Anti PD-L1 (Atezolizumab) as an Immune Primer and Concurrently With Extended Field Chemoradiotherapy for Node Positive Locally Advanced Cervical Cancer

Who is this study for? Adult female patients with Stage IB2 to IIA or IIB, IIIB, or IVA Cervical Squamous Cell Carcinoma, Adenocarcinoma, or Adenosquamous Carcinoma
What treatments are being studied? Atezolizumab
Status: Active_not_recruiting
Location: See all (16) locations...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 1
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.

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

• 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 creatinine is between 1.5 and 1.9 mg/dL are eligible for cisplatin if there is no hydronephrosis and the estimated creatinine clearance (CCr) is \>= 30 ml/min. For the purpose of estimating the CCr, the formula of Cockcroft and Gault for females should be used

• International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =\< 1.5 x ULN (this applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose)

• Patient does not have a known allergy to cisplatin or compounds of similar biologic composition

• Patient is not actively breastfeeding (or has agreed to discontinue breastfeeding before the initiation or protocol therapy)

• Thyroid-stimulating hormone (TSH) within normal limits or normal free T4 in those with abnormal TSH

• Ability to understand and the willingness to sign a written informed consent document

• Patients positive for human immunodeficiency virus (HIV) are allowed on study, but HIV-positive patients must have:

‣ A stable regimen of highly active anti-retroviral therapy (HAART)

⁃ No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections

⁃ A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard polymerase chain reaction (PCR)-based tests

Locations
United States
Alabama
University of Alabama at Birmingham Cancer Center
Birmingham
California
UC San Diego Moores Cancer Center
La Jolla
University of California Davis Comprehensive Cancer Center
Sacramento
Colorado
UCHealth University of Colorado Hospital
Aurora
Georgia
Augusta University Medical Center
Augusta
Iowa
University of Iowa/Holden Comprehensive Cancer Center
Iowa City
New York
Roswell Park Cancer Institute
Buffalo
Memorial Sloan Kettering Cancer Center
New York
Ohio
Cleveland Clinic Foundation
Cleveland
Ohio State University Comprehensive Cancer Center
Columbus
Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City
Pennsylvania
Thomas Jefferson University Hospital
Philadelphia
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh
Rhode Island
Women and Infants Hospital
Providence
Texas
UT Southwestern/Simmons Cancer Center-Dallas
Dallas
Wisconsin
Medical College of Wisconsin
Milwaukee
Time Frame
Start Date: 2019-01-07
Completion Date: 2025-09-18
Participants
Target number of participants: 40
Treatments
Experimental: Arm A (atezolizumab, standard cisplatin and radiation therapy)
Patients receive atezolizumab IV over 30-60 minutes on days -21, 0, and 21 in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care cisplatin chemotherapy IV over 90 minutes on days 0, 7, 14, 21, 28, and 35. Beginning on day 0, patients also receive standard of care radiation therapy once daily (Monday-Friday) for a total of 25 fractions with image guided brachytherapy beginning in week 4, 5, or at the end of radiation therapy.
Experimental: Arm B (atezolizumab, standard cisplatin and radiation therapy)
Patients receive atezolizumab IV over 30-60 minutes on days 0, 21, and 42 in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care cisplatin chemotherapy, radiation therapy, and image guided brachytherapy as in Arm A.
Related Therapeutic Areas
Sponsors
Leads: National Cancer Institute (NCI)
Collaborators: NRG Oncology

This content was sourced from clinicaltrials.gov

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