Ipilimumab in Treating Patients With Metastatic or Recurrent Human Papilloma Virus-Related Cervical Cancer

Part of paid clinical trials in Duarte, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01693783
Phase
PHASE2
Status
Completed

Conditions

  • Cervical Adenocarcinoma
  • Cervical Squamous Cell Carcinoma
  • Human Papillomavirus Infection
  • Recurrent Cervical Carcinoma
  • Stage IVA Cervical Cancer AJCC v6 and v7
  • Stage IVB Cervical Cancer AJCC v6 and v7

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab — BIOLOGICAL
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies

Study Details

This phase II trial studies how well ipilimumab works in treating patients with human papilloma virus (HPV)-related cervical cancer that has come back or that has spread to other areas of the body. Monoclonal antibodies, such as ipilimumab, can find tumor cells and help kill them or carry tumor-killing substances to them.

Key Dates

Start date
Dec 3, 2012
Status verified
Oct 2022
Primary completion
Mar 18, 2021
Completion
Nov 24, 2021

Study Design

Enrollment
42 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (ipilimumab)
    Patients receive ipilimumab IV over 90 minutes. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving objective response or stable disease continue to receive maintenance therapy comprising ipilimumab IV over 90 minutes once every 12 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Number of Adverse Events, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 [ Time Frame: Up to 1 year ]

Locations (5)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
City of Hope South PasadenaSouth PasadenaCalifornia91030-
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-

Find similar trials in Duarte, CA

By research site
City of Hope Comprehensive Cancer Center· Duarte, CAUniversity of California Davis Comprehensive Cancer Center· Sacramento, CACity of Hope South Pasadena· South Pasadena, CAUniversity of Chicago Comprehensive Cancer Center· Chicago, ILFox Chase Cancer Center· Philadelphia, PA

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