Ovarian CancerPhase 1/2INeOVNCT03249142

Immunotherapy With Neo-adjuvant Chemotherapy for OVarian Cancer

A Phase 1/2 study testing ARM A Durvalumab/chemotherapy association and ARM B Durvalumab/Tremelimumab/chemotherapy association in people with Ovarian Cancer, run by ARCAGY/ GINECO GROUP at 11 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a randomized, open, comparative, multi-centre study which will recruit up to 66 patients. The objective is mainly to explore the safety and feasibility in neo-adjuvant first-line ovarian cancer (including patients with primary peritoneal or fallopian tube adenocarcinoma) of various combinations of durvalumab… Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Ovarian Cancer
What is being tested?: ARM A Durvalumab/chemotherapy association and ARM B Durvalumab/Tremelimumab/chemotherapy association
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 69 participants
Where: 11 sitesFrance
Study dates: 18 Oct 2017to 31 Dec 2024
Phase: Phase 1/2
Are there results?: None posted in the registry

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 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

I-1 Female patients must be ≥ 18 years of age. I-2 Signed informed consent and ability to comply with treatment and follow-up. I-3 Patients with newly histologically confirmed epithelial ovarian cancer (or fallopian tube or primary peritoneal adenocarcinoma).
I-4 Advanced FIGO stage IIIC to IV. I-5 Patients for whom primary debulking surgery has been denied after an evaluation through laparoscopy or laparotomy.
I-6 Patient for whom a neo-adjuvant strategy has been planned. I-7 Interval between diagnosis and enrolment (informed consent signed) ≤ 8 weeks.
I-8 Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. I-9 Geriatric vulnerability score (GVS) < 3 for patients ≥ 70 years. I-10 Adequate organ and bone marrow function. I-11 Patients not receiving anticoagulant medication who have an International Normalized Ratio (INR) ≤ 1.5 and an Activated ProThrombin Time (aPTT) ≤ 1.5 x ULN. The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits (according to site medical standard) and if the patient is on a stable dose of anticoagulants for at least two weeks at the time of randomization.
I-12 As this study will include patients in France, a subject will be eligible for randomization in this study only if either affiliated to, or a beneficiary of, a social category.

Who cannot join

E-1 Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS).
E-2 Major surgical procedure (defined by the resection of at least one organ including ovary) within 28 days prior to the first dose.
E-3 Any concurrent chemotherapy, investigational product, biological, or hormonal therapy for cancer treatment.
E-4 Previous treatment with immunotherapy, including, but not limited to, anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies, or therapeutic anticancer vaccine.
E-5 Active or prior documented autoimmune or inflammatory disorders The following are exceptions to this criterion:
Patients with vitiligo or alopecia,

