metastatic or locally advanced vulvar cancer, persistent, Recurrent
Conditions
Brief summary
Efficacy of lenvatinib + pembrolizumab in terms of objective response rate (ORR). ORR will be defined as the proportion of patients with PR or CR within 24 weeks starting with the first study treatment. Tumor responses will be assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Detailed description
ORR for whole trial duration. DCR=proportion of pts with PR/CR/SD for 8 weeks. DOR=time from response until 1st PD or death, whichever occurs first. OS=time from therapy start to death. PFS=time from therapy start to PD or death, whichever occurs first. TFST=time from therapy start until start of 1st subsequent therapy or death whichever occurs first. TSST=time from therapy start until start of 2nd subsequent therapy or death whichever occurs first. Tumor response assessed by INV per RECIST 1.1., Quality of life is measured by patient reported outcome instruments EORTC QLQ-C30 and QLQ-VU34., Events according to common terminology criteria for adverse events (CTCAE Version 5.0), dose reductions, delays or interruptions.
Interventions
DRUGLenvatinib
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
Sponsors
AGO Research GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of lenvatinib + pembrolizumab in terms of objective response rate (ORR). ORR will be defined as the proportion of patients with PR or CR within 24 weeks starting with the first study treatment. Tumor responses will be assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR for whole trial duration. DCR=proportion of pts with PR/CR/SD for 8 weeks. DOR=time from response until 1st PD or death, whichever occurs first. OS=time from therapy start to death. PFS=time from therapy start to PD or death, whichever occurs first. TFST=time from therapy start until start of 1st subsequent therapy or death whichever occurs first. TSST=time from therapy start until start of 2nd subsequent therapy or death whichever occurs first. Tumor response assessed by INV per RECIST 1.1., Quality of life is measured by patient reported outcome instruments EORTC QLQ-C30 and QLQ-VU34., Events according to common terminology criteria for adverse events (CTCAE Version 5.0), dose reductions, delays or interruptions. | — |
Countries
Germany
Outcome results
None listed