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.
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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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