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Efficacy and Safety Study of Leukocyte Interleukin,Injection (LI) to Treat Cancer of the Oral Cavity (IT-MATTERS)

Primary Purpose

Squamous Cell Carcinoma of the Oral Cavity, Squamous Cell Carcinoma of the Soft Palate

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
LI
Cyclophosphamide
Indomethacin
Zinc
Surgery
Cisplatin
Radiotherapy
Sponsored by
CEL-SCI Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma of the Oral Cavity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria (main):

  • Untreated SCCHN of oral cavity (anterior tongue, floor of mouth, cheek)/soft palate, categories T1N1-2M0,T2N1-2M0,T3N0-2M0,T4N0-2M0 (T4 allowed only if invasion of mandible is negligible i. e. 5mm or less) scheduled for SOC
  • Primary tumor and any positive node(s) measurable in 2 dimensions
  • Normal immune function
  • No immunosuppressives with 1 year of entry
  • KPS>70/100
  • Age>18
  • Male or Female (non-pregnant)
  • Life expectancy >6 months
  • Able to take oral medication
  • Able to provide informed consent

Exclusion Criteria (main):

  • Subjects to be treated with other than SOC
  • Tumor invasion of bone (also see inclusion criteria)
  • Tumor classifications T1N0, T2N0, T4N3, any TN classification with M1
  • Tumors in locations other than those specified in inclusion criteria
  • Active peptic ulcer (or on full-dose therapeutic anti-coagulants)
  • Prior resection of jugular nodes ipsilateral to tumor
  • Acute or chronic viral, bacterial immune or other disease associated with abnormal immune function
  • Subjects on hemodialysis or peritoneal dialysis; or having a history of
  • History of asthma, allergy to fluoroquinolone antibiotics, congestive heart failure, or on hemodialysis or peritoneal dialysis
  • Any condition that in the opinion of the investigator would cause the subject to be unable to participate or tolerate the protocol regimen
  • Failure to meet inclusion criteria

Sites / Locations

  • Simmons Cancer Institute at Southern Illinois University
  • Henry Ford Health System Henry Ford Hospital
  • University of Cincinnati Medical Center
  • Medical College Of South Carolina MSC550
  • VA Puget Sound Healthcare System & University of WA
  • HNO-Klinik der medizinischen Universitat Graz
  • N.N. Alexandrov Research Istitute of Oncology and Medical Radiology
  • Vitebsk Regional Oncology Dispensary
  • University Clinical Centre Tuzla
  • Clinical Center Banja Luka
  • University Clinical Hospital Mostar
  • Clinical Centre University of Sarejevo Clinic for ENT
  • St. Josephs Healthcare Department of Surgery
  • Centre Hospitalier Universitaire de Sherbrooke
  • CHU de Quebec - L'Hotel Dieu de Quebec
  • CHC Osijek
  • General Hospital Dr. Josip Bencevic
  • CH Dubrava
  • Clinical Hospital Center Zagreb Kispaticeva 12
  • KBC Sestre Milosrdnice
  • KBC Zagreb
  • ICL 6 avenue Bourgogne CS30519
  • University of Debrecen Medical and Health Scioence Centre
  • National institute of Oncology
  • Semmelweis University
  • University of Pecs Institute of Oncotherapy
  • University of Szeged Dept of Oral and Maxillofacial Surgery
  • Markusovsky Teaching Hospital
  • Bibi General Hospital and Cancer Centre
  • Amrita Institute of Medical Sciences
  • Sujan Regional Cancer Hospital & Amravati Cancer Foundation
  • Government Medical College and Hospital
  • Tata Memorial Hospital
  • Curie Manavata Cancer Center
  • Searoc Cancer Center
  • V.N. Cancer Center G. Kuppuswamy Naidu Memorial Hospital
  • Meenakshi Mission Hospital and Research Centre
  • Regional Cancer Center
  • Galaxy Cancer Center
  • Rambam Health Care Campus
  • Rabin Medical Center
  • National Tumor Institute of Italy
  • Ospedale S.G. Moscati Santissima Annunziata
  • Dept of Head and Neck Surgery School of Medical Sciences Univ. Sains
  • University Kabangsan Medical Center
  • Wojewodzki Szpital Specjalistyczny im Kopernika
  • Swietokrzyskie Centrum Onkologii
  • Centrum Onkologii im. Prof. Lukaszcyka
  • Centrum Onkologi-Instytut im. Marie Sklodowskiej-Curie
  • ul. M. Sklodowskiej-Curie 24A
  • Szpital Specialistyczny im. Ludwika Rydgiera
  • Samodzielny Publiczny Szpital Kliniczny Klinika Otolarryngologii I Onkologii Laryngologicznej
  • Weilkopolskie Centrum Onkologii Klinika Chirurgii Glowy Szye Onkologii Laryngologiczne
  • Uniwersitecki Szpital Kliniczny Klinika Otolaryngologii Chirugii Glowy i Szxyi
  • Regional Institute of Oncology IASI
  • Spital Clinic Judetean Mures
  • Sverdlovsk Regional Cancer Center
  • Leningrad Regional Oncology Center
  • Kursk Regional Clinical Oncology Dispensary
  • Blokhin Cancer Research Center
  • N.N. Blokhin Russian Cancer Research Center
  • Budget Institution of Healthcare of Omsk Region Clincal Oncology Dispensary
  • Ryazan Clinical oncology Dispensary
  • Serbia Clinic for ENT and Maxillofacial Surgery
  • Clincal Center Serbia Clinic for Oral and Maxillofacial Surgery
  • Faculty of Dental Medicine Clinic for Maxillofacial Surgery
  • Military Medical Academy Clinic for Maxillofacial Surgery
  • Clinical Center Nis center for Oncology
  • Clinic for Stomatology department for maxillofacial Surgery
  • Clinical center Vojvodina Clinic for ORL
  • Clinical Centre Vojvodina Clinic for Maxillofacial Surgery
  • Hospital Universitari Vall d'Hebron
  • Hospital Universitario de Princesa
  • Hospital Universitario Ramon y Cajal
  • Hospital Madrid North Universitaro de Sanchinnaro
  • Complejo Hospitalario Univ. de Santiago
  • Consorsio Hospital General Universitario de valencia
  • National Cancer Institute Dept of Clinical Oncology & Radiotherapy
  • Oncology Unit Teaching Hospital Karapitya
  • Kaohsiung Branch Chang Gung Memorial Hospital
  • National Cheng Kung University Hospital
  • National Taiwan Research Hospital
  • Linkou Branch Chang Gung Memorial Hospital
  • Changua Christian Hospital
  • Buddhist Tzu Chi General Hospital, Hualien Branch
  • China Medical University Hospital
  • Taichung Veterans General Hospital
  • Shin-Kong Wu Ho-Su Memorial Hospital
  • Khon Kaen University Dept of Otolaryngology
  • Haceteppe University Dept of Otolaryngology - Head and Neck Surgery
  • Acibadem University Maslak Hospital ENT Department
  • Cherkasky Regional Oncological Dyspensary Dept. Head and Neck tumour
  • Clinical Diagnostic Laboratory of Dnepropetrovsk Municipal Institution City Multidisciplinary Clinical Hospital No. 4
  • Donetsk Regional Antitumor Center
  • Grigoriev Institute for Medical Radiology of National Academy of Medical Science of Ukraine Dept. of Remote, Combined Radiation and Complex Therapy
  • Kharkiv Regional Clinical Oncology Center Dept. Of Head and Neck Tumour
  • Kiev City Clinical Oncology Center of the Main Health Care Dept of Kiev Day Hospital Radiotherapy Dept.
  • Kiev City Clinical Oncology Center of the Main Health Care Dept. of the Kiev Day Hospital
  • Lviv State OncologyRegional treatment and Diagnostic Center
  • Sumy Regional Clinical Oncology Dyspensary
  • Zaporiz'ka Regional Clinical Oncology Dispensary
  • Aintree University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

