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NCT Number: NCT04058756

Rollover Study for Continued Safety and Tolerability in Subjects Treated With Spartalizumab Alone or in Combination With Other Study Treatments

The purpose of this study is to continue to assess safety and tolerability, and to allow continued access to study treatment for subjects already receiving spartalizumab as single agent or in combination with other study treatments.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Leuven, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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,
  • Subject is currently deriving clinical benefit from the study treatment, as determined by the investigator.

Other protocol defined inclusion criteria may apply

Exclusion criteria

  • Subject has been permanently discontinued from spartalizumab in the parent protocol for any reason other than enrollment in the Roll over Study
  • Subject does not meet the criteria specified in the parent protocol criteria for continued study treatment.

Treatment and study plan

PDR001

Drug

PDR001

Primary outcomes

  1. Frequency and nature of AE and SAE by subject

    Time frame: 5 years

    Safety data.

  2. Number of subjects with PDR001 dose interruption and/or reduction

    Time frame: 5 years

Secondary outcomes

  1. Number of subjects receiving PDR001

    Time frame: 5 years

  2. Subject's exposure duration

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2030
Study completion
2030
First posted
Aug 16, 2019
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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