Squamous Cell Carcinoma of the Head and NeckPhase 2NCT01218048

ERBITUX® Followed by Adjuvant Treatment With Chemoradiation and ERBITUX® for Locally Advanced Head and Neck Squamous Cell Carcinoma

A Phase 2 study testing Cetuximab, Surgery and Post-surgical radiation in people with Squamous Cell Carcinoma of the Head and Neck, run by Robert Ferris at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Squamous Cell Carcinoma of the Head and Neck
What is being tested?: Cetuximab, Surgery and Post-surgical radiation
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: Feb 2011to 14 Feb 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Histologically or cytologically confirmed, previously untreated HNC. Clinical stage III or IVA disease without distant metastases as determined by CT, and as defined by the American Joint Committee on Cancer Staging System, Sixth edition (See Appendix I).
Primary tumors of the oral cavity, oropharynx, hypopharynx, or larynx will be included. Primary tumors of the sinuses, paranasal sinuses, or nasopharynx, or unknown primary tumors are NOT allowed.
Macroscopic complete resection of the primary tumor must be planned.
Age greater than or equal to 18 years.
ECOG performance status 0-1.
Adequate hematologic, renal and hepatic function, as defined by:

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Absolute neutrophil count (ANC) greater than or equal to 1,500/ul, platelets greater than or equal to 100,000/ul.
Creatinine clearance > 40
Bilirubin less than or equal to 1.5 x ULN, AST or ALT less than or equal to 2.5 x ULN.
Have signed written informed consent.

Who cannot join

Subjects who fail to meet the above criteria.
Prior severe infusion reaction to a monoclonal antibody.
Pregnancy or breastfeeding. Women of childbearing potential (WOCBP) must practice acceptable methods of birth control to prevent pregnancy. Prior to study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.
All WOCBP MUST have a negative pregnancy test within 7 days prior to first receiving investigational product. If the pregnancy test is positive, the patient must not receive investigational product and must not be enrolled in the study. In addition, all WOCBP should be instructed to contact the Investigator immediately if they suspect they might be pregnant (e.g., missed or late menstrual period) at any time during study participation. The Investigator must immediately notify BMS in the event of a confirmed pregnancy in a patient participating in the study.
Subjects with an ECOG performance status of 2 or worse.
Evidence of distant metastasis.

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Any other malignancy active within 5 years except for non-melanoma skin cancer or carcinoma in situ of the cervix, DCIS or LCIS of the breast.
Prior history of HNC.
Prior therapy targeting the EGFR pathway.
Any unresolved chronic toxicity greater than or equal to grade 2 from previous anticancer therapy (except alopecia), according to Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
Acute hepatitis, known HIV, or active uncontrolled infection.
History of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, myocardial infarction within prior 6 months, untreated known coronary artery disease, uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction.
Uncontrolled peptic or gastric ulcer disease, or gastrointestinal bleeding within prior 6 months.
Active alcohol abuse or other illness that carries a likelihood of inability to comply with study treatment and follow-up.
Treatment with a non-approved or investigational drug within 30 days prior to Day 1 of study treatment.

Trial locations and contacts

1 site in 1 country.

United States1 site

UPCI - Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232

Other trials in United States

About this study

Official title: Phase II Study of Neoadjuvant Immune Biomarker Modulation With Cetuximab Followed by Adjuvant Therapy With Concurrent Chemoradiotherapy or Radiotherapy With or Without Cetuximab for Locally Advanced Head and Neck Squamous Cell Carcinoma

There are currently no useful tests to identify patients who will respond to cetuximab therapy, notably because EGFR levels do not correlate with the clinical responses observed. Thus, the investigators are investigating the role of cellular immunity and immune escape mechanisms to explain the differential clinical response to cetuximab.

Read the detailed description

This prospective phase II clinical trial of preoperative, single-agent cetuximab treated patients is being conducted in order to obtain specimens before and after 4 weeks of cetuximab for immune biomarker studies. Stage III/IV HNC patients will be treated with definitive surgical resection and observed for disease recurrence. Cetuximab will be administered for a 3-4 week preoperative period to study biomarker modulation in correlation clinical response by CT scan and tumor apoptosis/proliferation after tumor excision, immediately after neoadjuvant cetuximab but before surgery. We will biopsy the skin/acneiform rash in all patients to correlate rash with biomarker modulation and clinical response. Cetuximab may also be given in the adjuvant setting. A primary scientific hypothesis will be tested: does short term pre-operative exposure to cetuximab modulate blood immune biomarkers and is immune modulation associated with anti-tumor effect? Forty (n=40) patients with complete specimens (tumor, peripheral blood mononuclear cells (PBMC) and serum) are necessary to enable adequate statistical power to be reached using paired specimens. A secondary set of hypotheses will evaluate the association between pre-operative biomarker levels and modulation with disease recurrence. The proposed trial will accrue stage II, III or IV surgical candidates without distant metastasis.

