Olaptesed With Pembrolizumab And Nanoliposomal Irinotecan Or Gemcitabine/Nab-Paclitaxel In MSS Pancreatic Cancer

Study Overview

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

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.

N/A

Metastatic Pancreatic Cancer

DRUG: Olaptesed pegol
DRUG: Pembrolizumab

SNOXA12C701
2021-001963-25 (EUDRACT_NUMBER Identifier) (EUDRACT_NUMBER: )
KEYNOTE-B01 (OTHER Identifier) (OTHER: Merck Sharp & Dohme LLC)
MK-3475-B01 (OTHER Identifier) (OTHER: Merck Sharp & Dohme LLC)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-05-20	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-06-24
First Submitted that Met QC Criteria 2021-05-20	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-06-27
First Posted (ACTUAL) 2021-05-25	Results First Posted N/A	Last Verified 2025-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
Single

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Arm 1: olaptesed pegol + pembrolizumab + nanoliposomal irinotecan + 5-FU + LV	DRUG: Olaptesed pegol 400 mg per week as continous infusion until progression or intolerable toxicity DRUG: Pembrolizumab 200 mg every 3 weeks as i.v. infusion until progression or intolerable toxicity or a maximum of 35 administrations
EXPERIMENTAL: Arm 2: olaptesed pegol + pembrolizumab + gemcitabine + nab-paclitaxel	DRUG: Olaptesed pegol 400 mg per week as continous infusion until progression or intolerable toxicity DRUG: Pembrolizumab 200 mg every 3 weeks as i.v. infusion until progression or intolerable toxicity or a maximum of 35 administrations

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Arm 1: olaptesed pegol + pembrolizumab + nanoliposomal irinotecan + 5-FU + LV

DRUG: Olaptesed pegol

400 mg per week as continous infusion until progression or intolerable toxicity

DRUG: Pembrolizumab

200 mg every 3 weeks as i.v. infusion until progression or intolerable toxicity or a maximum of 35 administrations

EXPERIMENTAL: Arm 2: olaptesed pegol + pembrolizumab + gemcitabine + nab-paclitaxel

DRUG: Olaptesed pegol

400 mg per week as continous infusion until progression or intolerable toxicity

DRUG: Pembrolizumab

200 mg every 3 weeks as i.v. infusion until progression or intolerable toxicity or a maximum of 35 administrations

Primary Outcome Measures	Measure Description	Time Frame
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	until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab

Secondary Outcome Measures	Measure Description	Time Frame
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	until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab
DCR at 12 weeks		until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab
Progression free survival (PFS)		until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab
Overall response rate (ORR)		until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab
median Overall survival (mOS)		until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab
Duration of response (DOR)		until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab
Time-to-best overall response (TBOR)		until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab
Time-to-next-anticancer-treatment (TTNT)		until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Diede van den Ouden

Phone Number: +49-30-166 370 82 0

Email: clinicaltrialdisclosuredesk@tmepharma.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Patient with confirmed microsatellite-stable tumor pathology, if data available
Patient with histologically or cytologically confirmed primary metastatic adenocarcinoma of the pancreas, who

Measurable disease based on RECIST 1.1 as determined by the investigational site
Estimated minimum life expectancy 3 months
Eastern Cooperative Oncology Group (ECOG) performance score 0 to 1
Adequate organ function laboratory values within the ranges specified: Serum albumin ≥ 3.0 g/dL; Hematological system: Hemoglobin (Hb) ≥ 9.0 g/dL or ≥5.6 mmol/L, Absolute neutrophil count (ANC) ≥ 1,500/mm³, Platelets ≥ 100,000/mm³; Renal system: Creatinine ≤ 1.5 x ULN OR eGFR ≥30 mL/min for patient with creatinine levels >1.5 × institutional ULN; Hepatic system: Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ULN for patients with total bilirubin levels >1.5 × ULN, ALT and AST ≤ 2.5 x ULN (≤5 × ULN for patients with liver metastases); Coagulation: INR OR PT ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants, aPTT ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants

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.
Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137) and discontinued from that treatment due to a Grade 3 or higher irAE
Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug
Received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. Administration of killed vaccines are allowed
Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
History of (non-infectious) pneumonitis / interstitial lung disease that required steroids or current pneumonitis / interstitial lung disease
Active infection requiring systemic therapy
Known additional malignancy that is progressing or has required active treatment within the past 2 years.
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment
Previous allogeneic tissue/solid organ transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Merck Sharp & Dohme LLC

Investigators

Publications

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