Trial Title:
Personalized Medicine for Advanced Biliary Cancer Patients
NCT ID:
NCT05615818
Condition:
Biliary Tract Neoplasms
Conditions: Official terms:
Biliary Tract Neoplasms
Gemcitabine
Trastuzumab
Niraparib
Ivosidenib
Futibatinib
Neratinib
Conditions: Keywords:
Biliary Tract Neoplasms
Targeted therapy
Personalised medicine
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Futibatinib
Description:
Dose 20 mg once a day (QD)
Arm group label:
Experimental
Intervention type:
Drug
Intervention name:
Ivosidenib
Description:
Dose 500 mg QD
Arm group label:
Experimental
Other name:
Tibsovo
Intervention type:
Drug
Intervention name:
Zanidatamab
Description:
Dose: Patients < 70 kg: 1800 mg every 3 weeks (Q3W), Patients ≥ 70 kg: 2400 mg Q3W
Arm group label:
Experimental
Intervention type:
Drug
Intervention name:
Trastuzumab
Description:
Loading dose 8 mg/kg, then 6 mg/kg Q3W (Combination with neratinib)
Arm group label:
Experimental
Other name:
Zercepac
Intervention type:
Drug
Intervention name:
Neratinib
Description:
Dose: 240 mg QD (combination with trastuzumab)
Arm group label:
Experimental
Other name:
Nerlynx
Intervention type:
Drug
Intervention name:
Encorafenib
Description:
Dose: 450 mg QD (Combination with binimetinib)
Arm group label:
Experimental
Other name:
Braftovi
Intervention type:
Drug
Intervention name:
Binimetinib
Description:
Dose: 45 mg twice a day (BID) (Combination with encorafenib)
Arm group label:
Experimental
Other name:
Mektovi
Intervention type:
Drug
Intervention name:
Niraparib
Description:
Dose: 200 mg QD or 300 mg QD
Arm group label:
Experimental
Other name:
Zejula
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Dose: 25 mg/m2 IV on days 1 and 8 Q3W (CISGEM)
Arm group label:
Control
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Dose: 1000 mg/m2 IV on days 1 and 8 Q3W (CISGEM)
Arm group label:
Control
Summary:
The object of this trial is to evaluate whether the introduction of a targeted therapy
after 4 cycles of the current standard-of-care treatment for advanced biliary cancer is
superior to continuing with the standard treatment.
The trial is composed of two phases: (i) An initial screening phase to identify a
suitable patient population, during which a molecular profile of the patient's tumour
will be obtained, and (ii) a randomised comparative trial in which patients with disease
control after 4 cycles of standard treatment, and whose tumour harbours a targetable
molecular alteration, will be randomised (2:1) to receive either a matched targeted
therapy or to continue with the standard treatment.
Detailed description:
This is a Phase 3, multicentre, randomised, open-label trial to evaluate whether the
introduction of molecular targeted therapy (MTT) as maintenance after 4 cycles of
standard-of-care first-line systemic therapy (1L SoC) is superior to continuation of
1L-SoC in the treatment of patients with ABC. The trial is composed of two phases: (i) An
initial screening phase to identify a suitable patient population, and (ii) a randomised
comparative trial.
The aim of the screening phase is to identify a medically suitable population, to obtain
a molecular profile of the patient's tumour, to collect baseline data concerning patient
demographics and disease characteristics and to obtain pre-treatment blood and tumour
samples for further translational research.
A genetic profile will be obtained from tumour-derived DNA and RNA samples by
next-generation sequencing and from circulating tumour DNA. The trial Molecular Tumour
Board will determine whether each patient harbours a targetable molecular alteration for
one or more of the trial MTTs.
Patients with disease control after 4 cycles of 1L-SoC, who did not experience limiting
toxicity, and whose tumour harbours at least one targetable molecular alteration, will be
invited to participate in the randomised phase of the trial in which 159 eligible
patients will be randomised (2:1) to receive either maintenance therapy with a matched
MTT or to continue 1L-SoC treatment.
