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

Recruiting now · Phase 2

Conditions studied: 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)

In brief

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.

Key facts

Study ID: NCT06535607
Run by: AstraZeneca
People needed: 257
Starts: 2024-08-22
Expected to finish: 2028-11-30
Last updated by the study team: 2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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 it is running

Research Site — Jining, China (enrolling)
Research Site — Tianjin, China (enrolling)
Research Site — Changsha, China (enrolling)
Research Site — Hangzhou, China (enrolling)
Research Site — Shanghai, China (enrolling)
Research Site — Clayton, Australia (enrolling)
Research Site — Changchun, China (enrolling)
Research Site — Changsha, China (enrolling)
Research Site — Chengdu, China (enrolling)
Research Site — Fuzhou, China (enrolling)
Research Site — Shandong, China (enrolling)
Research Site — Shandong, China (enrolling)
Research Site — São Caetano do Sul, Brazil (enrolling)
Research Site — Vitória, Brazil (enrolling)
Research Site — Nedlands, Australia (enrolling)
Research Site — Baltimore, Maryland, United States (enrolling)
Research Site — Montreal, Quebec, Canada (enrolling)
Research Site — Ijuí, Brazil (enrolling)
Research Site — Londrina, Brazil (enrolling)
Research Site — Beijing, China (enrolling)
Research Site — Dongguan, China (enrolling)
Research Site — Beijing, China (enrolling)
Research Site — Kunming, China (enrolling)
Research Site — Nanning, China (enrolling)
Research Site — Wuhan, China (enrolling)

Full record on ClinicalTrials.gov

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