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Squamous Cell CarcinomaPhase 3NCT01161498

Study of Safety and Efficacy of Talimogene Laherparepvec With Cisplatin and Radiotherapy for Treatment of Locally Advanced Head and Neck Cancer

A Phase 3 study testing Talimogene Laherparepvec, Radiation and Cisplatin in people with Squamous Cell Carcinoma and Head and Neck Cancer, run by BioVex Limited at 6 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study is being conducted to learn about the safety and risks of using talimogene laherparepvec to treat patients with head and neck cancer and to see if talimogene laherparepvec and chemoradiation together can destroy the tumours versus the use of chemoradiation alone. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Squamous Cell Carcinoma, Head and Neck Cancer
What is being tested?
Talimogene Laherparepvec, Radiation and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
6 sitesin 2 countries
Study dates
Feb 2011to Oct 2011
Phase
Phase 3
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

  • Male or female ≥ 18 years
  • Eastern Co-Operative Oncology Group (ECOG) Performance Status ≤ 1
  • Histological evidence (from the primary lesion and/or lymph nodes) of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
  • Stage III or IV disease (T2N2-3M0, T3-4N1-3M0)
  • No evidence of distant metastases by computed tomography (CT) or positron emission tomography (PET)/CT scan
  • Life expectancy > 4 months
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  • Neutrophil count ≥ 2,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10 g/dL
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Creatinine clearance ≥ 60 mL/min
  • Female patients of child-bearing potential (i.e. not surgically sterile, or not having spontaneous amenorrhea for at least 12 months) must agree to use an effective form of contraception during the treatment phase of the study.
  • Male patients must agree to use a condom with spermicide or their female partner must use an effective method of birth control.
  • Provide written informed consent in accordance with all applicable regulations and follow the study procedures. Patients must be capable of understanding the investigational nature, potential risks and benefits of the study.

Who cannot join

  • Prior treatment for locally advanced SCCHN (No prior surgery for SCCHN except nodal sampling or biopsy for study disease).
  • Patients with T1-2N1 or T1N2-3.
  • Pre-existing peripheral neuropathy ≥ Grade 2 (motor or sensory).
  • Weight loss > 20% of body weight within 3 months of screening (unless purposeful).
  • Surgery ≤ 28 days before randomization with the exception of feeding tube placement, dental extractions, central venous catheter placement, biopsies and nodal sampling.
  • Cancer of the nasopharynx, sinus, salivary gland or skin.
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  • Previous radical radiation therapy (RT) to the head and neck region, excluding superficial RT for a non-melanomatous skin cancer.
  • Prior cancers, except: those diagnosed > 5 years ago with no evidence of disease recurrence and clinical expectation of recurrence of less than 5%; or successfully treated non-melanoma skin cancer; or carcinoma in situ of the cervix.
  • Significant intercurrent illness that will interfere with the chemotherapy or radiation therapy such as human immunodeficiency (HIV) infection, cardiac failure, pulmonary compromise (chronic obstructive pulmonary disease, pneumonia or respiratory decompensation) resulting in hospitalization within 12 months of screening, or active infection.
  • Any significant cardiac disease (e.g., New York Heart Association (NYHA) Class 3 or 4; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty or coronary artery bypass graft (CABG) within the past 6 months; or uncontrolled atrial or ventricular cardiac arrhythmias..
  • High risk for poor compliance with therapy or follow up as assessed by the investigator.
  • Active herpes labialis, other lesions due to herpes simplex virus type I (HSV1) or dermatoses involving or within 50 cm of the lesions to be injected; active HSV1 lesions must have resolved before talimogene laherparepvec is injected.
  • Prior systemic chemotherapy for any type of cancer.
  • Patients for whom radiation therapy is contraindicated.
  • Pregnant or breast-feeding female. Confirmation that women of child-bearing potential are not pregnant. A negative serum β- human chorionic gonadotropin (β-hCG) pregnancy test result must be obtained during the screening period.
  • Currently enrolled and receiving an investigational agent in a clinical research study or received an investigational agent for any reason within 4 weeks prior to screening.
  • Require intermittent or chronic treatment with an anti-herpetic drug (e.g., acyclovir), other than intermittent topical use.

