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

Last updated: May 2, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Not Recruiting

Phase

1

Condition

N/A

Treatment

PDR001

Clinical Study ID

NCT04058756
CPDR001X2X01B
  • Ages 18-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject is currently enrolled in a pre-defined Novartis-sponsored study and isreceiving spartalizumab as single agent or in combination with other studytreatment,

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

Other protocol defined inclusion criteria may apply

Exclusion

Exclusion Criteria:

  • Subject has been permanently discontinued from spartalizumab in the parent protocolfor any reason other than enrollment in the Roll over Study

  • Subject does not meet the criteria specified in the parent protocol criteria forcontinued study treatment.

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: PDR001
Phase: 1
Study Start date:
October 30, 2019
Estimated Completion Date:
April 30, 2030

Connect with a study center

  • Novartis Investigative Site

    Leuven, 3000
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Liege, 4000
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Novartis Investigative Site

    Montreal, Quebec H3T 1E2
    Canada

    Site Not Available

  • Novartis Investigative Site

    Guangzhou, Guangdong 510515
    China

    Site Not Available

  • Novartis Investigative Site

    Brno, Czech Republic 656 53
    Czechia

    Site Not Available

  • Novartis Investigative Site

    Praha 4, 140 59
    Czechia

    Site Not Available

  • Novartis Investigative Site

    France, Villejuif 94800
    France

    Site Not Available

  • Novartis Investigative Site

    Villejuif Cedex, Villejuif 94800
    France

    Site Not Available

  • Novartis Investigative Site

    Lille, 59037
    France

    Site Not Available

  • Novartis Investigative Site

    Lille Cedex, 59037
    France

    Site Not Available

  • Novartis Investigative Site

    Lyon, 69373
    France

    Site Not Available

  • Novartis Investigative Site

    Lyon Cedex, 69373
    France

    Site Not Available

  • Novartis Investigative Site

    Marseille, 13273
    France

    Site Not Available

  • Novartis Investigative Site

    Marseille Cedex 05, 13885
    France

    Site Not Available

  • Novartis Investigative Site

    Villejuif, 94800
    France

    Site Not Available

  • Novartis Investigative Site

    Essen, 45147
    Germany

    Site Not Available

  • Novartis Investigative Site

    Heidelberg, 69120
    Germany

    Site Not Available

  • Novartis Investigative Site

    Jena, 07740
    Germany

    Site Not Available

  • Novartis Investigative Site

    Ulm, 89081
    Germany

    Site Not Available

  • Novartis Investigative Site

    High West,
    Hong Kong

    Site Not Available

  • Novartis Investigative Site

    Hong Kong, 999077
    Hong Kong

    Site Not Available

  • Novartis Investigative Site

    Pokfulam,
    Hong Kong

    Site Not Available

  • Novartis Investigative Site

    Shatin,
    Hong Kong

    Site Not Available

  • Novartis Investigative Site

    Shatin New Territories,
    Hong Kong

    Site Not Available

  • Novartis Investigative Site

    Shatin, New Territories,
    Hong Kong

    Site Not Available

  • Novartis Investigative Site

    Budapest, H 1122
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Debrecen, 4032
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Milano, MI 20133
    Italy

    Site Not Available

  • Novartis Investigative Site

    Rozzano, MI 20089
    Italy

    Site Not Available

  • Novartis Investigative Site

    Modena, MO 41124
    Italy

    Site Not Available

  • Novartis Investigative Site

    Aviano, PN 33081
    Italy

    Site Not Available

  • Novartis Investigative Site

    Siena, SI 53100
    Italy

    Site Not Available

  • Novartis Investigative Site

    Milan, 20132
    Italy

    Site Not Available

  • Novartis Investigative Site

    Napoli, 80131
    Italy

    Site Not Available

  • Novartis Investigative Site

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Novartis Investigative Site

    Leiden, Zuid Holland 2333 ZA
    Netherlands

    Site Not Available

  • Novartis Investigative Site

    Gdansk, 80 952
    Poland

    Site Not Available

  • Novartis Investigative Site

    Poznan, 60-693
    Poland

    Site Not Available

  • Novartis Investigative Site

    Barcelona, Catalunya 08036
    Spain

    Site Not Available

  • Novartis Investigative Site

    Hospitalet de LLobregat, Catalunya 08907
    Spain

    Site Not Available

  • Novartis Investigative Site

    Valencia, Comunidad Valenciana 46010
    Spain

    Site Not Available

  • Novartis Investigative Site

    Madrid, 28009
    Spain

    Site Not Available

  • Novartis Investigative Site

    Zuerich, 8091
    Switzerland

    Site Not Available

  • Novartis Investigative Site

    Taipei, 10002
    Taiwan

    Site Not Available

  • Novartis Investigative Site

    Songkhla, Hat Yai 90110
    Thailand

    Site Not Available

  • Novartis Investigative Site

    Bangkok, 10330
    Thailand

    Site Not Available

  • Novartis Investigative Site

    Chiang Mai, 50200
    Thailand

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Columbia University Medical Center CUMC

    New York, New York 10032
    United States

    Site Not Available

  • Columbia University Medical Center New York Presbyterian

    New York, New York 10032
    United States

    Site Not Available

  • Columbia University Medical Center- New York Presbyterian

    New York, New York 10032
    United States

    Active - Recruiting

  • Providence Portland Medical Center

    Portland, Oregon 97123
    United States

    Site Not Available

  • MD Anderson Cancer Center Uni of Te

    Houston, Texas 77030
    United States

    Site Not Available

  • MD Anderson Cancer Center Uni of Te MDACC

    Houston, Texas 77030
    United States

    Site Not Available

  • MD Anderson Cancer Center/University of Texas MDACC

    Houston, Texas 77030
    United States

    Active - Recruiting

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