🏛️ Verified NIH Record • Updated 2026-08-10

ADP-A2M4CD8 Monotherapy and in Combination With Nivolumab in HLA-A2+ Subjects With MAGE-A4 Positive Ovarian Cancer (SURPASS-3) (NCT05601752)

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: USWM CT, LLC

🩺 Plain-English Summary (8th-Grade Level)

This is a phase 2, open-label, randomized, non-comparative clinical trial to evaluate the clinical outcome of ADP A2M4CD8 as monotherapy and in combination treatment with nivolumab in human leukocyte antigen (HLA) A2+ subjects with recurrent ovarian cancer positive for MAGE-A4.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (21 items) and avoid the listed exclusions (34 items).

Location: Honor Health — Scottsdale, Arizona

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Positive for HLA-A\*02:05 in either allele as determined by Adaptimmune-designated central laboratory testing. HLA-A\*02 alleles having the same protein sequence as HLA-A\*02:05 in the peptide binding domains (P groups) will also be excluded. Other alleles may be exclusionary after adjudication with the Sponsor.
  • Toxicity from previous anti-cancer therapy that has not recovered to Grade ≤ 1 or baseline prior to enrollment (except for nonclinically significant toxicities, e.g., alopecia and vitiligo). Subjects with Grade 2 toxicities that are deemed stable or irreversible (e.g., peripheral neuropathy) can be enrolled.
  • Subject has a history of allergic reactions attributed to compounds of similar chemical or biological composition to fludarabine, cyclophosphamide, or other agents used in the study.
  • Subject has an active autoimmune or immune-mediated disease that has not yet been resolved. Subjects with immune-mediated AEs secondary to treatment with immunotherapy that resolve to Grade ≤ 1 off steroids are permitted. Subjects with hypothyroidism, type I diabetes, adrenal insufficiency, or pituitary insufficiency that are stable on replacement therapy are eligible. Subjects with disorders such as asthma, vitiligo, psoriasis, or atopic dermatitis that are well controlled without requiring systemic immunosuppression are also eligible. Other stable immune conditions that do not require prednisone \> 20 mg/day (or its equivalent for other corticosteroid agents) may be acceptable with the agreement of the Sponsor.
  • Subject had major surgery within 4 weeks prior to lymphodepletion; subjects should have been fully recovered from any surgical-related toxicities. Surgical-related toxicities that are not clinically significant per Investigator assessment may be acceptable after discussion and agreement with the Study Physician.
  • Leptomeningeal disease, carcinomatous meningitis, or symptomatic central nervous system (CNS) metastases. Subjects with prior history of symptomatic CNS metastases must have received treatment (i.e., SRS, WBRT, or surgery) and be neurologically stable for at least 1 month, not requiring anti-seizure medications, or off steroids for at least 14 days prior to leukapheresis and lymphodepletion. Subjects who have asymptomatic CNS metastases without associated edema, shift, or requirement for steroids or anti-seizure medications are eligible. If such a subject receives SRS or WBRT, a minimum period of 2 weeks needs to lapse between the therapy and lymphodepletion. Prophylactic anti-seizure medication is allowed.
  • Subject has any other prior malignancy that is not considered by the Investigator to be in complete remission. Resectable squamous or basal cell carcinoma of the skin is acceptable. Prior malignancies that have been surgically resected and show no evidence of disease are acceptable.
  • Clinically significant cardiovascular disease including, but not limited to, any of the following:
  • Electrocardiogram (ECG) showing clinically significant abnormality at Screening
  • Uncontrolled clinically significant arrhythmias
  • Known family history or congenital history of prolonged QT syndrome or history of torsade de pointes

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (23 Sites)

  • Honor Health — Scottsdale, Arizona
  • City of Hope — Duarte, California
  • Augusta University — Augusta, Georgia
  • Karmanos Cancer Institute — Detroit, Michigan
  • Rutgers Cancer Institute of NJ — New Brunswick, New Jersey
  • Cleveland Clinic Foundation — Cleveland, Ohio
  • University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma
  • Avera Cancer Institute — Sioux Falls, South Dakota
  • Swedish Cancer Institute — Seattle, Washington
  • University Health Network (Princess Margaret Cancer Center) — Toronto, Ontario
  • Institut de Cancerologie des Hospices Civils de Lyon — Pierre-Bénite, Lyon
  • Centre Leon-Berard — Lyon,
  • Institut de Cancerologie de Strasbourg — Strasbourg,
  • Institut Gustave Roussy — Villejuif,
  • Vall d'Hebron Unversity Hospital — Barcelona,
  • Clinica Universidad de Navarra — Madrid,
  • Hospital Universitario Ramón y Cajal — Madrid,
  • Hospital Universitario Fundación Jiménez Díaz — Madrid,
  • Hospital Universitario 12 de Octubre — Madrid,
  • Centro Oncologico Clara Campal — Madrid,
  • Hospotal Clinico Universitario de Valencia — Valencia,
  • University College of London Hospital — London,
  • The Christie Hospital — Manchester,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