Metastatic Colorectal Carcinoma (mCRC)Phase 2NCT07150403

Second-line Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Fruquintinib Versus Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Bevacizumab in Metastatic Colorectal Cancer

A Phase 2 study testing Oxaliplatin intravenous, 5 FU bolus and Folinic acid in people with Metastatic Colorectal Carcinoma (mCRC), run by Federation Francophone de Cancerologie Digestive at 45 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Metastatic Colorectal Carcinoma (mCRC)
What is being tested?: Oxaliplatin intravenous, 5 FU bolus and Folinic acid
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 74 participants
Where: 45 sitesFrance
Study dates: 31 Dec 2025to 31 Oct 2028
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

- Age ≥ 18 years and ≤ 80 years; provided the score of the G8 geriatric questionnaire is >14 for patients 75 years or older
Patients with a histologically confirmed diagnosis of metastatic colorectal cancer (mCRC), with a documented disease progression (as per RECIST v1.1, assessed by the investigator and confirmed through CT or MRI).
Patients must have previously received first-line therapy with Bevacizumab or an EGFRi, in combination with either FOLFOX or FOLFIRI, for non-resectable mCRC. Patients who progressed during the adjuvant chemotherapy (FOLFOX) or within the 6 months following its completion are eligible for inclusion
Patients must have an unresectable tumor at the time of enrollment.
Patients must have at least one measurable/evaluable metastatic lesion according to RECIST v1.1 criteria; images have to be available for collection
Metastases not amenable to surgery and/or thermo-ablation and/or stereotaxic radiotherapy

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WHO performance status 0 or 1
Available parameters to compute the SPOD score: WHO PS, hemoglobin, platelet count, WBC/absolute neutrophil count ratio, lactate dehydrogenase (LDH), alkaline phosphatase, and the number of metastatic sites.
Adequate liver functions: Total Bilirubinemia < 2,5 ULN, AST and ALT ≤ 5 ULN
Adequate hematological (Hemoglobin ≥10g/dL, platelets ≥100G/L, neutrophils ≥1.5G/L) and renal (creatinine clearance ≥ 50 mL/min according to CKD-EPI) functions
Proteinuria < 2+ (dipstick urinalysis) (if 2+ or more, proteinuria must be ≤1g/24hour)
Life expectancy ≥ 3 months
Women of childbearing potential must agree to use a highly effective method of contraception during the trial and for at least 15 months after discontinuation of the experimental treatments. Men who have sexual relations with women of childbearing potential must agree to use contraception during treatment and for at least 12 months after discontinuation of the experimental treatments
Ability of the patient to understand, sign and date the information note and informed consent form before any study specific procedures
Patient affiliated to a social security scheme
Available tumor sample and pathology report for collection

Who cannot join

- Patients who have received more than one prior systemic therapy
FOLFIRINOX Regimen +/- targeted therapy in the first line setting
Unknown RAS status
BRAF V600E mutated tumor
MSI/dMMR tumor
Known brain metastasis

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Known peritoneal carcinomatosis if there are signs of clinical occlusion or sub-occlusion
History of gastric ulceration, or myocardial infarction, or severe coronaropathy or severe cardiac dysfunction, within the past 6 months prior to treatment start
Patients with dihydropyrimidine dehydrogenase deficiency (uracilemia ≥ 16 ng/mL)
Hypersensitivity to one of the study drugs or one of its excipients
Inability to swallow capsules
Live attenuated vaccines 30 days prior to treatment start
Untreated bone fracture
Significant haemorrhagic diathesis or coagulopathy (in the absence of anti-coagulant treatment)
Major surgery, open biopsy or major traumatic lesion in the prior 30 days or the need for major surgery during the trial
Pregnant or breastfeeding woman or patients with no adequate contraception
Known Uridine Diphosphate Glucuronyltransferase (UGT1A1) deficiency or known Gilbert disease
Strong inducers of CYP3A4 (treatment with St John's Wort (Hypericum perforatum), fampicin, phenobarbital, primidone, phenytoin and carbamazepine)
-- Strong inhibitors of CYP3A4, continuous use of azole antifungals (posaconazole, voriconazole, itraconazole, isavuconazole), ritonavir, verapamil, diltiazem, grapefruit juice (equivalent to half a fresh grapefruit/day)
Concomitant or recent treatment with sorivudine or its analogs (including brivudine) within 4 weeks prior to the administration of protocol treatment (related to Fluorouracil)
Concomitant treatment with phenytoin or its analogs
QT/QTc interval > 450 ms for men and > 470 ms for women
Uncontrolled hypertension (defined as systolic blood pressure >140 mmHg and/or diastolic blood pressure >90 mmHg) or history of hypertensive crisis (TA systolic> 20 mmHg) or hypertensive encephalopathy
History of veinous thromboembolic events, including deep vein thrombosis and pulmonary embolism, within the past month prior to study enrollment
History of stroke and/or transient ischemic attack (TIA) within the past 12 months
Residual Oxaliplatin neuropathy (grade ≥ 2) counter indicates FOLFOX administration
Persistence of clinically significant symptoms after a thromboembolic event despite anticoagulant treatment
Arterial thromboembolism (myocardial infarction, stroke, transient ischemic attack) occurring under antiangiogenic therapy
Other active cancers or history of cancer treated within the last 5 years except for carcinoma in situ of the cervix or basal cell or squamous cell skin carcinoma or any other carcinoma in situ, considered cured
Persons deprived of liberty or under guardianship or unable of giving consent
Inability to undergo the medical follow-up of the trial for geographical, social or psychological reasons

