A Phase 2 Study of MM-141 Plus Nab-paclitaxel and Gemcitabine in Front-line Metastatic Pancreatic Cancer

Summary

The purpose of this study is to determine whether the combination of MM-141 plus nab-paclitaxel and gemcitabine is more effective than nab-paclitaxel and gemcitabine alone based on Progression Free Survival (PFS) in front-line metastatic pancreatic cancer patients with high serum levels of free IGF-1.

Timeline

Start

2015-05

Primary completion

2018-08

Completion

2018-08

Outcome

Missed primary endpoint

paper In the high IGF-1 cohort, median PFS was 3.6 and 7.3 months in the experimental versus control arms, respectively [hazard ratio (HR) = 1.88, P = 0.027]. PMID 31912800 ↗

paper In the high IGF-1/HRG+ subgroup (n = 44), median PFS was 4.1 and 7.3 months, respectively (HR = 1.39, P = 0.42). PMID 31912800 ↗

Publications

• Kundranda M, Gracian AC, Zafar SF, Meiri E, Bendell J, Algul H, Rivera F, Ahn ER, Watkins D, Pelzer U, Charu V, Zalutskaya A, Kuesters G, Pipas JM, Santillana S, Askoxylakis V, Ko AH. Randomized, double-blind, placebo-controlled phase II study of istiratumab (MM-141) plus nab-paclitaxel and gemcitabine versus nab-paclitaxel and gemcitabine in front-line metastatic pancreatic cancer (CARRIE). Ann Oncol. 2020 Jan;31(1):79-87. doi: 10.1016/j.annonc.2019.09.004.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	istiratumab	Monoclonal antibody	2.8 g	Intravenous
Background	Gemcitabine	Small molecule	—	—
Background	Nab-paclitaxel	Small molecule	—	—

Indications