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

United States5 sites

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Medical Univesity of South Carolina

    Charleston, South Carolina, 29425

  • Investigative Clinical Research of Indiana

    Indianapolis, Indiana, 46260

  • James Graham Brown Cancer Center, University of Louisville

    Louisville, Kentucky, 40202

  • VCU Massey Cancer Center

    Richmond, Virginia, 23298

Other trials in United States

United Kingdom1 site

  • The Royal Marsden Hospital

    London, London, SE1 7EH

Other trials in United Kingdom

About this study

Official title: A Phase 3 Randomized Trial of Concurrent Cisplatin & Radiotherapy With Or Without ONCOVEX^GM-CSF In Previously Untreated Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck

This study is being conducted to learn about the safety and risks of using talimogene laherparepvec to treat patients with head and neck cancer and to see if talimogene laherparepvec and chemoradiation together can destroy the tumours versus the use of chemoradiation alone. This study may provide information on the usefulness of talimogene laherparepvec combined with chemoradiation as a future treatment for head and neck cancer.

Read the detailed description

The objective is to evaluate the efficacy and safety of treatment with chemoradiation (CRT) plus talimogene laherparepvec compared to CRT alone in previously untreated patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) for which surgical resection is not clinical indicated. The efficacy endpoints of the study aim to demonstrate overall clinical benefit for patients treated with talimogene laherparepvec as compared to CRT alone.

Being tested
Talimogene Laherparepvec, Radiation, Cisplatin
Keywords
squamous cell, OncoVEX^GM-CSF, Oncovex, chemoradiation, Cisplatin
Medical subject headings
Carcinoma, Squamous Cell, Head and Neck Neoplasms

What participants receive

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

  • Talimogene LaherparepvecBiological

    Also called OncoVEX^GM-CSF, IMLYGIC

    Administered by intratumoral injection

  • RadiationRadiation

    70 grays of radiation administered in 35 fractions over 7 weeks

  • CisplatinDrug

    Administered by intravenous infusion

Study groups in NCT01161498
Study groupRoleWhat they receive
Radiation/CisplatinActive comparatorParticipants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
Receives: Radiation: Radiation; Drug: Cisplatin
Talimogene Laherparepvec + Radiation/CisplatinExperimentalThe first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ plaque-forming units (PFU)/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
Receives: Biological: Talimogene Laherparepvec; Radiation: Radiation; Drug: Cisplatin

What is being measured

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

  1. 2-year Event-free Survival

    Event-free survival is defined as the time from randomization until the first evidence of relapse, disease progression (local, regional, metastatic, or second primary), or death from any cause. Because this study was terminated with only 5 participants enrolled, and the study was terminated in the first year, this endpoint was not analyzed.

    Measured: 2 years

Secondary outcomes (9)

  1. Clinical Objective Response (cOR)

    Tumor response was assessed by computed tomography (CT) scan according to a modified version of the revised Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.1). Objective response is defined as achieving a clinical partial response (cPR) or complete response (cCR). cCR is defined as disappearance of all baseline lesions. Any pathological lymph nodes must have a reduction in short axis to < 10 mm. cPR is defined as at least a 30% decrease in the sum of diameters of baseline lesions. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of baseline lesions, taking as reference the smallest sum on study, and an absolute increase of at least 5 mm, or the appearance of any new lesions.

    Because this study was terminated with 5 patients enrolled, data for this endpoint were summarized in by-patient listings only and the cOR rate was not calculated. Therefore a summary of response at the end of study is reported.

    Measured: End of trial; the maximum time on study was 20 weeks.

  2. Metabolic Complete Response (mCR)

    Response to therapy was assessed using [(18)F] fluorodeoxyglucose positron emission tomography (FDG PET) imaging to detect metabolically active tumors.

