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Study of Volrustomig for Advanced/Metastatic Solid Tumors

This study is testing a new treatment called Volrustomig, either by itself or with chemotherapy drugs like Cisplatin, Carboplatin, Paclitaxel, or 5-FU. It's for people with advanced or metastatic (spread to other parts of the body) solid tumors, including cervical cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, and unresectable pleural mesothelioma. Researchers want to see how well Volrustomig shrinks tumors (objective response rate) and if it causes any side effects. To join, you must be at least 18 years old, have a good performance status, and a life expectancy of at least 12 weeks. You may also need to provide a tumor sample to check for a biomarker called PD-L1. The study is currently recruiting participants.

Study design
This interventional study plans to enroll 257 participants across several sub-studies, testing Volrustomig alone or in combination with chemotherapy.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for an average of 4 years to measure tumor response and adverse events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06535607

Study of Volrustomig as Monotherapy or in Combination With Anti- Cancer Agents in Participants With Advanced/Metastatic Solid Tumors

Recruiting
PHASE2Ages 18+InterventionalTreatment
AstraZeneca
~257 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:VolrustomigCisplatinCarboplatinPaclitaxel5-FU

At a glance

Recruiting sites
41 of 97 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective response rate (ORR)
Measured over Through study completion, an average of 4 years
+1 more outcome measured

Conditions

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)

Explore related trials

Cervical CarcinomaEsophageal Squamous Cell CarcinomaHead and Neck Squamous Cell CarcinomaPleural Malignant MesotheliomaSolid Neoplasm

Where it's being run

97 sites across 17 states
China50
Germany10
Brazil8
Taiwan5
South Korea4
Italy3
United Kingdom3
New York2

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
+18772409479
Email the study team

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Eligibility criteria

Inclusion

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.
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.

Exclusion

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.

What this trial measures

  • Objective response rate (ORR)Through study completion, an average of 4 years

    Confirmed ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, as determined by Investigator per RECIST 1.1.

  • The number of participants with adverse events/serious adverse eventsThrough study completion, an average of 4 years

    Number of participants with adverse events and with serious adverse events including abnormal clinical observations, abnormal Electrocardiogram (ECG) parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline.