Olaptesed With Pembrolizumab and Nanoliposomal Irinotecan or Gemcitabine/Nab-Paclitaxel in MSS Pancreatic Cancer

ConditionMetastatic Pancreatic Cancer

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorTME Pharma AG

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient with confirmed microsatellite-stable tumor pathology, if data available

Patient with histologically or cytologically confirmed primary metastatic adenocarcinoma of the pancreas, who

Arm 1: stopped first-line treatment with gemcitabine/nab-paclitaxel after documented objective radiographic progression OR

Arm 2: stopped first-line treatment with FOLFIRINOX or modified FOLFIRINOX after documented objective radiographic progression

Disqualifiers

Prior systemic anti-cancer therapy including investigational agents within 4 weeks or 5 half-lives, whichever is shorter, prior to treatment.

Patients must have recovered from all AEs due to previous therapies to ≤ Grade 1 or baseline. Patients with ≤ Grade 2 neuropathy may be eligible. Patients with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible.

If the patient had major surgery, the patient must have recovered adequately from the procedure and/or any complications from the surgery prior to starting study intervention

Prior radiotherapy within 2 weeks of start of study treatment. Patients must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.

Trial design

Design model

Parallel

Treatments tested in this trial

Olaptesed pegol
Drug
400 mg per week as continous infusion until progression or intolerable toxicity
Pembrolizumab
Drug
200 mg every 3 weeks as i.v. infusion until progression or intolerable toxicity or a maximum of 35 administrations

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Arm 1: olaptesed pegol + pembrolizumab + nanoliposomal irinotecan + 5-FU + LVExperimental treatment 2 interventions

Group B: Arm 2: olaptesed pegol + pembrolizumab + gemcitabine + nab-paclitaxelExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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