Rollover Study for Continued Safety and Tolerability in Subjects Treated With Spartalizumab Alone or in Combination With Other Study Treatments
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Solid Tumors | Drug: PDR001 | Phase 1 |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: PDR001
All subjects in all combination will be entered in one arm
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Drug: PDR001
PDR001 |
- Frequency and nature of AE and SAE by subject [ Time Frame: 5 years ]Safety data.
- Number of subjects with PDR001 dose interruption and/or reduction [ Time Frame: 5 years ]
- Number of subjects receiving PDR001 [ Time Frame: 5 years ]
- Subject's exposure duration [ Time Frame: 5 years ]

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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Contact: Novartis Pharmaceuticals | 1-888-669-6682 | novartis.email@novartis.com | |
Contact: Novartis Pharmaceuticals | +41613241111 |
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 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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