Show all 34Show fewer

Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement or psoriasis not requiring systemic treatment.
E-6 Current/prior immunosuppressive medication ≤ 14 days before first durvalumab and tremelimumab dose (including, but not limited to, prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) within 2 weeks prior to Cycle 1, Day 1, or anticipated requirement for systemic immunosuppressive medications during the trial.
E-7 Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV). Patients with active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C. Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test) are eligible.
E-8 Uncontrolled diabetes mellitus, uncontrolled hypothyroidism. E-9 Treatment with systemic immunostimulatory agents (including but not limited to interferon-alpha (IFN-α) and interleukin-2 (IL-2) within 4 weeks or five half- lives of the drug (whichever is shorter) prior to Cycle 1, Day 1.
E-10 History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis. Radiation pneumonitis in the radiation field (fibrosis) detected on screening chest CT scan is permitted.
E-11 Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1. E-12 Administration of a live, attenuated vaccine within 4 weeks prior to Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study. Influenza vaccination should be given during influenza season only (example approximately October to March in the Northern Hemisphere). Patients must not receive live, attenuated influenza.
E-13 Current or recent (within 10 days prior to randomization) chronic use of aspirin > 325 mg/day.
E-14 Prior history of hypertensive crisis (CTC-AE grade 4) or hypertensive encephalopathy.
E-15 Inadequately controlled HTN (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg on antihypertensive medications).
E-16 Clinically significant (e.g. active) cardiovascular disease, including:
Myocardial infarction or unstable angina within ≤ 6 months of randomization,
New York Heart Association (NYHA) ≥ grade 2 congestive heart failure (CHF),
Poorly controlled cardiac arrhythmia despite medication (patients with rate controlled atrial fibrillation are eligible),
Peripheral vascular disease grade ≥ 3 (e.g. symptomatic and interfering with activities of daily living [ADL] requiring repair or revision).
E-17 Previous Cerebro-Vascular Accident (CVA), Transient Ischemic Attack (TIA) or Sub-Arachnoids Hemorrhage (SAH) within 6 months prior to randomization.
E-18 History or evidence of hemorrhagic disorders within 6 months prior to randomization.
E-19 Evidence of bleeding diathesis or significant coagulopathy (in the absence of coagulation).
E-20 History or clinical suspicion of brain metastases or spinal cord compression unless asymptomatic, treated, and stable off steroids and anti-convulsants for at least 1 month prior to entry.
E-21 History or evidence upon neurological examination of central nervous system (CNS) disease, unless adequately treated with standard medical therapy (e.g. uncontrolled seizures).
E-22 Pre-existing motor or sensory neurotoxicity (grade > 1). E-23 Significant traumatic injury within 4 weeks prior to randomization. E-24 Non-healing wound, active ulcer or bone fracture. Patients with granulating incisions healing by secondary intention with no evidence of facial dehiscence or infection are eligible but require 3 weekly wound examinations.
E-25 Current, clinically relevant bowel obstruction, including sub-occlusive disease, related to underlying disease.
E-26 Previous allogeneic bone marrow transplant or previous solid organ transplantation.
E-27 Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure.
E-28 Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment related complications.
E-29 Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential (< 2 years after last menstruation and not surgically sterile) who are not willing to employ effective birth control from screening to 180 days after the last dose of durvalumab + tremelimumab combination therapy or 90 days after the last dose of durvalumab monotherapy, whichever is the longer time period.
E-30 History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
E-31 Known hypersensitivity or allergy to biopharmaceuticals or to any component of the durvalumab or tremelimumab formulations.
E-32 Known hypersensitivity reaction or allergy to drugs chemically related to carboplatin, paclitaxel, or their excipients that contraindicates the subject's participation.

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

France11 sites

Institut Ste Catherine
Avignon
Institut Bergonié
Bordeaux
ICM Val d'Aurelle
Montpellier
Groupe confluent
Nantes, 44202
HEGP
Paris
Hôpital Cochin
Paris
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Institut René Godinot
Reims
Centre Eugene Marquis
Rennes
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy
Gustave Roussy
Villejuif

Other trials in France

About this study

Official title: A Multicentre Feasibility Randomized Study of Anti-PD-L1 Durvalumab (MEDI4736) With or Without Anti-CTLA-4 Tremelimumab in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Adenocarcinoma, Treated With a First-line Neo-adjuvant Strategy

Read the detailed description

The schedule is the following:

In a first step a run-in phase of 6 patients will be conducted to test the safety and feasibility of the combination of durvalumab with standard carboplatin-paclitaxel chemotherapy.

Cycle 1 : chemotherapy alone (day1) Cycle 2 : chemotherapy + durvalumab (day1) Cycle 3 : chemotherapy + durvalumab (day1)

In a second step, if first-step was found feasible, a run-in phase of 6 patients will be conducted to test the safety and feasibility of the combination of durvalumab plus tremelimumab with standard carboplatin-paclitaxel chemotherapy.

Cycle 1 : chemotherapy alone (day1) Cycle 2 : chemotherapy + durvalumab + tremelimumab (day1) Cycle 3 : chemotherapy + durvalumab (day1)

After the run-in phase, patients will be randomized in a ratio 1:1 between those included in the durvalumab-chemotherapy expansion phase (arm A) and those included in the durvalumab + tremelimumab-chemotherapy expansion phase (arm B).
This study will also allow to explore the feasibility of a salvage therapy personalized according to the results of interval surgery and type of previous neo-adjuvant therapy.

In those patients who achieved a complete surgical resection at interval debulking surgery, adjuvant treatment will include 3 cycles of durvalumab + chemotherapy and then a follow-up period.
In patients with residual tumor at interval debulking surgery, salvage therapy will depend on the initial treatment arm allocated.
In arm A, the tremelimumab will be added to the durvalumab-chemotherapy combination at day 1 of cycle 2 before a salvage surgery. Durvalumab (with one cycle of tremelimumab post S3) will be pursued in maintenance treatment, up to 1 year or until disease progression, unacceptable toxicity or patient withdrawn.
In arm B, the therapy will be according to the Investigator choice and managed according to local practice.

