New drug could keep cervical cancer away after chemoradiation

NCT ID NCT06079671

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 26, 2026 · Updated 4 times

Summary

This phase 3 trial is testing an immunotherapy drug called volrustomig in 800 women with high-risk locally advanced cervical cancer who have finished chemoradiation. The goal is to see if volrustomig can keep the cancer from coming back or improve survival compared to a placebo. Participants receive either volrustomig or a placebo by IV infusion.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: volrustomig (an immunotherapy drug given by IV)
What this could lead to: If it works, volrustomig could help prevent cervical cancer from returning after standard chemoradiation, offering a new treatment option for high-risk patients.
What could go wrong: This is an early-phase 3 trial, so results are not yet known. The drug may not improve survival or could cause side effects like immune-related reactions. It is also only for a specific group of patients.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 800 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Sep 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

15 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: For inclusion in the study, patients should fulfill the following criteria: 1. Female. 2. Aged at least 15 years at the time of screening. Note: Participants \< 18 years of age: physical changes should be aligned with Tanner Stage III. 3. Body weight \> 35 kg. 4. Histologically documented FIGO 2018 Stage IIIA to IVA cervical adenocarcinoma, cervical squamous carcinoma, or cervical adenosquamous carcinoma, with no evidence of metastatic disease. 5. Initial staging procedures performed no more than 56 days prior to the first dose of CCRT. 6. Provision of FFPE tumor sample to assess the PD-L1 expression. 7. Must not have progressed following CCRT, participants with persistent disease after definitive CCRT must not be amenable to other available therapies with curative intent. 8. WHO/ECOG performance status of 0 or 1; duration of life expectancy of ≥ 12 weeks. 9. Adequate organ and bone marrow function. 10. Capable of providing signed informed consent. Exclusion Criteria: Patients should not enter the study if any of the following exclusion criteria are fulfilled: 1. Diagnosis of small cell (neuroendocrine) or mucinous adenocarcinoma of cervical cancer. 2. Evidence of metastatic disease. 3. Intent to administer a fertility-sparing treatment regimen. 4. History of organ transplant or allogenic stem cell transplant. 5. History of active primary immunodeficiency or active or prior documented autoimmune or inflammatory disorders. 6. Uncontrolled intercurrent illness. 7. History of another primary malignancy except for a) Malignancy treated with curative intent with no known active disease ≥2 years before the first dose of study intervention; b) Adequately treated nonmelanoma skin cancer or lentigo maligna, or carcinoma in situ without evidence of disease. 8. Unresolved toxicities from previous CCRT except for irreversible toxicity that is not reasonably expected to be exacerbated. 9. Prior history or presence of vesicovaginal, colovaginal, or rectovaginal fistula. 10. History of anaphylaxis to any biologic therapy or vaccine. 11. Current or prior use of immunosuppressive medication within 14 days before the first dose of the study intervention is excluded. The following are exceptions to this criterion: a) Intranasal, inhaled, topical steroids, or local steroid injections (eg, intraarticular injection); b) Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication or chemotherapy premedication) or a single dose for palliative purpose (eg, pain control); c) Physiologic doses of oral corticosteroids, ie, not exceeding 10 mg/day of prednisone (or equivalent) in the preceding 14 days. 12. Patients who have undergone a previous hysterectomy, including a supracervical hysterectomy, or will have a hysterectomy as part of their initial cervical cancer therapy. 13. Any prior (besides prior CCRT) or concurrent treatment for cervical cancer. 14. Major surgical procedures within 4 weeks prior to the first dose of the study intervention or still recovering from prior surgery. 15. Exposure to immune mediated therapy prior to the study for any indication. 16. Receipt of live attenuated vaccine within 30 days prior to the first dose of the study intervention. 17. Participants with a known allergy or hypersensitivity to the study intervention, or any excipients of the study intervention.

