A Phase 2 Study of Ipilimumab in Women With Metastatic or Recurrent HPV-Related Cervical Carcinoma of Either Squamous Cell or Adenocarcinoma Histologies

Who is this study for? Adult female patients with Metastatic or Recurrent Cervical Squamous Cell Carcinoma, Adenocarcinoma, or Adenosquamous Carcinoma
What treatments are being studied? Ipilimumab
Status: Completed
Location: See all (13) locations...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients must have histologically or cytologically confirmed metastatic or recurrent cervical cancer of squamous, adenocarcinoma or mixed histology type not suited to definitive localized therapy; HPV status will be confirmed for all patients following enrollment

• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \> 10 mm with computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam

• Previous therapy:

‣ Patients may have undergone surgery and/or received definitive radiation or chemo-radiation for localized disease in the past

⁃ Radiation treatment with curative intent (radical chemoradiotherapy or adjuvant chemoradiotherapy) must have been completed \>= 3 months prior to enrollment

∙ Note: patients who completed palliative radiation therapy 2 weeks before start of ipilimumab are allowed as long as this does not affect measurable disease

⁃ Patients must have been exposed to platinum chemotherapy either as part of definitive chemo-radiation OR as first line systemic treatment for metastatic disease

⁃ Patients MAY have received up to two prior lines of systemic chemotherapy for metastatic or recurrent disease; patients with metastatic disease at first presentation MUST have received one platinum based line of chemotherapy

⁃ All chemotherapy must have been completed \>= 4 weeks prior to enrollment with radiologic evidence of radiological disease progression

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1

• Life expectancy of greater than 3 months

• Leukocytes \>= 3.0 x 10\^9/L

• Absolute neutrophil count \>= 1.5 x 10\^9/L

• Platelets \>= 100 x 10\^9/L

• Total bilirubin within normal institutional limits (except in Gilbert's syndrome)

• Thyroid stimulating hormone (TSH) =\< upper limit of normal (ULN)

• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional upper limit of normal

• Creatinine \< 1.25 ULN OR creatinine clearance \>= 50 mL/min/1.73 m\^2 as calculated by the Cockcroft and Gault formula

• All radiology studies must be performed =\< 3 weeks prior to the start of therapy

• Subjects with treated and asymptomatic brain metastases are eligible; patients that received palliative radiation (for brain metastases) are eligible if they have been asymptomatic for at least 2 weeks with use of maintenance steroid therapy, and last received radiation at least 4 weeks prior to start of therapy

• Ability to understand and willing to sign a written informed consent document

• Ongoing prior toxicities related to previous treatments must be recovered to =\< grade 1 at the time of registration (with the exception of alopecia or skin depigmentation)

• Patients are willing to undergo tumor biopsy pre-treatment (within 14 days prior to registration) and post-treatment (within the first week of cycle 2 onset); patients who consent but have tumor that is not amenable to safe biopsy will be allowed to enter the trial/continue therapy as per protocol if this has been addressed and permission is granted from the lead consortium principal investigator (PI) prior to registration continuation of treatment

Locations
United States
California
City of Hope Comprehensive Cancer Center
Duarte
University of California Davis Comprehensive Cancer Center
Sacramento
City of Hope South Pasadena
South Pasadena
Illinois
University of Chicago Comprehensive Cancer Center
Chicago
Pennsylvania
Fox Chase Cancer Center
Philadelphia
Other Locations
Canada
Tom Baker Cancer Centre
Calgary
Cross Cancer Institute
Edmonton
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton
London Regional Cancer Program
London
Ottawa Hospital and Cancer Center-General Campus
Ottawa
University Health Network-Princess Margaret Hospital
Toronto
BC Cancer Research Centre
Vancouver
BCCA-Vancouver Cancer Centre
Vancouver
Time Frame
Start Date: 2012-12-03
Completion Date: 2021-11-24
Participants
Target number of participants: 42
Treatments
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.
Authors
Related Therapeutic Areas
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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