Conditions: Ovarian Cancer
Being tested: ARM A Durvalumab/chemotherapy association, ARM B Durvalumab/Tremelimumab/chemotherapy association
Keywords: Ovarian Cancer, Anti-PD-L1, Anti-CLA-4, Neo-adjuvant
Medical subject headings: Ovarian Neoplasms

What participants receive

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

ARM A Durvalumab/chemotherapy associationDrug
NEO-ADJUVANT Cycle 1 : carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV alone (day1), every 3 weeks Cycle 2 : carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV + durvalumab 1125 mg IV (day1) Cycle 3 : carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV + durvalumab 1125 mg IV (day1)
ADJUVANT :
1. If complete surgical resection at interval debulking surgery : 3 cycles of durvalumab 1125 mg IV + carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV at day1, every 3 weeks.
2. If residual tumor at interval debulking surgery : the tremelimumab 75 mg IV will be added to the durvalumab-chemotherapy combination at day 1 of cycle 2 before a salvage surgery. Durvalumab 1125 mg IV (with one cycle of tremelimumab 75 mg IV post S3) will be pursued in maintenance treatment, up to 1 year or until disease progression, unacceptable toxicity or patient withdrawn.
ARM B Durvalumab/Tremelimumab/chemotherapy associationDrug
NEO-ADJUVANT Cycle 1 : carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV alone (day1), every 3 weeks Cycle 2 : carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV + durvalumab 1125 mg IV + tremelimumab 75 mg IV (day1) Cycle 3 : carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV + durvalumab 1125 mg IV (day1)
ADJUVANT :
1. If complete surgical resection at interval debulking surgery : 3 cycles of durvalumab 1125 mg IV + carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV at day1, every 3 weeks.
2. If residual tumor at interval debulking surgery : patients will be treated according to investigator choice.

Study groups in NCT03249142
Study group	Role	What they receive
ARM A Durvalumab/chemotherapy association	Experimental	Not described Receives: Drug: ARM A Durvalumab/chemotherapy association
ARM B Durvalumab/Tremelimumab/chemotherapy association	Experimental	Not described Receives: Drug: ARM B Durvalumab/Tremelimumab/chemotherapy association

What is being measured

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

Toxicity after neo-adjuvant treatment
frequency of adverse events according to CTCAE v4.03 criteria
Measured: At the end of cycle 3 (each cycle is 21 days)

Secondary outcomes (7)

Toxicity after adjuvant treatment
Measured: At the end of cycle 6 (each cycle is 21 days)
Toxicity after maintenance therapy
Measured: Up to 18 months
Safety after interval debulking surgery
adverse events according to the Clavien-Dindo classification
Measured: Up to 6 months
Progression Free Survival (PFS) based on investigator assessment using the RECIST version 1.1
Measured: From date of randomisation until the date of progression or death, which ever occurs earlier, assessed up to 36 months
Sugarbaker Peritoneal Index Score (PCI)
Measured: Up to 6 months
Time to start of first subsequent therapy or death
Measured: Up to 36 months
overall survival
Measured: from date of randomisation to death, assessed up to 36 months

Timeline

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

18 Oct 201731 Dec 2024

First posted15 Aug 2017
Study start18 Oct 2017
Primary completion31 Dec 2024
Study completion31 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Ovarian CancerStudies 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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 69 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03249142
Sponsor's protocol ID: GINECO-OV127b
Acronym: INeOV
Status last verified: Dec 2025
First submitted: 4 Aug 2017
Last updated: 3 Dec 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

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 locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicentre Feasibility Randomized Study of Anti-PD-L1 Durvalumab (MEDI4736) With or Without Anti-CTLA-4 Tremelimumab in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Adenocarcinoma, Treated With a First-line Neo-adjuvant Strategy
ClinicalTrials.gov ID: NCT03249142
Acronym / sponsor ID: INeOV / GINECO-OV127b
Conditions: Ovarian Cancer
Keywords: Ovarian Cancer, Anti-PD-L1, Anti-CLA-4, Neo-adjuvant
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 69 participants (actual)
Lead sponsor: ARCAGY/ GINECO GROUPUniversity, hospital or other
Collaborators: AstraZeneca
Study start: 18 Oct 2017 (actual)
Primary completion: 31 Dec 2024 (actual)
Study completion: 31 Dec 2024 (actual)
First posted: 15 Aug 2017 (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.

