Clinical Trials List
Protocol NumberCPDR001X2X01B
NCT Number(ClinicalTrials.gov Identfier)NCT04058756
Active
2019-08-01 - 2030-04-30
Phase I
Recruiting1
ICD-9199.0
Disseminated malignant neoplasm
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
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Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
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Sponsor
Novartis Pharmaceuticals
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Trial scale
Multi-Regional Multi-Center
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Update
2026/03/01
Investigators and Locations
Co-Principal Investigator
- JIN-YUAN SHIH Division of General Internal Medicine
- Chong-Jen Yu Division of General Internal Medicine
- HUAI-CHENG HUANG Division of Hematology & Oncology
- 徐偉勛 醫學研究部
- MING YAO Division of General Internal Medicine
- Jih-Hsiang Lee Division of Hematology & Oncology
- Yu-Chieh Tsai Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Advanced Solid Tumors
Objectives
Primary Objective(s)
To collect safety and tolerability data for
spartalizumab as single agent or in
combination with other study treatments
Secondary Objective(s)
To allow subjects enrolled in a
spartalizumab Novartis-sponsored study
continued access to study treatment
Test Drug
Spartalizumab (PDR001)
Active Ingredient
Spartalizumab (PDR001)
Dosage Form
powder for solution for i.v. infusion
Dosage
100
Endpoints
Safety
Frequency and nature of adverse events (AEs) and
serious adverse events (SAE)
Tolerability
Dose interruptions and reductions by subjects
Number of subjects receiving spartalizumab as single
agent or in combination with other study treatments and
duration of exposure
Frequency and nature of adverse events (AEs) and
serious adverse events (SAE)
Tolerability
Dose interruptions and reductions by subjects
Number of subjects receiving spartalizumab as single
agent or in combination with other study treatments and
duration of exposure
Inclution Criteria
1. Signed informed consent must be obtained prior to participation in the study.
2. 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.
3. Subject is currently deriving clinical benefit from the study treatment, as determined by the
investigator.
4. Subject has demonstrated compliance, as assessed by the investigator, with the parent
protocol requirements.
5. Subject is willing and able to comply with the scheduled visits and treatment plans.
2. 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.
3. Subject is currently deriving clinical benefit from the study treatment, as determined by the
investigator.
4. Subject has demonstrated compliance, as assessed by the investigator, with the parent
protocol requirements.
5. Subject is willing and able to comply with the scheduled visits and treatment plans.
Exclusion Criteria
Subject has been permanently discontinued from spartalizumab in the parent protocol for
any reason other than enrollment in the CPDR001X2X01B study.
Subject does not meet the criteria specified in the parent protocol criteria for continued
study treatment.
any reason other than enrollment in the CPDR001X2X01B study.
Subject does not meet the criteria specified in the parent protocol criteria for continued
study treatment.
The Estimated Number of Participants
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Taiwan
20 participants
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Global
130 participants