LI + CIZ + SOC

Standard of Care (SOC) only

LI + SOC

Arm Description

LI plus CIZ (cyclophosphamide, indomethacin and zinc-multivitamins) was given as neoadjuvant therapy prior to standard of care (SOC).

SOC for previously untreated SCCHN patients is currently surgery (with curative intent) followed by either radiotherapy or combined radiochemotherapy depending on the patient's risk status for recurrence as determined at surgery.

LI was administered without CIZ to determine the contribution of CIZ to the effects of LI.

Outcomes

Primary Outcome Measures

Overall Survival (OS)
OS was assessed using Kaplan-Meier life-table using a log rank test and confirmed further with tumor stage, tumor location, and geographic stratified log rank test. Both Stratified and unstratified log rank test are presented with the unstratified log rank test constituting the primary analysis. A two-sided p-value of 0.05 or less was considered statistically significant for comparing the two groups (i.e., Study comparator arms: LI+CIZ+SOC vs. SOC alone). Interim analyses were performed (by the iDMC) periodically throughout the study to assess safety, sample size and futility.
OS in Low Risk Subjects
OS was assessed using Kaplan-Meier life-table using a log rank test and confirmed further with tumor stage, tumor location, and geographic stratified log rank test. Both Stratified and unstratified log rank test are presented with the unstratified log rank test constituting the primary analysis. A two-sided p-value of 0.05 or less was considered statistically significant for comparing the two groups (i.e., Study comparator arms: LI+CIZ+SOC vs. SOC alone). Low-risk assessment and data analysis was never performed during the study and was done only after database lock.

