The purpose of this study is to provide a go/no-go decision for a randomized expansion study by assessing the disease control rate (DCR) at 6 weeks for the combination of olaptesed pegol on top of pembrolizumab and (Arm 1) nanoliposomal irinotecan, 5-FU and leucovorin or (Arm 2) gemcitabine and nab-paclitaxel, to assess safety and tolerability and time-to-event endpoints.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
400 mg per week as continous infusion until progression or intolerable toxicity
200 mg every 3 weeks as i.v. infusion until progression or intolerable toxicity or a maximum of 35 administrations
Go/no-go decision for a randomized expansion study
Assessment of the disease control rate (DCR) at 6 weeks for the combination of olaptesed pegol on top of pembrolizumab and (Arm 1) nanoliposomal irinotecan, 5-FU and leucovorin or (Arm 2) gemcitabine and nab-paclitaxel
Time frame: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab
Safety and tolerability
Safety and tolerability of olaptesed pegol pegol on top of pembrolizumab and (Arm 1) nanoliposomal irinotecan, 5-FU and leucovorin or (Arm 2) gemcitabine and nab-paclitaxel
Time frame: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab
DCR at 12 weeks
Time frame: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab
Progression free survival (PFS)
Time frame: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab
Overall response rate (ORR)
Time frame: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab
median Overall survival (mOS)
Time frame: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab
Duration of response (DOR)
Time frame: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab
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Time-to-best overall response (TBOR)
Time frame: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab
Time-to-next-anticancer-treatment (TTNT)
Time frame: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab