ADP-A2M4CD8 Monotherapy and in Combination With Nivolumab in HLA-A2+ Subjects With MAGE-A4 Positi… (NCT05601752) | Clinical Trial Compass
Active — Not RecruitingPhase 2
ADP-A2M4CD8 Monotherapy and in Combination With Nivolumab in HLA-A2+ Subjects With MAGE-A4 Positive Ovarian Cancer (SURPASS-3)
United States, Canada, France66 participantsStarted 2023-06-26
Plain-language summary
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 participate
Age range
18 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject (or legally authorized representative) has voluntarily agreed to participate by giving written informed consent in accordance with International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and applicable local regulations.
. Subject (or legally authorized representative) has agreed to abide by all protocol-required procedures including study related assessments and management by the treating institution for the duration of the study, including LTFU.
. Subject is ≥ 18 and ≤ 75 years of age at the time the Pre Screening informed consent form (ICF) is signed.
. Subject has histologically confirmed diagnosis of high-grade serous or high-grade endometrioid recurrent ovarian carcinoma, including primary peritoneal and fallopian tube carcinoma.
. Subject has measurable disease according to RECIST v1.1 prior to lymphodepletion. Measurable disease is not required prior to leukapheresis.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate the anti-tumor activity of genetically modified autologous T-cells (ADP-A2M4CD8) as monotherapy and in combination with nivolumab in HLA-A*02 positive subjects with MAGE-A4 positive recurrent ovarian cancer
. Subject has the following disease-specific prior therapy requirements:
. The initial therapy must have included at least 3 cycles of a prior platinum and taxane based chemotherapy regimen for primary disease, possibly including intraperitoneal therapy, consolidation, or extended therapy (maintenance/consolidation).
. Subjects may receive up to 4 prior regimens of combination or single agent systemic treatment for their disease, which may include investigational therapies unless discussed and agreed upon with the Sponsor or designee. Note: Neo-adjuvant/adjuvant treatment is considered as one line of treatment. Bridging therapy is permitted and is not considered as a line of treatment.
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.
. Subject has received or plans to receive the following therapy/treatment prior to to leukapheresis or lymphodepleting chemotherapy, unless stopped according to the washout requirements:
. 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.