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

Completed · Phase 2

Conditions studied: 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

In brief

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 facts

Study ID

NCT01693783

Run by

National Cancer Institute (NCI)

People needed

42

Starts

2012-12-03

Expected to finish

2021-11-24

Last updated by the study team

2022-11-08

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Patients who have had chemotherapy < 4 weeks prior to enrollment (< 6 weeks for nitrosoureas or mitomycin C) or who had radiation therapy with curative intent < 3 months prior to enrollment (< 2 weeks for palliative radiation therapy) or those who have not recovered (=< grade 1) from adverse events related to previous treatments are excluded
• Patients with a history of prior treatment with ipilimumab or other cytotoxic T-lymphocyte antigen 4 (CTLA4) agonists or antagonists, anti-programmed death 1 (PD 1) antibody, cluster of differentiation (CD)137 agonist or other immune activating therapy such as anti-CD 40 antibody are excluded
• Patients who are receiving any other investigational agents
• Autoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's granulomatosis]); central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome and Myasthenia Gravis, multiple sclerosis)
• Patients requiring immunosuppressive agents, unless required for treating potential immune related adverse effects; steroids at their lowest effective dose in patients with radiated brain metastases is permitted
• Patients with known immune impairment who may be unable to respond to anti-CTLA 4 antibody
• Any other prior malignancy from which the patient has been disease free for less than 3 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of any site or any other cancer
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to ipilimumab
• Patients requiring systemic steroids are excluded; narcotics should be used with caution
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; patients with chronic hepatitis B or hepatitis C infections should be excluded
• Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with ipilimumab
• Patients with active or chronic infection with human immunodeficiency virus (HIV) who have raised viral loads or uncontrolled disease are ineligible; those patients however who exhibit minimal viral loads with good control whilst on stable anti-viral regimen may be considered if they meet all other eligibility criteria

Where it is running

• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
• City of Hope South Pasadena — South Pasadena, California, United States
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Tom Baker Cancer Centre — Calgary, Alberta, Canada
• Cross Cancer Institute — Edmonton, Alberta, Canada
• BC Cancer Research Centre — Vancouver, British Columbia, Canada
• BCCA-Vancouver Cancer Centre — Vancouver, British Columbia, Canada
• Juravinski Cancer Centre at Hamilton Health Sciences — Hamilton, Ontario, Canada
• London Regional Cancer Program — London, Ontario, Canada
• Ottawa Hospital and Cancer Center-General Campus — Ottawa, Ontario, Canada
• University Health Network-Princess Margaret Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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