Trial Title:
ADP-A2M4CD8 Monotherapy and in Combination With Nivolumab in HLA-A2+ Subjects With MAGE-A4 Positive Ovarian Cancer (SURPASS-3)
NCT ID:
NCT05601752
Condition:
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Nivolumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Genetic
Intervention name:
Autologous genetically modified ADP-A2M4CD8 cells
Description:
Infusion of autologous genetically modified ADP-A2M4CD8 cells on Day 1
Arm group label:
Autologous genetically modified ADP-A2M4CD8 cells
Intervention type:
Combination Product
Intervention name:
Autologous genetically modified ADP-A2M4CD8 cells in combination with Nivolumab
Description:
Infusion of autologous genetically modified ADP-A2M4CD8 on Day 1 followed by nivolumab
480 mg IV at Week 4 and then every four weeks
Arm group label:
Autologous genetically modified ADP-A2M4CD8 cells in combination with Nivolumab
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Inclusion Criteria:
1. 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.
2. 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.
3. Subject is ≥ 18 and ≤ 75 years of age at the time the Pre Screening informed consent
form (ICF) is signed.
4. Subject has histologically confirmed diagnosis of high-grade serous or high-grade
endometrioid recurrent ovarian carcinoma, including primary peritoneal and fallopian
tube carcinoma.
5. Subject has measurable disease according to RECIST v1.1 prior to lymphodepletion.
Measurable disease is not required prior to leukapheresis.
6. Subject has the following disease-specific prior therapy requirements:
1. 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).
2. 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.
3. Subjects who have received only 1 line of platinum based therapy must have
progressed between 93 and 183 days of completing platinum based therapy as a
part of front line treatment of ovarian cancer. Subjects who have progressed
within 92 days of completing platinum based therapy in front line treatment are
excluded.
4. Subjects who have received 2 or more lines of platinum based therapy must have
progressed during or within 183 days of completing the latest platinum based
therapy for treatment of recurrent ovarian cancer. The number of days
(platinum-free interval) should be calculated from the date of the last
administered dose of platinum therapy to the date of documentation of
progression.
5. Subjects with a known BRCA mutation (germ line or somatic) must have received a
poly adenosine diphosphate-ribose polymerase (PARP).
6. Subjects must have received bevacizumab.
7. Positive for HLA-A*02:01, HLA-A*02:02, HLA-A*02:03, or HLA-A*02:06 allele as
determined by Adaptimmune-designated central laboratory testing. HLA-A*02 alleles
having the same protein sequence in the peptide binding domains (P group) will also
be included. Other HLA-A*02 alleles may be eligible after adjudication with the
Sponsor.
8. MAGE-A4 expression, defined as ≥ 30% of tumor cells that are ≥ 2+ by IHC, should be
documented at the pre screening period based on either an archival specimen or a
fresh biopsy. All samples must have been pathologically reviewed by an
Adaptimmune-designated central laboratory confirming expression.
9. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of
0 or 1.
10. Subject has left ventricular ejection fraction (LVEF) of ≥ 50% or the institutional
lower limit of normal range, whichever is lower.
11. Subject is fit for leukapheresis, and adequate venous access can be established for
the cell collection.
12. Subjects of childbearing potential must have a negative urine or serum pregnancy
test AND must agree to use a highly effective method of contraception starting at
the first dose of chemotherapy and continue for at least 12 months or for 4 months
after the gene-modified cells are no longer detected in the blood, or 6 months after
the last dose of nivolumab, whichever is longer. Subjects of childbearing potential
must also agree to refrain from egg donation, storage, or banking during these same
time periods.
13. Subjects must have ≥ 90% room air oxygen saturation test at rest at Screening
(within 7 days of leukapheresis) and at Baseline.
14. Subject must have adequate organ function as indicated by the laboratory values in
the table below.