Secondary Outcome Measures

Local Regional Control (LRC)
LRC is defined as the number of months from randomization to the date of documented local or regional failure (recurrence or progression) or date of last follow-up or death. LRC failure includes the reappearance (recurrence) of disease (at the original tumor sites), progressive disease (but not distant metastases), or any new disease (including new disease in lymph nodes), above the clavicle, not present at baseline. This is the traditional RTOG measure of local-regional control, also referred to as Freedom from Local Progression.
LRC in Low Risk Subjects
LRC is defined as the number of months from randomization to the date of documented local or regional failure (recurrence or progression) or date of last follow-up or death. LRC failure includes the reappearance (recurrence) of disease (at the original tumor sites), progressive disease (but not distant metastases), or any new disease (including new disease in lymph nodes), above the clavicle, not present at baseline. This is the traditional RTOG measure of local-regional control, also referred to as Freedom from Local Progression. Low risk assessment and data analysis was never performed during the study and was done only after database lock.
Progression Free Survival (PFS)
PFS is defined as the number of months from randomization to the date of first documented, progressive disease (any tumor recurrence, any new disease above clavicle or distant metastases) or the date of last follow-up or death. Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest dimension (LD) of target lesions, taking as reference the smallest sum of LD recorded since the treatment started or the appearance of one or more new lesions.
PFS in Low Risk Subjects
PFS is defined as the number of months from randomization to the date of first documented, progressive disease (any tumor recurrence, any new disease above clavicle or distant metastases) or the date of last follow-up or death. Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest dimension (LD) of target lesions, taking as reference the smallest sum of LD recorded since the treatment started or the appearance of one or more new lesions. Low risk assessment and data analysis was not performed during the study and was performed only after database lock.
Quality of Life by EORTC QLQ-C30 Global Health Status [GHS] at Month 2
The European Organisation for Research and Treatment of Cancer Quality of Life Questionaire C-30 Version 3.0 (EORTC QLQ-C30) V3.0 is composed of both multi-item scales and single-item measures. The Global Health Scale/QoL multi-item scale [GHS] is a comprised of two Items: Item 29 "How would you rate your overall health during the past week?", and item 30: "How would you rate your overall quality of life during the past week?". Both items are 7 point scales ranging from a score of 1 (very poor) to 7 (Excellent). The GHS is constructed by averaging Items 29 and 30 to obtain a raw score (RS). The RS is then transformed to a 0-100 scale by the equation GHS=100*[(RS-1)/6]. A higher score represents a higher ("better") QoL. Change in GHS is calculated as Observed - Baseline, so a positive change in GHS is improved QoL. Treatment comparisons are active treatment arms minus SOC, so a positive difference favors active treatment.
Quality of Life by EORTC QLQ-C30 Global Health Status [GHS] at Month 36
The European Organisation for Research and Treatment of Cancer Quality of Life Questionaire C-30 Version 3.0 (EORTC QLQ-C30) V3.0 is composed of both multi-item scales and single-item measures. The Global Health Scale/QoL multi-item scale [GHS] is a comprised of two Items: Item 29 "How would you rate your overall health during the past week?", and item 30: "How would you rate your overall quality of life during the past week?". Both items are 7 point scales ranging from a score of 1 (very poor) to 7 (Excellent). The GHS is constructed by averaging Items 29 and 30 to obtain a raw score (RS). The RS is then transformed to a 0-100 scale by the equation GHS=100*[(RS-1)/6]. A higher score represents a higher ("better") QoL. Change in GHS is calculated as Observed - Baseline, so a positive change in GHS is improved QoL. Treatment comparisons are active treatment arms minus SOC, so a positive difference favors active treatment.
EORTC Quality of Life Questionnaire (QLQ) - Head & Neck Cancer Module: QLQ-H&N35 at Month 2
The European Organisation for Research and Treatment of Cancer Quality of Life Questionaire C-30 Version 3.0 supplementary Head & neck cancer module (EORTC QLQ-C30 - QLQ H&N35) items 1-4 make up the symptom score for pain, items 5-8 for swallowing. The 4 pain questions score: "pain in your mouth, pain in your jaw, soreness in your mouth, a painful throat?" The 4 swallowing questions score "problems swallowing: liquids, pureed food, solid food, choking? Item are scored as 1 (Not at all) to 4 (Very much). Each symptom scale is constructed by averaging the 4 items to obtain a raw score (RS). The RS is then transformed to a 0-100 scale by the equation symptom score (pain or swallowing)=100*[(RS-1)/3]. A high score for these symptom scales represents a high level of symptoms.Change in symptom is calculated as Observed - Baseline, so a negative change is reduced symptomatology . Treatment comparisons are active treatment arms minus SOC, so a negative difference favors active treatment.
EORTC Quality of Life Questionnaire (QLQ) - Head & Neck Cancer Module: QLQ-H&N35 at Month 36
The European Organisation for Research and Treatment of Cancer Quality of Life Questionaire C-30 Version 3.0 supplementary Head & neck cancer module (EORTC QLQ-C30 - QLQ H&N35) items 1-4 make up the symptom score for pain, items 5-8 for swallowing. The 4 pain questions score: "pain in your mouth, pain in your jaw, soreness in your mouth, a painful throat?" The 4 swallowing questions score "problems swallowing: liquids, pureed food, solid food, choking? Item are scored as 1 (Not at all) to 4 (Very much). Each symptom scale is constructed by averaging the 4 items to obtain a raw score (RS). The RS is then transformed to a 0-100 scale by the equation symptom score (pain or swallowing)=100*[(RS-1)/3]. A high score for these symptom scales represents a high level of symptoms.Change in symptom is calculated as Observed - Baseline, so a negative change is reduced symptomatology . Treatment comparisons are active treatment arms minus SOC, so a negative difference favors active treatment.
Statistical Comparisons of Time-to-event Outcomes (OS, LRC, PFS) Were Repeated for Varying Levels of Histopathology (HP) Markers in Low Risk Subjects
HP analysis was performed in a blinded manner by a central pathology laboratory at the end of the study on available samples. To examine potential effects of HP markers on time-to-event efficacy outcomes (OS, LRC, PFS), participants were classified by HP marker levels: 20 HP markers were classified as (low, medium, high), 2 HP ratios as (low, medium, high) and 14 HP combinations as (low, high), resulting in 94 (20*3+2*3+2*14) possible treatment comparisons of LI + CIZ + SOC to SOC. A total of 282 (94 x 3 efficacy outcomes) statistical tests (Cox proportional hazards regressions to test for a significant treatment effect in the model) were made. Significance (two-sided p<0.05 favoring LI + CIZ + SOC) were reported under LI + CIZ + SOC. Significant test results favoring SOC were reported under SOC. The total number of statistical comparisons between LI + CIZ + SOC and SOC (282) is reported under both arms.

