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

March 25, 2024 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

121

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Recruiting
        • Novartis Investigative Site
      • Liege, Belgium, 4000
        • Recruiting
        • Novartis Investigative Site
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Novartis Investigative Site
  • China
      • Guangzhou, China, 510060
        • Recruiting
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Completed
        • Novartis Investigative Site
  • Czechia
      • Praha 4, Czechia, 140 59
        • Withdrawn
        • Novartis Investigative Site
    • Czech Republic
      • Brno, Czech Republic, Czechia, 656 53
        • Recruiting
        • Novartis Investigative Site
  • France
      • Lille, France, 59037
        • Completed
        • Novartis Investigative Site
      • Lyon, France, 69373
        • Completed
        • Novartis Investigative Site
      • Marseille, France, 13273
        • Completed
        • Novartis Investigative Site
      • Marseille Cedex 05, France, 13885
        • Active, not recruiting
        • Novartis Investigative Site
      • Villejuif, France, 94800
        • Active, not recruiting
        • Novartis Investigative Site
  • Germany
      • Essen, Germany, 45147
        • Recruiting
        • Novartis Investigative Site
      • Heidelberg, Germany, 69120
        • Recruiting
        • Novartis Investigative Site
      • Jena, Germany, 07740
        • Recruiting
        • Novartis Investigative Site
      • Ulm, Germany, 89081
        • Recruiting
        • Novartis Investigative Site
  • Hong Kong
      • High West, Hong Kong
        • Recruiting
        • Novartis Investigative Site
      • Hong Kong, Hong Kong
        • Recruiting
        • Novartis Investigative Site
      • Shatin New Territories, Hong Kong
        • Recruiting
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary, H 1122
        • Recruiting
        • Novartis Investigative Site
      • Debrecen, Hungary, 4032
        • Active, not recruiting
        • Novartis Investigative Site
      • Debrecen, Hungary, 4032
        • Recruiting
        • Novartis Investigative Site
  • Italy
      • Napoli, Italy, 80131
        • Recruiting
        • Novartis Investigative Site
      • Napoli, Italy, 80131
        • Completed
        • Novartis Investigative Site
    • MI
      • Milano, MI, Italy, 20133
        • Recruiting
        • Novartis Investigative Site
      • Milano, MI, Italy, 20132
        • Recruiting
        • Novartis Investigative Site
      • Milano, MI, Italy, 20141
        • Recruiting
        • Novartis Investigative Site
      • Rozzano, MI, Italy, 20089
        • Recruiting
        • Novartis Investigative Site
    • MO
      • Modena, MO, Italy, 41124
        • Recruiting
        • Novartis Investigative Site
    • PN
      • Aviano, PN, Italy, 33081
        • Recruiting
        • Novartis Investigative Site
    • SI
      • Siena, SI, Italy, 53100
        • Recruiting
        • Novartis Investigative Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 05505
        • Recruiting
        • Novartis Investigative Site
  • Netherlands
      • Leiden, Netherlands, 2333 ZA
        • Completed
        • Novartis Investigative Site
  • Poland
      • Gdansk, Poland, 80 952
        • Completed
        • Novartis Investigative Site
      • Poznan, Poland, 60-693
        • Active, not recruiting
        • Novartis Investigative Site
  • Spain
      • Madrid, Spain, 28009
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28041
        • Withdrawn
        • Novartis Investigative Site
      • Madrid, Spain, 28034
        • Completed
        • Novartis Investigative Site
    • Catalunya
      • Barcelona, Catalunya, Spain, 08035
        • Recruiting
        • Novartis Investigative Site
      • Barcelona, Catalunya, Spain, 08036
        • Recruiting
        • Novartis Investigative Site
      • Hospitalet de LLobregat, Catalunya, Spain, 08907
        • Recruiting
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain, 46010
        • Recruiting
        • Novartis Investigative Site
  • Switzerland
      • Zuerich, Switzerland, 8091
        • Recruiting
        • Novartis Investigative Site
  • Taiwan
      • Taipei, Taiwan, 10041
        • Recruiting
        • Novartis Investigative Site
  • Thailand
      • Bangkok, Thailand, 10310
        • Completed
        • Novartis Investigative Site
      • Chiang Mai, Thailand, 50200
        • Active, not recruiting
        • Novartis Investigative Site
    • Hat Yai
      • Songkhla, Hat Yai, Thailand, 90110
        • Completed
        • Novartis Investigative Site
  • United States
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center- New York Presbyterian
        • Principal Investigator:
          • Catherine Shu
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97123
        • Recruiting
        • Providence Portland Medical Center
        • Contact:
        • Principal Investigator:
          • Rom Leidner
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center Uni of Te MDACC
        • Principal Investigator:
          • Funda Meric-Bernstam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PDR001
All subjects in all combination will be entered in one arm
Drug: PDR001
PDR001

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2019

Primary Completion (Estimated)

March 7, 2030

Study Completion (Estimated)

March 7, 2030

Study Registration Dates

First Submitted

August 13, 2019

First Submitted That Met QC Criteria

August 14, 2019

First Posted (Actual)

August 16, 2019

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPDR001X2X01B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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