West Cancer Center

PANCREAS: Metastatic: 1st line: \"NLG2104\"

A phase I/II study of indoximod in combination with gemcitabine and nab-paclitaxel in patients with metastatic adenocarcinoma of the pancreas

Title

NewLink NLG2104

Study Title

A phase I/II study of indoximod in combination with gemcitabine and nab-paclitaxel in patients with metastatic adenocarcinoma of the pancreas

Site Link

NCT02077881

Malignancy

Pancreas, Pancreatic cancer

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

1st

Investigational Agent

Indoximod

Drug Class

IDO inhibitor

Brad Somer, MD

Sponsor

NewLink Genetics Corporation

Phase

Phase 2

Status

Closed to Accrual

Key Eligibility Criteria

https://www.clinicaltrials.gov/ct2/show/NCT02077881

Key Eligibility Criteria Details

Stage IV Adenocarcinoma of the pancreas
Diagnosed with metastatic disease within 8 weeks
At least 1 measurable lesion. No "nodal only" disease
No prior therapy for metastatic disease
At least 6 months since adjuvant tx (if received)
No prior immune therapy for cancer
No brain mets
No active autoimmune disease

Objective

Primary- OS

Secondary- Biomarker response, RR, TTP

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Adenocarcinoma

Dosing Frequency

Indoximod- 600-1200 PO bid

Control Agents

Gemcitabine and nab-paclitaxel

Study Protocol

Randomized