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
- Conditions
- solid cancer(s)malignancy10027655
- Registration Number
- NL-OMON51829
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To collect safety and tolerability data for spartalizumab as single agent or in<br /><br>combination with other study treatments</p><br>
- Secondary Outcome Measures
Name Time Method <p>To allow subjects enrolled in a spartalizumab Novartis-sponsored study<br /><br>continued access to study treatment</p><br>