Criteria for eligibility:
Criteria:
SCREENING PHASE
Inclusion Criteria:
1. Signed a written informed consent form prior to any trial specific procedures
(Consent #1)
2. Histologically-proven intrahepatic, perihilar or distal cholangiocarcinoma, or
gallbladder carcinoma (ampullary carcinoma excluded)
3. De novo or recurrent, locally advanced (non-resectable) or metastatic disease
4. Availability of a suitable archived sample of primary or metastatic tumour tissue
(frozen, or FFPE) or able to undergo a biopsy to obtain a suitable malignant tissue
sample
5. Aged ≥18 years
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
7. Estimated life expectancy >3 months
8. Candidate for 1L-SoC therapy, or has initiated first cycle of 1L-SoC therapy
9. Affiliated to a social security system or in possession of equivalent private health
insurance (according to local country health provision arrangements).
Exclusion Criteria:
1. Contraindication to 1L-SoC
2. Patients who are candidates for locoregional therapy
3. Contraindication to tumour biopsy in the absence of suitable archived sample of
tumour tissue
4. Prior anticancer therapy in the palliative setting. Adjuvant capecitabine allowed if
completed ≥ 183 days prior to study entry
5. Received more than 1 cycle of treatment with 1L-SoC
6. Prior treatment with any of the MTT under investigation in the SAFIR-ABC10 study
7. Current malignancies (other than ABC), with the exception of adequately treated
cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell
carcinoma of the skin. Cancer survivors, who have undergone potentially curative
therapy for a prior malignancy, have no evidence of that disease for 5 years or more
and are deemed at negligible risk for recurrence, are eligible for the trial
8. Any condition which in the Investigator's opinion makes it undesirable for the
subject to participate in the trial or which would jeopardize compliance with the
protocol
9. Women who are pregnant or breast-feeding
10. Patients unwilling or unable to comply with the medical follow-up required by the
trial because of geographic, familial, social, or psychological reasons
11. Individuals deprived of liberty or placed under protective custody or guardianship
RANDOMISED TRIAL
Inclusion Criteria:
1. Signed a written informed consent form prior to any trial specific procedures
(Consent #2)
2. Molecular profile showing the tumour harbours at least one targetable molecular
alteration with a MTT in the study portfolio (as determined by the trial MTB)
3. Disease control (stable or responsive) after 4 cycles of 1L-SoC, compared to a
pre-treatment disease evaluation, as assessed by the investigator
4. ECOG performance status of 0 or 1
5. Presence of at least one evaluable lesion according to RECIST v1.1, or complete
response to 12 weeks 1L-SoC
6. Adequate bone marrow function: absolute neutrophil count (ANC) ≥1.5 × 10⁹/L,
platelet count ≥100 × 10⁹/L, and haemoglobin ≥9 g/dL
7. Adequate liver function: total bilirubin level ≤1.5 × the upper limit of normal
(ULN) range (total bilirubin ≤3.0 ULN when the patient has documented Gilbert
syndrome), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT)
levels ≤2.5 × ULN (AST and ALT ≤5 ULN when documented tumour liver involvement)
8. Adequate renal function: estimated creatinine clearance ≥ 60 mL/min according to the
Cockcroft-Gault formula
9. Adequate cardiac function: left ventricular ejection fraction ≥50% at baseline as
determined by either echocardiogram or multigated acquisition scan (MUGA)
10. Adequate biliary drainage, with no evidence of ongoing infection
11. Men, and women of childbearing potential (WOCBP) must agree to use adequate
contraception for the duration of trial participation and as required after
completing study treatment. Men must also agree to not donate sperm and women must
agree to not donate oocytes during the specified period.
