Recruiting NCT06535607

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

Phase II Interventional 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)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Volrustomig, Cisplatin, Carboplatin, Paclitaxel.
Who it may be relevant to: Registry 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). Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Brazil, Canada, China +7
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Detailed description

eVOLVE-02 study will evaluate volrustomig monotherapy or volrustomig-based combination therapy in various advanced or metastatic solid tumors.

In sub-study 1, volrustomig will be evaluated as monotherapy in approximately 30 evaluable participants with cervical cancer.

In sub-study 2, volrustomig will be evaluated as monotherapy in approximately 20 evaluable participants with head and neck squamous cell carcinoma.

In sub-study 3, Volrustomig in Combination with Chemotherapy will be evaluated in approximately 60 evaluable participants with head and neck squamous cell carcinoma.

In sub-study 4, volrustomig in Combination with Chemotherapy will be evaluated in approximately 60 evaluable participants with esophagus squamous cell carcinoma.

In sub-study 5, volrustomig will be evaluated as monotherapy in approximately 75 evaluable participants with unresectable pleural mesothelioma.

Interventions

Biological Volrustomig
IV Infusion
Drug Cisplatin
IV Infusion
Drug Carboplatin
IV Infusion
Drug Paclitaxel
IV Infusion
Drug 5-FU
IV Infusion

Primary outcome measures

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]

Secondary outcome measures (9)

Duration Of Response (DOR) [Time frame: Through study completion, an average of 4 years]
Progression free survival (PFS) [Time frame: Through study completion, an average of 4 years]
Time to response (TTR) [Time frame: Through study completion, an average of 4 years]
Overall Survival (OS) [Time frame: Through study completion, an average of 4 years]
PK of volrustomig [Time frame: Through study completion, an average of 4 years]
The immunogenicity of volrustomig [Time frame: Through study completion, an average of 4 years]
Disease control rate (DCR) [Time frame: Through study completion, an average of 4 years]
PFS landmark [Time frame: Through study completion, an average of 4 years]
OS landmark [Time frame: Through study completion, an average of 4 years]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment

Study locations

China · 50 centers

Research Site — Anyang
Research Site — Beijing
Research Site — Beijing
Research Site — Beijing
Research Site — Beijing
Research Site — Beijing
Research Site — Bengbu
Research Site — Changchun
… and 42 more centers

Germany · 10 centers

Research Site — Cologne
Research Site — Frankfurt
Research Site — Gauting
Research Site — Großhansdorf
Research Site — Hamburg
Research Site — Heidelberg
Research Site — Mainz
Research Site — Münster
… and 2 more centers

Brazil · 8 centers

Research Site — Ijuí
Research Site — Londrina
Research Site — Natal
Research Site — Porto Alegre
Research Site — Santo André
Research Site — São Caetano do Sul
Research Site — Vitória
Research Site — Vitória

United States · 6 centers

Research Site — Los Angeles
Research Site — Baltimore
Research Site — New York
Research Site — Stony Brook
Research Site — Columbus
Research Site — Philadelphia

Taiwan · 5 centers