Atezolizumab + Chemoradiotherapy for Cervical Cancer
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on systemic immunosuppressive medications, you must stop them at least 2 weeks before starting the trial. Also, if you are taking a RANKL inhibitor, you need to discontinue it before treatment with atezolizumab.
What data supports the effectiveness of the treatment Atezolizumab + Chemoradiotherapy for Cervical Cancer?
Is the combination of Atezolizumab and chemoradiotherapy safe for treating cervical cancer?
The combination of Atezolizumab with other treatments like bevacizumab has been studied for safety in advanced cervical cancer, and chemoradiotherapy with cisplatin is a standard treatment with known safety profiles. Intensity-modulated radiation therapy (IMRT) can reduce side effects like gastrointestinal issues, and cisplatin is generally well-tolerated when used with radiotherapy.12678
How is the treatment Atezolizumab + Chemoradiotherapy for Cervical Cancer different from other treatments?
This treatment combines Atezolizumab, an immunotherapy drug that helps the immune system fight cancer, with chemoradiotherapy, which is the standard treatment for cervical cancer. The addition of Atezolizumab is novel as it may enhance the effectiveness of the existing chemoradiotherapy regimen by boosting the body's immune response against the cancer.124910
Research Team
Jyoti S Mayadev
Principal Investigator
NRG Oncology
Eligibility Criteria
This trial is for patients with advanced cervical cancer (stages IB2, II, IIIB, or IVA) that has spread to lymph nodes. Participants must have adequate blood counts and organ function, no severe allergies to cisplatin or immunotherapy drugs like atezolizumab, not be breastfeeding, and able to consent. HIV-positive patients can join if well-managed. Exclusions include prior pelvic radiation or systemic anticancer therapy within 3 years and certain health conditions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Immune Priming
Participants receive atezolizumab as an immune primer before chemoradiotherapy
Chemoradiotherapy
Participants receive standard of care cisplatin chemotherapy and radiation therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Atezolizumab
- Brachytherapy
- Cisplatin
- Radiation Therapy
Atezolizumab is already approved in United States, European Union for the following indications:
- Melanoma
- Hepatocellular carcinoma
- Small cell lung cancer
- Non-small cell lung cancer
- Urothelial carcinoma
- Melanoma
- Hepatocellular carcinoma
- Small cell lung cancer
- Non-small cell lung cancer
- Urothelial carcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
NRG Oncology
Collaborator