12. Women of childbearing potential must have a negative serum pregnancy test performed
within 3 days before the date of randomisation
13. Willing and able to comply with the protocol for the duration of the study including
scheduled visits, treatment plan, laboratory tests, and other study procedures
14. Affiliated to a social security system or in possession of equivalent private health
insurance (according to local country health provision arrangements)
Exclusion Criteria:
1. Disease progression occurring at any time prior randomisation, or toxicity that led
to the discontinuation of the 1L-SoC before 4 full cycles have been delivered
2. Toxicities from 1L-SoC not resolved to Grade ≤ 1 (according to version 5.0 the
National Cancer Institute - Common terminology criteria for adverse events
[NCI-CTCAE v5.0]) before randomisation, with the exception of alopecia
3. Contraindication or known hypersensitivity to the MTT for the molecular alteration
found in the patient, or any component in their formulation Note: For patients with
multiple target alterations, contraindication to one MTT will not warrant exclusion
if MTT to an alternative target is feasible.
4. Microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) cancers
5. Major surgery within 4 weeks of randomisation
6. Radiotherapy within 7 days of randomisation
7. Untreated central nervous system (CNS) metastases, symptomatic CNS metastases, or
radiation treatment for CNS metastases within 4 weeks of start of study treatment.
Stable, treated brain metastases are allowed (defined as subjects who are off
steroids and anticonvulsants and are neurologically stable with no evidence of
radiographic progression for at least 4 weeks at the time of screening).
8. Clinically significant cardiovascular disease (recent acute myocardial infarction,
treated congestive heart failure [2 or above on the New York Heart Association
functional classification scale], recent thromboembolic or cerebrovascular events
[within 12 weeks, excepted if related to indwelling catheter], known prolonged QT
syndrome).
9. Cardiorespiratory pathologies where hyperhydration is contraindicated.
10. Manifestation of tinnitus and/or hearing loss since initiation of cisplatin therapy.
11. Known leptomeningeal disease. If leptomeningeal disease has been reported
radiographically on baseline magnetic responance imaging (MRI), but is not suspected
clinically by the investigator, the subject must be free of neurological symptoms.
12. Concurrent malignancy (other than ABC), with the exception of adequately treated
cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell
carcinoma of the skin. Cancer survivors, who have undergone potentially curative
therapy for a prior malignancy, have no evidence of that disease for 5 years or more
and are deemed at negligible risk for recurrence, are eligible for the trial
13. Concomitant treatment with phenytoin in prophylactic use where this cannot be
substituted for another therapy
14. Known active hepatitis B virus or hepatitis C virus infection or human
immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome
15. Any condition which in the Investigator's opinion makes it undesirable for the
subject to participate in the trial or which would jeopardize compliance with the
protocol
16. Women who are pregnant or breast-feeding
17. Participation in another therapeutic trial within the 30 days prior to entering the
study. Participation in an observational trial would be acceptable
18. Patients unwilling or unable to comply with the medical follow-up required by the
trial because of geographic, familial, social, or psychological reasons
19. Individuals deprived of liberty or placed under protective custody or guardianship
ADDITIONAL EXCLUSION CRITERIA FOR SPECIFIC MTTs:
Patients assigned to receive oral therapies:
1. Inability or unwillingness to swallow pills
2. History of malabsorption syndrome or other condition that would interfere with
enteral absorption. For example, active intestine inflammation (e.g., Crohn's
disease or ulcerative colitis) requiring immunosuppressive therapy
Futibatinib:
1. History and/or current evidence of any of the following disorders:
1. Non-tumour related alteration of the calcium-phosphorus homeostasis that is
considered clinically significant in the opinion of the Investigator
2. Ectopic mineralization/calcification, including but not limited to soft tissue,
kidneys, intestine, or myocardia and lung, considered clinically significant in
the opinion of the Investigator
3. Retinal or corneal disorder confirmed by retinal/corneal examination and
considered clinically significant in the opinion of the Investigator
2. Concomitant treatment with strong CYP3A/P-gp inhibitors or strong or moderate
CYP3A/P gp inducers where these cannot be substituted for another therapy.