Full Information

First Posted
December 22, 2010
Last Updated
August 17, 2022
Sponsor
CEL-SCI Corporation
Collaborators
Teva Branded Pharmaceutical Products R&D, Inc., Orient Europharma Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01265849
Brief Title
Efficacy and Safety Study of Leukocyte Interleukin,Injection (LI) to Treat Cancer of the Oral Cavity
Acronym
IT-MATTERS
Official Title
Phase III Study of LI [Multikine®] Plus SOC (Surgery + Radiotherapy or Surgery + Concurrent Radiochemotherapy) in Subjects With Advanced Primary Squamous Cell Carcinoma of the Oral Cavity/Soft Palate vs. SOC Only
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 2010 (Actual)
Primary Completion Date
May 15, 2020 (Actual)
Study Completion Date
December 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CEL-SCI Corporation
Collaborators
Teva Branded Pharmaceutical Products R&D, Inc., Orient Europharma Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study was to determine whether LI administered in combination with cyclophosphamide, indomethacin and zinc in a multivitamin (CIZ) combination prior to standard of care therapy (surgery followed by radiotherapy or concurrent radiochemotherapy) is safe and will increase the overall survival of subjects with previously untreated locally advanced primary squamous cell carcinoma of the oral cavity or soft palate at a median of 3 to 5 years
Detailed Description
Head and neck carcinomas constitute about 5% of all cancers annually worldwide. In the US there are about 65,000 new cases annually. Ninety percent are squamous cell carcinoma of the head and neck (SCCHN). Approximately 2/3 of SCCHN patients present on their first visit with locally advanced disease. The median 3 year overall survival (OS) for these patients with existing standard of care (SOC) therapies - surgery followed by radiotherapy or concurrent radiochemotherapy - is estimated to be between 52 and 55%; the 5 year OS is approximately 43%. There are clearly many of SCCHN patients not well served by available modalities. Regional intra or perilymphatic and/or intratumoral or peritumoral low dose cytokine therapy may have important therapeutic effects in SCCHN patients and constitute an additional anti-tumor mechanism of action different and distinct from current SOC. Leukocyte Interleukin Injection (LI) [Multikine] contains a defined mixture of naturally derived cytokines and chemokines with demonstrated safety and immunomodulatory activity in animals and in man in Phase I and Phase II clinical trials. LI is administered prior to SOC and in combination with low non-chemotherapeutic doses of cyclophosphamide, indomethacin, and zinc (CIZ) in studies with LI. The results of these studies indicate that the local/regional injection of mixed interleukins (LI) with CIZ prior to SOC can overcome local immunosuppression, break tumor tolerance to tumor antigens and allow for a sustainable and effective anti-tumor immune response. LI was tested in this large, global, multinational Phase III clinical trial to develop definitive proof of its efficacy and safety in treating SCCHN. The trial is an open-label randomized multi-center controlled study of LI + CIZ + SOC in subjects with advanced primary SCCHN of the oral cavity/soft palate vs. SOC [the comparator arm]. OS is the primary efficacy endpoint.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of the Oral Cavity, Squamous Cell Carcinoma of the Soft Palate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
928 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LI + CIZ + SOC
Arm Type
Experimental
Arm Description
LI plus CIZ (cyclophosphamide, indomethacin and zinc-multivitamins) was given as neoadjuvant therapy prior to standard of care (SOC).
Arm Title
Standard of Care (SOC) only
Arm Type
Active Comparator
Arm Description
SOC for previously untreated SCCHN patients is currently surgery (with curative intent) followed by either radiotherapy or combined radiochemotherapy depending on the patient's risk status for recurrence as determined at surgery.
Arm Title
LI + SOC
Arm Type
Experimental
Arm Description
LI was administered without CIZ to determine the contribution of CIZ to the effects of LI.
Intervention Type
Biological
Intervention Name(s)
LI
Other Intervention Name(s)
Multikine, Leukocyte interleukin, injection
Intervention Description
LI 400 IU (2.0mL total daily) 1.0 mL peritumoral, 1.0 mL perilymphatic 5x weekly x3 consecutive weeks administered as neoadjuvant therapy prior to SOC, (surgery followed by radiation or concurrent radiochemotherapy with cisplatin 100 mg/m^2 intravenously x3) to determine if LI plus CIZ affects the 3-5 year overall survival.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Cyclophosphamide was administered IV bolus (one time only) at a dose of 300mg/m^2 three days prior to beginning treatment with LI. Standard of care (SOC) for previously untreated squamous cell carcinoma of the head and neck is currently surgery followed by radiotherapy (60-70Gy in 30 to 35 fractions over 6 to 7 weeks) for higher risk subjects (subjects determined at surgery to have adverse features per the National Comprehensive Cancer Network (NCCN) guidelines, such as, positive surgical margins, 2 or more clinically positive nodes or extracapsular nodal spread, etc. that would pre-dispose them for higher risk of recurrence) radiotherapy is combined with concurrent chemotherapy (cisplatin 100mg/m^2 intravenously on day 1 of weeks 1, 4 and 7 of radiotherapy.
Intervention Type
Drug
Intervention Name(s)
Indomethacin
Intervention Description
One 25mg capsule of indomethacin was self administered orally (BID) beginning on day one of LI treatment daily until the day before surgery.
Intervention Type
Dietary Supplement
Intervention Name(s)
Zinc
Other Intervention Name(s)
Multivitamins
Intervention Description
One capsule daily self administered beginning on day one of treatment with LI until one day before surgery
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
Excise tumor and nodes
