Just noticed the Clinical Trials website for the MAST study has...

Just noticed the Clinical Trials website for the MAST study has been updated on the 20th of March. Have they now included overall survival? 9 sites now recruiting. Anyone with trials expertise able to comment further? Many thanks. Primary Outcome Measures: 1. Frequency and severity of Adverse Events of IV and IT CF33-hNIS as a monotherapy or in combination with pembrolizumab [ Time Frame: From first dose of study drug through 30 days following the last dose of study treatment. ] Adverse events will be graded according to CTCAE v5.0. 2. Maximum ToleratedRecommended Phase 2Dose (MTDRP2D) of CF33-hNIS as a monotherapy or in combination with pembrolizumab [ Time Frame: From first dose of study drug through 21-42 days following the first dose of study treatment. ] The MTD is defined as the dose level below the dose inducing Dose Limiting Toxicity (DLT) in > 33% of patients.RP2D determination will be based on evaluation of Dose Limiting Toxicities (DLT) as well as other safety, efficacy and correlative data. Secondary Outcome Measures: 1. Objective Response Rate (ORR) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab [ Time Frame: Up to 2 years from first dose of study drug. ] ORR is defined as the proportion of patients in the efficacy population who achieve a radiographic Investigator-assessed confirmed complete response (CR) or partial response (PR), per RECIST v1.1 or confirmed immune complete response (iCR) or immune partial response (iPR) per iRECIST v1.0. 2. Progression-free survival (PFS) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab. [ Time Frame: Up to 2 years from first dose of study drug. ] PFS, defined as the time from start of treatment to the first documentation of progressive disease (PD) or death from any cause, whichever occurs first. 3. Overall survival (OS) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab. [ Time Frame:Up to 2 years from first dose of study drug.] defined as the time from the start of treatment until death due to any cause. Median OS and OS rate at 12 months will be reported. 34. Duration of Response (DOR) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab. [ Time Frame: Up to 2 years from first dose of study drug. ] DOR is defined as the time from the date a response of PR/iPR or better was first recorded to the date on which progressive disease was first noted or the date of death due to any cause. 45. Disease Control Rate (DCR) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab. [ Time Frame: Up to 2 years from first dose of study drug. ] DCR is defined as the proportion of patients who achieve an Investigator-assessed confirmed CR/iCR, PR/iPR, or Stable Disease (SD)/immune SD (iSD) per RECIST v1.1 and iRECIST v1.0. 56. To evaluate viral titers of CF33-hNIS [ Time Frame: Up to 2 years from first dose of study drug. ] Viral Plaque Assay (VPA) and polymerase chain reaction (PCR) testing from serum, urine, oral swab, rectal swab, injection site(s) swab and wound dressing swab. 67. To evaluate infection of tumors with CF33-hNIS [ Time Frame: 21 days from first dose of study drug ] hNIS-based imaging via SPECT technetium-99 (99TC). Other Outcome Measures: 1. To evaluation antiviral immune activation [ Time Frame: Up to 2 years from first dose of study drug. ] Up regulation of PD-L1 expression as compared to baseline in tumor tissue and circulating tumor cells (CTC). Analysis of lymphocyte subsets and cytokine profile compared to baseline.

Eligibility Minimum Age: 18 Years Maximum Age: Sex: All Gender Based: Accepts Healthy Volunteers: No Criteria: Inclusion Criteria: Written informed consent from patient or legally authorized representative Age ≥ 18 years old on the date of consent Any metastatic or advanced solid tumor with documented radiological progression following at least two prior lines of treatment (which may have included prior immune checkpoint inhibitor treatment) ECOG performance status 0 - 2 At least one measurable lesion Adequate renal function Adequate liver function Adequate hematologic function Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures Exclusion Criteria: Prior treatment with an oncolytic virus. Continuous systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 4 weeks prior to first dose of study treatment. Prior radiotherapy within 2 weeks of start of study treatment. Active autoimmune disease Receipt of radiation therapy to the lung within 6 months of the first dose of trial treatment.Prior allogenic tissue/organ transplant or other medical conditions requiring ongoing treatment with immunosuppressive drugs or any condition resulting in a systemic immunosuppressed state Prior allogenic tissue/organ transplant or other medical conditions requiring ongoing treatment with immunosuppressive drugs or any condition resulting in a systemic immunosuppressed stateInadequate pulmonary function per Investigator assessment. Uncontrolled brain or other central nervous system (CNS) metastases. History of documented congestive heart failure (New York Heart Association [NYHA] class III - IV), unstable angina, poorly controlled hypertension, clinically significant valvular heart disease or high-risk uncontrolled arrhythmias

Contacts/Locations Central Contact Person: Amanda Seiz Telephone: 613 9824 52542 9423 0881 Email: [email protected] Locations: United States, Arkansas Highlands Oncology [Recruiting] Springdale, Arkansas, United States, 72762 Contact:Contact: Morgan Burns Contact:Principal Investigator: Patrick Travis, MD United States, California City of Hope Medical Center [Recruiting] Duarte, California, United States, 91010 Contact:Contact: Aruna Parikh Contact:Principal Investigator: Dan Li United States, Florida University of Miami [Not yet recruiting] Miami, Florida, United States, 33136 Contact:Contact: Alain Fernandez Marrero Contact:Principal Investigator: Jaime Merchan, MD United States, Michigan Barbara Ann Karmanos Cancer Institute [Recruiting] Detroit, Michigan, United States, 48201 Contact:Contact: Kelly Schneider Contact:Principal Investigator: Hirva Mamdani United States, Ohio University of Cincinnati [Recruiting] Cincinnati, Ohio, United States, 45219 Contact:Contact: Kayla Webb Contact:Principal Investigator: Jennifer Leddon United States, Utah Huntsman Cancer Institute [Recruiting] Salt Lake City, Utah, United States, 84112 Contact:Contact: Susan Sharry Contact:Principal Investigator: Wallace Akerly United States, Virginia NEXT Oncology [Recruiting] Fairfax, Virginia, United States, 22031 Contact:Contact: Hoda Kassab Contact:Principal Investigator: Alexander Spira Australia, Queensland Tasman Oncology Research [Recruiting] Southport, Queensland, Australia, 4215 Contact:Contact: Molly Phillips Contact:Principal Investigator: Andrew Hill, BHB, MBChB, FRACP Australia, Victoria St. Vincent's Hospital [Recruiting] Fitzroy, Victoria, Australia, 3065 Contact:Contact: Jane Mack Contact:Principal Investigator: Gavin Wright, MBBS, PhD

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References Citations: Links: URL:http://www.imugene.com Description: Imugene Limited (ASX: IMU) is a publicly-listed Australian biotechnology company developing cancer immunotherapies. Available IPD/Information:

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