Ivosidenib:
1. Patients with history of torsade de pointes
2. Concomitant treatment with digoxin where this cannot be substituted for another
therapy
3. Patients with a heart-rate corrected QT interval (using Fridericia's formula) (QTcF)
≥ 450 msec or other factors that increased the risk of QT prolongation or arrhythmic
events (e.g. heart failure, hypokalemia, family history of long QT interval
syndrome)
4. Concomitant treatment with strong CYP3A4 inducers or dabigatran where these cannot
be substituted for another therapy
5. Concomitant treatment with medicinal products known to prolong the QTc interval, or
moderate or strong CYP3A4 inhibitors where these cannot be substituted for another
therapy
6. Familial history of sudden death or polymorphic ventricular arrhythmia.
7. Hypokalemia, hypomagnesemia or hypocalcemia where this cannot be corrected by
supplementation
Zanidatamab:
1. Treatment with anthracyclines within 90 days before first dose of zanidatamab and/or
total lifetime load exceeding 360 mg/m2 Adriamycin® or equivalent
2. Use of corticosteroids administered at doses equivalent to > 15 mg per day of
prednisone within 2 weeks of first zanidatamab dosing unless otherwise approved by
the coordinating investigator. Topical, ocular, intra-articular, intranasal, and/or
inhalational corticosteroids are permitted
3. QTcF > 470 ms
4. History of myocardial infarction or unstable angina within 6 months prior to
enrollment, troponin levels consistent with myocardial infarction, or clinically
significant cardiac disease, such as ventricular arrhythmia requiring therapy,
uncontrolled hypertension, or any history of symptomatic congestive heart failure
5. Acute or chronic uncontrolled pancreatitis or Child-Pugh Class C liver disease
6. Clinically significant infiltrative pulmonary disease not related to lung metastases
7. A history of life-threatening hypersensitivity to monoclonal antibodies or
recombinant proteins
Neratinib & trastuzumab:
1. Patients with severe hepatic impairment (Child-Pugh Class C)
2. Co-administration with the following medical products that are strong inducers of
the CYP3A4/P-gp isoform of cytochrome P450, such as carbamazepine, phenytoin
(antiepileptics), St John's wort (Hypericum perforatum) or rifampicin
(antimycobacterial)
3. Patients who are experiencing dyspnoea at rest due to complications of advanced
malignancy or co-morbidities
4. Hypersensitivity to murine proteins
5. Current active pneumonitis within 90 days of receiving trastuzumab or a known
history of interstitial lung disease
Encorafenib & binimetinib:
1. Patients with a history or current evidence of retinal vein occlusion or risk
factors for retinal vein occlusion (e.g., uncontrolled glaucoma or history of
hyperviscosity or hypercoagulability syndrome)
2. Patients with concurrent neuromuscular disorders associated with elevated creatine
phosphokinase (>ULN)
3. Patients with hypokalemia, hypomagnesemia, or hypocalcemia (i.e. Serum potassium,
magnesium or calcium < lower normal limit)
4. Patients with a QTcF ≥ 450 msec for men, or ≥ 470 msec for women
5. Current or expected use of a strong inhibitor of CYP3A4
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cliniques universitaires Saint-Luc
Address:
City:
Brussels
Country:
Belgium
Status:
Not yet recruiting
Contact:
Last name:
Ivan BORBATH, MD
Investigator:
Last name:
Ivan BORBATH, MD
Email:
Principal Investigator
Facility:
Name:
Cliniques universitaires de Bruxelles - Hôpital Erasme ULB
Address:
City:
Bruxelles
Country:
Belgium
Status:
Not yet recruiting
Contact:
Last name:
Anne DEMOLS, MD
Investigator:
Last name:
Anne DEMOLS, MD
Email:
Principal Investigator
Facility:
Name:
Universitair Ziekenhuis Antwerpen (UZA)
Address:
City:
Edegem
Country:
Belgium
Status:
Not yet recruiting
Contact:
Last name:
Timon VANDAMME, MD
Investigator:
Last name:
Timon VANDAMME, MD
Email:
Principal Investigator
Facility:
Name:
