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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 : June 22, 2020
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 : 105 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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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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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
France
Novartis Investigative Site Recruiting
Marseille, France, 13273
Novartis Investigative Site Recruiting
Villejuif Cedex, France, 94805
Germany
Novartis Investigative Site Recruiting
Essen, Germany, 45147
Novartis Investigative Site Recruiting
Jena, Germany, 07740
Novartis Investigative Site Recruiting
Ulm, Germany, 89081
Hong Kong
Novartis Investigative Site Recruiting
Hong Kong, Hong Kong
Italy
Novartis Investigative Site Recruiting
Milano, MI, Italy, 20133
Novartis Investigative Site Recruiting
Napoli, Italy, 80131
Spain
Novartis Investigative Site Recruiting
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site Recruiting
Madrid, Spain, 28009
Novartis Investigative Site Recruiting
Madrid, Spain, 28034
Switzerland
Novartis Investigative Site Recruiting
Zuerich, Switzerland, 8091
Taiwan
Novartis Investigative Site Recruiting
Taipei, Taiwan, 10041
Thailand
Novartis Investigative Site Recruiting
Songkhla, Hat Yai, Thailand, 90110
Novartis Investigative Site Recruiting
Bangkok, Thailand, 10310
Novartis Investigative Site 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: June 22, 2020
Last Verified: June 2020

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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