System Laboratory Value Hematological Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
(without granulocyte colony stimulating factor [G-CSF] support) Platelets ≥ 100 × 109/L
(without transfusion support within 5 days prior to leukapheresis and lymphodepletion)
Hemoglobin (Hb) ≥ 90 g/L (without transfusion support within 5 days prior to
leukapheresis and lymphodepletion) Coagulation Prothrombin time or international
normalized ratio (INR) ≤ 1.5 × upper limit of normal (ULN), unless receiving therapeutic
anticoagulation Partial thromboplastin time ≤ 1.5 × ULN, unless receiving therapeutic
anticoagulation Renal Glomerular filtration rate (GFR) or creatinine clearance (CrCl)
(estimated or calculated)1 ≥ 50 mL/min /1.73 m2 or ≥ 50 mL/min Hepatic Serum total
bilirubin ≤ 1.5 × ULN (unless subject has documented Gilbert's Syndrome with direct
bilirubin < 35% of total bilirubin) Exception: Subjects with liver metastasis ≤ 2.5 × ULN
Alanine aminotransferase (ALT) / Aspartate aminotransferase (AST) ≤ 2.5 × ULN Albumin ≥ 3
g/dL (Without albumin deficit replacement within 7 days only prior to leukapheresis)
Exception: Subjects with liver metastasis ≤ 5.0 × ULN
1 Renal function (GFR or CrCl) will be estimated or measured according to standard
practice at the treating institution. Renal function will be reassessed at Baseline using
the same methodology.
Note: Laboratory values that are slightly out of the laboratory test parameters, if
assessed as not clinically significant by the site study Investigator, may be acceptable
after discussion and review by the Sponsor Study Physician. This applies to screening
laboratory assessments and baseline laboratory assessments.
Exclusion Criteria:
1. 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.
2. 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:
Cytotoxic chemotherapy Required Washout Prior to Leukapheresis 3 weeks Required
Washout Prior to Lymphodepletion: 3 weeks
Small molecules/tyrosine kinase inhibitors (TKIs), such as dabrafenib, trametinib,
vemurafenib, and cobimetinib Note: No washout period is required for compounds that
do not cause bone marrow suppression/lymphopenia or for epidermal growth factor
receptor and alkaline phosphatase/ ROS 1 inhibitors. Required Washout Prior to
Leukapheresis 1 week Required Washout Prior to Lymphodepletion: 1 week
Immune therapy (including monoclonal antibody therapy, checkpoint inhibitors, and
biologics) other than anti-PD(L)1 Required Washout Prior to Leukapheresis 2 weeks
Required Washout Prior to Lymphodepletion: 2 weeks
Anti-PD(L)1 Required Washout Prior to Leukapheresis 2 weeks Required Washout Prior
to Lymphodepletion: 6 weeks
Experimental anti-cancer vaccine Required Washout Prior to Leukapheresis: N/A
Required Washout Prior to Lymphodepletion: Eight weeks in the absence of tumor
response.
The subject should be excluded if their disease is responding to an experimental
vaccine given within 6 months.
Gene therapy using an integrating vector Subjects who have received a gene therapy
using any DNA-integrating vector other than a lentivirus (retrovirus,
Adeno-associated Virus (AAV), etc.) are excluded from this study. Use of previous
gene therapy using a lentiviral vector is permitted. If transduced T-cells represent
< 1% of PBMCs (< 1500 copies of vectors/μg of PBMC DNA) at the time of screening.
Eligibility testing must be done by Adaptimmune's designated Contract Research
Organization (CRO). Required Washout Prior to Lymphodepletion: N/A
Corticosteroids or any other immunosuppressive therapy Note: Use of topical or
inhaled steroids is not an exclusion. See Section 6.5.1 for exceptions.
Required Washout Prior to Leukapheresis: 2 weeks Required Washout Prior to
Lymphodepletion 2 weeks
Anti-MAGE-A4 therapy Note: Fresh screening biopsy post-anti-MAGE-A4 therapy must be
obtained to confirm MAGE-A4 positivity by IHC. Required Washout Prior to
Leukapheresis: 2 weeks Required Washout Prior to Lymphodepletion: 2 weeks
Investigational treatment Required Washout Prior to Leukapheresis 2 weeks or 5
half-lives, whichever is shorter Required Washout Prior to Lymphodepletion: 2 weeks
or 5 half-lives, whichever is shorter.