    Metabolic complete response (mCR) is defined as complete disappearance of FDG uptake attributable to tumor compared to baseline scan.

    Partial metabolic response (mPR) is defined as a > 40% decrease in specific uptake compared to the initial value in over half of the lesions.

    Disease progression (mPD) is defined as a specific uptake increase in any lesion, appearance of new lesions, or presence of extended areas of disease activity.

    Stable metabolic response (mSD) is defined as a decrease in uptake < 40% of the initial value of over half the lesions.

    Because this study was terminated with 5 patients enrolled, data for this endpoint were summarized in by-patient listings only and the metabolic complete response rate was not calculated. Therefore a summary of metabolic response at end of study is reported.

    Measured: End of study; the maximum time on study was 20 weeks.

  3. Pathologic Complete Response (mCR)

    Response to therapy was assessed histopathologically from biopsies taken at surgery for those participants who had surgery prior to Week 22.

    If no viable tumor cells were identified in surgical specimens (where the patient had surgery) the patient was classified as having a pathological complete response (pCR), and if viable tumor cells were identified, the patient was classified as having an incomplete pathologic response.

    Because this study was terminated with 5 patients enrolled, data for this endpoint were summarized in by-patient listings only and the pathologic complete response rate was not calculated. Therefore a summary of participants with a pathologic complete response before the end of study is reported.

    Measured: Up to Week 20

  4. Time to Locoregional Failure

    Locoregional failure is defined as disease progression in the head and neck area at any time following completion of chemoradiotherapy.

    Because this study was terminated with 5 subjects enrolled, time to locoregional failure was not analyzed.

    Measured: Up to 27 months

  5. Time to Distant Failure

    Distant failure is defined as disease progression at any site other than the head and neck area at any time following completion of chemoradiotherapy.

    Because this study was terminated with 5 participants enrolled, time to distant failure was not analyzed.

    Measured: Up to 27 months

  6. Time to Any Failure

    Any failure is defined as disease progression at any site at any time following completion of chemoradiotherapy.

    Because this study was terminated with 5 participants enrolled, time to any failure was not analyzed.

    Measured: Up to 27 months

  7. Overall Survival

    Overall survival is defined as the time from randomization to death from any cause.

    Because this study was terminated with 5 participants enrolled, overall survival was not analyzed.

    Measured: Up to 5 years after chemoradiotherapy

  8. Disease-specific Survival

    Disease-specific survival is defined as the time from randomization to death of the patient due to the cancer under study.

    Because this study was terminated with 5 participants enrolled, disease-specific survival was not analyzed.

    Measured: Up to 5 years after chemoradiotherapy

  9. Participants With N1-2 Disease at Baseline Requiring Neck Dissection

    Participants with Baseline Nl or N2 disease (lymph node metastasis not more than 6 cm in greatest dimension) with persistent disease as determined at the post chemoradiotherapy assessment of response were to proceed to neck dissection as permitted by the institution no later than Week 22. Since this study terminated prematurely neck dissection data were not collected or analyzed.

    Measured: Weeks 19 - 21

Timeline

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

  1. First posted13 Jul 2010 (estimated)
  2. Study startFeb 2011
  3. Primary completionOct 2011
  4. Study completionOct 2011

Why it stopped: The changing aetiology of squamous cell carcinoma of the head and neck (SCCHN).

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01161498
Sponsor's protocol ID
006/09
Other IDs
20110130
Status last verified
Jan 2016
First submitted
12 Jul 2010
Last updated
8 Feb 2016
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Talimogene Laherparepvec, Radiation and Cisplatin in people with Squamous Cell Carcinoma and Head and Neck Cancer, run by BioVex Limited at 6 sites in 2 countries.

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 16 inclusion and 17 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: stopped early, as of the sponsor's last update on 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, United Kingdom. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 17 Dec 2015). 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?

2-year Event-free Survival (time frame: 2 years). 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 NCT01161498.

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 8 Feb 2016.

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