A Phase 3 interventional study of Talimogene Laherparepvec and Radiation in Squamous Cell Carcinoma and Head and Neck Cancer, sponsored by BioVex Limited. Terminated at 6 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-08.
Sponsored by BioVex Limited · Phase 3, Interventional, and Treatment
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.
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.
6,738 studies on the registry are indexed under Carcinoma; 1,159 are open to participants now.
This study's enrollment of 5 is below the median of 45 across 5,167 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →BioVex Limited is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Participants 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.
Radiation: Radiation · Drug: Cisplatin
The 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.
Biological: Talimogene Laherparepvec · Radiation: Radiation · Drug: Cisplatin
Administered by intratumoral injection
Also known as: OncoVEX^GM-CSF, IMLYGIC
70 grays of radiation administered in 35 fractions over 7 weeks
Administered by intravenous infusion
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.
Time frame: 2 years
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.
Time frame: End of trial; the maximum time on study was 20 weeks.
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.
Time frame: End of study; the maximum time on study was 20 weeks.
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.
Time frame: Up to Week 20
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.
Time frame: Up to 27 months
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.
Time frame: Up to 27 months
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.
Time frame: Up to 27 months
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.
Time frame: Up to 5 years after chemoradiotherapy
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.
Time frame: Up to 5 years after chemoradiotherapy
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.
Time frame: Weeks 19 - 21
This study was open to patients with advanced, non-metastatic, stage III or IV squamous cell carcinoma of the head and neck (SCCHN).
| Milestone | Radiation/Cisplatin | Talimogene Laherparepvec + Radiation/Cisplatin |
|---|---|---|
| Started | 3 | 2 |
| Completed | 3 | 1 |
| Not completed | 0 | 1 |
| Withdrew: Disease progression | 0 | 1 |
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.
No measurements were reported for this outcome.
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.
| participants | Radiation/Cisplatin | Talimogene Laherparepvec + Radiation/Cisplatin |
|---|---|---|
| Clinical Complete Response (cCR) | 2 | 1 |
| Clinical Partial Response (cPR) | 0 | 0 |
| Progressive Disease | 1 | 0 |
| Unevaluable | 0 | 1 |
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.
| participants | Radiation/Cisplatin | Talimogene Laherparepvec + Radiation/Cisplatin |
|---|---|---|
| Metabolic Complete Response (mCR) | 1 | 1 |
| Metabolic Partial Response (mPR) | 0 | 0 |
| Metabolic Progressive Disease (mPD) | 1 | 0 |
| Stable Metabolic Response (mSD) | 0 | 0 |
| Unevaluable | 1 | 1 |
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.
| participants | Radiation/Cisplatin | Talimogene Laherparepvec + Radiation/Cisplatin |
|---|---|---|
| Pathologic Complete Response (mCR) | 0 | — |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Collected over 20 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Radiation/Cisplatin | — | 2/3 (66.7%) | 3/3 (100%) |
| Talimogene Laherparepvec + Radiation/Cisplatin | — | 2/2 (100%) | 2/2 (100%) |
| Event | Radiation/Cisplatin | Talimogene Laherparepvec + Radiation/Cisplatin |
|---|---|---|
| Lung infectionInfections and infestations | 0/3 | 1/2 |
| Urinary tract infectionInfections and infestations | 0/3 | 1/2 |
| HyperglycaemiaMetabolism and nutrition disorders | 0/3 | 1/2 |
| Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/3 | 1/2 |
| Renal failure acuteRenal and urinary disorders | 0/3 | 1/2 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 0/3 | 1/2 |
| Mouth haemorrhageGastrointestinal disorders | 1/3 | 0/2 |
| DehydrationMetabolism and nutrition disorders | 1/3 | 0/2 |
| Event | Radiation/Cisplatin | Talimogene Laherparepvec + Radiation/Cisplatin |
|---|---|---|
| Abdominal painGastrointestinal disorders | 0/3 | 2/2 |
| DiarrhoeaGastrointestinal disorders | 1/3 | 2/2 |
| NauseaGastrointestinal disorders | 1/3 | 2/2 |
| Salivary duct inflammationGastrointestinal disorders | 1/3 | 2/2 |
| StomatitisGastrointestinal disorders | 3/3 | 1/2 |
| AnaemiaBlood and lymphatic system disorders | 2/3 | 0/2 |
| VomitingGastrointestinal disorders | 2/3 | 1/2 |
| ConstipationGastrointestinal disorders | 1/3 | 1/2 |
| Dry mouthGastrointestinal disorders | 0/3 | 1/2 |
| DysphagiaGastrointestinal disorders | 0/3 | 1/2 |
| Age, Categorical(Participants) | Radiation/Cisplatin | Talimogene Laherparepvec + Radiation/Cisplatin | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 1 | 4 |
| >=65 years | 0 | 1 | 1 |
| Sex: Female, Male(Participants) | Radiation/Cisplatin | Talimogene Laherparepvec + Radiation/Cisplatin | Total |
|---|---|---|---|
| Female | 1 | 0 | 1 |
| Male | 2 | 2 | 4 |
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