Trial locations and contacts

45 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sofia BOUHLAL JOURDAN, PhD contact

+33(0)7 55 67 67 95

prodige115.ulysse@ffcd.fr

City, postcode or hospital

45 sites in 1 country

France45 sites

ICO Site Paul Papin
Angers
Victor SIMMET, MD, victor.simmet@ch-cholet.fr
Les Bonnettes
Arras
Bruno HUGUENIN, MD, drbhuguenin@orange.fr
Ght Unyon Auxerre
Auxerre
Anne-Laure VILLING, MD, alvilling@ch-auxerre.fr
Bayeux Ch
Bayeux
Annie PEYTIER, MD, a.peytier@ch-ab.fr
Cote Basque
Bayonne
Franck AUDEMAR, MD, faudemar@ch-cotebasque.fr
Beauvais Ch
Beauvais
Hanifa AMMARGUELLAT, MD, h.ammarguellat@ch-beauvais.fr
Jean Minjoz
Besançon
Antoine EL KADDISSI, MD, aelkaddissi@chu-besancon.fr
Centre Pierre Curie
Beuvry
Laurent BASSON, MD, laurent.basson@ichf.fr
BERGONIÉ
Bordeaux
Simon PERNOT, MD, s.pernot@bordeaux.unicancer.fr
TIVOLI
Bordeaux
Valérie COCHIN, MD, v.cochin@tivoli-oncologie.fr
Chauny Ch
Chauny
Marc KANAAN, MD, marc.kanaan@ch-chauny.fr
Cholet Ch
Cholet
Thomas DAVIEAU, MD, thomas.davieau@ch-cholet.fr
Saint Côme
Compiègne
Kaïs ALDABBAGH, MD, kais.aldabbagh@stcome.com
Clinique de Flandre
Coudekerque-Branche
Jean Baptiste AISENFARB, MD, jbaisenfarb@iadonco.org
GHPSO Site de Creil
Creil
Candice CAROLA DELVALLEZ, MD, Candice.CarolaDelvallez@ghpso.fr
Centre Leonard de Vinci
Dechy
Claire GIRAUD, MD, cgiraud@clinique-psv.fr
Dijon Bourgogne
Dijon
Jean-Louis JOUVE, MD, jean-louis.jouve@chu-dijon.fr
Institut de cancérologie de Bourgogne GRReCC
Dijon
Antoine DROUILLARD, MD, adrouillard@icb-cancer.fr
CHD Vendée
La Roche-sur-Yon
Margot LALY, MD, margot.laly@ght85.fr
Docteur Schaffner
Lens
Fabienne WATELLE, MD, fwatelle@ch-lens.fr
Franco Britannique
Levallois-Perret
Benoist CHIBAUDEL, MD, benoist.chibaudel@ihfb.org
Jean Mermoz
Lyon
Léa CLAVEL, MD, leaclavel1@gmail.com
La Timone
Marseille
Laétitia DAHAN, MD, laetitia.dahan@ap-hm.fr
LAYNÉ CH
Mont-de-Marsan
Morgan ANDRE, MD, morgan.andre@ch-mdm.fr
Centre de Cancérologie du Grand Montpellier
Montpellier
Emmanuel GUARDIOLA, MD, guardiola@ccgm.fr
Confluent Sas
Nantes
Benjamin LINOT, MD, benjamin.linot@groupeconfluent.fr
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris
Olivier DUBREUIL, MD, odubreuil@hopital-dcss.org
Hôpital Européen G Pompidou
Paris
Julien TAIEB, MD, julien.taieb@aphp.fr
La Pitié Salpêtrière
Paris
Jean-Baptiste BACHET, MD, jean-baptiste.bachet@aphp.fr
Saint Louis
Paris
Thomas APARICIO, MD, thomas.aparicio@aphp.fr
La Miletrie
Poitiers
David TOUGERON, MD, david.tougeron@chu-poitiers.fr
Jean Godinot
Reims
Damien BOTSEN, MD, dbotsen@chu-reims.fr
Robert Debré
Reims
Olivier BOUCHÉ, MD, obouche@chu-reims.fr
Saint Gregoire Chp
Saint-Grégoire
Caroline CHENEAU, MD, caroline.cheneau@icrb.fr
ICO Site René Gauducheau
Saint-Herblain
Sandrine HIRET, MD, sandrine.hiret@ico.unicancer.fr
Clinique Mutualiste de L'Estuaire
Saint-Nazaire
Catherine LIGEZA POISSON, MD, catherine.ligeza@hospigrandouest.fr
Hopital Nord Chu Saint Etienne
Saint-Priest-en-Jarez
Jean-Marc PHELIP, MD, j.marc.phelip@chu-st-etienne.fr
Saint Malo Ch
St-Malo
Anaïs BODERE, MD, a.bodere@ch-stmalo.fr
ICAN Institut de Cancérologie de Strasbourg Europe
Strasbourg
Meher BEN ABDELGHANI, MD, m.ben-abdelghani@icans.eu
Sainte Anne
Strasbourg
Louis-Marie DOURTHE, MD, lm.dourthe@solcrr.org
LEMAN
Thonon-les-Bains
Fanny POMMERET, MD, f-pommeret@ch-hopitauxduleman.fr
Valence Ch
Valence
Nicolas ETCHEPARE, MD, netchepare@ch-valence.fr
BRABOIS
Vandœuvre-lès-Nancy
Marie MULLER, MD, m.muller7@chru-nancy.fr
Ch Nord Ouest
Villefranche-sur-Saône
Boris MOREL, MD, bomorel@hno.fr
Gustave Roussy
Villejuif
Valérie BOIGE, MD, valerie.boige@gustaveroussy.fr

