Immunotherapy With IFx-Hu2.0 Vaccine for Advanced MCC or cSCC
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|ClinicalTrials.gov Identifier: NCT04160065|
Recruitment Status : Recruiting
First Posted : November 12, 2019
Last Update Posted : February 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Merkel Cell Carcinoma Cutaneous Squamous Cell Carcinoma||Biological: IFx-Hu2.0||Phase 1|
Approximately twenty adult patients (≥ 18 years of age), of any sex, ethnicity, and race with histologically confirmed MCC or cSCC with accessible lesions, will be eligible for study enrollment and treatment with IFx-Hu2.0 (i.e. 20 total patients across both indications). These types of non-melanoma cancers are very rare in the pediatric population (< 18 years of age) with only scattered case reports. The potential for development of this product for pediatric subjects with MCC or cSCC will be evaluated after the results of this study are available.
Patients must have at least one injectable lesion, defined as an easily palpable superficial lesion (cutaneous, subcutaneous or lymph nodal metastasis) that can be accurately localized, stabilized by palpation, and is superficial enough to enable intralesional injection.
To be eligible for this study, patients must have progressed despite standard therapy(ies), or are intolerant to or refused standard therapy(ies).
Enrollees will receive IFx-Hu2.0 as a monotherapy at up to three time points. Depending on the number of accessible lesions, a patient could receive up to three doses across three lesions (one dose per lesion). The maximum number of lesions to be injected at any time point under this protocol is three lesions. Blood will be collected from these patients prior to treatment administration at every drug administration visit. These samples will be used to perform CBC and clinical chemistry tests. A urine sample will be obtained for urinalysis for protein and blood at the same frequency. Blood samples will also be drawn at the same intervals for immune response evaluation as well.
This is primarily a safety study that is designed to evaluate IFx-Hu2.0 monotherapy and provide foundational evidence to potentially support further studies investigating IFx-Hu2.0 + anti-PD-1 combination therapy for patients with advanced MCC or cSCC.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Trial of Intralesional Immunotherapy With IFx-Hu2.0 Vaccine in Patients With Advanced Merkel Cell Carcinoma or Cutaneous Squamous Cell Carcinoma|
|Estimated Study Start Date :||March 2020|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||September 2021|
Experimental: IFx-Hu2.0 (plasmid DNA) 0.1 mg/lesion/time point
Route of Administration:
Mechanism of Action:
Other Name: pAc/emm55
- Number of Grade 3-5, Treatment-Related Adverse Events per CTCAE 5.0 [ Time Frame: 28 days from last injection ]
- Number of Enrolled Subjects who have completed the Trial without Major Protocol Deviations [ Time Frame: 28 days from last injection ]
- Objective Response Rate (ORR) per 2018 FDA Guidance on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics [ Time Frame: 28 days from last injection ]
- Best Overall Response per RECIST v1.1 [ Time Frame: 28 days from last injection ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04160065
|Contact: Michael JP Lawman, PhD||813-875-6600 ext firstname.lastname@example.org|
|Contact: Patricia D Lawman, PhD||813-875-6600 ext email@example.com|
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Andrew S Brohl, MD 813-745-4673 Andrew.Brohl@moffitt.org|
|Principal Investigator: Andrew S Brohl, MD|
|Principal Investigator:||Andrew S Brohl, MD||Collaborator|