Volrustomig Priming Regimens Exploratory Phase II Platform Study

Part of paid clinical trials in Los Angeles, California.

Sponsor
AstraZeneca
Study ID
NCT06448754
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Volrustomig — DRUG
    Participants will receive volrustomig via intravenous (IV) infusion.
  • Carboplatin — DRUG
    Participants will receive carboplatin via IV infusion.
  • Pemetrexed — DRUG
    Participants will receive pemetrexed via IV infusion.
  • Ramucirumab — DRUG
    Participants will receive ramucirumab via IV infusion.
  • Paclitaxel — DRUG
    Participants will receive paclitaxel via IV infusion.

Study Details

Purpose of this study is to assess the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of volrustomig in combination with other anticancer drugs in participants with specified solid tumors.

Key Dates

Start date
Aug 27, 2024
Status verified
Jun 2026
Primary completion
Jul 30, 2027
Completion
Jul 30, 2027

Study Design

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

Arms

  • Experimental: Substudy 1: Arm 1A: Volrustomig dose regimen 1 + Carboplatin and Pemetrexed
    Volrustomig priming dose followed by volrustomig dosing regimen 1 in combination with carboplatin and pemetrexed.
  • Experimental: Substudy 1: Arm 1B: Volrustomig dose regimen 2 + Carboplatin and Pemetrexed
    Volrustomig priming dose followed by volrustomig dosing regimen 2 in combination with carboplatin and pemetrexed.
  • Experimental: Substudy 2: Arm 2A: Volrustomig dose regimen 2 +Ramucirumab + Carboplatin + Pemetrexed or Paclitaxel
    Volrustomig priming dose followed by volrustomig dosing regimen 2 in combination with ramucirumab and histology-specific chemotherapy (carboplatin+ either pemetrexed or paclitaxel).

Primary Outcome Measure

Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From screening (Days -28 to Day -1) up to 2 year 10 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Research SiteLos AngelesCalifornia90067-
Research SiteGrand JunctionColorado81501-
Research SiteWheat RidgeColorado80033-
Research SiteBaltimoreMaryland21231-
Research SiteDetroitMichigan48202-
Research SiteChapel HillNorth Carolina27514-
Research SiteTacomaWashington98405-

Find similar trials in Los Angeles, CA

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By research site
Research Site· Los Angeles, CAResearch Site· Grand Junction, COResearch Site· Wheat Ridge, COResearch Site· Baltimore, MDResearch Site· Detroit, MIResearch Site· Chapel Hill, NC

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