Recurrent, metastatic, or persistent Cervical Carcinoma
Conditions
Brief summary
• Cohort 1 and 2: ORR as assessed by the IRC per RECIST v1.1; • Cohort 3: Incidence of Grade ≥ 3 treatment-emergent adverse events (TEAEs); • Cohorts 4 and 5: Because of the small sample size, results will be reported as appropriate by descriptive statistics.
Detailed description
Cohort 1 and 2: DOR, DCR, and PFS as assessed by the IRC per RECIST v1.1., Cohort 1 and 2: ORR, DOR, DCR, and PFS as assessed by the Investigator per RECIST v1.1., Cohort 1 and 2: OS, Cohort 1 and 2: Incidence of severity, seriousness, relationship to study treatment, and characteristics of treatment-emergent adverse events (TEAEs), including serious AEs (SAEs), therapy-related AEs, and AEs leading to early discontinuation from treatment or withdrawal from the Assessment Period or death., Cohort 3: ORR, DOR, DCR, and PFS as assessed by the Investigator per RECIST v1.1., Cohort 3: OS, Cohorts 4 and 5: Because of the small sample size, results will be reported as appropriate by descriptive statistics.
Interventions
Sponsors
Iovance Biotherapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Cohort 1 and 2: ORR as assessed by the IRC per RECIST v1.1; • Cohort 3: Incidence of Grade ≥ 3 treatment-emergent adverse events (TEAEs); • Cohorts 4 and 5: Because of the small sample size, results will be reported as appropriate by descriptive statistics. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cohort 1 and 2: DOR, DCR, and PFS as assessed by the IRC per RECIST v1.1., Cohort 1 and 2: ORR, DOR, DCR, and PFS as assessed by the Investigator per RECIST v1.1., Cohort 1 and 2: OS, Cohort 1 and 2: Incidence of severity, seriousness, relationship to study treatment, and characteristics of treatment-emergent adverse events (TEAEs), including serious AEs (SAEs), therapy-related AEs, and AEs leading to early discontinuation from treatment or withdrawal from the Assessment Period or death., Cohort 3: ORR, DOR, DCR, and PFS as assessed by the Investigator per RECIST v1.1., Cohort 3: OS, Cohorts 4 and 5: Because of the small sample size, results will be reported as appropriate by descriptive statistics. | — |
Countries
France, Germany, Italy, Netherlands, Spain
Outcome results
None listed