New immunotherapy combo shows promise for tough cancers

NCT ID NCT06535607

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Sep 11, 2026 · Updated 4 times

Summary

This phase 2 trial is testing an experimental drug called volrustomig, either alone or with chemotherapy, in people with advanced cervical, head and neck, esophageal, or mesothelioma cancers. The study aims to see if the drug can shrink tumors and how safe it is. About 257 participants will receive the treatment intravenously.

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 experimental immunotherapy) given alone or with chemotherapy drugs (cisplatin, carboplatin, paclitaxel, 5-FU)
What this could lead to: If successful, this could provide a new treatment option for people with advanced cancers that are hard to treat.
What could go wrong: This is an early-phase trial with only 257 participants, so results may not apply to everyone. Side effects from the immunotherapy or chemo could be serious.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 257 people

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

Started

Aug 2024

Expected to finish

Nov 2028

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

18 years and older

Sex

Anyone

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: * Age ≥18 at the time of signing the ICF. * Provision of tumor sample to assess the PD-L1 expression (if applicable). * ECOG performance status of 0 or 1. * Measurable disease according to RECIST 1.1 (variations of RECIST 1.1 if applicable). * Life expectancy ≥ 12 weeks. * Adequate organ and bone marrow function. * Body weight \> 35 kg * Capable of giving signed informed consent. Exclusion Criteria: * Spinal cord compression. * For sub-study 1,2,3,4, brain metastases unless asymptomatic, stable, and not requiring steroids for at least 14 days prior to start of study intervention. For sub-study 5, participants with untreated or progressive brain metastases. * For sub-study 1,2,3, participants with primary neuroendocrine, mesenchymal, sarcomatoid histologies, or other histologies not mentioned as part of the inclusion criteria. * Have not recovered (ie, ≤ Grade 1 or at baseline) from an AE due to a previously administered anti-cancer therapy. * For sub-study 2, have had radiotherapy within 2 weeks prior to enrollment. * For sub-study 3,4, participants have contraindications to any of the following drugs: 5-FU, paclitaxel and carboplatin * 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 and of low potential risk for recurrence; b) Adequately treated nonmelanoma skin cancer or lentigo maligna, or carcinoma in situ without evidence of disease. * Any evidence of diseases, and/or history of organ transplant or allogenic stem cell transplant, which makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol. * Evidence of the following infections: active infection including tuberculosis; known HIV infection. that is not well controlled; active or uncontrolled HBV or HCV; or active hepatitis A. * History of active primary immunodeficiency or active or prior documented autoimmune or inflammatory disorders. * Participants who are candidates for curative therapy. * Prior exposure to any immune-mediated therapy. * 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). * For sub-study 1,2,3,4, participants are ineligible if they have received any anti-cancer therapy within 28 days prior to the first dose of study intervention or within 5 half-lives of the respective agent, whichever is longer. * Any concurrent chemotherapy except study intervention, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment. * Radiotherapy treatment with a wide field of radiation or to more than 30% of the bone marrow within 4 weeks, prior to the first dose of study intervention. * Major surgical procedures within 4 weeks prior to the first dose of the study intervention or still recovering from prior surgery. * Receipt of live attenuated vaccine within 30 days prior to the first dose of the study intervention. * Participants with a known allergy or hypersensitivity to any study intervention, on any excipients of any study intervention. * For substudy 5: Participants with any prior systemic therapy, non-palliative radiotherapy, radical pleuropneumonectomy for pleural mesothelioma.

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Conditions

The condition(s) this trial relates to.

cervical cancer esophageal squamous cell carcinoma head and neck squamous cell carcinoma malignant pleural mesothelioma Squamous Cell Carcinoma of Head and Neck Uterine Cervical Neoplasms

As listed by the trial registrant

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

Cervical cancer Head and neck squamous cell carcinoma Sub-study 1 cervical cancer (volrustomig monotherapy) Sub-study 2 head and neck squamous cell carcinoma (volrustomig monotherapy) Sub-study 3 head and neck squamous cell carcinoma (volrustomig in combination with chemotherapy) Sub-study 4 esophageal squamous cell carcinoma (volrustomig in combination with chemotherapy) Sub-study 5 unresectable pleural mesothelioma (volrustomig monotherapy)

How to take part

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

The places running it

69 sites in 12 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.

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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

