The purpose of this study is to allow collection of safety and tolerability data in subjects benefitting from treatment with spartalizumab as a single agent or in combination with other study treatments in a pre-defined (Appendix Section 16.1)…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To collect safety and tolerability data for spartalizumab as single agent or in
combination with other study treatments
Secondary outcome
To allow subjects enrolled in a spartalizumab Novartis-sponsored study
continued access to study treatment
Background summary
Spartalizumab is a high-affinity, ligand-blocking, humanized anti-programmed
death-1 (PD-1) IgG4 antibody that blocks the binding of Programmed death-ligand
1 (PD-L1) and programmed death-ligand 2 (PD-L2) to PD-1. Spartalizumab
recognizes PD-1 in cynomolgus monkeys and shows functional activity in vitro/ex
vivo. For further details, please refer to (spartalizumab Investigator*s
Brochure).
Study objective
The purpose of this study is to allow collection of safety and tolerability
data in subjects benefitting from treatment with spartalizumab as a single
agent or in combination with other study treatments in a pre-defined (Appendix
Section 16.1) Novartis-sponsored spartalizumab study that has reached its
primary objective(s) and the requirements for writing the primary CSR, or has
been terminated for other reasons.
Study design
Multi-level, open label roll-over study. Eligible parent protocols are listed
in appendix section 16.1 of the protocol.
Intervention
Study treatment is defined as spartalizumab as monotherapy or in combination
with other treatments intended to treat cancer, as defined in the parent
protocol.
Study burden and risks
Risks: possible side-effect of PDR001 and/or study drugs used in combination.
Risks and discomforts associated with the study assessments like blood sampling
and CT-scans.
Burden: 1 visit every 4 weeks during which various study assessments are
performed. This might be physical exams, blooddraws and a CT-scan or a
radiology assessment to determine if progression of disease.
Haaksbergweg 16
Amsterdam 1101BX
NL
Haaksbergweg 16
Amsterdam 1101BX
NL
Listed location countries
Age
Inclusion 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.
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.
Subject not willing to comply with the contraception requirements outlined in
the exclusion criteria of the parent protocol.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-000508-14-NL |
| CCMO | NL80782.058.22 |