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Evaluating Volrustomig for Advanced Solid Tumors

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

Phase 2 Interventional AstraZeneca · NCT06535607

This study is testing a new treatment called volrustomig for people with advanced solid tumors, including cervical cancer and head and neck cancer, to see how well it works and if it's safe.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment257 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionschemotherapy, radiation
Locations59 sites (Los Angeles, California and 58 other locations)
Trial IDNCT06535607 on ClinicalTrials.gov

What this trial studies

The eVOLVE-02 study aims to assess the efficacy and safety of volrustomig, both as a standalone treatment and in combination with other anti-cancer agents, for patients with advanced or metastatic solid tumors. This Phase II study includes two sub-studies: one focusing on cervical cancer and the other on head and neck squamous cell carcinoma, each enrolling approximately 30 participants. The study will analyze the impact of volrustomig on tumor response and safety profiles, with the goal of informing future Phase III studies.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced or metastatic cervical cancer or head and neck squamous cell carcinoma who have experienced disease progression after prior treatments.

Not a fit: Patients with early-stage tumors or those who have not received prior systemic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced cervical cancer and head and neck squamous cell carcinoma.

How similar studies have performed: Other studies evaluating similar immunotherapy approaches have shown promise, suggesting potential for success in this novel application.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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 this trial is running

Los Angeles, California and 58 other locations

+9 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Sub-study 1 Cervical CancerSub-study 2 Head and Neck Squamous Cell CarcinomaSub-study 3 Head and Neck Squamous Cell CarcinomaSub-study 4 Esophageal Squamous Cell CarcinomaSub-study 5 Unresectable Pleural MesotheliomaCervical CancerHead and Neck Squamous Cell CarcinomaeVOLVE-02
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.