Study on ADP-A2M4CD8 Alone and with Nivolumab for Treating MAGE-A4 Positive Ovarian Cancer in HLA-A2+ Patients (SURPASS-3)

Sponsor: Adaptimmune

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05601752

This clinical trial is testing a new treatment using ADP-A2M4CD8, alone and combined with nivolumab, for patients with recurrent ovarian cancer that is positive for MAGE-A4 and HLA-A2+. The study aims to evaluate the effectiveness and safety of these treatments.

Patient Parameters

Program Overview

This study is a phase 2 clinical trial that is open to participants and does not compare treatments directly. It aims to assess the outcomes of using ADP-A2M4CD8 as a standalone treatment and in combination with nivolumab in patients with recurrent ovarian cancer who have specific genetic markers (HLA-A2+ and MAGE-A4 positive).

Eligibility Criteria

Inclusion Criteria

  • Must be between 18 and 75 years old.
  • Have a confirmed diagnosis of high-grade serous or endometrioid ovarian cancer, including related types.
  • Have measurable cancer based on specific medical criteria.
  • Have received certain prior treatments, including platinum and taxane-based chemotherapy, and possibly other therapies.
  • Must be positive for specific HLA-A2 alleles and MAGE-A4 expression.
  • Be in good general health with a performance status of 0 or 1.
  • Have adequate heart function and be fit for blood cell collection.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception.
  • Have adequate organ function based on specific blood tests.

Exclusion Criteria

  • Positive for specific HLA-A2 alleles that are not allowed in the study.
  • Have received certain treatments too close to the start of the study, such as chemotherapy or immunotherapy, without the required break period.
  • Have unresolved side effects from previous cancer treatments.
  • Have a history of severe allergic reactions to study drugs.
  • Have active autoimmune diseases that are not controlled.
  • Have had major surgery recently without full recovery.
  • Have certain brain conditions or untreated brain metastases.
  • Have other active cancers that are not in remission.
  • Have significant heart or lung diseases.
  • Have active infections like HIV, hepatitis B or C.
  • Be pregnant or breastfeeding.
  • Have a history of drug or alcohol dependency in the past year.
  • Be unlikely to comply with study requirements.
  • Have a known intolerance to nivolumab.

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