Persistent or Recurrent Rare Epithelial Ovarian Tumors
Conditions
Brief summary
Confirmed ORR as determined by the investigator according to RECIST v1.1
Detailed description
1. DOR as determined by the investigator and IRC according to RECIST v1.1, 2. DCR as determined by the investigator and IRC according to RECIST v1.1, 3. PFS as determined by the investigator and IRC according to RECIST v1.1, 4. Overall survival, 5. Confirmed ORR, as determined by the IRC according to RECIST v1.1, 6. Six (6)-month PFS rate as determined by the investigator, 7. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0)
Interventions
DRUGCotellic
DRUGAvastin 25 mg/ml concentrate for solution for infusion.
DRUGLynparza 150 mg film-coated tablets
DRUGIpatasertib
DRUGINAVOLISIB
DRUGVerzenios 50 mg film-coated tablets
DRUGLynparza 100 mg film-coated tablets
DRUGLETRO-cell® 2
DRUGRO7197597
DRUGTecentriq 1
DRUGlösning
DRUGsolution à diluer pour perfusion
DRUGEndoxan 50 mg dengtos tabletės
Sponsors
F. Hoffmann-La Roche AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Confirmed ORR as determined by the investigator according to RECIST v1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. DOR as determined by the investigator and IRC according to RECIST v1.1, 2. DCR as determined by the investigator and IRC according to RECIST v1.1, 3. PFS as determined by the investigator and IRC according to RECIST v1.1, 4. Overall survival, 5. Confirmed ORR, as determined by the IRC according to RECIST v1.1, 6. Six (6)-month PFS rate as determined by the investigator, 7. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0) | — |
Countries
Czechia, France, Germany, Italy, Spain
Outcome results
None listed