Clinical Trial Search

Primary: Incidence of the Composite Endpoint of Human Papillomavirus (HPV) 16/18-related Cervical Intraepithelial Neoplasia (CIN) 2 or Worse in the Base Study — 0.0; 0.4…

Primary: Incidence of Objective Response — 32; 36; 30; 0 Participants — p=0.043

Primary: Number of Participants With Dose Limiting Toxicities (DLTs) — 0; 1; 0 Participants

Primary: Cumulative Rate of Cervical Intraepithelial Neoplasia (CIN2+) (CIN2, CIN3 or Invasive Cancer) by Week 130 — 24.9; 26.5 Events per 100 persons

Primary: Feasibility of Intravaginal Use 5-FU and Imiquimod on Alternating Weeks in Women With Biopsy Confirmed High Grade Cervical Squamous Intraepithelial Lesions. — 4; 1…

Primary: Percentage of Participants With at Least 1 Treatment Emergent Adverse Event (TEAE) — 100; 100 percentage of participants

Primary: Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN)(Any Grade), Adenocarcinoma In Situ (AIS) or Cervical Cancer — 0; 1.2 incidence rate per 100…

Primary: Acceptability of Self-Collection Paired With Mobile Mammography — 33 Participants

Primary: HPV Identification — 95; 142; 78 biopsies

Primary: Safety and Feasibility as Assessed by Number of Participants With Treatment-related Adverse Events — 5; 3; 8; 7 Participants

Primary: Tumor Response — 1; 7; 17; 34 participants

Primary: Number of Adverse Events, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 — 56 Adverse Events

Primary: Overall Survival Rate at 5 Years — 71; 72 Percentage of participants

Primary: Toxicity (Number of Participants With Serious Adverse Events) — 10 Participants

Primary: Cumulative Number of Participants Diagnosed by the Community Pathologist With Cervical Intraepithelial Neoplasia Grade 2 or Higher (CIN2+): "Community-based CIN2+"…

Primary: Progression-free Survival (PFS) at 2 Years — 75.5 percentage of patients

Primary: Anti-tumor Activity as Measured by Surviving Progression-free — 59 percentage of participants

Primary: Number of Participants With Serious Adverse Events — 0; 0; 0; 0 Participants

Primary: Response to Treatment Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Evaluable Population) — 8; 7; 11; 6 participant

Primary: Number of Patients With Dose-limiting Toxicities, as Assessed by CTCAE v 4.0 — 0 Participants

Primary: Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies — 125; 2; 122; 3 Participants

Primary: Overall Survival (OS) — 11.7; 8.5 Months — p=<0.00001

Primary: Progression-free Survival Greater Than 6 Months — 30; 5 participants

Primary: Histologic Regression — 40; 34.1 percentage of participants

Primary: Number of Patients With Measurable Concentration of Gemcitabine in Uterine Vein (dFdC) — 5 Participants

Primary: Maximum Tolerated Dose (MTD) — 2 # of cells x 10^11

Primary: Overall Survival — 21.9; 19.5 months — p=0.125

Primary: Feasibility of Acquiring In-vivo High-Resolution Microendoscopy (HRME) Images of Cervix Prior to Conization

Primary: Progression-free Survival (PFS) — 65 percentage of patients

Primary: Number of Participants With an Objective Clinical Response — 3; 2; 2; 0 Participants