Other trials in France

About this study

Official title: A Phase II, Open-label, Non-comparative, Randomized Study of Second-line Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Fruquintinib Versus Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Bevacizumab in Metastatic Colorectal Cancer

The standard second-line treatment for metastatic colorectal cancer (mCRC) involves chemotherapy (FOLFOX or FOLFIRI) combined with an antiangiogenic agent, such as bevacizumab or aflibercept. Maintaining VEGF inhibition between first and second-line treatments has shown modest clinical benefits, with exploratory analyses suggesting that bevacizumab is more effective in smaller tumors. The ULYSSE trial aims to evaluate the efficacy and safety of Fruquintinib, a potent antiangiogenic agent, combined with a doublet chemotherapy (FOLFOX or FOLFIRI) in second-line treatment for BRAF wild-type, MSS mCRC patients who have failed prior treatment.

Conditions: Metastatic Colorectal Carcinoma (mCRC)
Being tested: Oxaliplatin intravenous, 5 FU bolus, Folinic acid, 5 FU continuous, Irinotecan
Medical subject headings: Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oxaliplatin intravenousDrug
85 mg/m² IV over 2 hours ; 1 cycle each 15 days
5 FU bolusDrug
5 fluorouracil : 400 mg/m² in bolus of 10 minutes (intravenous)
Folinic acidDrug
400 mg/m² in intravenous
5 FU continuousDrug
2400 mg/m² intravenously over 46 hours
IrinotecanDrug
180 mg/m² IV over 1h30
FRUQUINTINIBDrug
5 mg capsule, taken orally, once daily for 3 weeks, followed by a 7-day break, then resumed (Day 1= Day 29).
BEVACIZUMABDrug
5 mg/kg over 90 minutes for the 1st course and in case of good tolerance the 2nd course should be administered over 60 minutes. The next courses should be administered in 30 minutes in case of good tolerance during the 2nd course

Study groups in NCT07150403
Study group	Role	What they receive
Experimental arm A FOLFOX/FOLFIRI + Fruquintinib	Experimental	FOLFOX (if FOLFIRI in first line) OR FOLFIRI (if FOLFOX in first line); D1 = D15 + FRUQUINTINIB Receives: Drug: Oxaliplatin intravenous; Drug: 5 FU bolus; Drug: Folinic acid; Drug: 5 FU continuous; Drug: Irinotecan; Drug: FRUQUINTINIB
Control arm B FOLFOX/FOLFIRI + Bevacizumab	Active comparator	FOLFOX (if FOLFIRI in first line) OR FOLFIRI (if FOLFOX in first line); D1 = D15 + BEVACIZUMAB (D1 = D15) Receives: Drug: Oxaliplatin intravenous; Drug: 5 FU bolus; Drug: Folinic acid; Drug: 5 FU continuous; Drug: Irinotecan; Drug: BEVACIZUMAB

What is being measured

The primary outcome is the main question the study is designed to answer.

Disease Control Rate (DCR)
the percentage of patients with a complete response, a partial response or a stable disease at 4 months after the start of treatment.
Measured: at 4 months after the start of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Dec 202531 Oct 2028

First posted2 Sep 2025
Study start31 Dec 2025 (estimated)
Primary completion28 Feb 2028 (estimated)
Study completion31 Oct 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Metastatic Colorectal Carcinoma (mCRC)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 74 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07150403
Sponsor's protocol ID: PRODIGE 115 - FFCD 2406-ULYSSE
Other IDs: 2025-522108-26-00, 2025
Status last verified: Sep 2025
First submitted: 25 Aug 2025
Last updated: 8 Sep 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Sofia BOUHLAL JOURDAN, PhD

+33(0)7 55 67 67 95

prodige115.ulysse@ffcd.fr

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 1/2
Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread
Metastatic Breast Cancer, Metastatic Gastric Adenocarcinoma
RecruitingPhase 3
Phase III Study of Ivonescimab or Bevacizumab Combined With FOLFOX in Patients With Metastatic Colorectal Cancer
Metastatic Colorectal Cancer (CRC)
RecruitingPhase 2
FOLFIRI and Bevacizumab With or Without Pelareorep for Second-Line Treatment of Metastatic RAS-Mutated, Microsatellite-Stable Colorectal Cancer
Ras-mutated Metastatic Colorectal Cancer, mCRC
Not yet recruitingObservational study
Real-World Study: Panitumumab N01 vs Cetuximab Plus FOLFOX in First-Line RAS Wild-Type mCRC
Colorectal Cancer Metastatic
RecruitingPhase 1
A Study to Investigate CEA-PRIT 2.0 in Participants With Metastatic Colorectal Cancer (mCRC)
Metastatic Colorectal Cancer

All Metastatic Colorectal Carcinoma (mCRC) trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Open-label, Non-comparative, Randomized Study of Second-line Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Fruquintinib Versus Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Bevacizumab in Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT07150403
Acronym / sponsor ID: PRODIGE 115 - FFCD 2406-ULYSSE
Conditions: Metastatic Colorectal Carcinoma (mCRC)
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 74 participants (estimated)
Lead sponsor: Federation Francophone de Cancerologie DigestiveUniversity, hospital or other
Study start: 31 Dec 2025 (estimated)
Primary completion: 28 Feb 2028 (estimated)
Study completion: 31 Oct 2028 (estimated)
First posted: 2 Sep 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Experimental arm A FOLFOX/FOLFIRI + Fruquintinib	Experimental	Drug: Oxaliplatin intravenous, Drug: 5 FU bolus, Drug: Folinic acid, Drug: 5 FU continuous, Drug: Irinotecan, Drug: FRUQUINTINIBFOLFOX (if FOLFIRI in first line) OR FOLFIRI (if FOLFOX in first line); D1 = D15 + FRUQUINTINIB
Control arm B FOLFOX/FOLFIRI + Bevacizumab	Active comparator	Drug: Oxaliplatin intravenous, Drug: 5 FU bolus, Drug: Folinic acid, Drug: 5 FU continuous, Drug: Irinotecan, Drug: BEVACIZUMABFOLFOX (if FOLFIRI in first line) OR FOLFIRI (if FOLFOX in first line); D1 = D15 + BEVACIZUMAB (D1 = D15)

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

- Age ≥ 18 years and ≤ 80 years; provided the score of the G8 geriatric questionnaire is >14 for patients 75 years or older
Patients with a histologically confirmed diagnosis of metastatic colorectal cancer (mCRC), with a documented disease progression (as per RECIST v1.1, assessed by the investigator and confirmed through CT or MRI).
Patients must have previously received first-line therapy with Bevacizumab or an EGFRi, in combination with either FOLFOX or FOLFIRI, for non-resectable mCRC. Patients who progressed during the adjuvant chemotherapy (FOLFOX) or within the 6 months following its completion are eligible for inclusion
Patients must have an unresectable tumor at the time of enrollment.
Patients must have at least one measurable/evaluable metastatic lesion according to RECIST v1.1 criteria; images have to be available for collection

Key exclusion criteria (31 listed)

- Patients who have received more than one prior systemic therapy
FOLFIRINOX Regimen +/- targeted therapy in the first line setting
Unknown RAS status
BRAF V600E mutated tumor
MSI/dMMR tumor

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Oxaliplatin intravenous85 mg/m² IV over 2 hours ; 1 cycle each 15 days	Drug	Control arm B FOLFOX/FOLFIRI + Bevacizumab, Experimental arm A FOLFOX/FOLFIRI + Fruquintinib
5 FU bolus5 fluorouracil : 400 mg/m² in bolus of 10 minutes (intravenous)	Drug	Control arm B FOLFOX/FOLFIRI + Bevacizumab, Experimental arm A FOLFOX/FOLFIRI + Fruquintinib
Folinic acid400 mg/m² in intravenous	Drug	Control arm B FOLFOX/FOLFIRI + Bevacizumab, Experimental arm A FOLFOX/FOLFIRI + Fruquintinib
5 FU continuous2400 mg/m² intravenously over 46 hours	Drug	Control arm B FOLFOX/FOLFIRI + Bevacizumab, Experimental arm A FOLFOX/FOLFIRI + Fruquintinib
Irinotecan180 mg/m² IV over 1h30	Drug	Control arm B FOLFOX/FOLFIRI + Bevacizumab, Experimental arm A FOLFOX/FOLFIRI + Fruquintinib
FRUQUINTINIB5 mg capsule, taken orally, once daily for 3 weeks, followed by a 7-day break, then resumed (Day 1= Day 29).	Drug	Experimental arm A FOLFOX/FOLFIRI + Fruquintinib
BEVACIZUMAB5 mg/kg over 90 minutes for the 1st course and in case of good tolerance the 2nd course should be administered over 60 minutes. The next courses should be administered in 30 minutes in case of good tolerance during the 2nd course	Drug	Control arm B FOLFOX/FOLFIRI + Bevacizumab

Primary outcome

Disease Control Rate (DCR)
Time frame: at 4 months after the start of treatment
the percentage of patients with a complete response, a partial response or a stable disease at 4 months after the start of treatment.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
Individual participant dataSharing planned: No

Related trials for Metastatic Colorectal Carcinoma (mCRC)

RecruitingPhase 1/2
Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread
Metastatic Breast Cancer, Metastatic Gastric Adenocarcinoma
RecruitingPhase 3
Phase III Study of Ivonescimab or Bevacizumab Combined With FOLFOX in Patients With Metastatic Colorectal Cancer
Metastatic Colorectal Cancer (CRC)
RecruitingPhase 2
FOLFIRI and Bevacizumab With or Without Pelareorep for Second-Line Treatment of Metastatic RAS-Mutated, Microsatellite-Stable Colorectal Cancer
Ras-mutated Metastatic Colorectal Cancer, mCRC
Not yet recruitingObservational study
Real-World Study: Panitumumab N01 vs Cetuximab Plus FOLFOX in First-Line RAS Wild-Type mCRC
Colorectal Cancer Metastatic
RecruitingPhase 1
A Study to Investigate CEA-PRIT 2.0 in Participants With Metastatic Colorectal Cancer (mCRC)
Metastatic Colorectal Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Sofia BOUHLAL JOURDAN, PhD contact

+33(0)7 55 67 67 95

prodige115.ulysse@ffcd.fr

45 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sofia BOUHLAL JOURDAN, PhD (+33(0)7 55 67 67 95, prodige115.ulysse@ffcd.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Control Rate (DCR) (time frame: at 4 months after the start of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07150403.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.