Pancreatic Adenocarcinoma, Pancreatic Adenocarcinoma Metastatic, Pancreatic Cancer, Pancreatic Cancer Metastatic, Pancreatic Ductal Adenocarcinoma, Pancreatic Ductal Adenocarcinoma (PDAC), PDAC, PDAC - Pancreatic Ductal Adenocarcinoma
Conditions
Keywords
mitogen-activated protein kinase (MAPK), MAPK, MEK, metastatic cancer, gemcitabine, nab-paclitaxel, nab-p, atebimetinib
Brief summary
The purpose of this study is to evaluate the safety and efficacy of atebimetinib in combination with modified GnP compared with SOC GnP alone.
Detailed description
This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with atebimetinib plus a modified schedule of gemcitabine and nab-paclitaxel will improve overall survival compared with standard gemcitabine and nab-paclitaxel when given as first-line treatment in patients with metastatic pancreatic adenocarcinoma. Patients will be randomized to one of two arms: Arm A with atebimetinib + gemcitabine and nab-paclitaxel (modified dosing schedule) or Arm B with gemcitabine and nab-paclitaxel.
Interventions
DRUGAtebimetinib
Once daily oral tablets
DRUGGnP
Standard of care regimen for intravenous infusions of gemcitabine and nab-paclitaxel weekly for three weeks followed by one week without an infusion
DRUGmGnP
Biweekly intravenous infusions of chemotherapy (gemcitabine and nab-paclitaxel)
Sponsors
Immuneering Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must be ≥18 years of age * Must have confirmed diagnosis according to AJCC staging as follows: * Metastatic pancreatic adenocarcinoma within 12 weeks prior to screening * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Participants must be treatment naive as follows: * First-line PDAC participants will have received no previous systemic anti-cancer therapy * Must have evidence of measurable disease (at least one target lesion) per RECIST v1.1 criteria * Adequate organ function, hepatic function, coagulation studies and protocol determined clinical laboratory values
Exclusion criteria
* Inability to swallow oral medications * Participant has squamous, adenosquamous, neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma * Participants with only locally advanced disease * Symptomatic, untreated, or actively progressing known central nervous system (CNS) metastases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Up to approximately 2 years | The OS of participants with atebimetinib in combination with mGnP versus GnP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | Up to approximately 2 years | The PFS of participants with atebimetinib in combination with mGnP versus GnP |
| Overall Response Rate (ORR) | Up to approximately 2 years | The ORR of participants with atebimetinib in combination with mGnP versus GnP |
| Disease Control Rate (DCR) | Up to approximately 2 years | The DCR in participants with atebimetinib in combination with mGnP versus GnP |
| Incidence of Adverse Events (AEs) | Up to approximately 2 years | The safety and tolerability of atebimetinib in combination with mGnP versus GnP assessed by percentage of participants with AEs based on Common Terminology Criteria for Adverse Events (CTCAE) v6 |
| Quality of Life (QOL) with European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Up to approximately 2 years | EORTC QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, pain, nausea/vomiting, dyspnea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties), and an overall scale for global health status. Change from baseline in EORTC QLQ-C30 global health status will be assessed, with higher scores reflecting better functioning. |
Countries
Australia, United States
Contacts
CONTACTImmuneering Study Team
Outcome results
None listed