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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04058756
Recruitment Status : Recruiting
First Posted : August 16, 2019
Last Update Posted : July 21, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: PDR001 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 121 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 31, 2019
Estimated Primary Completion Date : January 16, 2025
Estimated Study Completion Date : January 16, 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: PDR001
All subjects in all combination will be entered in one arm
 Drug: PDR001
PDR001


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Number of subjects receiving PDR001 [ Time Frame: 5 years ]
  2. Subject's exposure duration [ Time Frame: 5 years ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04058756


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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United States, New York
Columbia University Medical Center- New York Presbyterian Recruiting
New York, New York, United States, 10032
Principal Investigator: Catherine Shu         
United States, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97123
Contact: Ashley Drokin    503-215-6805    Ashley.Drokin@providence.org   
Principal Investigator: Rom Leidner         
United States, Texas
MD Anderson Cancer Center/University of Texas MDACC Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Funda Meric-Bernstam         
Belgium
Novartis Investigative Site Recruiting
Leuven, Belgium, 3000
Canada, Ontario
Novartis Investigative Site Recruiting
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Novartis Investigative Site Recruiting
Montreal, Quebec, Canada, H3T 1E2
China, Guangdong
Novartis Investigative Site Recruiting
Guangzhou, Guangdong, China, 510515
China
Novartis Investigative Site Recruiting
Guangzhou, China, 510060
Czechia
Novartis Investigative Site Recruiting
Brno, Czech Republic, Czechia, 656 53
Novartis Investigative Site Withdrawn
Praha 4, Czechia, 140 59
France
Novartis Investigative Site Recruiting
Villejuif Cedex, Villejuif, France, 94800
Novartis Investigative Site Completed
Lille Cedex, France, 59037
Novartis Investigative Site Recruiting
Lyon Cedex, France, 69373
Novartis Investigative Site Recruiting
Marseille Cedex 05, France, 13885
Novartis Investigative Site Completed
Marseille, France, 13273
Germany
Novartis Investigative Site Recruiting
Essen, Germany, 45147
Novartis Investigative Site Recruiting
Heidelberg, Germany, 69120
Novartis Investigative Site Recruiting
Jena, Germany, 07740
Novartis Investigative Site Recruiting
Ulm, Germany, 89081
Hong Kong
Novartis Investigative Site Recruiting
Hong Kong, Hong Kong
Novartis Investigative Site Recruiting
Shatin, New Territories, Hong Kong
Hungary
Novartis Investigative Site Active, not recruiting
Debrecen, Hungary, 4032
Italy
Novartis Investigative Site Recruiting
Milano, MI, Italy, 20132
Novartis Investigative Site Recruiting
Milano, MI, Italy, 20133
Novartis Investigative Site Recruiting
Milano, MI, Italy, 20141
Novartis Investigative Site Recruiting
Rozzano, MI, Italy, 20089
Novartis Investigative Site Recruiting
Aviano, PN, Italy, 33081
Novartis Investigative Site Recruiting
Napoli, Italy, 80131
Korea, Republic of
Novartis Investigative Site Recruiting
Seoul, Korea, Republic of, 03080
Novartis Investigative Site Recruiting
Seoul, Korea, Republic of, 05505
Poland
Novartis Investigative Site Completed
Gdansk, Poland, 80 952
Novartis Investigative Site Active, not recruiting
Poznan, Poland, 60-693
Spain
Novartis Investigative Site Recruiting
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site Recruiting
Valencia, Comunidad Valenciana, Spain, 46010
Novartis Investigative Site Recruiting
Madrid, Spain, 28009
Novartis Investigative Site Recruiting
Madrid, Spain, 28034
Novartis Investigative Site Recruiting
Madrid, Spain, 28041
Switzerland
Novartis Investigative Site Recruiting
Zuerich, Switzerland, 8091
Taiwan
Novartis Investigative Site Recruiting
Taipei, Taiwan, 10041
Thailand
Novartis Investigative Site Completed
Songkhla, Hat Yai, Thailand, 90110
Novartis Investigative Site Completed
Bangkok, Thailand, 10310
Novartis Investigative Site Active, not recruiting
Chiang Mai, Thailand, 50200
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04058756    
Other Study ID Numbers: CPDR001X2X01B
First Posted: August 16, 2019    Key Record Dates
Last Update Posted: July 21, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Phase Ib
PDR001
PD-1
continued access
Additional relevant MeSH terms:
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Spartalizumab
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents