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Phase I Study MK-3475 With Chemotherapy in Patients With Advanced GI Cancers

NCT02268825 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2018-11-13

No results posted yet for this study

Summary

This is a Phase I dose escalation trial to assess MTD of MK-3475 in combination with mFOLFOX6 followed by a safety expansion open label, nonrandomized trial with MK-3475 at MTD in combination with mFOLFOX6 and supplemental celecoxib in 4 cohorts of advanced/metastatic GI malignancies (pancreatic, gastro esophageal, colorectal/appendiceal adenocarcinoma and biliary carcinoma) to assess response rate, clinical benefit rate, progression free survival and overall survival. The safety expansion cohort will assess the effect of the addition of celecoxib to patients that do not respond to combination MK-3475/mFOLFOX treatment.

Conditions

  • Advanced GI Cancer

Interventions

DRUG

MK-3475

MK-3475 in combination with mFOLFOX6 in a 14 day cycle Phase 1 and safety expansion Phased Regimen mFOLFOX6 Administered Day 1 of each cycle Leucovorin 400 mg/m2 IV 5-FU 400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hrs Oxaliplatin (Eloxatin) 85 mg/m2 IV MK-3475 IV to be administered before mFOLFOX6 starting with Cycle 3 (after 28 days of chemotherapy alone); day 1 of each cycle (q 2 weeks) Phase 1: 2 dose levels of MK-3475 Level -1: 50mg IV q 2 weeks Level 1: 75mg IV q 2 weeks Level 2: 200mg IV q 2 weeks Safety Expansion: MK-3475 at highest tolerated dose

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-23
Primary Completion
2017-01-25
Completion
2017-06-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02268825 on ClinicalTrials.gov