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

NCT ID: NCT04058756

Last Updated: 2025-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-30

Study Completion Date

2030-04-30

Brief Summary

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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

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Conditions

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Advanced Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PDR001

All subjects in all combination will be entered in one arm

Group Type EXPERIMENTAL

PDR001

Intervention Type DRUG

PDR001

Interventions

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PDR001

PDR001

Intervention Type DRUG

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Columbia University Medical Center

New York, New York, United States

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Providence Portland Medical Center

Portland, Oregon, United States

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MD Anderson Cancer Center Uni of Te

Houston, Texas, United States

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Novartis Investigative Site

Leuven, , Belgium

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Liège, , Belgium

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Guangzhou, Guangdong, China

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Guangzhou, , China

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Brno, , Czechia

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Lille, , France

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Lyon, , France

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Marseille, , France

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Marseille, , France

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Villejuif, , France

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Jena, Thuringia, Germany

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Essen, , Germany

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Heidelberg, , Germany

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Ulm, , Germany

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High West, , Hong Kong

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Hong Kong, , Hong Kong

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Pokfulam, , Hong Kong

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Budapest, , Hungary

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Debrecen, , Hungary

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Milan, MI, Italy

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Milan, MI, Italy

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Milan, MI, Italy

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Rozzano, MI, Italy

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Modena, MO, Italy

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Aviano, PN, Italy

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Siena, SI, Italy

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Napoli, , Italy

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Leiden, South Holland, Netherlands

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Gdansk, , Poland

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Poznan, , Poland

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Seoul, , South Korea

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Seoul, , South Korea

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L'Hospitalet de Llobregat, Barcelona, Spain

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Barcelona, Catalonia, Spain

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Barcelona, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Valencia, , Spain

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Zurich, , Switzerland

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Taipei, , Taiwan

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Songkhla, Hat Yai, Thailand

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Bangkok, , Thailand

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Chiang Mai, , Thailand

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Countries

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

Other Identifiers

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CPDR001X2X01B

Identifier Type: -

Identifier Source: org_study_id

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