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A Phase I, Dose Escalation Safety and Tolerability Study of VAXINIA (CF33-hNIS), Administered Intratumorally or Intravenously as a Monotherapy or in Combination with Pembrolizumab in Adult Patients with Metastatic or Advanced Solid Tumors (MAST)
Cancer Categories
Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Head and Neck,Lung
Karmanos Trial ID
2021-071
NCT ID
NCT05346484
Age Group
Adult
Scope
National
Phase
Phase I
Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
Phase I
Principal Investigator
Hirva
Mamdani, M.D.
Lung Cancer Screening, Oncology - Medical
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Objective:
PRIMARY OBJECTIVE:
To evaluate safety of IV and IT CF33-hNIS in monotherapy and in combination with pembrolizumab. To determine Recommended Phase 2 Dose (RP2D) of CF33-hNIS in monotherapy and in combination with pembrolizumab.
SECONDARY OBJECTIVES:
Anti-tumor activity of CF33-hNIS administered as a monotherapy and in combination with pembrolizumab based on objective response rate (ORR) using RECIST v1.1 (Seymour et al., 2017) and immune Response Evaluation Criteria in Solid Tumors (iRECIST) v1.0
Efficacy of IT and IV CF33-hNIS administered as a monotherapy and in combination with pembrolizumab:
a. Progression-free survival (PFS)
b. Overall survival (OS)
c. Duration of Response (DOR)
d. Disease Control Rate (DCR)
Viral titers of CF33-hNIS
Infection of tumors with CF33-hNIS
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Eligibility
Locations
Applicable Disease Site
Therapies | Drugs | Devices
Eligibility
Eligibility
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 a poxvirus based 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
Prior allogenic tissue/organ transplant or other medical conditions requiring ongoing treatment with immunosuppressive drugs or any condition resulting in a systemic immunosuppressed state
Inadequate pulmonary function per Investigator assessment.
Uncontrolled brain or other central nervous system (CNS) metastases.
Locations
Locations
Karmanos Cancer Institute - Detroit Headquarters
4100 John R
Detroit, MI 48201
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Phone:
1-800-527-6266
Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills
31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone:
1-800-527-6266
Applicable Disease Site
Applicable Disease Site
Anus; Breast; Cervix; Colon; Corpus Uteri; Esophagus; Kidney; Lip, Oral Cavity and Pharynx; Liver; Lung; Ovary; Pancreas; Prostate; Rectum; Small Intestine; Stomach; Urinary Bladder
Therapies, Drugs, Devices
Therapies | Drugs | Devices
Therapies
Biological Therapy, Immunotherapy, Oncolytic Virus
Drugs
CF33-hNIS; Pembrolizumab
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