Research Site
WITHDRAWN

Los Angeles, California, 90025, United States
Research Site
RECRUITING

Baltimore, Maryland, 21201, United States
Research Site
RECRUITING

New York, New York, 10065, United States
Research Site
RECRUITING

Stony Brook, New York, 11794, United States
Research Site
NOT_YET_RECRUITING

Columbus, Ohio, 43210, United States
Research Site
WITHDRAWN

Columbus, Ohio, 43210, United States
Research Site
NOT_YET_RECRUITING

Philadelphia, Pennsylvania, 19104, United States
Research Site
RECRUITING

Clayton, 3168, Australia
Research Site
RECRUITING

Nedlands, 6009, Australia
Research Site
RECRUITING

Ijuí, 98700-000, Brazil
Research Site
RECRUITING

Londrina, 86015-520, Brazil
Research Site
RECRUITING

Natal, 59075-740, Brazil
Research Site
NOT_YET_RECRUITING

Porto Alegre, 91350-200, Brazil
Research Site
NOT_YET_RECRUITING

Santo André, 09060-650, Brazil
Research Site
RECRUITING

São Caetano do Sul, 09541-270, Brazil
Research Site
RECRUITING

Vitória, 29043-260, Brazil
Research Site
NOT_YET_RECRUITING

Vitória, 29043-260, Brazil
Research Site
RECRUITING

Edmonton, Alberta, T6G 1Z2, Canada
Research Site
RECRUITING

Montreal, Quebec, H2X 0A9, Canada
Research Site
NOT_YET_RECRUITING

Anyang, 455000, China
Research Site
NOT_YET_RECRUITING

Beijing, 100142, China
Research Site
RECRUITING

Beijing, 100142, China
Research Site
ACTIVE_NOT_RECRUITING

Beijing, 100730, China
Research Site
RECRUITING

Beijing, 100730, China
Research Site
ACTIVE_NOT_RECRUITING

Beijing, CN-100730, China
Research Site
WITHDRAWN

Bengbu, 233004, China
Research Site
WITHDRAWN

Changchun, 130021, China
Research Site
RECRUITING

Changchun, 130021, China
Research Site
COMPLETED

Changsha, 410003, China
Research Site
COMPLETED

Changsha, 410008, China
Research Site
ACTIVE_NOT_RECRUITING

Changsha, 410008, China
Research Site
COMPLETED

Changsha, 410013, China
Research Site
COMPLETED

Chengdu, 610041, China
Research Site
ACTIVE_NOT_RECRUITING

Chengdu, 610041, China
Research Site
RECRUITING

Chengdu, 610072, China
Research Site
ACTIVE_NOT_RECRUITING

Chongqing, 400030, China
Research Site
WITHDRAWN

Chongqing, 400030, China
Research Site
ACTIVE_NOT_RECRUITING

Dongguan, 523009, China
Research Site
RECRUITING

Dongguan, 523009, China
Research Site
COMPLETED

Fuzhou, 350011, China
Research Site
RECRUITING

Fuzhou, 350014, China
Research Site
NOT_YET_RECRUITING

Fuzhou, 350014, China
Research Site
NOT_YET_RECRUITING

Guangzhou, 510000, China
Research Site
ACTIVE_NOT_RECRUITING

Hangzhou, 310022, China
Research Site
NOT_YET_RECRUITING

Harbin, 150081, China
Research Site
WITHDRAWN

Hefei, 230031, China
Research Site
COMPLETED

Jining, 272029, China
Research Site
COMPLETED

Kunming, 650118, China
Research Site
RECRUITING

Kunming, 650118, China
Research Site
TERMINATED

Nanchang, 330006, China
Research Site
NOT_YET_RECRUITING

Nanjing, 210009, China
Research Site
COMPLETED

Nanning, 530021, China
Research Site
RECRUITING

Nanning, 530021, China
Research Site
RECRUITING

Shandong, 250117, China
Research Site
COMPLETED

Shandong, China
Research Site
NOT_YET_RECRUITING

Shandong, China
Research Site
RECRUITING

Shandong, China
Research Site
ACTIVE_NOT_RECRUITING

Shanghai, 200120, China
Research Site
ACTIVE_NOT_RECRUITING

Shenyang, 110004, China
Research Site
COMPLETED

Tianjin, 300060, China
Research Site
RECRUITING

Tianjin, 300060, China
Research Site
COMPLETED

Wuhan, 430022, China
Research Site
ACTIVE_NOT_RECRUITING

Wuhan, 430022, China
Research Site
RECRUITING

Wuhan, 430030, China
Research Site
RECRUITING

Wuhan, 430040, China
Research Site
WITHDRAWN

Wuhan, 430079, China
Research Site
RECRUITING

Wuhou District, 610041, China
Research Site
NOT_YET_RECRUITING

Zhengzhou, 450008, China
Research Site
RECRUITING

Cologne, 51109, Germany
Research Site
NOT_YET_RECRUITING

Frankfurt, 60488, Germany
Research Site
RECRUITING

Gauting, 82131, Germany
Research Site
RECRUITING

Großhansdorf, 22927, Germany
Research Site
RECRUITING

Hamburg, 21075, Germany
Research Site
RECRUITING

Heidelberg, 69120, Germany
Research Site
NOT_YET_RECRUITING

Mainz, 55131, Germany
Research Site
RECRUITING

Münster, 48153, Germany
Research Site
NOT_YET_RECRUITING

Offenbach, 63069, Germany
Research Site
RECRUITING

Regensburg, 93049, Germany
Research Site
RECRUITING

Alessandria, 15100, Italy
Research Site
RECRUITING

Bergamo, 24125, Italy
Research Site
RECRUITING

Orbassano, 10043, Italy
Research Site
NOT_YET_RECRUITING

Kashiwa, 277-8577, Japan
Research Site
NOT_YET_RECRUITING

Yokohama, 241-8515, Japan
Research Site
NOT_YET_RECRUITING

Incheon, 21565, South Korea
Research Site
RECRUITING

Namdong-gu, 21565, South Korea
Research Site
RECRUITING

Seoul, 03722, South Korea
Research Site
NOT_YET_RECRUITING

Seoul, 03722, South Korea
Research Site
RECRUITING

Kaohsiung City, 80756, Taiwan
Research Site
NOT_YET_RECRUITING

Kaohsiung City, 80756, Taiwan
Research Site
NOT_YET_RECRUITING

Kaohsiung City, 83301, Taiwan
Research Site
RECRUITING

Taichung, 40705, Taiwan
Research Site
RECRUITING

Taipei, 112, Taiwan
Research Site
NOT_YET_RECRUITING

Taipei, 112, Taiwan
Research Site
RECRUITING

Cambridge, CB2 0QQ, United Kingdom
Research Site
RECRUITING

Glasgow, G12 0YN, United Kingdom
Research Site
RECRUITING

Manchester, M23 9LT, United Kingdom
Research Site
RECRUITING

Hanoi, 100000, Vietnam
Research Site
RECRUITING

Ho Chi Minh City, 700000, Vietnam

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