Universitair Ziekenhuis Leuven
Address:
City:
Leuven
Country:
Belgium
Status:
Not yet recruiting
Contact:
Last name:
Jeroen DEKERVEL, MD
Investigator:
Last name:
Jeroen DEKERVEL, MD
Email:
Principal Investigator
Facility:
Name:
CHU Amiens Picardie
Address:
City:
Amiens
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Vincent HAUTEFEUILE, MD
Investigator:
Last name:
Vincent HAUTEFEUILE, MD
Email:
Principal Investigator
Facility:
Name:
CHU d'Angers
Address:
City:
Angers
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Carole Vitellius
Investigator:
Last name:
Carole Vitellius, MD
Email:
Principal Investigator
Facility:
Name:
Institut de cancerologie de l'Ouest - Angers
Address:
City:
Angers
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Victor SIMMET, MD
Investigator:
Last name:
Victor SIMMET, MD
Email:
Principal Investigator
Facility:
Name:
Institut du Cancer Avignon Provence
Address:
City:
Avignon
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Clémence TOULLEC
Investigator:
Last name:
Clémence TOULLEC, MD
Email:
Principal Investigator
Facility:
Name:
CHU de Besançon
Address:
City:
Besançon
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Christophe BORG
Investigator:
Last name:
Christophe BORG, MD
Email:
Principal Investigator
Facility:
Name:
CHU de Bordeaux - Hôpital Haut-Leveque
Address:
City:
Bordeaux
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Jean-Frédéric BLANC
Investigator:
Last name:
Jean-Frédéric BLANC, MD
Email:
Principal Investigator
Facility:
Name:
Centre François Baclesse
Address:
City:
Caen
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Stéphane CORBINAIS
Investigator:
Last name:
Stéphane CORBINAIS, MD
Email:
Principal Investigator
Facility:
Name:
Centre Jean Perrin
Address:
City:
Clermont-Ferrand
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Florence OSAER-POLYCARPE
Investigator:
Last name:
Florence OSAER-POLYCARPE, MD
Email:
Principal Investigator
Facility:
Name:
CHU Estaing de Clermont Ferrand
Address:
City:
Clermont-Ferrand
Country:
France
Status:
Recruiting
Contact:
Last name:
Marine JARY, MD
Investigator:
Last name:
Marine JARY, MD
Email:
Principal Investigator
Facility:
Name:
APHP - Hopital Henri Mondor
Address:
City:
Créteil
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Christophe TOURNIGAND, MD
Investigator:
Last name:
Christophe TOURNIGAND, MD
Email:
Principal Investigator
Facility:
Name:
CHU de Dijon
Address:
City:
Dijon
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Sylvain MANFREDI
Investigator:
Last name:
Sylvain MANFREDI, MD
Email:
Principal Investigator
Facility:
Name:
CHU Grenoble Alpes
Address:
City:
Grenoble
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Gael ROTH, MD
Investigator:
Last name:
Gael ROTH, MD
Email:
Principal Investigator
Facility:
Name:
Groupe hospitalier mutaliste de Grenoble - Institut Daniel Hollard
Address:
City:
Grenoble
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Camille HERVE, MD
Investigator:
Last name:
Camille HERVE, MD
Email:
Principal Investigator
Facility:
Name:
Centre Oscar Lambret
Address:
City:
Lille
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Aurélien CARNOT, MD
Investigator:
Last name:
Aurélien CARNOT, MD
Email:
Principal Investigator
Facility:
Name:
CHU Lille
Address:
City:
Lille
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Anthony TURPIN, MD
Investigator:
Last name:
Anthony TURPIN, MD
Email:
Principal Investigator
Facility:
Name:
CHU Dupuytren
Address:
City:
Limoges
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Frédéric THUILLIER, MD
Investigator:
Last name:
Frédéric THUILLIER, MD
Email:
Principal Investigator
Facility:
Name:
Centre Leon Bérard
Address:
City:
Lyon
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Philippe CASSIER, MD
Investigator:
Last name:
Philippe CASSIER, MD
Email:
Principal Investigator
Facility:
Name:
CHU de Lyon
Address:
City:
Lyon