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Conditions

The condition(s) this trial relates to.

cervical cancer cervical carcinoma

As listed by the trial registrant

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

Locally advanced cervical cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

149 sites in 17 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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Birmingham, Alabama, 35233, United States
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Phoenix, Arizona, 85016, United States
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Tucson, Arizona, 85711, United States
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Little Rock, Arkansas, 72205, United States
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La Jolla, California, 92093, United States
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West Hollywood, California, 90048, United States
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Atlanta, Georgia, 30322, United States
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Augusta, Georgia, 30912, United States
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Savannah, Georgia, 31405, United States
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Melrose Park, Illinois, 60160, United States
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Indianapolis, Indiana, 46202, United States
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New Orleans, Louisiana, 70112, United States
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New Orleans, Louisiana, 70121, United States
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Shreveport, Louisiana, 71103, United States
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New York, New York, 10016, United States
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Syracuse, New York, 13210, United States
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Cleveland, Ohio, 44195, United States
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Columbus, Ohio, 43210, United States
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Eugene, Oregon, 97401, United States
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Philadelphia, Pennsylvania, 19107, United States
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Providence, Rhode Island, 02905, United States
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Dallas, Texas, 75390, United States
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Fort Worth, Texas, 76104, United States
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Houston, Texas, 77030, United States
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Tyler, Texas, 75702, United States
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Charlottesville, Virginia, 22908, United States
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Fairfax, Virginia, 22031, United States
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Richmond, Virginia, 23298, United States
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Barretos, 14784-400, Brazil
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Belo Horizonte, 30130-100, Brazil
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Curitiba, 80730-150, Brazil
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Fortaleza, 60336-045, Brazil
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Fortaleza, 60430-230, Brazil
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Goiânia, 74110-060, Brazil
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Ijuí, 98700-000, Brazil
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Natal, 59075-740, Brazil
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Porto Alegre, 90570-060, Brazil
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Porto Alegre, 90619-900, Brazil
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Porto Alegre, 98850-170, Brazil
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Porto Velho, 76834-899, Brazil
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Recife, 52010-075, Brazil
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Rio de Janeiro, 20220-410, Brazil
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Salvador, 40050 410, Brazil
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São Paulo, 01246-000, Brazil
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São Paulo, 01323-000, Brazil
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São Paulo, 1323001, Brazil
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Teresina, 64049-200, Brazil
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Hamilton, Ontario, L8V 1C3, Canada
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London, Ontario, N6A 5W9, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H2X 0C1, Canada
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Montreal, Quebec, H3G 1A4, Canada
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Ste-Foy, Quebec, G1V 4G2, Canada
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Beijing, 100026, China
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Beijing, 100142, China
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Beijing, 100730, China
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Changde, 415000, China
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Changsha, 410008, China
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Changsha, 410013, China
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Chengdu, 610041, China
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Chengdu, 610044, China
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Chongqing, 400030, China
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Fuzhou, 350014, China
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Ganzhou, 341000, China
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Guangzhou, 510060, China
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Guangzhou, 510120, China
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Hangzhou, 310022, China
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Harbin, 150081, China
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Kunming, 650118, China
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Lanzhou, 730000, China
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Lanzhou, 730050, China
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Linyi, 276001, China
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Luzhou, 646000, China
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Nanchang, 330006, China
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Nanchang, 330029, China
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Shandong, China
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Shanghai, 200032, China
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Shanghai, 200080, China
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Shenyang, 110004, China
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Shenzhen, 518036, China
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Shenzhen, 518116, China
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Tianjin, 300060, China
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Wuhan, 430022, China
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Wuhan, 430030, China
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Xi'an, 710061, China
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Yibin, 610500, China
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Yinchuan, 750004, China
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Zhengzhou, 450008, China
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Zhengzhou, 450052, China
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Zhuzhou, 412007, China
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Aarhus N, 8200, Denmark
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København Ø, 2100, Denmark
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Odense, 5000, Denmark
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Berlin, 13353, Germany
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Bonn, 53127, Germany
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Hamburg, 20246, Germany
