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

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.

Locations

FACILITYZIPCITYSTATE
Honor Health85258ScottsdaleArizona
City of Hope91010DuarteCalifornia
Augusta University30912AugustaGeorgia
Karmanos Cancer Institute48201DetroitMichigan
Rutgers Cancer Institute of NJ08901New BrunswickNew Jersey
Duke Cancer Center27710DurhamNorth Carolina
Cleveland Clinic Foundation44195ClevelandOhio
Ohio State University43210ColumbusOhio
University of Oklahoma Health Sciences Center73104Oklahoma CityOklahoma
Avera Cancer Institute57105Sioux FallsSouth Dakota

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