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Thomas WALTER, MD
Investigator:
Last name:
Thomas WALTER, MD
Email:
Principal Investigator
Facility:
Name:
Clinique Privée Jean Mermoz
Address:
City:
Lyon
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Lea CLAVEL, MD
Investigator:
Last name:
Lea CLAVEL, MD
Email:
Principal Investigator
Facility:
Name:
Hospices Civils de Lyon - Croix Rousse
Address:
City:
Lyon
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Marielle GUILLET, MD
Investigator:
Last name:
Marielle GUILLET, MD
Email:
Principal Investigator
Facility:
Name:
APHM - CHU La Timone
Address:
City:
Marseille
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Laétitia DAHAN, MD
Investigator:
Last name:
Laétitia DAHAN, MD
Email:
Principal Investigator
Facility:
Name:
Hôpital Européen
Address:
City:
Marseille
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Nicolas BARRIERE, MD
Investigator:
Last name:
Nicolas BARRIERE, MD
Email:
Principal Investigator
Facility:
Name:
Institut Paoli Calmettes
Address:
City:
Marseille
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Simon LAUNAY, MD
Investigator:
Last name:
Simon LAUNAY, MD
Email:
Principal Investigator
Facility:
Name:
CHU Montpellier
Address:
City:
Montpellier
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Eric ASSENAT, MD
Investigator:
Last name:
Eric ASSENAT, MD
Email:
Principal Investigator
Facility:
Name:
Institut de Cancer de Montpellier
Address:
City:
Montpellier
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Fabienne PORTALES, MD
Investigator:
Last name:
Fabienne PORTALES, MD
Email:
Principal Investigator
Facility:
Name:
CHU Nantes - Hôtel Dieu
Address:
City:
Nantes
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Yann TOUCHEFEU, MD
Investigator:
Last name:
Yann TOUCHEFEU, MD
Email:
Principal Investigator
Facility:
Name:
Centre Antoine Lacassagne
Address:
City:
Nice
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Ludovic EVESQUE, MD
Investigator:
Last name:
Ludovic EVESQUE, MD
Email:
Principal Investigator
Facility:
Name:
APHP - Hôpital Beaujon
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Mohamed BOUATTOUR, MD
Investigator:
Last name:
Mohamed BOUATTOUR, MD
Email:
Principal Investigator
Facility:
Name:
APHP - Hôpital Cochin
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Romain CORIAT, MD
Investigator:
Last name:
Romain CORIAT, MD
Email:
Principal Investigator
Facility:
Name:
APHP - Hôpital Saint Antoine
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Helene BOUSSION DESLOGES, MD
Investigator:
Last name:
Helene BOUSSION DESLOGES, MD
Email:
Principal Investigator
Facility:
Name:
Groupe Hospitalier Diaconesses Croix Saint-Simon
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Olivier DUBREUIL, MD
Investigator:
Last name:
Olivier DUBREUIL, MD
Email:
Principal Investigator
Facility:
Name:
Institute Mutualiste Montsouris
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
David MALKA, MD
Investigator:
Last name:
David MALKA, MD
Email:
Principal Investigator
Facility:
Name:
CH de Pau
Address:
City:
Pau
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Juliette THAURY, MD
Investigator:
Last name:
Juliette THAURY, MD
Email:
Principal Investigator
Facility:
Name:
Hôpital Privé des Côtes d'Armor
Address:
City:
Plérin
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Jérôme MARTIN-BABAU, MD
Investigator:
Last name:
Jérôme MARTIN-BABAU, MD
Email:
Principal Investigator
Facility:
Name:
CHU Poitiers
Address:
City:
Poitiers
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
David TOUGERON, MD
Investigator:
Last name:
David TOUGERON, MD
Email:
Principal Investigator
Facility:
Name:
CH Cornouaille
Address:
City:
Quimper
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Christophe AGNELLO, MD
Investigator:
Last name:
Christophe AGNELLO, MD
Email:
Principal Investigator
Facility:
Name:
CHU de Reims
Address:
City:
Reims
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Elia GIGANTE, MD
