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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508841-42-00

Acronym

CPDR001X2X01B

Enrollment

Registered

2024-03-22

Start date

2019-10-30

Completion date

Unknown

Last updated

2025-10-28

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

Conditions

Different types of advanced cancer

Brief summary

The primary endpoint is the frequency and nature of adverse events (AEs) and serious adverse events (SAE), as well as subjects with dose interruptions and dose reductions.

Detailed description

Number of subjects receiving spartalizumab as single agent or in combination with other study treatments and duration of exposure

Interventions

DRUGLXH254

DRUGNIR178

DRUGTRAMETINIB DIMETHYL SULFOXIDE

DRUGPDR001

DRUGMCS110

DRUGINC280

DRUGDABRAFENIB MESYLATE

DRUGLAG525

DRUGNIZ985

DRUGDKY709

DRUGTMT212

DRUGCANAKINUMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the frequency and nature of adverse events (AEs) and serious adverse events (SAE), as well as subjects with dose interruptions and dose reductions.	—

Secondary

Measure	Time frame
Number of subjects receiving spartalizumab as single agent or in combination with other study treatments and duration of exposure	—

Countries

Belgium, Czechia, France, Germany, Hungary, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026