Conditions: Squamous Cell Carcinoma of the Head and Neck
Being tested: Cetuximab, Surgery, Post-surgical radiation, Cisplatin or carboplatin
Keywords: Carcinoma, Head and Neck, Cetuximab, Locally Advanced Head and Neck Squamous Cell Carcinoma
Medical subject headings: Squamous Cell Carcinoma of Head and Neck, Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CetuximabDrug
Also called ERBITUX®
Pre-Surgery: IV, 400 mg/m2 day 1 then 250 mg/m2 alone days 8 and 15; Post-surgery: IV, 250 mg/m2 weekly concurrent with RT
SurgeryProcedure or surgery
Surgery for tumor
Post-surgical radiationRadiation
Radiation (2 Gy/d) to min of 60 Gy + max of 66 Gy post-surgery
Cisplatin or carboplatinDrug
Cisplatin 30 mg/m2 or carboplatin AUC 1.5-2/week weekly, Concurrent with radiotherapy

Study groups in NCT01218048
Study group	Role	What they receive
Neo-Adjuvant Cetuximab	Experimental	Neo-Adjuvant Cetuximab + Surgery + Post-Surgical Radiation + Cisplatin (or Carboplatin) NOTE: Based the results of surgery if the treating physician feels patient is not a candidate for chemotherapy, radiation can be given alone or with cetuximab. Receives: Drug: Cetuximab; Procedure: Surgery; Radiation: Post-surgical radiation; Drug: Cisplatin or carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

NK Cell Activation
Cetuximab-mediated NK cell activation (percentage of activity) measures at pre-/post-cetuximab exposure for patients in peripheral blood lymphocytes (PBL) and tumor infiltrating lymphocytes (TIL) and in those patients that did and did not respond to treatment.
Measured: Prior to each weekly cetuximab treatment (up to 4 weeks); at the time of surgery (at 3-4 weeks after first cetuximab treatments)
Serum Cytokines Levels
Serum cytokines levels measured at pre-/post-cetuximab, exposure measured in picogram per milliliter of plasma (pg/ml)
Measured: Prior to each weekly cetuximab treatment (up to 4 weeks); at the time of surgery (at 3-4 weeks after first cetuximab treatments)
T Cell Activation
T cell activation measured at pre-/post-cetuximab exposure
Measured: Prior to each weekly cetuximab treatment (up to 4 weeks); at the time of surgery (at 3-4 weeks after first cetuximab treatments)

Secondary outcomes (6)

Frequency of EGFR-specific T Cells (EGFR853-861 Peptide-specific Tetramer+ CD8+T Cells)
Difference in frequency of circulating EGFR-specific T cells between cetuximab-treated and cetuximab-naive patients
Measured: Prior to each weekly cetuximab treatment (up to 4 weeks); at the time of surgery (at 3-4 weeks after first cetuximab treatments)
Progression-free Survival (PFS)
The length of time during and after study treatment that participants lived with disease that did not progress per RECIST 1.0. Progression per RECIST 1.0 is defined as a 20% increase the in longest dimension (LD) lesion from Nadir.
Measured: Up to 54 months
Overall Survival (OS)
Number of patients remaining alive.
Measured: Up to 2 years
Objective Response (Rate)
The percentage of participants that experienced a response to study treatment, per RECIST 1.0: Number of participant with (Complete Response (CR) + number of participants with Partial Response (PR) / Total number of participants evaluable for response.
Measured: Up to 2 years
3-year Progression-free Survival (PFS)
Percentage of participants alive at 3 years that did not experience disease progression per RECIST 1.0. Progression per RECIST 1.0 is defined as a 20% increase the in longest dimension (LD) lesion from Nadir.
Measured: 3 years
Change in Tumor Size
Largest percent change (decrease) in tumor size before and after neoadjuvant cetuximab.
Measured: Prior to each weekly cetuximab treatment (up to 4 weeks); at the time of surgery (at 3-4 weeks after first cetuximab treatments)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 201114 Feb 2017

First posted8 Oct 2010 (estimated)
Study startFeb 2011
Primary completion4 Nov 2015
Study completion14 Feb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Squamous Cell Carcinoma of the Head and NeckStudies of the same condition, open and under way.
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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01218048
Sponsor's protocol ID: UPCI 08-013
Status last verified: Jul 2018
First submitted: 7 Oct 2010
Last updated: 16 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Li J, Srivastava RM, Ettyreddy A, Ferris RL. Cetuximab ameliorates suppressive phenotypes of myeloid antigen presenting cells in head and neck cancer patients. J Immunother Cancer. 2015 Nov 17;3:54. doi: 10.1186/s40425-015-0097-6. eCollection 2015.
PubMed 26579227