Radiation to vital organs (e.g., liver, kidney) Required Washout Prior to
Leukapheresis: N/A Required Washout Prior to Lymphodepletion: 4 weeks
Radiation to the pelvis Required Washout Prior to Leukapheresis: 4 weeks Required
Washout Prior to Lymphodepletion: 4 weeks
Whole brain radiotherapy (WBRT) or brain stereotactic radiosurgery (SRS) Required
Washout Prior to Leukapheresis N/A Required Washout Prior to Lymphodepletion: 2
weeks
Radiotherapy to the target lesions Required Washout Prior to Leukapheresis: N/A
Required Washout Prior to Lymphodepletion: 3 months prior to lymphodepleting
chemotherapy or a target lesion with progression post radiotherapy (Note: There is
no washout period for palliative radiation to non-target organs.)
PARP inhibitor Required Washout Prior to Leukapheresis: 1 week Required Washout
Prior to Lymphodepletion: 1 week
Antibody drug conjugates (such as mirvetuximab) Required Washout Prior to
Leukapheresis: 3 weeks Required Washout Prior to Lymphodepletion: 3 weeks Note:
Duration of any other anti-cancer therapies must be discussed and agreed upon with
the Sponsor Study Physician
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. Clinically significant cardiovascular disease including, but not limited to, any of
the following:
1. Electrocardiogram (ECG) showing clinically significant abnormality at Screening
2. Uncontrolled clinically significant arrhythmias
3. Known family history or congenital history of prolonged QT syndrome or history
of torsade de pointes
4. Uncontrolled hypertension despite optimal medical therapy
5. Acute coronary syndrome (angina or myocardial infarction) in the last 6 months
6. Clinically significant cardiac disease defined by congestive heart failure New
York Heart Association Class 3 and 4
7. History of stroke, CNS bleeding, transient ischemic attack, or reversible
ischemic neurologic deficit within last 6 months
10. Uncontrolled intercurrent illness including, but not limited to, any of the
following:
1. Ongoing or active systemic infection, or localized infection which may become
systemic due to leukapheresis procedure, e.g., catheter insertion will be
excluded. Subjects with urinary tract infections will be included only
following treatment with antibiotics.(For SARS-CoV 2 [COVID-19] infection, see
Section 10.4.4.1)
2. Clinically significant pulmonary disease with any 1 pulmonary function
parameter < 60% predicted (forced expiratory volume first forced breath [FEV1],
total lung capacity [TLC], or diffusing capacity of lungs for carbon monoxide
[DLCO]; note: for patients with anemia, corrected DLCO could be used) assessed
prior to leukapheresis and within 2 months of the start of lymphodepleting
chemotherapy
3. Requirement for oxygen support (due to cardiac or pulmonary disease)
4. Interstitial lung disease (pneumonitis) or history of pneumonectomy or chronic
obstructive pulmonary disease with ≥ 1 exacerbation within 1 year prior to the
Screening Visit that required treatment with systemic corticosteroids or
resulted in hospitalization
5. Hospitalization for bowel obstruction in last 2 months
6. Hematosis or significant organ bleeding in last 2 months
7. Ascites or pleural effusion which requires repeated (2 within 4 weeks)
paracentesis or thoracentesis within last 2 months
8. Cardiac or pericardial tumor involvement (prior to lymphodepletion)
11. Active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV),
hepatitis C virus (HCV), or human T cell leukemia virus (HTLV) as defined below.
Re-screening for infectious disease markers is not required at baseline (prior to
lymphodepletion) unless > 6 months has elapsed.
1. Positive serology for HIV
2. Active hepatitis B infection as demonstrated by test for hepatitis B surface
antigen. Subjects who are hepatitis B surface antigen negative but are
hepatitis B core antibody-positive must have undetectable hepatitis B DNA and
receive prophylaxis against viral reactivation. Prophylaxis should be initiated
prior to lymphodepleting therapy and continued for 6 months.
3. Active hepatitis C infection as demonstrated by hepatitis C ribonucleic acid
(RNA) test. Subjects who are HCV antibody-positive will be screened for HCV RNA
by any reverse transcription-polymerase chain reaction (RT PCR) or branched DNA
(bDNA) assay. If HCV antibody is positive, eligibility will be determined based
on a negative screening RNA value.