Investigator:
Last name:
Elia GIGANTE, MD
Email:
Principal Investigator
Facility:
Name:
Institut Jean Godinot
Address:
City:
Reims
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Damien BOTSEN, MD
Investigator:
Last name:
Damien BOTSEN, MD
Email:
Principal Investigator
Facility:
Name:
Centre Eugène Marquis
Address:
City:
Rennes
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Julien Edeline
Investigator:
Last name:
Julien Edeline, MD
Email:
Principal Investigator
Facility:
Name:
CHU Charles Nicolle
Address:
City:
Rouen
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Frederic DI FIORE, MD
Investigator:
Last name:
Frederic DI FIORE, MD
Email:
Principal Investigator
Facility:
Name:
Institut Curie - Saint Cloud
Address:
City:
Saint Cloud
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Cindy NEUZILLET, MD
Investigator:
Last name:
Cindy NEUZILLET, MD
Email:
Principal Investigator
Facility:
Name:
Institut de Cancerologie de l'Ouest
Address:
City:
Saint-Herblain
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Amélie MALLET, MD
Investigator:
Last name:
Amélie MALLET, MD
Email:
Principal Investigator
Facility:
Name:
Hôpital Foch
Address:
City:
Suresnes
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Jaafar BENNOUNA, MD
Investigator:
Last name:
Jaafar BENNOUNA, MD
Email:
Principal Investigator
Facility:
Name:
CHU Toulouse
Address:
City:
Toulouse
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Nadim FARES, MD
Investigator:
Last name:
Nadim FARES, MD
Email:
Principal Investigator
Facility:
Name:
CH Valence
Address:
City:
Valence
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Hélène FOISY, MD
Investigator:
Last name:
Hélène FOISY, MD
Email:
Principal Investigator
Facility:
Name:
CHRU de Nancy
Address:
City:
Vandœuvre-lès-Nancy
Country:
France
Status:
Recruiting
Contact:
Last name:
Marie MULLER, MD
Investigator:
Last name:
Marie MULLER, MD
Email:
Principal Investigator
Facility:
Name:
APHP - Hôpital Paul Brousse
Address:
City:
Villejuif
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Olivier ROSMORDUC, MD
Investigator:
Last name:
Olivier ROSMORDUC, MD
Email:
Principal Investigator
Facility:
Name:
Gustave Roussy
Address:
City:
Villejuif
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Antoine Hollebecque
Investigator:
Last name:
Antoine Hollebecque, MD
Email:
Principal Investigator
Facility:
Name:
Belfast City Hospital
Address:
City:
Belfast
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Martin EATOCK, MD
Investigator:
Last name:
Martin EATOCK, MD
Email:
Principal Investigator
Facility:
Name:
Queen Elizabeth Hospital
Address:
City:
Birmingham
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Yuk Ting MA, MD
Investigator:
Last name:
Yuk Ting MA, MD
Email:
Principal Investigator
Facility:
Name:
Bristol Haematology and Oncology Centre
Address:
City:
Bristol
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Stephen FALK, MD
Investigator:
Last name:
Stephen FALK, MD
Email:
Principal Investigator
Facility:
Name:
Addenbrooke's Hospital
Address:
City:
Cambridge
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Pippa CORRIE, MD
Investigator:
Last name:
Pippa CORRIE, MD
Email:
Principal Investigator
Facility:
Name:
Castle Hill Hospital
Address:
City:
Cottingham
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Anthony MARAVEYAS, MD
Investigator:
Last name:
Anthony MARAVEYAS, MD
Email:
Principal Investigator
Facility:
Name:
St James's Hospital
Address:
City:
Leeds
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Alan ANTHONEY, MD
Investigator:
Last name:
Alan ANTHONEY, MD
Email:
Principal Investigator
Facility:
Name:
Clatterbridge Cancer Centre NHS Foundation Trust
Address:
City:
Liverpool
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Daniel PALMER, MD
Investigator:
Last name:
Daniel PALMER, MD
Email:
Principal Investigator
Facility:
Name:
Guy's & St Thomas' Hospital
Address:
City:
London
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Paul ROSS, MD
Investigator:
Last name:
Paul ROSS, MD
Email:
Principal Investigator
Facility:
Name:
Hammersmith Hospital
Address:
City:
London
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Harpreet WASAN, MD
Investigator:
Last name:
Harpreet WASAN, MD
Email:
Principal Investigator
Facility:
Name:
Royal Free Hospital
Address:
City:
London
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Roopinder GILLMORE, MD
Investigator:
Last name:
Roopinder GILLMORE, MD
Email:
Principal Investigator
Facility:
Name:
Royal Marsden Hospital
Address:
City:
London
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Sheela RAO, MD
Investigator:
Last name:
Sheela RAO, MD
Email:
Principal Investigator
Facility:
Name:
University College London
Address:
City:
London
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
John BRIDGEWATER, MD
Investigator:
Last name:
John BRIDGEWATER, MD
Email:
Principal Investigator
Facility:
Name:
Maidstone Hospital
Address:
City:
Maidstone
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Justin WATERS, MD
Investigator:
Last name:
Justin WATERS, MD
Email:
Principal Investigator
Facility:
Name:
The Christie Hospital
Address:
City:
Manchester
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Mairead MCNAMARA, MD
Investigator:
Last name:
Mairead MCNAMARA, MD
Email:
Principal Investigator
Facility:
Name:
Mount Vernon Cancer Centre
Address:
City:
Northwood
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Vasiliki MICHALAREA, MD
Investigator:
Last name:
Vasiliki MICHALAREA, MD
Email:
Principal Investigator
Facility:
Name:
Norfolk and Norwich University Hospitals NHS Foundation Trust
Address:
City:
Norwich
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Daniel HOLYOAKE, MD
Investigator:
Last name:
Daniel HOLYOAKE, MD
Email:
Principal Investigator
Facility:
Name:
Nottingham University Hospital
Address:
City:
Nottingham
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Aurora ARVIND, MD
Investigator:
Last name:
Aurora ARVIND, MD
Email:
Principal Investigator
Facility:
Name:
Churchill Hospital
Address:
City:
Oxford
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Paul MILLER, MD
Investigator:
Last name:
Paul MILLER, MD
Email:
Principal Investigator
Facility:
Name:
North West Anglia NHS Foundation Trust
Address:
City:
Peterborough
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Ankit RAO, MD
Investigator:
Last name:
Ankit RAO, MD
Email:
Principal Investigator
Facility:
Name:
Weston Park Cancer Centre
Address:
City:
Sheffield
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Ahmad SABBAGH, MD
Investigator:
Last name:
Ahmad SABBAGH, MD
Email:
Principal Investigator
Facility:
Name:
Southampton General Hospital
Address:
City:
Southampton
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Tim IVESON, MD
Investigator:
Last name:
Tim IVESON, MD
Email:
Principal Investigator
Facility:
Name:
Singleton Hospital
Address:
City:
Swansea
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Steve KIHARA, MD
Investigator:
Last name:
Steve KIHARA, MD
Email:
Principal Investigator
Start date:
May 29, 2024
Completion date:
June 2028
Lead sponsor:
Agency:
UNICANCER
Agency class:
Other
Collaborator:
Agency:
Cancer Research UK & UCL Cancer Trials Centre
Agency class:
Other
Collaborator:
Agency:
Belgian Group of Digestive Oncology
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute, France
Agency class:
Other
Collaborator:
Agency:
Cancer Research UK
Agency class:
Other
Collaborator:
Agency:
Taiho Oncology, Inc.
Agency class:
Industry
Collaborator:
Agency:
Servier
Agency class:
Industry
Collaborator:
Agency:
Zymeworks BC Inc.
Agency class:
Industry
Collaborator:
Agency:
Accord Healthcare, Inc.
Agency class:
Industry
Collaborator:
Agency:
Pierre Fabre Medicament
Agency class:
Industry
Source:
UNICANCER
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05615818