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Squamous Cell Carcinoma of the Head and Neck trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Study of Neoadjuvant Immune Biomarker Modulation With Cetuximab Followed by Adjuvant Therapy With Concurrent Chemoradiotherapy or Radiotherapy With or Without Cetuximab for Locally Advanced Head and Neck Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT01218048
Acronym / sponsor ID: UPCI 08-013
Conditions: Squamous Cell Carcinoma of the Head and Neck
Keywords: Carcinoma, Head and Neck, Cetuximab, Locally Advanced Head and Neck Squamous Cell Carcinoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Robert FerrisUniversity, hospital or other
Collaborators: Bristol-Myers Squibb
Study start: Feb 2011
Primary completion: 4 Nov 2015 (actual)
Study completion: 14 Feb 2017 (actual)
First posted: 8 Oct 2010 (estimated)
Results: Posted 16 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Neo-Adjuvant Cetuximab	Experimental	Drug: Cetuximab, Procedure: Surgery, Radiation: Post-surgical radiation, Drug: Cisplatin or carboplatinNeo-Adjuvant Cetuximab + Surgery + Post-Surgical Radiation + Cisplatin (or Carboplatin) NOTE: Based the results of surgery if the treating physician feels patient is not a candidate for chemotherapy, radiation can be given alone or with cetuximab.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Histologically or cytologically confirmed, previously untreated HNC. Clinical stage III or IVA disease without distant metastases as determined by CT, and as defined by the American Joint Committee on Cancer Staging System, Sixth edition (See Appendix I).
Primary tumors of the oral cavity, oropharynx, hypopharynx, or larynx will be included. Primary tumors of the sinuses, paranasal sinuses, or nasopharynx, or unknown primary tumors are NOT allowed.
Macroscopic complete resection of the primary tumor must be planned.
Age greater than or equal to 18 years.
ECOG performance status 0-1.

Key exclusion criteria (15 listed)

Subjects who fail to meet the above criteria.
Prior severe infusion reaction to a monoclonal antibody.
Pregnancy or breastfeeding. Women of childbearing potential (WOCBP) must practice acceptable methods of birth control to prevent pregnancy. Prior to study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.
All WOCBP MUST have a negative pregnancy test within 7 days prior to first receiving investigational product. If the pregnancy test is positive, the patient must not receive investigational product and must not be enrolled in the study. In addition, all WOCBP should be instructed to contact the Investigator immediately if they suspect they might be pregnant (e.g., missed or late menstrual period) at any time during study participation. The Investigator must immediately notify BMS in the event of a confirmed pregnancy in a patient participating in the study.
Subjects with an ECOG performance status of 2 or worse.

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
CetuximabAlso: ERBITUX®Pre-Surgery: IV, 400 mg/m2 day 1 then 250 mg/m2 alone days 8 and 15; Post-surgery: IV, 250 mg/m2 weekly concurrent with RT	Drug	Neo-Adjuvant Cetuximab
SurgerySurgery for tumor	Procedure or surgery	Neo-Adjuvant Cetuximab
Post-surgical radiationRadiation (2 Gy/d) to min of 60 Gy + max of 66 Gy post-surgery	Radiation	Neo-Adjuvant Cetuximab
Cisplatin or carboplatinCisplatin 30 mg/m2 or carboplatin AUC 1.5-2/week weekly, Concurrent with radiotherapy	Drug	Neo-Adjuvant Cetuximab

Primary outcome

NK Cell Activation
Time frame: Prior to each weekly cetuximab treatment (up to 4 weeks); at the time of surgery (at 3-4 weeks after first cetuximab treatments)
Cetuximab-mediated NK cell activation (percentage of activity) measures at pre-/post-cetuximab exposure for patients in peripheral blood lymphocytes (PBL) and tumor infiltrating lymphocytes (TIL) and in those patients that did and did not respond to treatment.
Serum Cytokines Levels
Time frame: Prior to each weekly cetuximab treatment (up to 4 weeks); at the time of surgery (at 3-4 weeks after first cetuximab treatments)
Serum cytokines levels measured at pre-/post-cetuximab, exposure measured in picogram per milliliter of plasma (pg/ml)
T Cell Activation
Time frame: Prior to each weekly cetuximab treatment (up to 4 weeks); at the time of surgery (at 3-4 weeks after first cetuximab treatments)
T cell activation measured at pre-/post-cetuximab exposure

