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

NCT02924233 | Withdrawn Phase 1

• 1 other identifier: Sym004-10
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Squamous Non-Small Cell Lung Cancer

Keywords

Squamous; Non-Small Cell Lung Cancer; NSCLC

Outcome Measures

Primary Outcomes (2)

• 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

  1 year

• Phase 2b: Evaluation of the antitumor effects of the RP2D of Sym004 when administered in combination with a standard dose of nivolumab as measured by Response Rate

  1.5 years

Study Arms (3)

Sym004 + nivolumab

EXPERIMENTAL

Phase 1b, dose-escalation: Dose Level 1: Sym004 + nivolumab (Q2W) Dose Level 2: Sym004 + nivolumab (Q2W) Dose Level -1: Sym004 + nivolumab, if needed

Drug: Sym004; Drug: Nivolumab

Sym004 (RP2D) + nivolumab

EXPERIMENTAL

Phase 2b, dose-expansion: Receiving Sym004 in the RP2D in combination with nivolumab (Q2W)

Drug: Sym004; Drug: Nivolumab

Nivolumab

ACTIVE COMPARATOR

Phase 2b, dose-expansion: Receiving nivolumab monotherapy (Q2W)

Drug: Nivolumab

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

Sym004 (RP2D) + nivolumab; Sym004 + nivolumab

Nivolumab DRUG

Nivolumab is a humanized immunoglobulin G4 (IgG4) anti-PD-1 monoclonal antibody. Nivolumab will be administered via 60-minute infusion Q2W

Nivolumab; Sym004 (RP2D) + nivolumab; Sym004 + nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated written informed consent
• Male or female ≥18 years of age at the time of informed consent
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Life expectancy \>3 months assessed during Screening
• Histologically or cytologically confirmed, locally advanced or metastatic squamous NSCLC

You may not qualify if:

• Any antineoplastic agent (standard or investigational) within 2 weeks prior to starting trial treatment
• Radiosurgery or radiotherapy for target lesions within 2 weeks prior to starting trial treatment
• Prophylactic use of hematopoietic growth factors within 1 week prior to starting trial treatment
• Active Central Nervous System (CNS) metastases or carcinomatous meningitis
• Women who are pregnant
• Women who are breastfeeding

Sponsors & Collaborators

• Symphogen A/S: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

futuximab; Nivolumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: October 5, 2016
• Study Start: November 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: August 28, 2017

Record last verified: 2017-08