4. Positive serology for HTLV 1 or 2
12. Subject is pregnant or breastfeeding.
13. Subjects who have illicit drug or alcohol dependency within the past year.
14. In the opinion of the Investigator, subject will be unlikely to fully comply with
protocol requirements.
15. Intolerance to nivolumab includes severe allergic reaction to nivolumab or any
components (active or inactive) of nivolumab.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Honor Health
Address:
City:
Scottsdale
Zip:
85258
Country:
United States
Status:
Recruiting
Contact:
Last name:
Research Nurse Navigators
Phone:
480-583-7114
Email:
clinicaltrials@honorhealth.com
Investigator:
Last name:
Justin Moser
Email:
Principal Investigator
Facility:
Name:
City of Hope
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Temi Olaitan
Phone:
626-218-5230
Email:
tolaitan@coh.org
Investigator:
Last name:
Lorna Rodriguez, MD
Email:
Principal Investigator
Facility:
Name:
Augusta University
Address:
City:
Augusta
Zip:
30912
Country:
United States
Status:
Recruiting
Contact:
Last name:
Katie Dorr
Phone:
706-721-3460
Email:
kdorr@augusta.edu
Investigator:
Last name:
Sharad Ghamande
Email:
Principal Investigator
Facility:
Name:
Karmanos Cancer Institute
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alexandra VanSlembrouck
Phone:
313-576-9236
Email:
vanslema@karmanos.org
Investigator:
Last name:
Robert Morris
Email:
Principal Investigator
Facility:
Name:
Rutgers Cancer Institute of NJ
Address:
City:
New Brunswick
Zip:
08901
Country:
United States
Status:
Recruiting
Contact:
Last name:
Anita Trupiano
Phone:
732-454-9795
Email:
ar2069@cinj.rutgers.edu
Contact backup:
Last name:
Kassie DiOrio
Investigator:
Last name:
Eugenia Girda
Email:
Principal Investigator
Facility:
Name:
Duke Cancer Center
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
Jeffery Clarke, MD
Email:
Principal Investigator
Facility:
Name:
Cleveland Clinic Foundation
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jacqueline Ludwig
Phone:
216-390-2492
Email:
ludwigj@ccf.org
Investigator:
Last name:
Peter Rose
Email:
Principal Investigator
Facility:
Name:
Ohio State University
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
David O'Malley, MD
Email:
Principal Investigator
Facility:
Name:
University of Oklahoma Health Sciences Center
Address:
City:
Oklahoma City
Zip:
73104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Tyler Tennyson
Phone:
405-271-8001
Email:
Tyler-Tennyson@ouhsc.edu
Investigator:
Last name:
Manu Pandey
Email:
Principal Investigator
Facility:
Name:
Avera Cancer Institute
Address:
City:
Sioux Falls
Zip:
57105
Country:
United States
Status:
Recruiting
Contact:
Last name:
David Starks
Phone:
605-322-7535
Email:
david.starks@avera.org
Contact backup:
Last name:
Natasha Filer
Phone:
605-322-7536
Email:
gyn.breastresearch@avera.org
Investigator:
Last name:
David Starks
Email:
Principal Investigator
Facility:
Name:
Houston Methodist Dr. Mary and Ron Neal Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
Tarrik Zaid
Email:
Principal Investigator
Facility:
Name:
Swedish Cancer Institute
Address:
City:
Seattle
Zip:
98104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Chunfang Qiu
Phone:
206-215-6430
Email:
chun-fang.qiu@swedish.org
Investigator:
Last name:
Fernanda Musa
Email:
Principal Investigator
Facility:
Name:
University Health Network (Princess Margaret Cancer Center)
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Jeshani Sivakumar
Phone:
416-946-4501
Phone ext:
2639
Email:
Jeshani.sivakumar@uhn.ca
Investigator:
Last name:
Neesha Dhani, MD
Email:
Principal Investigator
Facility:
Name:
Institut de Cancerologie des Hospices Civils de Lyon
Address:
City:
Pierre-Bénite
Zip:
69310
Country:
France
Status:
Recruiting
Contact:
Last name:
Christine Gerentet
Phone:
+33 (0)4 78 86 17 71
