Study on Volrustomig Alone or with Other Cancer Drugs for Advanced Solid Tumors

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT06535607

This clinical trial is testing the safety and effectiveness of a new drug, Volrustomig, used alone or with other cancer treatments in adults with advanced solid tumors.

Patient Parameters

Program Overview

The eVOLVE-02 study is exploring how well Volrustomig works by itself or when combined with other cancer drugs in treating advanced or metastatic solid tumors. The study includes different parts focusing on specific types of cancer, such as cervical cancer and head and neck cancer.

Description

The eVOLVE-02 study is divided into three parts:

  • In the first part, Volrustomig will be tested on its own in about 30 patients with cervical cancer.
  • In the second part, Volrustomig will again be tested alone in about 20 patients with head and neck cancer.
  • In the third part, Volrustomig will be combined with chemotherapy in about 60 patients with head and neck cancer.

The goal is to see how safe and effective Volrustomig is in these different settings.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must provide a tumor sample to check for a specific protein (PD-L1).
  • Must have a measurable tumor based on specific medical criteria.
  • Must be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Must have a life expectancy of at least 12 weeks.
  • Must have good organ and bone marrow function.
  • Must weigh more than 35 kg (about 77 pounds).
  • Must be able to give informed consent.
  • For cervical cancer patients: Must have experienced disease progression after standard treatment and have had 1-2 prior treatments.
  • For head and neck cancer patients: Must have documented HPV status and specific medical history related to the cancer.
  • For head and neck cancer patients in the combination therapy group: Must meet specific medical criteria related to the cancer.

Exclusion Criteria

  • Have spinal cord compression.
  • Have brain metastases unless they are stable and not requiring steroids.
  • Have certain types of cancer not included in the study.
  • Have not recovered from side effects of previous cancer treatments.
  • Have had recent radiotherapy or have contraindications to certain chemotherapy drugs.
  • Have a history of another primary cancer unless it was treated and inactive for at least 2 years.
  • Have certain infections or autoimmune disorders.
  • Are candidates for curative therapy.
  • Have used immune therapy or immunosuppressive medication recently.
  • Have received other cancer treatments recently.
  • Have had major surgery recently.
  • Have received a live vaccine recently.
  • Have allergies to the study drugs.

Locations

FACILITYZIPCITYSTATE
Research Site90025Los AngelesCalifornia
Research Site21201BaltimoreMaryland
Research Site11794Stony BrookNew York
Research Site43210ColumbusOhio

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