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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (3 UK sites)
Research Site
Cambridge CB2 0QQ, United Kingdom
Research Site
Glasgow G12 0YN, United Kingdom
Research Site
Manchester M23 9LT, United Kingdom
How to Get in Touch
AstraZeneca Clinical Study Information Center
Sponsor contactCONTACT
