Tests volrustomig alone or with chemotherapy in several advanced solid cancers

Trial details

Who runs it

AstraZeneca

Trial code

NCT06535607EU 2025-523947-36-00

Record updated

11 September 2026

Original description

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.Read full original descriptionShow less

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

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.

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.

Exclusion: 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.

ClinicalTrials.gov NCT06535607 · EU CTIS 2025-523947-36-00