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

NCT03738228 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-11-12

Study results available
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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.

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

Interventions

DRUG

Atezolizumab

Given IV

RADIATION

Brachytherapy

Undergo standard of care image guided brachytherapy

DRUG

Cisplatin

Given IV

RADIATION

Radiation Therapy

Undergo standard of care radiation therapy

Sponsors & Collaborators

  • NRG Oncology

    collaborator OTHER

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Jyoti S Mayadev · NRG Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-07
Primary Completion
2022-05-01
Completion
2025-09-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03738228 on ClinicalTrials.gov