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Taking people in CanadaPhase 2

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
Edmonton and Montreal, CanadaSee the 2 sitesAlso in 11 other countries, 68 sites
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 Canada

Also in 11 other countries, 68 sites

  • Edmonton, AlbertaHospital not named in the registryTaking people
  • Montreal, QuebecHospital 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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data 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