Study of Efficacy and Safety of LJM716 and Cetuximab in Head and Neck Squamous Cell Carcinoma Patients

NCT02143622 | Withdrawn Phase 1

• 1 other identifier: CLJM716X2104
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

To establish whether LJM716 in combination with cetuximab is safe and has beneficial effects in patients with platinum-pretreated recurrent/metastatic head and neck squamous cell carcinoma.

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Head and neck cancer

Outcome Measures

Primary Outcomes (3)

• Phase Ib: Target lesion change compared to baseline in patients, per RECIST 1.1

  Assessment of the preliminary anti-tumor activity of LJM716 in combination. Change in target lesion measurements, from baseline as per RECIST 1.1

  6 months

• Phase Ib: Number of Total Dose-limiting Toxicity (DLT) During Dose Escalation to Determine Maximum Tolerated Dose (MTD)

  The dose escalation part of the study will be guided by a well-established statistical method/model to estimate the maximum tolerated dose of LJM716 in combination with cetuximab

  35 days

• Phase II: Percentage of Patients with an Objective Overall Response (OOR) per RECIST 1.1

  Patients with an Objective Overall Response (OOR) were those whose best response to treatment was a complete response (CR) or a partial response (PR) assessed by imaging, as pr RECIST 1.1.

  6 months

Secondary Outcomes (6)

• Safety and tolerability of the LJM716- cetuximab combination

  6 months

• blood concentration versus time profiles blood PK parameters of LJM716 and cetuximab concentration

  6 months

• Best overall response (BOR), per RECIST 1.1

  6 months

• Duration of response (DOR) per RECIST 1.1

  6 months

• Overall survival (OS) per RECIST 1.1

  12 months

Study Arms (1)

LJM716+cetuximab

EXPERIMENTAL

Biological: LJM716; Biological: cetuximab

Interventions

LJM716 BIOLOGICAL

antibody

LJM716+cetuximab

cetuximab BIOLOGICAL

antibody

LJM716+cetuximab

Eligibility Criteria

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

You may qualify if:

• Most recent regimen contains both platinum and cetuximab (Phase II, group B).
• ECOG Performance Status (PS) ≤ 2.
• Recovery from all AEs of previous anti-cancer therapies, to baseline or to CTCAE Grade ≤ 1, except for alopecia.
• Measurable disease as determined by RECIST v1.1.

You may not qualify if:

• Previous anti-HER3 antibody treatment.
• Symptomatic brain metastasis.
• Prior systemic anti-cancer treatment, within a period of time that is shorter than the cycle length used for that treatment prior to starting study treatment.
• Prior anaphylactic or other severe infusion reaction to human immunoglobulin or antibody formulations.
• Inadequate end organ function.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms

Interventions

elgemtumab; Cetuximab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

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

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: May 21, 2014
• Study Start: March 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: April 21, 2016

Record last verified: 2016-04