Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma (MAPKeeper 301)

Immuneering Corporation

Status and phase: Enrolling; Phase 3

Conditions: Pancreatic Cancer Metastatic; Pancreatic Adenocarcinoma Metastatic; PDAC - Pancreatic Ductal Adenocarcinoma; PDAC; Pancreatic Adenocarcinoma; Pancreatic Ductal Adenocarcinoma (PDAC); Pancreatic Ductal Adenocarcinoma; Pancreatic Cancer

Treatments: Drug: mGnP; Drug: GnP; Drug: Atebimetinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT07562152

IMM1104-301

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of atebimetinib in combination with modified GnP compared with SOC GnP alone.

Full 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.

Enrollment: 510 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must be ≥18 years of age

• Must have confirmed diagnosis according to AJCC staging as follows:

  • Metastatic pancreatic adenocarcinoma at least 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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510 participants in 2 patient groups

Atebimetinib + mGnP

Experimental group

Description:

Atebimetinib in combination with modified gemcitabine and nab-paclitaxel for first line pancreatic adenocarcinoma

Treatment:

Drug: Atebimetinib

Drug: mGnP

GnP

Active Comparator group

Description:

Standard of care gemcitabine and nab-paclitaxel for first line pancreatic adenocarcinoma

Treatment:

Drug: GnP