Rollover Study for Continued Safety and Tolerability in S... | NCT04058756

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

NCT04058756

Sponsor

Novartis Pharmaceuticals

Status

Active, not recruiting

Last Update Posted

Oct 7, 2025Actual

Enrollment

120Actual

Phase

Phase 1

Conditions

Advanced Solid Tumors

Interventions

PDR001

Countries

United States
Belgium
Canada
China
Czechia
France
Germany
Hong Kong
Hungary
Italy
Netherlands
Poland
South Korea
Spain
Switzerland
Taiwan
Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 30, 2019Actual

Primary Completion Date

Apr 30, 2030Estimated

Completion Date

Apr 30, 2030Estimated

First Submitted Date

Aug 13, 2019

First Submission Date that Met QC Criteria

Aug 14, 2019

First Posted Date

Aug 16, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 6, 2025

Last Update Posted Date

Oct 7, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PDR001	Experimental	All subjects in all combination will be entered in one arm	Drug: PDR001

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PDR001	Drug	PDR001	PDR001

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency and nature of AE and SAE by subject	Safety data.	5 years
Number of subjects with PDR001 dose interruption and/or reduction		5 years

Secondary Outcomes

Measure	Description	Time Frame
Number of subjects receiving PDR001		5 years
Subject's exposure duration		5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Columbia University Medical Center		New York	New York	10032	United States
Providence Portland Medical Center

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms