Inclusion Criteria:
- At least 18 years of age
- Eastern Cooperative Oncology Group (ECOG) ≤ 2 or Karnofsky Performance Status of ≥ 60
- Participants must have recurrent, persistent, or metastatic cervical cancer, including
squamous cell, adenocarcinoma, and adenosquamous histologies recurrent, persistent, or
metastatic HPV + squamous cell cancer of the vagina or vulva
- Measurable disease per irRECIST
- Previously irradiated lesions can be considered as measurable disease only if
progressive disease has been unequivocally documented at that site since
radiation
- Measurable lesions are defined as those that can be accurately measured in at
least one dimension (longest diameter to be recorded) as ≥10 mm (≥1 cm) with
computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by
clinical exam.
- Must have at least 2 distinct lesions as documented by imaging studies within 4 weeks
prior to randomization
- Consent to biopsy of metastatic site or consent to retrieval of archival tissue
Exclusion Criteria:
- Patients with known brain metastasis
- Active or history of autoimmune disease or immune deficiency, including, but not
limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus
erythematosus, rheumatoid arthritis, autoimmune thyroid disease, inflammatory bowel
disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren's
syndrome, Guillain-Barré syndrome, or multiple sclerosis with the following
exceptions:
- Patients with a history of autoimmune-related hypothyroidism who are on
thyroid-replacement hormone are eligible for the study
- Patients with controlled type 1 diabetes mellitus who are on an insulin regimen
are eligible for the study
- History of prior malignancy within 2 years prior to screening, with the exception of
those with a negligible risk of metastasis or death (e.g., 5-year OS of > 90%), such
as but not limited to, non-melanoma skin carcinoma, ductal carcinoma in situ, or stage
I endometrioid uterine cancer, and others at the discretion of the Principal
Investigator (PI)
- Treatment with systemic immunosuppressive medication (including, but not limited to,
corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and
anti-tumor necrosis factor (TNF)-α agents) within 2 weeks prior to initiation of study
treatment, or anticipation of need for systemic immunosuppressive medication during
the course of the study, with the following exceptions:
- Patients who received acute, low-dose systemic immunosuppressant medication or a
one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of
corticosteroids for a contrast allergy)
- Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids
for chronic obstructive pulmonary disease or asthma, or low-dose corticosteroids
for orthostatic hypotension or adrenal insufficiency