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Leipzig, 04103, Germany
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Calicut, 673601, India
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Jaipur, 302017, India
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Lucknow, 226003, India
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Madurai, 625107, India
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Mohali, 160055, India
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Nagpur, 440001, India
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Nashik, 422009, India
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Nashik, 422011, India
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New Delhi, 110029, India
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Vadodara, 391760, India
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Bari, 70124, Italy
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Bologna, 40138, Italy
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Catania, 95126, Italy
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Florence, 50141, Italy
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Lecco, 23900, Italy
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Milan, 20133, Italy
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Milan, 20141, Italy
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Milan, 20159, Italy
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Monza, 20900, Italy
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Naples, 80131, Italy
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Roma, 161, Italy
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Rome, 00168, Italy
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Turin, 10128, Italy
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Fukuoka, 812-8582, Japan
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Ginowan-shi, 901-2725, Japan
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Hidaka-shi, 350-1298, Japan
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Kagoshima, 890-8520, Japan
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Kōtoku, 135-8550, Japan
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Kurume-shi, 830-0011, Japan
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Maebashi, 371-8511, Japan
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Matsuyama, 791-0280, Japan
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Morioka, 028-3695, Japan
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Nagoya, 464-8681, Japan
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Osaka, 541-8567, Japan
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Sapporo, 003-0804, Japan
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Sapporo, 060-8638, Japan
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Shinjuku-ku, 160-8582, Japan
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Suita-shi, 565-0871, Japan
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Sunto-gun, 411-8777, Japan
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Toon-Shi, 791-0295, Japan
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Coyoacán, 04380, Mexico
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Culiacán, 80040, Mexico
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Guadalajara, 44650, Mexico
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Guadalajra, 44260, Mexico
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Mexico City, 03240, Mexico
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México, 04700, Mexico
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México, 14080, Mexico
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Monterrey, 64460, Mexico
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Oslo, 424, Norway
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Trondheim, 7030, Norway
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Concepción, 12125, Peru
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Lima, 15036, Peru
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Lima, 15038, Peru
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Lima, 15102, Peru
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Lima, LIMA 29, Peru
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Lima, Lima 34, Peru
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Lima, Lima39, Peru
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Bialystok, 15-027, Poland
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Gdansk, 80-214, Poland
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Gliwice, 44-101, Poland
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Krakow, 30-348, Poland
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Lodz, 90-513, Poland
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Poznan, 61-866, Poland
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Warsaw, 02-781, Poland
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Wroclaw, 53-413, Poland
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San Juan, 00927, Puerto Rico
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Daegu, 42601, South Korea
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Goyang-si, 10408, South Korea
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Gyeonggi-do, 13605, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 06351, South Korea
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Seoul, 5505, South Korea
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A Coruña, 15009, Spain
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Barcelona, 08036, Spain
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Barcelona, 8035, Spain
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Córdoba, 14004, Spain
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Girona, 17007, Spain
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Hospitalet deLlobregat, 08907, Spain
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Madrid, 28034, Spain
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Madrid, 28040, Spain
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Madrid, 28041, Spain
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Madrid, 28046, Spain
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Palma de Mallorca, 07010, Spain
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Valencia, 46009, Spain
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Valencia, 46010, Spain
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Changhua, 50006, Taiwan
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Kaohsiung City, 81362, Taiwan
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Kaohsiung City, 833, Taiwan
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New Taipei City, 220, Taiwan
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Taichung, 40447, Taiwan
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Taichung, 40705, Taiwan
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Tainan, 704, Taiwan
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Taipei, 10449, Taiwan
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Taipei, 11217, Taiwan
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Taoyuan, 333, Taiwan
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Bangkok, 10330, Thailand
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Bangkok, 10400, Thailand
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Bangkok, 10700, Thailand
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Muang, 50200, Thailand
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Udon Thani, 41330, Thailand
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Adana, 01250, Turkey (Türkiye)
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Ankara, 06100, Turkey (Türkiye)
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Ankara, 06490, Turkey (Türkiye)
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Cordaleo, 35575, Turkey (Türkiye)
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Istanbul, 32098, Turkey (Türkiye)
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Istanbul, 34214, Turkey (Türkiye)

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