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An open-label, multi-center rollover protocol for continued characterization of safety and tolerability for subjects who have participated in a Novartis-sponsored spartalizumab study as single agent or in combination with other study treatments

An open-label, multi-center rollover protocol for continued characterization of safety and tolerability for subjects who have participated in a Novartis-sponsored spartalizumab study as single agent or in combination with other study treatments - CPDR001X2X01B

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51829
Enrollment
1
Registered
2022-05-11
Start date
2022-08-30
Completion date
Unknown
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

solid cancer(s)

Interventions

Study treatment is defined as spartalizumab as monotherapy or in combination with other treatments intended to treat cancer, as defined in the parent protocol.

Sponsors

Novartis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Signed informed consent must be obtained prior to participation in the study. 2. Subject is currently enrolled in a pre-defined Novartis-sponsored study and is receiving spartalizumab as single agent or in combination with other study treatment. 3. Subject is currently deriving clinical benefit from the study treatment, as determined by the investigator. 4. Subject has demonstrated compliance, as assessed by the investigator, with the parent protocol requirements. 5. Subject is willing and able to comply with the scheduled visits and treatment plans.

Exclusion criteria

Exclusion criteria: Subject has been permanently discontinued from spartalizumab in the parent protocol for any reason other than enrollment in the CPDR001X2X01B study. Subject does not meet the criteria specified in the parent protocol criteria for continued study treatment. Subject not willing to comply with the contraception requirements outlined in the exclusion criteria of the parent protocol.

Design outcomes

Primary

MeasureTime frame
To collect safety and tolerability data for spartalizumab as single agent or in combination with other study treatments

Secondary

MeasureTime frame
To allow subjects enrolled in a spartalizumab Novartis-sponsored study continued access to study treatment

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)