Recruiting
Phase 2

Volrustomig

Sponsor:

AstraZeneca

Code:

NCT06535607

Conditions

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)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Volrustomig

Cisplatin

Carboplatin

Paclitaxel

5-FU

Study Details

Brief summary:

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.

Conditions

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)

Study ID

NCT06535607

Start date

Aug 22, 2024

Status verified date

Mar, 2026

Completion date

Nov 30, 2028

Anticipated

Primary completion date

Nov 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

257 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sub-study 1

Volrustomig monotherapy

experimental: Sub-study 2

Volrustomig monotherapy

experimental: Sub-study 3 Arm A

Volrustomig in combination with carboplatin plus paclitaxel

experimental: Sub-study 3 Arm B

Volrustomig in combination with carboplatin plus paclitaxel

experimental: Sub-study 3 Arm C

Volrustomig in combination with 5-FU plus platinum

experimental: Sub-study 4 Arm A

Volrustomig in combination with cisplatin + 5-FU

experimental: Sub-study 4 Arm B

Volrustomig in combination with cisplatin + paclitaxel

experimental: Sub-study 5

Volrustomig monotherapy

Interventions

Volrustomig

IV Infusion

Cisplatin

IV Infusion

Carboplatin

IV Infusion

Paclitaxel

IV Infusion

5-FU

IV Infusion

Primary outcome measure

  • Objective response rate (ORR) [ Time Frame: Through study completion, an average of 4 years ]
  • The number of participants with adverse events/serious adverse events [ Time Frame: Through study completion, an average of 4 years ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

+18772409479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Baltimore, Maryland, United States, 21201

Research Site

Recruiting

New York, New York, United States, 10065

Research Site

Recruiting

Stony Brook, New York, United States, 11794

Research Site

Recruiting

Edmonton, Alberta, Canada, T6G 1Z2

Research Site

Recruiting

Montreal, Quebec, Canada, H2X 0A9

More Information

Sponsor

AstraZeneca

Last update posted

Sep 11, 2026

Last verified

Mar, 2026

Keywords

  • Cervical Cancer
  • Head and Neck Squamous Cell Carcinoma
  • eVOLVE-02
  • Volrustomig
  • Esophageal Squamous Cell Carcinoma
  • Unresectable Pleural Mesothelioma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-27. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-09-11. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.