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CAR T-cell Therapy
ADP-A2M4CD8 + Nivolumab for Ovarian Cancer
Phase 2
Recruiting
Research Sponsored by Adaptimmune
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects will be assessed for eligibility prior to leukapheresis AND prior to lymphodepleting chemotherapy (unless otherwise noted) and must meet all specified criteria for study participation.
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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2.5 years
Awards & highlights
Study Summary
This trial tests a new therapy for ovarian cancer, combining existing drug nivolumab with a new drug, to see if it improves outcomes.
Who is the study for?
This trial is for adults aged 18-75 with HLA-A2+ and MAGE-A4 positive recurrent ovarian cancer who've had specific prior treatments, including platinum-based chemotherapy. They must have an ECOG performance status of 0 or 1, be fit for leukapheresis, not pregnant, agree to contraception if applicable, and have adequate organ function. Exclusions include certain heart conditions, uncontrolled illnesses, active infections like HIV/HBV/HTLV or hepatitis C virus (HCV), autoimmune diseases unless stable on treatment, recent major surgery without full recovery from any related toxicities.Check my eligibility
What is being tested?
The study tests ADP A2M4CD8 cells alone and combined with Nivolumab in patients with ovarian cancer that expresses a protein called MAGE-A4. It's an open-label phase 2 trial where participants are randomly assigned to receive either the monotherapy or combination therapy to assess clinical outcomes.See study design
What are the potential side effects?
Potential side effects may include immune system reactions due to genetically modified cells or Nivolumab causing inflammation in organs; infusion-related reactions; fatigue; blood disorders; increased risk of infection; allergic responses similar to those seen with fludarabine and cyclophosphamide used during the study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I meet all the requirements for the study before my leukapheresis and chemotherapy.
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My first treatment included at least 3 rounds of platinum and taxane chemotherapy.
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I have a BRCA mutation and have been treated with a PARP inhibitor.
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My tumor shows high MAGE-A4 levels as confirmed by a central lab.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My heart pumps blood effectively, meeting the minimum health standard.
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I am between 18 and 75 years old.
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I have received bevacizumab treatment.
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I have a confirmed diagnosis of advanced ovarian, peritoneal, or fallopian tube cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
Secondary outcome measures
Durable Response (DR)
Duration of Response (DOR)
Levels of serum CA125
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Autologous genetically modified ADP-A2M4CD8 cells in combination with NivolumabExperimental Treatment1 Intervention
Group II: Autologous genetically modified ADP-A2M4CD8 cellsExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
GOG FoundationNETWORK
42 Previous Clinical Trials
16,675 Total Patients Enrolled
7 Trials studying Ovarian Cancer
3,213 Patients Enrolled for Ovarian Cancer
AdaptimmuneLead Sponsor
17 Previous Clinical Trials
10,553 Total Patients Enrolled
3 Trials studying Ovarian Cancer
200 Patients Enrolled for Ovarian Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I meet all the requirements for the study before my leukapheresis and chemotherapy.My ovarian cancer worsened within 6 months after my last platinum-based treatment.My first treatment included at least 3 rounds of platinum and taxane chemotherapy.My tumor shows high MAGE-A4 levels as confirmed by a central lab.I am fully active or restricted in physically strenuous activity but can do light work.My heart pumps blood effectively, meeting the minimum health standard.I am healthy enough for a procedure to collect white blood cells and have good veins for it.I need oxygen support for heart or lung issues.I have had up to 4 treatments for my recurrent or metastatic disease.I have a BRCA mutation and have been treated with a PARP inhibitor.My oxygen levels are above 90% without assistance.I have active hepatitis B or need prophylaxis for viral reactivation.I can't be pregnant, will use birth control, and won't donate eggs during treatment.I do not have any infections that could worsen from a medical procedure.I had major surgery over 4 weeks ago and have recovered from any related issues.You have had allergic reactions to drugs similar to fludarabine, cyclophosphamide, or other drugs used in the study.I have a family or personal history of prolonged QT syndrome or torsade de pointes.My high blood pressure is not controlled, even with medication.I do not have any uncontrolled illnesses.I have had a heart attack or severe chest pain in the last 6 months.I have not had significant bleeding or blood disorders in the last 2 months.My heart or the sac around it has been affected by cancer.You have tested positive for HIV.You have tested positive for HTLV 1 or 2 in your blood.I am between 18 and 75 years old.My cancer can be measured using specific criteria before a certain treatment.My organ functions are within the required range.My ovarian cancer worsened 3 to 6 months after platinum therapy.I have an autoimmune disease but it's under control without high-dose steroids.I have lung issues like pneumonitis, had a lung removed, or COPD with a recent severe flare-up.My side effects from past cancer treatments are mild or back to normal, except for stable issues like hair loss or skin changes.I've needed fluid drained from my abdomen or chest twice in the last month.I meet the specific previous treatment requirements for my condition.I have stable brain metastases and haven't needed seizure medication or steroids recently.I have given my written consent to participate in this study.My genetic test shows I have the HLA-A*02:05 gene.I plan to or have received specific treatments before leukapheresis or lymphodepleting chemotherapy.I do not have serious heart problems.I have heart rhythm problems that are not well-controlled.Your ECG shows a serious problem during the screening.I have had cancer before, but it's either completely gone or was a type of skin cancer that could be removed.My lung function tests are below 60% of what's expected.I do not have an active infection with HIV, HBV, HCV, or HTLV.I have an active hepatitis C infection confirmed by a test.You have had a severe allergic reaction to nivolumab or any of its ingredients.I have severe heart failure.I have received bevacizumab treatment.I haven't had a stroke or similar brain event in the past 6 months.I was hospitalized for a blocked intestine in the last 2 months.I have a confirmed diagnosis of advanced ovarian, peritoneal, or fallopian tube cancer.My genetic test shows I have a specific HLA-A*02 type.
Research Study Groups:
This trial has the following groups:- Group 1: Autologous genetically modified ADP-A2M4CD8 cells in combination with Nivolumab
- Group 2: Autologous genetically modified ADP-A2M4CD8 cells
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA given authorization for Autologous genetically modified ADP-A2M4CD8 cells to be utilized in conjunction with Nivolumab?
"Our team at Power has rated the safety of Autologous genetically modified ADP-A2M4CD8 cells combined with Nivolumab a 2 due to its Phase 2 status; there is evidence that it can be used without danger, but none suggesting efficacy."
Answered by AI
Is the enrollment phase of this trial still open to participants?
"According to up-to-date information on clinicaltrials.gov, this medical research is currently in need of participants. It was posted on June 26th 2023 and has been updated as recently as the 30th of the same month."
Answered by AI
How many participants are being enrolled in this research program?
"A total of 66 participants adhering to the trial's inclusion standards must be recruited in order for this study to commence. Adaptimmune, the sponsor, has selected City of Hope (Duarte, California) and University of California (San Diego, Florida) as two primary locations for conducting the research."
Answered by AI
Is it possible to enlist in this experiment?
"This clinical trial seeks to recruit 66 individuals, aged 18 and 75, who have been diagnosed with ovarian cancer. To participate in this study, patients must fulfill the following criteria: Assessment for eligibility before leukapheresis AND before lymphodepleting chemotherapy (with exceptions), express written consent as per ICH GCP guidelines and local regulations, agreement to abide by all protocol-mandated activities such as assessments during the duration of the research including LTFU; being between 18-75 years old at signing ICF; histologically confirmed diagnosis of high-grade serous or endometrioid recurrent ovarian carcinoma inclusive of primary"
Answered by AI
Does this research initiative include participants above the age of 25?
"Applicants to this medical trial must be aged between 18 and 75. For those outside of the age range, there are 30 trials for minors and 659 studies available for individuals over 65 years old."
Answered by AI
Are there any American healthcare facilities currently conducting this research?
"With 30 sites globally, including ones in Duarte, San Diego and Tampa Bay, patients can opt for the closest clinic to them when enrolling in this medical trial. This reduces any travel requirements."
Answered by AI
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