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin was administered 100mg/m^2 IV concurrent with radiotherapy. The chemotherapy agent (cisplatin 100mg/m^2) was administered intravenously on day 1 of weeks 1, 4 and 7 of radiotherapy.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
Total 60 to 70 Gy (2Gy per day) in 30 to 35 fractions over 6 to 7 weeks to subjects determined at surgery to be at lower risk for recurrence (per NCCN guidelines). For subjects determined at surgery to be at higher risk for recurrence due to having positive surgical margins, 2 or more clinically positive nodes or extracapsular nodal spread etc. (per NCCN guidelines), radiotherapy (as above) is combined with concurrent chemotherapy (cisplatin 100 mg/m^2) intravenously on day 1 of weeks 1, 4 and 7 of radiotherapy.
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS was assessed using Kaplan-Meier life-table using a log rank test and confirmed further with tumor stage, tumor location, and geographic stratified log rank test. Both Stratified and unstratified log rank test are presented with the unstratified log rank test constituting the primary analysis. A two-sided p-value of 0.05 or less was considered statistically significant for comparing the two groups (i.e., Study comparator arms: LI+CIZ+SOC vs. SOC alone). Interim analyses were performed (by the iDMC) periodically throughout the study to assess safety, sample size and futility.
Time Frame
From the date of treatment assignment to death or the last follow-up date. Maximum follow-up was approximately 113 months.
Title
OS in Low Risk Subjects
Description
OS was assessed using Kaplan-Meier life-table using a log rank test and confirmed further with tumor stage, tumor location, and geographic stratified log rank test. Both Stratified and unstratified log rank test are presented with the unstratified log rank test constituting the primary analysis. A two-sided p-value of 0.05 or less was considered statistically significant for comparing the two groups (i.e., Study comparator arms: LI+CIZ+SOC vs. SOC alone). Low-risk assessment and data analysis was never performed during the study and was done only after database lock.
Time Frame
From the date of treatment assignment to death or the last follow-up date. Maximum follow-up was approximately 113 months.
Secondary Outcome Measure Information:
Title
Local Regional Control (LRC)
Description
LRC is defined as the number of months from randomization to the date of documented local or regional failure (recurrence or progression) or date of last follow-up or death. LRC failure includes the reappearance (recurrence) of disease (at the original tumor sites), progressive disease (but not distant metastases), or any new disease (including new disease in lymph nodes), above the clavicle, not present at baseline. This is the traditional RTOG measure of local-regional control, also referred to as Freedom from Local Progression.
Time Frame
From the date of treatment assignment to LRC or the last follow-up date. Maximum follow-up was approximately 113 months.
Title
LRC in Low Risk Subjects
Description
LRC is defined as the number of months from randomization to the date of documented local or regional failure (recurrence or progression) or date of last follow-up or death. LRC failure includes the reappearance (recurrence) of disease (at the original tumor sites), progressive disease (but not distant metastases), or any new disease (including new disease in lymph nodes), above the clavicle, not present at baseline. This is the traditional RTOG measure of local-regional control, also referred to as Freedom from Local Progression. Low risk assessment and data analysis was never performed during the study and was done only after database lock.
Time Frame
From the date of treatment assignment to LRC or the last follow-up date. Maximum follow-up was approximately 113 months.
Title
Progression Free Survival (PFS)
Description
PFS is defined as the number of months from randomization to the date of first documented, progressive disease (any tumor recurrence, any new disease above clavicle or distant metastases) or the date of last follow-up or death. Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest dimension (LD) of target lesions, taking as reference the smallest sum of LD recorded since the treatment started or the appearance of one or more new lesions.
Time Frame
From the date of treatment assignment to PFS or the last follow-up date. Maximum follow-up was approximately 113 months.
Title
PFS in Low Risk Subjects
Description
PFS is defined as the number of months from randomization to the date of first documented, progressive disease (any tumor recurrence, any new disease above clavicle or distant metastases) or the date of last follow-up or death. Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest dimension (LD) of target lesions, taking as reference the smallest sum of LD recorded since the treatment started or the appearance of one or more new lesions. Low risk assessment and data analysis was not performed during the study and was performed only after database lock.
Time Frame
From the date of treatment assignment to PFS or the last follow-up date. Maximum follow-up was approximately 113 months.
Title
Quality of Life by EORTC QLQ-C30 Global Health Status [GHS] at Month 2
Description
The European Organisation for Research and Treatment of Cancer Quality of Life Questionaire C-30 Version 3.0 (EORTC QLQ-C30) V3.0 is composed of both multi-item scales and single-item measures. The Global Health Scale/QoL multi-item scale [GHS] is a comprised of two Items: Item 29 "How would you rate your overall health during the past week?", and item 30: "How would you rate your overall quality of life during the past week?". Both items are 7 point scales ranging from a score of 1 (very poor) to 7 (Excellent). The GHS is constructed by averaging Items 29 and 30 to obtain a raw score (RS). The RS is then transformed to a 0-100 scale by the equation GHS=100*[(RS-1)/6]. A higher score represents a higher ("better") QoL. Change in GHS is calculated as Observed - Baseline, so a positive change in GHS is improved QoL. Treatment comparisons are active treatment arms minus SOC, so a positive difference favors active treatment.
