PDR001 in Combination With Bevacizumab and mFOLFOX6 as First Line Therapy in Patients With Metastatic MSS Colorectal Cancer

Sponsor
Novartis Pharmaceuticals
Study ID
NCT03176264
Phase
PHASE1
Status
Terminated

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PDR001 — DRUG
    400 mg every 4 weeks
  • bevacizumab — DRUG
    5 mg/kg every 2 weeks
  • mFOLFOX6 — DRUG
    Combination of chemotherapy administered every 2 weeks: oxaliplatin (85mg/m2), 5-Fluorouracil (2400mg/m2) and folinic acid (=leucovorin, 400mg/m2)

Study Details

This was a phase Ib study of PDR001 in combination with bevacizumab and mFOLFOX6 as first line therapy in patients with metastatic microsatellite stable (MSS) colorectal cancer. The study was to have assessed primarily, the safety and tolerability and then the efficacy of PDR001 in combination with bevacizumab and mFOLFOX6. Particular attention would have been paid to the level of activity of study drug combinations in CMS4 patients (retrospective analysis). The study was terminated early due to company decision.

Key Dates

First listed
Jun 5, 2017
Start date
Sep 25, 2017
Status verified
Oct 2021
Primary completion
Jan 30, 2018
Completion
Jan 30, 2018

Study Design

Enrollment
1 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: PDR001

Primary Outcome Measure

Incidence of Dose-limiting toxicity (DLT) [ Time Frame: 12 months ]

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