once enrolled in the study, participants may continue study treatment with sabatolimab until occurrence of unacceptable toxicity that precludes further treatment, disease progression, withdrawal of consent, discontinuation at the discretion of the investigator, initiation of a new anticancer therapy and/or discontinuation for any other reason.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic

Keywords

roll-over study, MBG453, sabatolimab, azacitidine, decitabine, venetoclax, spartalizumab, HMA, INQOVI (oral decitabine)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Masking Description

Open Label

Allocation

Non-Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sabatolimab + azacitidine

Arm Type

Experimental

Arm Description

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

Arm Title

sabatolimab + decitabine

Arm Type

Experimental

Arm Description

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

Arm Title

sabatolimab + venetoclax + azacitidine

Arm Type

Experimental

Arm Description

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

Arm Title

sabatolimab + spartalizumab + decitabine

Arm Type

Experimental

Arm Description

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.

Arm Title

sabatolimab + HMA

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

decitabine

Intervention Description

Solution for intravenous infusion

Intervention Type

Drug

Intervention Name(s)

Spartalizumab

Other Intervention Name(s)

PDR001

Intervention Description

Solution for intravenous infusion

Intervention Type

Drug

Intervention Name(s)

Sabatolimab

Other Intervention Name(s)

MBG453

Intervention Description

Solution for intravenous infusion

Intervention Type

Drug

Intervention Name(s)

Azacitidine

Intervention Description

Solution for subcutaneous injection or intravenous infusion

Intervention Type

Drug

Intervention Name(s)

Venetoclax

Intervention Description

Tablet for oral administration

Intervention Type

Drug

Intervention Name(s)

INQOVI (oral decitabine)

Intervention Description

Tablet for oral administration. HMA = azactidine or decitabine INQOVI = decitabine (oral)

Primary Outcome Measure Information:

Title

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

Description

Time Frame

5 years

Title

Severity of AEs and SAEs

Description

Severity of AEs and SAEs will be measured according to the CTCAE v5.0

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Duration of exposure to sabatolimab

Description

The length of time patients will be exposed to sabatolimab and will be reported by treatment groups.

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Participant is currently benefiting from the treatment with sabatolimab as determined by guidelines of the parent protocol and investigator's judgment. Participant has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements. Willingness and ability to comply with scheduled visits, treatment plan and any other study procedures. Written informed consent obtained prior to enrolling in the roll-over study. Exclusion Criteria: Participants in cohorts or treatment groups not receiving sabatolimab in 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. Participant currently has unresolved toxicities for which sabatolimab dosing has been interrupted in the parent study (participants meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow sabatolimab dosing to resume). Pregnant or nursing (lactating) women. Where pregnancy is defined as the state of a female after conception confirmed by a positive serum hCG laboratory test and until the termination of gestation. Participant not willing to comply with the contraception requirements outlined in the exclusion criteria of the parent protocol. Local access to commercially available sabatolimab for parent protocol indications.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Novartis Pharmaceuticals

Phone

1-888-669-6682

novartis.email@novartis.com

First Name & Middle Initial & Last Name or Official Title & Degree

Novartis Pharmaceuticals

Phone

+41613241111

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Massachusetts General Hospital .

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Olivia Green

ogreen2@mgh.harvard.edu

First Name & Middle Initial & Last Name & Degree

Andrew M Brunner

Facility Name

Oregon Health and Science Uni

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rachel Mahoney

Phone

503-494-8311

mahoneyr@ohsu.edu

First Name & Middle Initial & Last Name & Degree

Elie Traer

Facility Name

Novartis Investigative Site

City

Alexandroupolis

State/Province

Evros

ZIP/Postal Code

681 00

Country

Greece

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08036

Country

Spain

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

IPD Sharing URL

https://www.clinicalstudydatarequest.com

Learn more about this trial

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.

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