Time Frame
Global Health Status (GHS) at Baseline [pre-randomization], Long Term Follow-up Month 2
Title
Quality of Life by EORTC QLQ-C30 Global Health Status [GHS] at Month 36
Description
The European Organisation for Research and Treatment of Cancer Quality of Life Questionaire C-30 Version 3.0 (EORTC QLQ-C30) V3.0 is composed of both multi-item scales and single-item measures. The Global Health Scale/QoL multi-item scale [GHS] is a comprised of two Items: Item 29 "How would you rate your overall health during the past week?", and item 30: "How would you rate your overall quality of life during the past week?". Both items are 7 point scales ranging from a score of 1 (very poor) to 7 (Excellent). The GHS is constructed by averaging Items 29 and 30 to obtain a raw score (RS). The RS is then transformed to a 0-100 scale by the equation GHS=100*[(RS-1)/6]. A higher score represents a higher ("better") QoL. Change in GHS is calculated as Observed - Baseline, so a positive change in GHS is improved QoL. Treatment comparisons are active treatment arms minus SOC, so a positive difference favors active treatment.
Time Frame
Global Health Status (GHS) at Baseline [pre-randomization], Long Term Follow-up Month 36
Title
EORTC Quality of Life Questionnaire (QLQ) - Head & Neck Cancer Module: QLQ-H&N35 at Month 2
Description
The European Organisation for Research and Treatment of Cancer Quality of Life Questionaire C-30 Version 3.0 supplementary Head & neck cancer module (EORTC QLQ-C30 - QLQ H&N35) items 1-4 make up the symptom score for pain, items 5-8 for swallowing. The 4 pain questions score: "pain in your mouth, pain in your jaw, soreness in your mouth, a painful throat?" The 4 swallowing questions score "problems swallowing: liquids, pureed food, solid food, choking? Item are scored as 1 (Not at all) to 4 (Very much). Each symptom scale is constructed by averaging the 4 items to obtain a raw score (RS). The RS is then transformed to a 0-100 scale by the equation symptom score (pain or swallowing)=100*[(RS-1)/3]. A high score for these symptom scales represents a high level of symptoms.Change in symptom is calculated as Observed - Baseline, so a negative change is reduced symptomatology . Treatment comparisons are active treatment arms minus SOC, so a negative difference favors active treatment.
Time Frame
Baseline [pre-randomization], Long Term Follow-up Month 2
Title
EORTC Quality of Life Questionnaire (QLQ) - Head & Neck Cancer Module: QLQ-H&N35 at Month 36
Description
The European Organisation for Research and Treatment of Cancer Quality of Life Questionaire C-30 Version 3.0 supplementary Head & neck cancer module (EORTC QLQ-C30 - QLQ H&N35) items 1-4 make up the symptom score for pain, items 5-8 for swallowing. The 4 pain questions score: "pain in your mouth, pain in your jaw, soreness in your mouth, a painful throat?" The 4 swallowing questions score "problems swallowing: liquids, pureed food, solid food, choking? Item are scored as 1 (Not at all) to 4 (Very much). Each symptom scale is constructed by averaging the 4 items to obtain a raw score (RS). The RS is then transformed to a 0-100 scale by the equation symptom score (pain or swallowing)=100*[(RS-1)/3]. A high score for these symptom scales represents a high level of symptoms.Change in symptom is calculated as Observed - Baseline, so a negative change is reduced symptomatology . Treatment comparisons are active treatment arms minus SOC, so a negative difference favors active treatment.
Time Frame
Baseline [pre-randomization], Long Term Follow-up Month 36
Title
Statistical Comparisons of Time-to-event Outcomes (OS, LRC, PFS) Were Repeated for Varying Levels of Histopathology (HP) Markers in Low Risk Subjects
Description
HP analysis was performed in a blinded manner by a central pathology laboratory at the end of the study on available samples. To examine potential effects of HP markers on time-to-event efficacy outcomes (OS, LRC, PFS), participants were classified by HP marker levels: 20 HP markers were classified as (low, medium, high), 2 HP ratios as (low, medium, high) and 14 HP combinations as (low, high), resulting in 94 (20*3+2*3+2*14) possible treatment comparisons of LI + CIZ + SOC to SOC. A total of 282 (94 x 3 efficacy outcomes) statistical tests (Cox proportional hazards regressions to test for a significant treatment effect in the model) were made. Significance (two-sided p<0.05 favoring LI + CIZ + SOC) were reported under LI + CIZ + SOC. Significant test results favoring SOC were reported under SOC. The total number of statistical comparisons between LI + CIZ + SOC and SOC (282) is reported under both arms.
Time Frame
From the date of treatment assignment to event (LRC,PFS,OS) or the last follow-up date. Maximum follow-up was approximately 113 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria (main): Untreated SCCHN of oral cavity (anterior tongue, floor of mouth, cheek)/soft palate, categories T1N1-2M0,T2N1-2M0,T3N0-2M0,T4N0-2M0 (T4 allowed only if invasion of mandible is negligible i. e. 5mm or less) scheduled for SOC Primary tumor and any positive node(s) measurable in 2 dimensions Normal immune function No immunosuppressives with 1 year of entry KPS>70/100 Age>18 Male or Female (non-pregnant) Life expectancy >6 months Able to take oral medication Able to provide informed consent Exclusion Criteria (main): Subjects to be treated with other than SOC Tumor invasion of bone (also see inclusion criteria) Tumor classifications T1N0, T2N0, T4N3, any TN classification with M1 Tumors in locations other than those specified in inclusion criteria Active peptic ulcer (or on full-dose therapeutic anti-coagulants) Prior resection of jugular nodes ipsilateral to tumor Acute or chronic viral, bacterial immune or other disease associated with abnormal immune function Subjects on hemodialysis or peritoneal dialysis; or having a history of History of asthma, allergy to fluoroquinolone antibiotics, congestive heart failure, or on hemodialysis or peritoneal dialysis Any condition that in the opinion of the investigator would cause the subject to be unable to participate or tolerate the protocol regimen Failure to meet inclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eyal Talor, PhD
