Health Trials

Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma

ConditionsPancreatic CancerPancreatic Cancer MetastaticPDACPDAC - Pancreatic Ductal AdenocarcinomaPancreatic Ductal AdenocarcinomaPancreatic Adenocarcinoma MetastaticPancreatic Ductal Adenocarcinoma (PDAC)Pancreatic Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorImmuneering Corporation

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Must be ≥18 years of age

Metastatic pancreatic adenocarcinoma within 12 weeks prior to screening

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

First-line PDAC participants will have received no previous systemic anti-cancer therapy

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Atebimetinib

    Drug

    Once daily oral tablets

  • GnP

    Drug

    Standard of care regimen for intravenous infusions of gemcitabine and nab-paclitaxel weekly for three weeks followed by one week without an infusion

  • mGnP

    Drug

    Biweekly intravenous infusions of chemotherapy (gemcitabine and nab-paclitaxel)

Treatment groups

510 Participants
are divided into 2 treatment groups
Group A: Atebimetinib + mGnPExperimental treatment 2 interventions
Group B: GnPActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall Survival

The OS of participants with atebimetinib in combination with mGnP versus GnP

Time frame
Up to approximately 2 years

Secondary outcomes

1

Progression Free Survival (PFS)

The PFS of participants with atebimetinib in combination with mGnP versus GnP

Time frame
Up to approximately 2 years
2

Overall Response Rate (ORR)

The ORR of participants with atebimetinib in combination with mGnP versus GnP

Time frame
Up to approximately 2 years
3

Disease Control Rate (DCR)

The DCR in participants with atebimetinib in combination with mGnP versus GnP

Time frame
Up to approximately 2 years
4

Incidence of Adverse Events (AEs)

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

Time frame
Up to approximately 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Immuneering Corporation

Lead sponsor

Source ClinicalTrials.gov
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