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

NCT06535607
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Phase
Phase 2
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Recruitment status
Recruiting
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Participants
257
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Lead sponsor
AstraZeneca
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Start date
2024-08-22
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Number of sites
98
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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.
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Acronym
eVOLVE-02
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Short title
Study of Volrustomig as Monotherapy or in Combination With Anti- Cancer Agents in Participants With Advanced/Metastatic Solid Tumors
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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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2028-11-30
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First posted
2024-08-02
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Registry last updated
2026-09-11
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Primary completion date
2028-11-30
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Start date
2024-08-22
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Participants
257
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Participant count basis
Estimated
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Planned participants
257
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Protocol amendments
5
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Number of sites
98
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
AstraZeneca
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06535607
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ClinicalTrials.gov ID
NCT06535607
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Objective response rate (ORR)

    Timeframe: Through study completion, an average of 4 years

    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.

  2. The number of participants with adverse events/serious adverse events

    Timeframe: Through study completion, an average of 4 years

    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.

  1. Duration Of Response (DOR)

    Timeframe: Through study completion, an average of 4 years

    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.

  2. Progression free survival (PFS)

    Timeframe: Through study completion, an average of 4 years

    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.

  3. Time to response (TTR)

    Timeframe: Through study completion, an average of 4 years

    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.

  4. Overall Survival (OS)

    Timeframe: Through study completion, an average of 4 years

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

  5. PK of volrustomig

    Timeframe: Through study completion, an average of 4 years

    Concentration of Volrustomig in serum.

  6. The immunogenicity of volrustomig

    Timeframe: Through study completion, an average of 4 years

    Incidence of ADAs against volrustomig in serum.

  7. Disease control rate (DCR)

    Timeframe: Through study completion, an average of 4 years

    Disease control rate is defined as the proportion of participants with a BOR of confirmed CR, confirmed PR, or SD, as determined by Investigator per RECIST 1.1.

  8. PFS landmark

    Timeframe: Through study completion, an average of 4 years

    The landmark of PFS rates at 6, 9, and 12 months.

  9. OS landmark

    Timeframe: Through study completion, an average of 4 years

    The median OS and the landmark of OS rate at 12 months.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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.

  • 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.
Sources for eligibility
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  • Research SiteLos Angeles, United StatesWithdrawn
  • Research SiteBaltimore, United StatesRecruiting
  • Research SiteNew York, United StatesRecruiting
  • Research SiteStony Brook, United StatesRecruiting
  • Research SiteColumbus, United StatesNot yet recruiting
  • Research SiteColumbus, United StatesWithdrawn
  • Research SitePhiladelphia, United StatesNot yet recruiting
  • Research SiteClayton, AustraliaRecruiting
  • Research SiteNedlands, AustraliaRecruiting
  • Research SiteIjuí, BrazilRecruiting
  • Research SiteLondrina, BrazilRecruiting
  • Research SiteNatal, BrazilRecruiting
  • Research SitePorto Alegre, BrazilNot yet recruiting
  • Research SiteSanto André, BrazilNot yet recruiting
  • Research SiteSão Caetano do Sul, BrazilRecruiting
  • Research SiteVitória, BrazilRecruiting
  • Research SiteVitória, BrazilNot yet recruiting
  • Research SiteEdmonton, CanadaRecruiting
  • Research SiteMontreal, CanadaRecruiting
  • Research SiteAnyang, ChinaNot yet recruiting
  • Research SiteBeijing, ChinaNot yet recruiting
  • Research SiteBeijing, ChinaRecruiting
  • Research SiteBeijing, ChinaActive, not recruiting
  • Research SiteBeijing, ChinaRecruiting
  • Research SiteBeijing, ChinaActive, not recruiting

And 73 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Related records

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