Health Trials

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

ConditionsSub-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)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Volrustomig

    Biological/Vaccine

    IV Infusion

  • Cisplatin

    Drug

    IV Infusion

  • Carboplatin

    Drug

    IV Infusion

  • Paclitaxel

    Drug

    IV Infusion

  • 5-FU

    Drug

    IV Infusion

Treatment groups

257 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Sub-study 1Experimental treatment 1 intervention
Group B: Sub-study 2Experimental treatment 1 intervention
Group C: Sub-study 3 Arm AExperimental treatment 4 interventions
Group D: Sub-study 3 Arm BExperimental treatment 4 interventions
Group E: Sub-study 3 Arm CExperimental treatment 4 interventions
Group F: Sub-study 4 Arm AExperimental treatment 3 interventions
Group G: Sub-study 4 Arm BExperimental treatment 3 interventions
Group H: Sub-study 5Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

Confirmed ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, as determined by Investigator per RECIST 1.1.

Time frame
Through study completion, an average of 4 years
2

The number of participants with adverse events/serious adverse events

Number of participants with adverse events and with serious adverse events including abnormal clinical observations, abnormal Electrocardiogram (ECG) parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline.

Time frame
Through study completion, an average of 4 years

Secondary outcomes

1

Duration Of Response (DOR)

DoR is defined as the time from the date of first documented confirmed response (which is subsequently confirmed) until date of documented progression per RECIST 1.1 as assessed by Investigator or ICR, or death due to any cause.

Time frame
Through study completion, an average of 4 years
2

Progression free survival (PFS)

PFS is defined as the time from date of first dose of study intervention until progression per RECIST 1.1 as assessed by Investigator or ICR, or death due to any cause.

Time frame
Through study completion, an average of 4 years
3

Time to response (TTR)

TTR is defined as the time from the date of the first dose of study intervention until the date of first documented objective response, which is subsequently confirmed per RECIST 1.1, as assessed by Investigator or ICR.

Time frame
Through study completion, an average of 4 years
4

Overall Survival (OS)

OS is defined as the time from the date of first dose of study intervention until the date of death due to any cause.

Time frame
Through study completion, an average of 4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov
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