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

Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:

A Phase Ib/II, Multicenter Study of LJM716 in Combination With Cetuximab in Patients With Platinum-pretreated Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02143622
• Other study ID #: CLJM716X2104
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: May 19, 2014
• Last updated: April 19, 2016
• Start date: March 2015
• Est. completion date: August 2018

Study information

• Verified date: April 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices (BfArM)Canada: Health CanadaFrance: National Agency for the Safety of Medicines and Health Products (MSNA)Spain: Agencia Española de Medicamentos y Productos SanitariosSingapore: Health Sciences AuthoritySwitzerland: SwissmedicNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Italy: The Italian Medicines AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• Ongoing diarrhea CTCAE Grade = 2. Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Head and Neck Squamous Cell Carcinoma

Intervention

Biological:
• LJM716
antibody
• cetuximab
antibody

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes
Primary	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	No
Secondary	Safety and tolerability of the LJM716- cetuximab combination	This will be assessed by looking at the number of Adverse Events (AEs), serious AEs (SAEs) changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs), dose interruptions, reductions and dose intensity.	6 months	Yes
Secondary	blood concentration versus time profiles blood PK parameters of LJM716 and cetuximab concentration	blood concentration versus time profiles blood PK parameters will be used to characterize the PK profiles of LJM716 and cetuximab concentration when used in combination	6 months	No
Secondary	Best overall response (BOR), per RECIST 1.1	BOR will be used to further assess the anti-tumor activity of LJM716-cetuximab combination.	6 months	No
Secondary	Duration of response (DOR) per RECIST 1.1	Duration of response will be used to further assess the anti-tumor activity of LJM716-cetuximab combination	6 months	No
Secondary	Overall survival (OS) per RECIST 1.1	Overall survival will be used to further assess the anti-tumor activity of LJM716-cetuximab combination	12 months	No
Secondary	Progression free survival (PFS) per RECIST 1.1	Progression free survival will be used to further assess the anti-tumor activity of LJM716-cetuximab combination	6 months	No