- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04901741
Olaptesed With Pembrolizumab and Nanoliposomal Irinotecan or Gemcitabine/Nab-Paclitaxel in MSS Pancreatic Cancer (OPTIMUS)
January 30, 2024 updated by: TME Pharma AG
An Open-label Phase 2 Study of Olaptesed Pegol (NOX-A12) Combined With Pembrolizumab and Nanoliposomal Irinotecan/5-FU/Leucovorin or Gemcitabine/Nab-paclitaxel in Microsatellite-stable Metastatic Pancreatic Cancer Patients
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 Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Phase 2
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: Diana Beyer, Dr.
- Phone Number: 100 +49 30 72 62 47
- 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.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1: olaptesed pegol + pembrolizumab + nanoliposomal irinotecan + 5-FU + LV
|
400 mg per week as continous infusion until progression or intolerable toxicity
Other Names:
200 mg every 3 weeks as i.v.
infusion until progression or intolerable toxicity or a maximum of 35 administrations
Other Names:
|
Experimental: Arm 2: olaptesed pegol + pembrolizumab + gemcitabine + nab-paclitaxel
|
400 mg per week as continous infusion until progression or intolerable toxicity
Other Names:
200 mg every 3 weeks as i.v.
infusion until progression or intolerable toxicity or a maximum of 35 administrations
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Go/no-go decision for a randomized expansion study
Time Frame: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab
|
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
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability
Time Frame: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab
|
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
Time Frame: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab
|
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
|
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
|
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
|
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
|
until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab
|
|
Time-to-best overall response (TBOR)
Time Frame: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab
|
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
|
until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 Major Dates
Study Start (Estimated)
June 1, 2024
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2027
Study Registration Dates
First Submitted
May 20, 2021
First Submitted That Met QC Criteria
May 20, 2021
First Posted (Actual)
May 25, 2021
Study Record Updates
Last Update Posted (Actual)
February 1, 2024
Last Update Submitted That Met QC Criteria
January 30, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Pembrolizumab
Other Study ID Numbers
- SNOXA12C701
- 2021-001963-25 (EudraCT Number)
- KEYNOTE-B01 (Other Identifier: Merck Sharp & Dohme LLC)
- MK-3475-B01 (Other Identifier: Merck Sharp & Dohme LLC)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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