Atezolizumab Before and/or With Chemoradiotherapy in Immune System Activation in Patients With Node Positive Stage IB2, II, IIIB, or IVA Cervical Cancer

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT03738228
Phase
PHASE1
Status
Completed

Conditions

  • Cervical Adenocarcinoma
  • Cervical Adenosquamous Carcinoma
  • Cervical Squamous Cell Carcinoma
  • Stage IB2 Cervical Cancer AJCC v8
  • Stage II Cervical Cancer AJCC v8
  • Stage IIA Cervical Cancer AJCC v8
  • Stage IIA1 Cervical Cancer AJCC v8
  • Stage IIA2 Cervical Cancer AJCC v8
  • Stage IIB Cervical Cancer AJCC v8
  • Stage IIIB Cervical Cancer AJCC v8
  • Stage IVA Cervical Cancer AJCC v8

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Given IV
  • Brachytherapy — RADIATION
    Undergo standard of care image guided brachytherapy
  • Cisplatin — DRUG
    Given IV
  • Radiation Therapy — RADIATION
    Undergo standard of care radiation therapy

Study Details

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.

Key Dates

Start date
Jan 7, 2019
Status verified
Oct 2025
Primary completion
May 1, 2022
Completion
Sep 12, 2025

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Immune Response [ Time Frame: Arm A: 42 days from the first dose of Atezolizumab Arm B: 21 days from the first dose of Atezolizumab ]

Locations (16)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham Cancer CenterBirminghamAlabama35233-
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
UCHealth University of Colorado HospitalAuroraColorado80045-
Augusta University Medical CenterAugustaGeorgia30912-
University of Iowa/Holden Comprehensive Cancer CenterIowa CityIowa52242-
Roswell Park Cancer InstituteBuffaloNew York14263-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Cleveland Clinic FoundationClevelandOhio44195-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-
Women and Infants HospitalProvidenceRhode Island02905-
UT Southwestern/Simmons Cancer Center-DallasDallasTexas75390-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham Cancer Center· Birmingham, ALUC San Diego Moores Cancer Center· La Jolla, CAUniversity of California Davis Comprehensive Cancer Center· Sacramento, CAUCHealth University of Colorado Hospital· Aurora, COAugusta University Medical Center· Augusta, GAUniversity of Iowa/Holden Comprehensive Cancer Center· Iowa City, IA

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