6 secondary outcomes

Frequency of EGFR-specific T Cells (EGFR853-861 Peptide-specific Tetramer+ CD8+T Cells)
Time frame: Prior to each weekly cetuximab treatment (up to 4 weeks); at the time of surgery (at 3-4 weeks after first cetuximab treatments)
Progression-free Survival (PFS)
Time frame: Up to 54 months
Overall Survival (OS)
Time frame: Up to 2 years
Objective Response (Rate)
Time frame: Up to 2 years
3-year Progression-free Survival (PFS)
Time frame: 3 years
Change in Tumor Size
Time frame: Prior to each weekly cetuximab treatment (up to 4 weeks); at the time of surgery (at 3-4 weeks after first cetuximab treatments)

Results and safety

Results posted to the registry on 16 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Neo-Adjuvant Cetuximab	40	40

Primary outcome: NK Cell Activation

Time frame: Prior to each weekly cetuximab treatment (up to 4 weeks); at the time of surgery (at 3-4 weeks after first cetuximab treatments). Median (Inter-Quartile Range). Unit: percentage of activity

Measure	Neo-Adjuvant Cetuximab n = 17
Percent NK cells (PBL): pre-cetuximab	19 (13 to 22)
Percent NK cells (PBL): post-cetuximab	20 (12 to 27)
Percent NK cells (TIL): pre-cetuximab	4 (2 to 7)
Percent NK cells (TIL): post-cetuximab	3 (1 to 4)
Percent CD16+ NK cells(PBL): pre-cetuximab	55 (40 to 66)
Percent CD16+ NK cells (PBL): post-cetuximab	49 (34 to 65)
Percent CD16+ NK cells (TIL): pre-cetuximab	10 (4 to 15)
Percent CD16+ NK cells (TIL): post-cetuximab	6 (4 to 9)

Population analysed: Participants that received preoperative treatment with single-agent cetuximab for a minimum of 3-4 weeks.Patients defined as responders, demonstrated upregulation of CD137 on tumor infiltrating NK cells following cetuximab therapy compared with non-responders.

Primary outcome: Serum Cytokines Levels

Time frame: Prior to each weekly cetuximab treatment (up to 4 weeks); at the time of surgery (at 3-4 weeks after first cetuximab treatments). Median (Inter-Quartile Range). Unit: pg/ml

Measure	Neo-Adjuvant Cetuximab n = 33
Responders: pre-cetuximab GM-CSF	2.5 (2.0 to 8.0)
Non-responders: pre-cetuximab GM-CSF	18.0 (2.0 to 22.0)
Responders: post-cetuximab GM-CSF	11.0 (7.0 to 13.0)
Non-responders: post-cetuximab GM-CSF	5.0 (2.0 to 12.5)
Responders: pre-cetuximab CCL2	260 (175 to 500)
Non-responders: pre-cetuximab CCL2	500 (100 to 1600)
Responders: post-cetuximab CCL2	250 (200 to 400)
Non-responders: post-cetuximab CCL2	200 (100 to 750)

Population analysed: Participants that received preoperative treatment with single-agent cetuximab for a minimum of 3-4 weeks.

Primary outcome: T Cell Activation

Measure	Neo-Adjuvant Cetuximab n = 33
Pre-cetuximab	0.25 (0.20 to 0.30)
Post-cetuximab	1.0 (0.90 to 1.40)

Population analysed: Participants that received preoperative treatment with single-agent cetuximab for a minimum of 3-4 weeks.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Neo-Adjuvant Cetuximab	8 of 40 (20%)	32 of 40 (80%)	32 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26579227Li J, Srivastava RM, Ettyreddy A, Ferris RL. Cetuximab ameliorates suppressive phenotypes of myeloid antigen presenting cells in head and neck cancer patients. J Immunother Cancer. 2015 Nov 17;3:54. doi: 10.1186/s40425-015-0097-6. eCollection 2015.

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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.

Rober L Ferris, MD, PhD principal investigator

University of Pittsburgh Med Ctr (UPCI)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cetuximab, Surgery and Post-surgical radiation in people with Squamous Cell Carcinoma of the Head and Neck, run by Robert Ferris at 1 site in United States.

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 10 inclusion and 15 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: finished, as of the sponsor's last update on 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 phase mean?

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?

Yes. Results are posted in the registry (first posted 16 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

NK Cell Activation (time frame: Prior to each weekly cetuximab treatment (up to 4 weeks); at the time of surgery (at 3-4 weeks after first cetuximab treatments)). 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?

On the ClinicalTrials.gov record for NCT01218048, which also lists 1 linked publication.

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 16 Aug 2018.