ClinicalTrials.gov

History of Changes for Study: NCT04901741
Olaptesed With Pembrolizumab and Nanoliposomal Irinotecan or Gemcitabine/Nab-Paclitaxel in MSS Pancreatic Cancer
Latest version (submitted January 30, 2024) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 May 20, 2021 None (earliest Version on record)
2 July 27, 2021 Study Status, Study Identification and Sponsor/Collaborators
3 April 4, 2022 Study Status
4 July 19, 2022 Study Status, Contacts/Locations and Study Identification
5 February 21, 2023 Study Status
6 August 24, 2023 Study Status and Study Design
7 January 30, 2024 Study Identification, Arms and Interventions and Study Status
Comparison Format:

Scroll up to access the controls

Study NCT04901741
Submitted Date:  May 20, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: SNOXA12C701
Brief Title: Olaptesed With Pembrolizumab and Nanoliposomal Irinotecan or Gemcitabine/Nab-Paclitaxel in MSS Pancreatic Cancer
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
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2021
Overall Status: Not yet recruiting
Study Start: October 2021
Primary Completion: May 2023 [Anticipated]
Study Completion: October 2025 [Anticipated]
First Submitted: May 20, 2021
First Submitted that
Met QC Criteria:
May 20, 2021
First Posted: May 25, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
May 20, 2021
Last Update Posted: May 25, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: TME Pharma AG
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
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.
Detailed Description:
Open or close this module Conditions
Conditions: Metastatic Pancreatic Cancer
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Single (Participant)
Allocation: Non-Randomized
Enrollment: 68 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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 Names:
  • NOX-A12
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 Names:
  • NOX-A12
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Diana Beyer, Dr.
Telephone: +49 30 72 62 47 Ext. 100
Email: clinicaltrialdisclosuredesk@noxxon.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services