Phase 2 Study on the Effectiveness and Safety of Atezolizumab and Tiragolumab for Cancer of Unknown Primary

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06754501

Provider View

This clinical trial is exploring whether a combination of two immunotherapy drugs, atezolizumab and tiragolumab, can help control cancers where the original tumor site is unknown. The study will also look at the safety and effects of this drug combination.

Patient Parameters

Program Overview

The aim of this study is to find out if using atezolizumab and tiragolumab together can help manage cancers of unknown primary origin. Researchers will also study how safe this combination is and what effects it has on the cancer.

Description

The main goal of this study is to see how well the combination of tiragolumab and atezolizumab works against tumors in patients with cancer of unknown primary (CUP). Researchers will measure the response of the cancer to the treatment using specific criteria.

Secondary goals include evaluating the overall response rate, how long the response lasts, and the time patients remain free from cancer progression. The study will also look at overall survival rates and the safety of the treatment combination.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of cancer of unknown primary (CUP) that cannot be surgically removed and has spread or returned.
  • Must have tried at least one chemotherapy treatment that did not work or be unable to receive chemotherapy.
  • Must have at least one tumor that can be measured by scans or exams.
  • Must be 18 years or older.
  • Must be in good general health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Must have adequate organ and bone marrow function as shown by specific blood tests.
  • Must be able to provide a tissue sample for analysis.
  • Must test negative for HIV, hepatitis B, and hepatitis C, or have these conditions under control.
  • Women of childbearing potential must agree to use effective contraception during and after the study.
  • Men must agree to use condoms or abstain from intercourse and refrain from donating sperm during and after the study.
  • Must be able to understand and sign a consent form agreeing to participate in the study.

Exclusion Criteria

  • Have received certain types of immunotherapy or other investigational drugs before.
  • Have not fully recovered from side effects of previous cancer treatments.
  • Have active or uncontrolled infections or other serious medical conditions.
  • Have a history of autoimmune diseases or immune deficiencies, with some exceptions.
  • Have significant heart or lung diseases.
  • Have had another type of cancer within the last five years, with some exceptions.
  • Are pregnant or breastfeeding, or plan to become pregnant during the study.
  • Have had major surgery recently or plan to have major surgery during the study.
  • Are taking medications that are not allowed during the study.
  • Have a history of severe allergic reactions to similar drugs.

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