Tests volrustomig alone or with chemotherapy in several advanced solid cancers
Tests volrustomig, alone or with chemotherapy, in adults with advanced solid tumors.
Key facts
- Who runs it
- AstraZeneca
- Where
- Kaohsiung City, Taichung, and Taipei, TaiwanSee the 3 sitesAlso in 11 other countries, 67 sites
- Trial code
- Registry title
- Study of Volrustomig as Monotherapy or in Combination With Anti- Cancer Agents in Participants With Advanced/Metastatic Solid Tumors
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 257 people, planned
- Started
- 22 Aug 2024
- Expected to end
- 30 Nov 2028
- Type of study
- Interventional, 8 groups
- Treatments tested
- Volrustomig
- Cisplatin
- Carboplatin
- Paclitaxel
- 5-FU
- Record updated
- 11 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or spread (metastatic) solid tumors: cervical cancer, head and neck squamous cell cancer, esophageal squamous cell cancer or pleural mesothelioma that cannot be removed by surgery. Volrustomig is given alone or with other cancer medicines.
- Age
- From 18 years to 64 years.
- Sex
- All sexes can join.
- Disease stage
- Advanced or metastatic solid tumor. Sub-studies cover cervical cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma and unresectable pleural mesothelioma. Measurable disease by RECIST 1.1 is needed.
- Earlier treatment
- Cannot join if they had any immune-mediated therapy before. For sub-studies 1, 2, 3 and 4, no anti-cancer therapy within 28 days before the first dose. For sub-study 5, no earlier systemic therapy or non-palliative radiotherapy.
- Biomarker or test result
- A tumor sample is needed to test PD-L1 expression, if applicable.
Main reasons for not taking part
- Spinal cord compression
- Untreated, symptomatic or unstable brain metastases
- Active or past autoimmune or inflammatory disease
- Active infection such as tuberculosis, uncontrolled HIV, HBV or HCV, or active hepatitis A
- Candidates for treatment meant to remove all of the disease
The registry criteria, word for word
Show all 28 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
- 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
- For substudy 5: Participants with any prior systemic therapy, non-palliative radiotherapy, radical pleuropneumonectomy for pleural mesothelioma
- 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
- Participants with a known allergy or hypersensitivity to any study intervention, on any excipients of any study intervention
- Spinal cord compression
- For sub-study 1,2,3, participants with primary neuroendocrine, mesenchymal, sarcomatoid histologies, or other histologies not mentioned as part of the inclusion criteria
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Taiwan
Also in 11 other countries, 67 sites
- Kaohsiung CityHospital not named in the registryTaking people
- TaichungHospital not named in the registryTaking people
- TaipeiHospital not named in the registryTaking people
About the trial
What the trial wants to find out
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.
The 8 groups in the trial
- Sub-study 1Treatment being tested
Volrustomig monotherapy
Treatment: Volrustomig
- Sub-study 2Treatment being tested
Volrustomig monotherapy
Treatment: Volrustomig
- Sub-study 3 Arm ATreatment being tested
Volrustomig in combination with carboplatin plus paclitaxel
Treatment: Volrustomig, Cisplatin, Carboplatin, and Paclitaxel
- Sub-study 3 Arm BTreatment being tested
Volrustomig in combination with carboplatin plus paclitaxel
Treatment: Volrustomig, Cisplatin, Carboplatin, and Paclitaxel
- Sub-study 3 Arm CTreatment being tested
Volrustomig in combination with 5-FU plus platinum
Treatment: Volrustomig, Cisplatin, Carboplatin, and 5-FU
- Sub-study 4 Arm ATreatment being tested
Volrustomig in combination with cisplatin + 5-FU
Treatment: Volrustomig, Cisplatin, and 5-FU
- Sub-study 4 Arm BTreatment being tested
Volrustomig in combination with cisplatin + paclitaxel
Treatment: Volrustomig, Cisplatin, and Paclitaxel
- Sub-study 5Treatment being tested
Volrustomig monotherapy
Treatment: Volrustomig
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Phase II, Multi-Center Study to Evaluate the Efficacy and Safety of Volrustomig as Monotherapy or in Combination With Anti-cancer Agents in Participants With Advanced/Metastatic Solid Tumors
- Plain-language title
- Tests volrustomig alone or with chemotherapy in several advanced solid cancersGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06535607, who can take part
- Record updated
- 11 September 2026