Organizational Affiliation
CEL-SCI Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Simmons Cancer Institute at Southern Illinois University
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794
Country
United States
Facility Name
Henry Ford Health System Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Medical College Of South Carolina MSC550
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29435
Country
United States
Facility Name
VA Puget Sound Healthcare System & University of WA
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Facility Name
HNO-Klinik der medizinischen Universitat Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
N.N. Alexandrov Research Istitute of Oncology and Medical Radiology
City
Lesnoy 2
State/Province
Minsk
ZIP/Postal Code
223040
Country
Belarus
Facility Name
Vitebsk Regional Oncology Dispensary
City
Vitebsk
ZIP/Postal Code
210603
Country
Belarus
Facility Name
University Clinical Centre Tuzla
City
Trnovac
State/Province
Tuzla
ZIP/Postal Code
75 000
Country
Bosnia and Herzegovina
Facility Name
Clinical Center Banja Luka
City
Banja Luka
ZIP/Postal Code
78 000
Country
Bosnia and Herzegovina
Facility Name
University Clinical Hospital Mostar
City
Mostar
ZIP/Postal Code
88000
Country
Bosnia and Herzegovina
Facility Name
Clinical Centre University of Sarejevo Clinic for ENT
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
St. Josephs Healthcare Department of Surgery
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N4A6
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
JiH 5N4
Country
Canada
Facility Name
CHU de Quebec - L'Hotel Dieu de Quebec
City
Quebec
ZIP/Postal Code
G1R2J6
Country
Canada
Facility Name
CHC Osijek
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Facility Name
General Hospital Dr. Josip Bencevic
City
Slavonski Brod
ZIP/Postal Code
35000
Country
Croatia
Facility Name
CH Dubrava
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Clinical Hospital Center Zagreb Kispaticeva 12
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
KBC Sestre Milosrdnice
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
KBC Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
ICL 6 avenue Bourgogne CS30519
City
Vandoeuvre les Nancy
ZIP/Postal Code
54519
Country
France
Facility Name
University of Debrecen Medical and Health Scioence Centre
City
Debrecen
State/Province
Hajdu Bihar
ZIP/Postal Code
krt. 98
Country
Hungary
Facility Name
National institute of Oncology
City
Budapest
State/Province
Rath Gyorgy
ZIP/Postal Code
H-1122
Country
Hungary
Facility Name
Semmelweis University
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
University of Pecs Institute of Oncotherapy
City
Pecs
ZIP/Postal Code
7628
Country
Hungary
Facility Name
University of Szeged Dept of Oral and Maxillofacial Surgery
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Markusovsky Teaching Hospital
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Bibi General Hospital and Cancer Centre
City
Malkapet
State/Province
Andhra Pradesh
ZIP/Postal Code
500024
Country
India
Facility Name
Amrita Institute of Medical Sciences
City
Kochi
State/Province
Kerala
ZIP/Postal Code
682041
Country
India
Facility Name
Sujan Regional Cancer Hospital & Amravati Cancer Foundation
City
Amravati
State/Province
Maharashtra
ZIP/Postal Code
444606
Country
India
Facility Name
Government Medical College and Hospital
City
Aurangabad
State/Province
Maharashtra
ZIP/Postal Code
431001
Country
India
Facility Name
Tata Memorial Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
Facility Name
Curie Manavata Cancer Center
City
Mumbai
State/Province
Naka Nashik
ZIP/Postal Code
422004
Country
India
Facility Name
Searoc Cancer Center
City
Jaipur
State/Province
Rajashlan
ZIP/Postal Code
302013
Country
India
Facility Name
V.N. Cancer Center G. Kuppuswamy Naidu Memorial Hospital
City
Coimbatore
State/Province
Tamil Nadu
ZIP/Postal Code
641037
Country
India
Facility Name
Meenakshi Mission Hospital and Research Centre
City
Madurai
State/Province
Tamil Nadu
ZIP/Postal Code
625107
Country
India
Facility Name
Regional Cancer Center
City
Kerola
State/Province
Thiruvananthapuram
ZIP/Postal Code
695011
Country
India
Facility Name
Galaxy Cancer Center
City
Ghaziabad
State/Province
Uttar Pradesh
ZIP/Postal Code
210010
Country
India
Facility Name
Rambam Health Care Campus
City
Sha'ar Ha'Aliya
State/Province
Saint Haifa
ZIP/Postal Code
31906
Country
Israel
Facility Name
Rabin Medical Center
City
Petaẖ Tiqwa
State/Province
Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
National Tumor Institute of Italy
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
Ospedale S.G. Moscati Santissima Annunziata
City
Taranto
ZIP/Postal Code
74010
Country
Italy
Facility Name
Dept of Head and Neck Surgery School of Medical Sciences Univ. Sains
City
Kuantan
State/Province
Penang
ZIP/Postal Code
16150
Country
Malaysia
Facility Name
University Kabangsan Medical Center
City
Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia
Facility Name
Wojewodzki Szpital Specjalistyczny im Kopernika
City
Lodz
State/Province
Ul Paderewskiego 4
ZIP/Postal Code
93-509
Country
Poland
Facility Name
Swietokrzyskie Centrum Onkologii
City
Kielce
State/Province
Ul. Artwinskiego 3
ZIP/Postal Code
25-734
Country
Poland
Facility Name
Centrum Onkologii im. Prof. Lukaszcyka
City
Warsaw
State/Province
Ul. Roentgena 5
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Centrum Onkologi-Instytut im. Marie Sklodowskiej-Curie
City
Warszawa
State/Province
Ul. Roentgena 5
ZIP/Postal Code
02-781
Country
Poland
