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REOLYSIN

Phase 3

Carcinoma, Squamous Cell of the Head and Neck | Monoclonal antibody | Oncology |Oncolytics Biotech Inc.|Last Updated: Aug 4, 2023

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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment181
FDA Designations
No designations recorded
Clinical trial landscape

REOLYSIN · 11 trials · 15 indications

Phase 3 1Phase 2 7Phase 1 3
NCT01166542Efficacy Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Platinum-Refractory Head and Neck CancersCarcinoma, Squamous Cell of the Head and Neck
COMPLETED167 Analytics
PHASE3COMPLETED
Efficacy Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Platinum-Refractory Head and Neck Cancers
Carcinoma, Squamous Cell of the Head and Neck
NCT01166542167
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Study Endpoints
Primary Endpoints
Overall survival
every 3 months until death.
Progression free survival
24 months
Objective response rate (complete response (CR) + partial response (PR)) of the treatment regimen in the study population
6 months
Determine the clinical benefit rate (Complete Response (CR) + Partial Response (PR) + Stable Disease (SD))in the study population
4 weeks
Determine the antitumor effect in terms of objective response rates (i.e., partial response (PR) and complete response (CR) to treatment)
must be confirmed 4 weeks after the criteria for response are first met.
Determine the objective response rate (complete response (CR) + partial response (PR)) of the treatment regimen in the study population
For PR or CR, changes in tumor measurements must be confirmed 4 weeks after the criteria for response are first met.
Complete response (CR) and partial response (PR) as well as prolonged stabilization of disease (SD) will be considered indicative of response. RECIST criteria will be utilized to assess radiographic response.
For PR or CR, changes in tumor measurements must be confirmed 4 weeks after the criteria for response are first met. For SD, follow-up measurements must have met the SD criteria at least once after trial entry at a minimum interval of 12 weeks.
Determine the safety and DLTs of REOLYSIN® and chemotherapy (gemcitabine OR irinotecan OR 5FU) in combination with pembrolizumab in patients with advanced pancreatic adenocarcinoma who have progressed after (or did not tolerate) first line treatment
During the first cycle of treatment (3 week cycle)
Dose limiting toxicity to define maximum tolerated dose and recommended Phase 2 dose
During the first cycle of treatment (4 week cycle)
Pharmacokinetic parameters for irinotecan and 5-FU when combined with REOLYSIN®
During the first cycle of treatment (4 week cycle)
determine the maximum tolerated dose
in the first 28 days following REOLYSIN® administration
and response rate of treated tumors
evaluated monthly for 6 months following REOLYSIN® administration
determine the dose limiting toxicity
in the first 28 days following REOLYSIN® administration
Secondary Endpoints
Progression-free survival
Assessed every 6 weeks until disease progression or death.
Objective response (complete response (CR) + partial response (PR)) rate and duration
Evaluation of response is conducted every 6 weeks on and after study. Duration of objective response is measured from the time measurement criteria are first met for CR or PR until recurrent or progressive disease is objectively documented.
Number of participants with adverse events as a measure of safety and tolerability of REOLYSIN when administered in combination with paclitaxel and carboplatin.
Within 30 days of the last dose of REOLYSIN.
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
REOLYSIN, paclitaxel, carboplatinACTIVE_COMPARATOR -
placebo, paclitaxel, carboplatinPLACEBO_COMPARATOR -
Paclitaxel plus ReolysinEXPERIMENTALPaclitaxel given weekly on days 1, 8, 15 every 4 weeks plus reolysin days 1, 2, 8, 9, 15 and 16.
PaclitaxelACTIVE_COMPARATORPaclitaxel given weekly on days 1, 8 and 15 every 4 weeks.
Interventions
NameTypeDescription
REOLYSINBIOLOGICAL3E10 TCID50, 1 hour intravenous infusion, administered on Days 1, 2, 3, 4 and 5 of a 21 day cycle
CarboplatinDRUG5 AUC mg/mL min, 30 min intravenous infusion, given on Day 1 of a 21 day cycle
PaclitaxelDRUG175 mg/m2, 3 hour intravenous infusion, given on Day 1 of a 21 day cycle
PlaceboDRUGPlacebo
GemcitabineDRUG800 mg/m2 30-min infusion on Days 1 and 8 of a 21-day cycle.
REOLYSIN®BIOLOGICAL3x10E10 TCID50, 1 hour intravenous infusion, administered on Days 1, 2, 3, 4 and 5 of a 21 day cycle
ChemotherapyDRUGPatients may be treated with one of three chemotherapy backbone regimens. The decision on the chemotherapy backbone is based on physician preference.This includes either: a) Gemcitabine or b) Irinotecan or c)Leucovorin followed by 5-fluorouracil
IrinotecanDRUG125 mg/m2 intravenous infusion over 90 minutes on Day 1 of a 21-day cyle or
LeucovorinDRUGLeucovorin (LV) followed by 5-fluorouracil (5FU). LV 200 mg/m2 intravenous infusion over 2 hours on Day 1, 5FU 200 mg/m2 intravenous infusion bolus over 5-10 minutes on Day 1, followed by 5FU 1200 mg/m2 continuous intravenous infusion over 22 hours on Day 1 of a 21-day cycle
5-fluorouracilDRUGLeucovorin (LV) followed by 5-fluorouracil (5FU). LV 200 mg/m2 intravenous infusion over 2 hours on Day 1, 5FU 200 mg/m2 intravenous infusion bolus over 5-10 minutes on Day 1, followed by 5FU 1200 mg/m2 continuous intravenous infusion over 22 hours on Day 1 of a 21-day cycle
PembrolizumabDRUGPembrolizumab, 2 mg/kg intravenous infusion 30 minutes on Day 8 of a 21-day cycle
Fluorouracil (5-FU)DRUG400 mg/m2 intravenous bolus followed by 2400 mg/m2 as a continuous intravenous infusion over 46 hours administered on Day 1 every 2 weeks.
BevacizumabDRUG30, 60 or 90 minute infusion on Day 1 every 2 weeks. Dose level 5 mg/kg.
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites77

Inclusion Criteria: Each patient MUST: * have recurrent or metastatic (R/M) histologically confirmed squamous cell carcinoma (SCC) of the head and neck (oropharynx, oral cavity, larynx, hypopharynx) or squamous cell nasopharynx cancer (NPC) with distal metastasis(es) and no secondary cancers (Patie...

Countries:United StatesBelgiumCanadaFranceGermanyGreeceHungaryItalyPolandRussiaSloveniaSpainUnited Kingdom
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