A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La
The purpose of this extension study is to provide continued treatment with Roche investigational medicinal product (IMP\[s\]) monotherapy or Roche IMP(s) combined with other agent(s) or comparator agent(s) for eligible participants with cancer who are still on study treatment at the time of roll-over from the parent st
| Condition(s) | Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | The purpose of this extension study is to provide continued treatment with Roche investigational medicinal product (IMP\[s\]) monotherapy or Roche IMP(s) combined with other agent(s) or comparator agent(s) for eligible participants with cancer who are still on study treatment at the time of roll-over from the parent study and who do not have access to the study treatment locally. |
| Who can participate | Inclusion Criteria: * Eligible for continuing Roche IMP-based therapy at the time of roll-over from the parent study, as per the parent study protocol OR * Eligible for continuing the comparator agent(s) in a Genentech- or Roche-sponsored study as per the parent study protocol, with no access to commercially available comparator agent * First dose of study treatment in this extension study will be received within 7 days of the treatment interruption window allowed by the parent study * Continue to benefit from the Roche IMP-based therapy or comparator at the time of roll-over from the parent study as assessed by the investigator * Ability to comply with the extension study protocol, per Investigator's judgement Exclusion Criteria: * Meet any of the study treatment discontinuation criteria |
| Sex | All |
| Lead sponsor | Hoffmann-La Roche |
| Locations | Charleroi, Belgium; Kortrijk, Belgium; Leuven, Belgium; Toronto, Ontario, Canada; XI 'an City, Shaanxi Province, Shaanxi, China; Shanghai, Shanghai Municipality, China (+56 more sites) |
| Start date | 2023-06-01 |
| NCT ID | NCT05862285 |
| Official listing | https://clinicaltrials.gov/study/NCT05862285 |