Facility Name
ul. M. Sklodowskiej-Curie 24A
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Szpital Specialistyczny im. Ludwika Rydgiera
City
Krakow
ZIP/Postal Code
31826
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Klinika Otolarryngologii I Onkologii Laryngologicznej
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Weilkopolskie Centrum Onkologii Klinika Chirurgii Glowy Szye Onkologii Laryngologiczne
City
Poznan
ZIP/Postal Code
61-866
Country
Poland
Facility Name
Uniwersitecki Szpital Kliniczny Klinika Otolaryngologii Chirugii Glowy i Szxyi
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Regional Institute of Oncology IASI
City
Iasi
ZIP/Postal Code
700483
Country
Romania
Facility Name
Spital Clinic Judetean Mures
City
Targu Mures
ZIP/Postal Code
540072
Country
Romania
Facility Name
Sverdlovsk Regional Cancer Center
City
Sverdlov
State/Province
Ekaterinberg
ZIP/Postal Code
620905
Country
Russian Federation
Facility Name
Leningrad Regional Oncology Center
City
St. Petersburg
State/Province
Leningradskaya
ZIP/Postal Code
188663
Country
Russian Federation
Facility Name
Kursk Regional Clinical Oncology Dispensary
City
Kursk
ZIP/Postal Code
305035
Country
Russian Federation
Facility Name
Blokhin Cancer Research Center
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
N.N. Blokhin Russian Cancer Research Center
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Budget Institution of Healthcare of Omsk Region Clincal Oncology Dispensary
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
Ryazan Clinical oncology Dispensary
City
Ryazan
ZIP/Postal Code
39011
Country
Russian Federation
Facility Name
Serbia Clinic for ENT and Maxillofacial Surgery
City
Belgrade
State/Province
Pasterova 14
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clincal Center Serbia Clinic for Oral and Maxillofacial Surgery
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Faculty of Dental Medicine Clinic for Maxillofacial Surgery
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Military Medical Academy Clinic for Maxillofacial Surgery
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Center Nis center for Oncology
City
Nis
ZIP/Postal Code
18 000
Country
Serbia
Facility Name
Clinic for Stomatology department for maxillofacial Surgery
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Clinical center Vojvodina Clinic for ORL
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Clinical Centre Vojvodina Clinic for Maxillofacial Surgery
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario de Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Madrid North Universitaro de Sanchinnaro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Complejo Hospitalario Univ. de Santiago
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Consorsio Hospital General Universitario de valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
National Cancer Institute Dept of Clinical Oncology & Radiotherapy
City
Colombo
ZIP/Postal Code
10280
Country
Sri Lanka
Facility Name
Oncology Unit Teaching Hospital Karapitya
City
Galle
Country
Sri Lanka
Facility Name
Kaohsiung Branch Chang Gung Memorial Hospital
City
Niaosong
State/Province
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Taipei
State/Province
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan Research Hospital
City
Chengshan
State/Province
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Linkou Branch Chang Gung Memorial Hospital
City
Guishan
State/Province
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Changua Christian Hospital
City
Chang-hua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Buddhist Tzu Chi General Hospital, Hualien Branch
City
Hualien City
ZIP/Postal Code
970
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Shin-Kong Wu Ho-Su Memorial Hospital
City
Taipei
ZIP/Postal Code
111
Country
Taiwan
Facility Name
Khon Kaen University Dept of Otolaryngology
City
Nai- Muang
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Haceteppe University Dept of Otolaryngology - Head and Neck Surgery
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Acibadem University Maslak Hospital ENT Department
City
Istanbul
Country
Turkey
Facility Name
Cherkasky Regional Oncological Dyspensary Dept. Head and Neck tumour
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Clinical Diagnostic Laboratory of Dnepropetrovsk Municipal Institution City Multidisciplinary Clinical Hospital No. 4
City
Dnepropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Donetsk Regional Antitumor Center
City
Donetsk
ZIP/Postal Code
83092
Country
Ukraine
Facility Name
Grigoriev Institute for Medical Radiology of National Academy of Medical Science of Ukraine Dept. of Remote, Combined Radiation and Complex Therapy
City
Kharkiv
ZIP/Postal Code
61024
Country
Ukraine
Facility Name
Kharkiv Regional Clinical Oncology Center Dept. Of Head and Neck Tumour
City
Kharkiv
Country
Ukraine
Facility Name
Kiev City Clinical Oncology Center of the Main Health Care Dept of Kiev Day Hospital Radiotherapy Dept.
City
Kiev
Country
Ukraine
Facility Name
Kiev City Clinical Oncology Center of the Main Health Care Dept. of the Kiev Day Hospital
City
Kiev
Country
Ukraine
Facility Name
Lviv State OncologyRegional treatment and Diagnostic Center
City
Lviv
ZIP/Postal Code
79031
Country
Ukraine
Facility Name
Sumy Regional Clinical Oncology Dyspensary
City
Sumy
ZIP/Postal Code
40004
Country
Ukraine
Facility Name
Zaporiz'ka Regional Clinical Oncology Dispensary
City
Zaporiz'ka Oblast'
ZIP/Postal Code
69040
Country
Ukraine
Facility Name
Aintree University Hospital
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan
Links:
URL
http://www.cel-sci.com
Description
Click here for more information about this study: Phase 3 Efficacy and Safety Study of Leukocyte Interleukin,Injection (LI) to Treat Cancer of the Oral Cavity (IT-MATTERS)

Learn more about this trial

Efficacy and Safety Study of Leukocyte Interleukin,Injection (LI) to Treat Cancer of the Oral Cavity

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