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Looking for participantsPhase2

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

Sponsor: AstraZeneca

NCT ID: NCT06535607

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Volrustomig (biological), Cisplatin (drug), Carboplatin (drug), Paclitaxel (drug)
How long the study runs
Study runs about 51 months (dates as stated)
About the drug or intervention
Volrustomig — biological: IV Infusion · Cisplatin — drug: IV Infusion · Carboplatin — drug: IV Infusion · Paclitaxel — drug: IV Infusion · 5-FU — drug: IV Infusion
Patient visit burden
Not specified by the sponsor

In plain English

This study is testing a drug called volrustomig, either on its own or together with other anti-cancer medicines, in people with advanced or spread solid tumours. It has five parts (sub-studies) covering cervical cancer, head and neck cancer, food pipe (oesophageal) cancer, and a type of lung lining cancer called pleural mesothelioma. The study is funded by AstraZeneca.

Who can take part

  • Age 18 or over
  • Able to give a tumour sample so doctors can test for PD-L1 (a protein on cancer cells), where this applies
  • Generally well and active (performance status score of 0 or 1)
  • Cancer that can be measured on scans
  • Expected to live at least 12 weeks
  • Healthy enough organs and bone marrow
  • Body weight over 35 kg
  • Able to give informed consent to take part

Who may not be able to

  • Cancer pressing on the spinal cord
  • Brain secondaries that cause symptoms or are unstable (rules differ by sub-study — ask the trial team)
  • Certain rare cancer types, for some sub-studies
  • Still having side effects from earlier cancer treatment
  • Radiotherapy within 2 weeks before joining (sub-study 2)
  • Not able to have chemotherapy drugs used in the study (5-FU, paclitaxel, carboplatin) (sub-studies 3 and 4)
  • Another cancer in the last 2 years, with some exceptions such as treated skin cancer
  • An organ or stem cell transplant, or another condition that would make taking part unsafe
  • Certain infections, such as tuberculosis, uncontrolled HIV, hepatitis B, hepatitis C or hepatitis A
  • Current or past immune system or autoimmune disorders
  • Cancer that could be treated with the aim of a cure
  • Previous treatment with immune-based (immunotherapy) medicines
  • Use of medicines that damp down the immune system in the last 14 days, with some exceptions like steroid creams or inhalers
  • Cancer treatment within 28 days before the first study dose (sub-studies 1–4)
  • Other cancer treatment at the same time as the study, such as chemotherapy or radiotherapy
  • Wide-field radiotherapy or radiotherapy to over 30% of the bone marrow in the last 4 weeks
  • Major surgery in the last 4 weeks, or still recovering from surgery
  • A live vaccine in the last 30 days
  • Known allergy to the study medicines or their ingredients
  • For the mesothelioma sub-study: any earlier whole-body treatment, non-palliative radiotherapy, or radical pleuropneumonectomy surgery

What taking part involves

  • • Volrustomig on its own (sub-studies 1, 2 and 5)
  • • Volrustomig together with chemotherapy (sub-studies 3 and 4)

Time commitment: Not stated — ask the trial team about how many visits are needed, how long the study lasts, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
257
Started
2024-08-22
Last checked
2026-03

Plain English Summary

What is this study?

  • • Testing a new treatment for sub-study 1 cervical cancer (volrustomig monotherapy)
  • • Phase2 - 257 participants
  • • eVOLVE-02 study will evaluate the efficacy and safety of volrustomig as monotherapy or in combination with anti-cancer agents in participants with advanced/metastatic solid tumors

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with sub-study 1 cervical cancer (volrustomig monotherapy)

Where?

  • • Cambridge - Research Site
  • • Glasgow - Research Site
  • • Manchester - Research Site

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

eVOLVE-02 study will evaluate the efficacy and safety of volrustomig as monotherapy or in combination with anti-cancer agents in participants with advanced/metastatic solid tumors.

More detail

eVOLVE-02 study will evaluate volrustomig monotherapy or volrustomig-based combination therapy in various advanced or metastatic solid tumors. In sub-study 1, volrustomig will be evaluated as monotherapy in approximately 30 evaluable participants with cervical cancer. In sub-study 2, volrustomig will be evaluated as monotherapy in approximately 20 evaluable participants with head and neck squamous cell carcinoma. In sub-study 3, Volrustomig in Combination with Chemotherapy will be evaluated in approximately 60 evaluable participants with head and neck squamous cell carcinoma. In sub-study 4, volrustomig in Combination with Chemotherapy will be evaluated in approximately 60 evaluable participants with esophagus squamous cell carcinoma. In sub-study 5, volrustomig will be evaluated as monotherapy in approximately 75 evaluable participants with unresectable pleural mesothelioma.

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 this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders
  • How fit you need to be: ECOG 0 or better

Biomarkers mentioned

PD-L1

Treatment history

Treatments you must NOT have had:

  • ✗ use of immunosuppressive medication within 14 days before the first dose of the study intervention

What the study is looking for

  • ✓Age ≥18 at the time of signing the ICF.
  • ✓Provision of tumor sample to assess the PD-L1 expression (if applicable).
  • ✓Fit enough for normal activity (ECOG 0) or 1.
  • ✓cancer that can be measured on scans according to (standard scan measurements) (variations of (standard scan measurements) if applicable).
  • ✓Life expectancy ≥ 12 weeks.

Who cannot take part

  • ✗Spinal cord compression.
  • ✗For sub-study 1,2,3, participants with primary neuroendocrine, mesenchymal, sarcomatoid histologies, or other...
  • ✗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
See the full criteria
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.

Where Is This Study? (3 UK sites)

Research Site

Cambridge CB2 0QQ, United Kingdom

Recruiting

Research Site

Glasgow G12 0YN, United Kingdom

Recruiting

Research Site

Manchester M23 9LT, United Kingdom

Recruiting

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

+18772409479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-03