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

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ClinicalTrials.gov Identifier: NCT04901741
Recruitment Status : Not yet recruiting
First Posted : May 25, 2021
Last Update Posted : February 1, 2024
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
TME Pharma AG

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Cancer Drug: Olaptesed pegol Drug: Pembrolizumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : June 2024
Estimated Primary Completion Date : October 2026
Estimated Study Completion Date : October 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
Other Name: NOX-A12

Drug: Pembrolizumab
200 mg every 3 weeks as i.v. infusion until progression or intolerable toxicity or a maximum of 35 administrations
Other Name: KEYTRUDA®
Experimental: Arm 2: olaptesed pegol + pembrolizumab + gemcitabine + nab-paclitaxel Drug: Olaptesed pegol
400 mg per week as continous infusion until progression or intolerable toxicity
Other Name: NOX-A12

Drug: Pembrolizumab
200 mg every 3 weeks as i.v. infusion until progression or intolerable toxicity or a maximum of 35 administrations
Other Name: KEYTRUDA®


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. DCR at 12 weeks [ Time Frame: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab ]
  3. Progression free survival (PFS) [ Time Frame: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab ]
  4. Overall response rate (ORR) [ Time Frame: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab ]
  5. median Overall survival (mOS) [ Time Frame: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab ]
  6. Duration of response (DOR) [ Time Frame: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab ]
  7. Time-to-best overall response (TBOR) [ Time Frame: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab ]
  8. Time-to-next-anticancer-treatment (TTNT) [ Time Frame: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

    1. Arm 1: stopped first-line treatment with gemcitabine/nab-paclitaxel after documented objective radiographic progression OR
    2. 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04901741


Contacts
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Contact: Diana Beyer, Dr. +49 30 72 62 47 ext 100 clinicaltrialdisclosuredesk@tmepharma.com

Sponsors and Collaborators
TME Pharma AG
Merck Sharp & Dohme LLC
More Information
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Responsible Party: TME Pharma AG
ClinicalTrials.gov Identifier: NCT04901741    
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 )
First Posted: May 25, 2021    Key Record Dates
Last Update Posted: February 1, 2024
Last Verified: January 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
 Endocrine System Diseases
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action