Trials Sponsors Conditions Drugs Pricing

Conditions

Aerodigestive Precancerous Lesions and Malignancies

Keywords

Aerodigestive Lesions and MalignanciesHuman PapillomavirusSquamous Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

Adverse events measured and graded in accordance with "Common Terminology Criteria for Adverse Events (CTCAE)", NCI version 4.03
Up to 6 months
Injection site reactions including skin erythema, induration pain and tenderness at administration site
Up to 15 weeks

Secondary Outcomes (3)

HPV6 specific Ig levels
Up to 6 months
Number of antigen-specific IFN-γ-secreting cells in response to stimulation with HPV6 by antigen-specific IFN-γ ELISpot assays
Up to 6 months
Cytotoxic T cells in response to HPV6 specific immunotherapy by flow cytometry
Up to 6 months

Other Outcomes (1)

Time to new anti-cancer therapy
First dose to Week 26

Study Arms (2)

Cohort I

EXPERIMENTAL

3 mg of INO-3106 (D0); 6 mg of INO-3106 (Wk3); 6 mg of INO-3106 + 1 mg of INO-9012 (Wk6); 6 mg of INO-3106 + 1 mg of INO-9012 (Wk9);

Biological: INO-3106, INO-9012

Cohort II

EXPERIMENTAL

6 mg of INO-3106 in combination with 1 mg of INO-9012, or at the MTD determined above at D0, Wk3, Wk6, Wk9

Biological: INO-3106, INO-9012

Interventions

INO-3106, INO-9012Biological

Cohort ICohort II

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Signed and dated written Ethics Committee approved informed consent
Age ≥18 years

Sponsors & Collaborators

Inovio Pharmaceuticals
Industrylead
University of Pennsylvania
Othercollaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

MeSH Terms

Conditions

NeoplasmsCarcinoma, Squamous Cell

Interventions

rocakinogene sifuplasmid

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous Cell

Study Officials

Jeffrey Skolnik, MD
Inovio Pharmaceuticals
STUDY DIRECTOR

Enrollment

3 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 11, 2014

First Posted

September 16, 2014

Study Start

May 2014

Date type not reported

This date has not been verified as actual or estimated.

Immunotherapy in Subjects With HPV-6 Associated Aerodigestive Precancerous Lesions and Malignancies

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Other Outcomes (1)

Study Arms (2)

Cohort I

Cohort II

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Other Outcomes (1)

Study Arms (2)

Cohort I

Cohort II

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations