Sym004 in Combination With Nivolumab Versus Nivolumab Monotherapy in EGFR-amplified Squamous Non-Small Cell Lung Cancer

Sponsor
Symphogen A/S
Study ID
NCT02924233
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

  • Squamous Non-Small Cell Lung Cancer

Eligibility Criteria

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

Interventions

  • Sym004 — DRUG
    Sym004 is a 1:1 mixture of two monoclonal antibodies (mAbs) which bind to two non-overlapping epitopes of the Epidermal Growth Factor Receptor (EGFR). Sym004 will be administered at different dose-levels via infusion Q2W
  • Nivolumab — DRUG
    Nivolumab is a humanized immunoglobulin G4 (IgG4) anti-PD-1 monoclonal antibody. Nivolumab will be administered via 60-minute infusion Q2W

Study Details

This is a phase 1b/2b study investigating the safety and preliminary antitumor effects of Sym004 in combination with nivolumab versus nivolumab monotherapy when administered every second week.

Key Dates

Start date
Nov 30, 2016
Status verified
Aug 2017
Primary completion
Feb 28, 2017
Completion
Feb 28, 2017

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sym004 + nivolumab
    Phase 1b, dose-escalation: Dose Level 1: Sym004 + nivolumab (Q2W) Dose Level 2: Sym004 + nivolumab (Q2W) Dose Level -1: Sym004 + nivolumab, if needed
  • Experimental: Sym004 (RP2D) + nivolumab
    Phase 2b, dose-expansion: Receiving Sym004 in the RP2D in combination with nivolumab (Q2W)
  • Active Comparator: Nivolumab
    Phase 2b, dose-expansion: Receiving nivolumab monotherapy (Q2W)

Primary Outcome Measure

Phase 1b: Determination of the Dose-Limiting Toxicities (DLT) and the MTD and/or RP2D of escalating doses of Sym004 in combination with a standard dose of nivolumab [ Time Frame: 1 year ]

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