Trial purpose
Cancer treatment
Tumor type
Haematological
Age
12 - 99
Clinical summary
Summary
There is no conventional screening period in this study as participants are expected to transition directly from treatment on the parent protocol to treatment on this roll-over protocol. Participants who are candidates from the roll-over protocol will be evaluated by the Investigator in the parent protocol for eligibility for the roll-over protocol.
If eliigble, the parent protocol end of treatment visit will be performed and the informed consent for the roll-over protocol will be signed. Participants then continue treatment on this protocol with the next planned dose of Sabatolimab as monotherapy or with other combination agent(s).
Conditions
This trial is treating people with people with myelodysplastic syndromes or chronic myelomonocytic leukaemia who have benefited from Sabatolimab in a previous clinical trial
Eligibility
Inclusion
- 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
- 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.
Other protocol-defined Inclusion/Exclusion may apply.
Inclusion
- You have previously participated in a certain specific clinical trial.
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Novartis Pharmaceuticals
Scientific 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
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