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M7824 + Gemcitabine in Advanced Pancreatic Adenocarcinoma

NCT03451773Phase 2

Key facts

Status: Terminated
Start: May 2018
Primary completion: May 2020
Countries: 1
Sponsor: National Cancer Institute
Modality: Immune Checkpoint Inhibitors, Fc-Fusion Proteins

Drugs: bintrafusp alfa
Conditions: pancreatic adenocarcinoma (PDAC)

Overview

Phase 2, open-label trial of bintrafusp alfa in pancreatic adenocarcinoma (PDAC) (2 arms), sponsored by National Cancer Institute. Primary endpoints: Number and Severity of Grade 1-2 Adverse Events Possibly, Probably, or Definitely Related to Treatment, Number and Severity of Grade 3-5 Adverse Events Possibly, Probably, or Definitely Related to Treatment and 2 more. Started May 2018; status: terminated.

Design

2 arms

Study design: Non-randomizedOpen-label

Gemcitabine + De-escalating M7824
Gemcitabine + de-escalating dose of M7824
Gemcitabine + RP2D M7824
Gemcitabine + Recommended Phase 2 Dose of M7824

Who it enrols

Adult patients with histologically confirmed pancreatic adenocarcinoma who have progressed on standard first-line chemotherapy, with ECOG 0-1 and adequate organ function. Excludes prior immunotherapy, active CNS metastases, and autoimmune disease.

Endpoints

Primary

Number and Severity of Grade 1-2 Adverse Events Possibly, Probably, or Definitely Related to Treatment30 days after treatment
Number and Severity of Grade 3-5 Adverse Events Possibly, Probably, or Definitely Related to Treatment30 days after treatment
Best Overall ResponseEvery 8 weeks, up to 2 years
Duration of Treatment-related Adverse EventsUp to 12 months

Secondary

Immune-related Best Overall ResponseEvery 6-12 weeks, up to 1 year
Percentage of Evaluable Participants Alive at 6 Months and 9 Months9 months
Percentage of Participants Who Have Not Progressed at 3 Months3 months
Overall Median SurvivalUp to 1 year
Overall Progression Free SurvivalUp to 6 months

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