Rollover Study for Continued Safety and Tolerability in Subjects Treated With Spartalizumab Alone or in Combination With Other Study Treatments
Study Details
Study Description
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 |
---|---|---|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: PDR001 All subjects in all combination will be entered in one arm |
Drug: PDR001
PDR001
|
Outcome Measures
Primary Outcome Measures
- Frequency and nature of AE and SAE by subject [5 years]
Safety data.
- Number of subjects with PDR001 dose interruption and/or reduction [5 years]
Secondary Outcome Measures
- Number of subjects receiving PDR001 [5 years]
- Subject's exposure duration [5 years]
Eligibility Criteria
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
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Columbia University Medical Center- New York Presbyterian | New York | New York | United States | 10032 |
2 | Providence Portland Medical Center | Portland | Oregon | United States | 97123 |
3 | MD Anderson Cancer Center/University of Texas MDACC | Houston | Texas | United States | 77030 |
4 | Novartis Investigative Site | Leuven | Belgium | 3000 | |
5 | Novartis Investigative Site | Toronto | Ontario | Canada | M5G 2M9 |
6 | Novartis Investigative Site | Montreal | Quebec | Canada | H3T 1E2 |
7 | Novartis Investigative Site | Guangzhou | Guangdong | China | 510515 |
8 | Novartis Investigative Site | Guangzhou | China | 510060 | |
9 | Novartis Investigative Site | Brno | Czech Republic | Czechia | 656 53 |
10 | Novartis Investigative Site | Praha 4 | Czechia | 140 59 | |
11 | Novartis Investigative Site | Villejuif Cedex | Villejuif | France | 94800 |
12 | Novartis Investigative Site | Lille Cedex | France | 59037 | |
13 | Novartis Investigative Site | Lyon Cedex | France | 69373 | |
14 | Novartis Investigative Site | Marseille Cedex 05 | France | 13885 | |
15 | Novartis Investigative Site | Marseille | France | 13273 | |
16 | Novartis Investigative Site | Essen | Germany | 45147 | |
17 | Novartis Investigative Site | Heidelberg | Germany | 69120 | |
18 | Novartis Investigative Site | Jena | Germany | 07740 | |
19 | Novartis Investigative Site | Ulm | Germany | 89081 | |
20 | Novartis Investigative Site | Hong Kong | Hong Kong | ||
21 | Novartis Investigative Site | Shatin, New Territories | Hong Kong | ||
22 | Novartis Investigative Site | Debrecen | Hungary | 4032 | |
23 | Novartis Investigative Site | Milano | MI | Italy | 20132 |
24 | Novartis Investigative Site | Milano | MI | Italy | 20133 |
25 | Novartis Investigative Site | Milano | MI | Italy | 20141 |
26 | Novartis Investigative Site | Rozzano | MI | Italy | 20089 |
27 | Novartis Investigative Site | Aviano | PN | Italy | 33081 |
28 | Novartis Investigative Site | Napoli | Italy | 80131 | |
29 | Novartis Investigative Site | Seoul | Korea, Republic of | 03080 | |
30 | Novartis Investigative Site | Seoul | Korea, Republic of | 05505 | |
31 | Novartis Investigative Site | Gdansk | Poland | 80 952 | |
32 | Novartis Investigative Site | Poznan | Poland | 60-693 | |
33 | Novartis Investigative Site | Barcelona | Catalunya | Spain | 08035 |
34 | Novartis Investigative Site | Valencia | Comunidad Valenciana | Spain | 46010 |
35 | Novartis Investigative Site | Madrid | Spain | 28009 | |
36 | Novartis Investigative Site | Madrid | Spain | 28034 | |
37 | Novartis Investigative Site | Madrid | Spain | 28041 | |
38 | Novartis Investigative Site | Zuerich | Switzerland | 8091 | |
39 | Novartis Investigative Site | Taipei | Taiwan | 10041 | |
40 | Novartis Investigative Site | Songkhla | Hat Yai | Thailand | 90110 |
41 | Novartis Investigative Site | Bangkok | Thailand | 10310 | |
42 | Novartis Investigative Site | Chiang Mai | Thailand | 50200 |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CPDR001X2X01B