Immunotherapy boosts standard treatment for aggressive cervical cancer

NCT ID NCT03738228

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 ยท Last updated Jun 27, 2026

Summary

This early-phase trial tested whether adding the immunotherapy drug atezolizumab before and during standard chemoradiation could help control advanced cervical cancer that has spread to lymph nodes. Forty participants received the combination to see if it activated the immune system more effectively. The goal was to improve disease control, not to cure the cancer, as ongoing management is still needed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

40 people

The number who actually took part.

Started

Jan 2019

Finished

Sep 2025

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * Patients who have received prior radiation therapy to the pelvis or abdominal cavity, PALN radiation, or previous therapy of any kind for this malignancy or pelvic, PALN, or abdominal radiation for any prior malignancy * Patients with PALN nodal metastasis above the T12/L1 interspace * Patients who had a radical hysterectomy with positive PALNs are not eligible * Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation * Patients previously treated with systemic anticancer therapy (e.g., chemotherapy, targeted therapy, immunotherapy) within 3 years prior to entering the study * Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \[anti-TNF\] agents) within 2 weeks prior to cycle 1, day 1 * Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea or steroids as CT scan contrast premedication) may be enrolled * The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed * Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies * History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins * Patients requiring treatment with a RANKL inhibitor (e.g., denosumab) who cannot discontinue it before treatment with atezolizumab * Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease * Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen \[HBsAg\] test and a positive anti-HBc \[antibody to hepatitis B core antigen\] antibody test) are eligible * Patients positive for hepatitis C virus (HCV) antibody * History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis * Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible * Patients with controlled type 1 diabetes mellitus on a stable insulin regimen or type 2 diabetes mellitus are eligible * Patients with eczema, psoriasis, lichen simplex chronicus or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions: * Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations * Rash must cover less than 10% of body surface area (BSA) * Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%) * No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation \[PUVA\], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or steroids) * History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted * Patients with active tuberculosis (TB) are excluded * Severe infections within 4 weeks prior to cycle 1, day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia * Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1 * Received intravenous (IV) antibiotics within 2 weeks prior to cycle 1, day 1. Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible * Major surgical procedure within 28 days prior to cycle 1, day 1 or anticipation of need for a major surgical procedure during the course of the study * Administration of a live, attenuated vaccine within 4 weeks before cycle 1, day 1 or anticipation that such a live, attenuated vaccine will be required during the study and up to 5 months after the last dose of atezolizumab * Influenza vaccination should be given during influenza season only (approximately October to March). Patients must not receive live, attenuated influenza vaccine within 4 weeks prior to cycle 1, day 1 or at any time during the study * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Severe, active co-morbidity defined as follows: * Current (within 28 days of cycle 1, day 1) signs and/or symptoms of bowel obstruction * Patients who require parental hydration and/or nutrition * Patients who require drainage gastrostomy tube * Evidence of bleeding diathesis or clinically significant coagulopathy * Serious, non-healing or dehiscing wound, active ulcer or untreated bone fracture * History of hemoptysis (\>= 1/2 teaspoon of bright red blood per episode) within 1 month of study enrollment * Significant cardiovascular or cerebrovascular disease including: * Uncontrolled hypertension (systolic blood pressure \[SBP\] \>= 150; diastolic blood pressure \[DBP\] \>= 90) * History of myocardial infarction within 6 months * Unstable angina * New York Heart Association functional classification II, III or IV * Baseline ejection fraction =\< 50% as assessed by echocardiogram or multigated acquisition scan (MUGA) * Cerebral vascular accident (CVA) or transient ischemic attack (TIA) within 6 months * Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or peripheral arterial thrombosis) within 6 months * History of abdominal/pelvic or tracheoesophageal fistula or gastrointestinal perforation and/or abscess within 6 months prior to initiation of treatment * If patients are of child-bearing potential and do not agree to use two forms of birth control then they are ineligible * Patients who have had a hysterectomy or are planning to have an adjuvant hysterectomy following radiation as part of their cervical cancer treatment are ineligible * Patients scheduled to be treated with adjuvant consolidation chemotherapy at the conclusion of their standard chemoradiation * Pregnant women are excluded from this study because radiation therapy has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with atezolizumab, breastfeeding should be discontinued if the mother is treated with atezolizumab * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for the 5 months (150 days) after the last dose of the study agent. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately * Patients taking bisphosphonate therapy for symptomatic hypercalcemia. Use of bisphosphonate therapy for other reasons (e.g. osteoporosis) is allowed * Patients with known primary central nervous system (CNS) malignancy or CNS metastases are excluded * Patients with a prior known history of vesicovaginal, enterovaginal or colovaginal fistula

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Cervical adenocarcinoma are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Augusta University Medical Center

    Augusta, Georgia, 30912, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263, United States

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093, United States

  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045, United States

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390, United States

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233, United States

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817, United States

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242, United States

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

  • University of Pittsburgh Cancer Institute (UPCI)

    Pittsburgh, Pennsylvania, 15232, United States

  • Women and Infants Hospital

    Providence, Rhode Island, 02905, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.