Atezolizumab Before and/or With Chemoradiotherapy in Immune System Activation in Patients With No… (NCT03738228) | Clinical Trial Compass
CompletedPhase 1
Atezolizumab Before and/or With Chemoradiotherapy in Immune System Activation in Patients With Node Positive Stage IB2, II, IIIB, or IVA Cervical Cancer
United States40 participantsStarted 2019-01-07
Plain-language summary
This phase I trial studies how well atezolizumab before and/or with standard of care chemoradiotherapy works in immune system activation in patients with stage IB2, II, IIIB, or IVA cervical cancer that has spread to the lymph nodes. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving atezolizumab before and/or with chemoradiotherapy may lower the chance of tumors growing or spreading.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Patients with histologically confirmed newly diagnosed advanced cervical cancer (squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma): Federation of Gynecology and Obstetrics (FIGO) clinical stages IB2/IIA with positive para-aortic nodes, or FIGO clinical stages IIB/IIIB/IVA with positive pelvic or para-aortic lymph nodes (PALN). Pelvic or PALN nodal status confirmed by PET/CT scan or fine needle biopsy or extra peritoneal biopsy or laparoscopic biopsy. The PALN must be inferior to the T12/L1 interspace
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
* Leukocytes \>= 2,500/mcL
* Absolute neutrophil count \>= 1,500/mcL
* Platelets \>= 100,000/mcL (\> 50,000 for patients with hematologic malignancies)
* Hemoglobin \>= 8 g/dL (can be transfused with red blood cells pre-study)
* Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =\< 3 x ULN may be enrolled)
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 x ULN (AST and/or ALT =\< 5 x ULN for patients with liver involvement)
* Alkaline phosphatase =\< 2.5 x ULN (=\< 5 x ULN for patients with documented liver involvement or bone metastases)
* Creatinine clearance =\< 1.5 mg/dL to receive weekly cisplatin
* Patients whose serum cre…
What they're measuring
1
Immune Response
Timeframe: Arm A: 42 days from the first dose of Atezolizumab Arm B: 21 days from the first dose of Atezolizumab