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

Part of paid clinical trials in Los Angeles, California.

Sponsor
AstraZeneca
Study ID
NCT06535607
Phase
PHASE2
Status
Recruiting
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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 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Volrustomig — BIOLOGICAL
    IV Infusion
  • Cisplatin — DRUG
    IV Infusion
  • Carboplatin — DRUG
    IV Infusion
  • Paclitaxel — DRUG
    IV Infusion
  • 5-FU — DRUG
    IV Infusion

Study Details

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.

Key Dates

Start date
Aug 22, 2024
Status verified
Mar 2026
Primary completion
Nov 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
257 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: Through study completion, an average of 4 years ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Research SiteLos AngelesCalifornia90025-
Research SiteBaltimoreMaryland21201-
Research SiteNew YorkNew York10065-
Research SiteStony BrookNew York11794-
Research SiteColumbusOhio43210-
Research SitePhiladelphiaPennsylvania19104-

Find similar trials in Los Angeles, CA

By research site
Research Site· Los Angeles, CAResearch Site· Baltimore, MDResearch Site· New York, NYResearch Site· Stony Brook, NYResearch Site· Columbus, OHResearch Site· Philadelphia, PA