Atezolizumab + Chemoradiotherapy for Cervical Cancer

Recruiting in Palo Alto (17 mi)

+16 other locations

Overseen byJyoti S Mayadev

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Breakthrough Therapy

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.

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

My hemoglobin level is at least 8 g/dL.

International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN

Platelets >= 100,000/mcL (> 50,000 for patients with hematologic malignancies)

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Exclusion Criteria

I have not received a live vaccine in the last 4 weeks and do not plan to during the study.

I have a history of lung scarring or inflammation.

I haven't had major surgery in the last 28 days and don't expect to need one during the study.

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Treatment Details

Interventions

Atezolizumab (Monoclonal Antibodies)
Brachytherapy (Radiation)
Cisplatin (Platinum-containing Compound)
Radiation Therapy (Radiation)

Trial OverviewThe study tests the effectiveness of atezolizumab when given before and/or alongside standard chemoradiotherapy in activating the immune system against cervical cancer. Atezolizumab is a monoclonal antibody designed to help the body's immune system detect and fight tumor cells.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Arm B (atezolizumab, standard cisplatin and radiation therapy)Experimental Treatment4 Interventions

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.

Group II: Arm A (atezolizumab, standard cisplatin and radiation therapy)Experimental Treatment4 Interventions

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.

Atezolizumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Tecentriq for: