Head and Neck Squamous Cell CarcinomaPhase 1/2NCT02143622
Study of Efficacy and Safety of LJM716 and Cetuximab in Head and Neck Squamous Cell Carcinoma Patients
A Phase 1/2 study testing LJM716 and cetuximab in people with Head and Neck Squamous Cell Carcinoma, run by Novartis Pharmaceuticals.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- LJM716 and cetuximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Aug 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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
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
- Being tested
- LJM716, cetuximab
- Keywords
- Head and neck cancer
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LJM716Biological
antibody
cetuximabBiological
antibody
| Study group | Role | What they receive |
|---|---|---|
| LJM716+cetuximab | Experimental | Not described Receives: Biological: LJM716; Biological: cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 6 months
Secondary outcomes (6)
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.
Measured: 6 months
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
Measured: 6 months
Best overall response (BOR), per RECIST 1.1
BOR will be used to further assess the anti-tumor activity of LJM716-cetuximab combination.
Measured: 6 months
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
Measured: 6 months
Overall survival (OS) per RECIST 1.1
Overall survival will be used to further assess the anti-tumor activity of LJM716-cetuximab combination
Measured: 12 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study startMar 2015
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143622
- Sponsor's protocol ID
- CLJM716X2104
- Status last verified
- Apr 2016
- First submitted
- 19 May 2014
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02143622
- Acronym / sponsor ID
- CLJM716X2104
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- Head and neck cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 21 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LJM716+cetuximab | Experimental | Biological: LJM716, Biological: cetuximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LJM716antibody | Biological | LJM716+cetuximab |
| cetuximabantibody | Biological | LJM716+cetuximab |
Primary outcome
Phase Ib: Target lesion change compared to baseline in patients, per RECIST 1.1
Time frame: 6 months
Assessment of the preliminary anti-tumor activity of LJM716 in combination. Change in target lesion measurements, from baseline as per RECIST 1.1
Phase Ib: Number of Total Dose-limiting Toxicity (DLT) During Dose Escalation to Determine Maximum Tolerated Dose (MTD)
Time frame: 35 days
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
Phase II: Percentage of Patients with an Objective Overall Response (OOR) per RECIST 1.1
Time frame: 6 months
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 secondary outcomes
Safety and tolerability of the LJM716- cetuximab combination
Time frame: 6 months
blood concentration versus time profiles blood PK parameters of LJM716 and cetuximab concentration
Time frame: 6 months
Best overall response (BOR), per RECIST 1.1
Time frame: 6 months
Duration of response (DOR) per RECIST 1.1
Time frame: 6 months
Overall survival (OS) per RECIST 1.1
Time frame: 12 months
Progression free survival (PFS) per RECIST 1.1
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LJM716 and cetuximab in people with Head and Neck Squamous Cell Carcinoma, run by Novartis Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Ib: Target lesion change compared to baseline in patients, per RECIST 1.1 (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2016.