Email:
christine.gerentet@chu-lyon.fr
Investigator:
Last name:
Benoit You
Email:
Principal Investigator
Facility:
Name:
Centre Leon-Berard
Address:
City:
Lyon
Zip:
69008
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Isabelle Ray-Coquard
Email:
Principal Investigator
Facility:
Name:
L'Institut du Cancer de Montpellier
Address:
City:
Montpellier
Zip:
34090
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Michel Fabbro
Email:
Principal Investigator
Facility:
Name:
Institut de Cancerologie de Strasbourg
Address:
City:
Strasbourg
Zip:
67200
Country:
France
Status:
Recruiting
Contact:
Last name:
Valentine Strub
Phone:
+33 (0)368767141
Email:
v.strub@icans.eu
Investigator:
Last name:
Laurianne Eberst
Email:
Principal Investigator
Facility:
Name:
Institut Gustave Roussy
Address:
City:
Villejuif
Zip:
94805
Country:
France
Status:
Recruiting
Contact:
Last name:
Amandina Da Rocha
Phone:
+33 142 115 558
Email:
amandina.da-rocha@gustaveroussy.fr
Investigator:
Last name:
Alexandra Leary
Email:
Principal Investigator
Facility:
Name:
Vall d'Hebron Unversity Hospital
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Alba Miere
Phone:
+34 932746000
Email:
ameire@vhio.net
Investigator:
Last name:
Ana Oaknin
Email:
Principal Investigator
Facility:
Name:
Clinica Universidad de Navarra
Address:
City:
Madrid
Zip:
28027
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Maria Aleman Ramos
Phone:
+34 91353920
Email:
maleman@unav.es
Investigator:
Last name:
Antonio Gonzalez-Martin
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario Ramón y Cajal
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Javier Galan
Phone:
+34 913368263
Email:
jgalanmartinez@salud.madrid.org
Investigator:
Last name:
Alfonso Cortes Salgado
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario Fundación Jiménez Díaz
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Elena Garravo
Phone:
+34 (0)15504800
Phone ext:
2125
Email:
elena.garrayo@startmadrid.com
Investigator:
Last name:
Victor Moreno, MD
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Raquel Rodriguez
Phone:
+34 91 390 89 22
Email:
unidadfase1.imas12@h12o.es
Investigator:
Last name:
Ainhoa Madariaga
Email:
Principal Investigator
Facility:
Name:
Centro Oncologico Clara Campal
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Laura Franco
Phone:
+34 917567800
Email:
lfranco@hmhospitales.com
Investigator:
Last name:
Arantzazu Barquin Garcia
Email:
Principal Investigator
Facility:
Name:
Hospotal Clinico Universitario de Valencia
Address:
City:
Valencia
Zip:
46010
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Andres Manuel Cervantes Ruiperez
Phone:
+34 96197383
Email:
Andres.cervantes@uv.es
Contact backup:
Last name:
Inmaculada Blasco
Phone:
+34 961973527
Email:
iblasco@incliva.es
Investigator:
Last name:
Andres Manuel Cervantes Ruiperez
Email:
Principal Investigator
Facility:
Name:
University College of London Hospital
Address:
City:
London
Zip:
NW1 2PG
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Leigh Wood
Phone:
+44 7908 399001
Email:
leigh.wood@nhs.net
Investigator:
Last name:
Rowan Miller
Email:
Principal Investigator
Facility:
Name:
The Royal Marsden NHS Foundation Trust
Address:
City:
London
Zip:
W1G 0PL
Country:
United Kingdom
Status:
Not yet recruiting
Investigator:
Last name:
Andrew Furness
Email:
Principal Investigator
Facility:
Name:
The Christie Hospital
Address:
City:
Manchester
Zip:
M20 4GJ
Country:
United Kingdom
Status:
Not yet recruiting
Investigator:
Last name:
Fiona Thistlethwaite
Email:
Principal Investigator
Start date:
June 26, 2023
Completion date:
August 12, 2026
Lead sponsor:
Agency:
Adaptimmune
Agency class:
Industry
Collaborator:
Agency:
GOG Foundation
Agency class:
Other
Source:
Adaptimmune
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05601752