Detailed description

The schedule is the following:

In a first step a run-in phase of 6 patients will be conducted to test the safety and feasibility of the combination of durvalumab with standard carboplatin-paclitaxel chemotherapy.

Cycle 1 : chemotherapy alone (day1) Cycle 2 : chemotherapy + durvalumab (day1) Cycle 3 : chemotherapy + durvalumab (day1)

In a second step, if first-step was found feasible, a run-in phase of 6 patients will be conducted to test the safety and feasibility of the combination of durvalumab plus tremelimumab with standard carboplatin-paclitaxel chemotherapy.

Cycle 1 : chemotherapy alone (day1) Cycle 2 : chemotherapy + durvalumab + tremelimumab (day1) Cycle 3 : chemotherapy + durvalumab (day1)

After the run-in phase, patients will be randomized in a ratio 1:1 between those included in the durvalumab-chemotherapy expansion phase (arm A) and those included in the durvalumab + tremelimumab-chemotherapy expansion phase (arm B).
This study will also allow to explore the feasibility of a salvage therapy personalized according to the results of interval surgery and type of previous neo-adjuvant therapy.

In those patients who achieved a complete surgical resection at interval debulking surgery, adjuvant treatment will include 3 cycles of durvalumab + chemotherapy and then a follow-up period.
In patients with residual tumor at interval debulking surgery, salvage therapy will depend on the initial treatment arm allocated.
In arm A, the tremelimumab will be added to the durvalumab-chemotherapy combination at day 1 of cycle 2 before a salvage surgery. Durvalumab (with one cycle of tremelimumab post S3) will be pursued in maintenance treatment, up to 1 year or until disease progression, unacceptable toxicity or patient withdrawn.
In arm B, the therapy will be according to the Investigator choice and managed according to local practice.

Study design

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

Arm	Type	Receives
ARM A Durvalumab/chemotherapy association	Experimental	Drug: ARM A Durvalumab/chemotherapy association
ARM B Durvalumab/Tremelimumab/chemotherapy association	Experimental	Drug: ARM B Durvalumab/Tremelimumab/chemotherapy association

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

I-1 Female patients must be ≥ 18 years of age. I-2 Signed informed consent and ability to comply with treatment and follow-up. I-3 Patients with newly histologically confirmed epithelial ovarian cancer (or fallopian tube or primary peritoneal adenocarcinoma).
I-4 Advanced FIGO stage IIIC to IV. I-5 Patients for whom primary debulking surgery has been denied after an evaluation through laparoscopy or laparotomy.
I-6 Patient for whom a neo-adjuvant strategy has been planned. I-7 Interval between diagnosis and enrolment (informed consent signed) ≤ 8 weeks.
I-8 Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. I-9 Geriatric vulnerability score (GVS) < 3 for patients ≥ 70 years. I-10 Adequate organ and bone marrow function. I-11 Patients not receiving anticoagulant medication who have an International Normalized Ratio (INR) ≤ 1.5 and an Activated ProThrombin Time (aPTT) ≤ 1.5 x ULN. The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits (according to site medical standard) and if the patient is on a stable dose of anticoagulants for at least two weeks at the time of randomization.
I-12 As this study will include patients in France, a subject will be eligible for randomization in this study only if either affiliated to, or a beneficiary of, a social category.

Key exclusion criteria (34 listed)

E-1 Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS).
E-2 Major surgical procedure (defined by the resection of at least one organ including ovary) within 28 days prior to the first dose.
E-3 Any concurrent chemotherapy, investigational product, biological, or hormonal therapy for cancer treatment.
E-4 Previous treatment with immunotherapy, including, but not limited to, anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies, or therapeutic anticancer vaccine.
E-5 Active or prior documented autoimmune or inflammatory disorders The following are exceptions to this criterion:

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
ARM A Durvalumab/chemotherapy associationNEO-ADJUVANT Cycle 1 : carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV alone (day1), every 3 weeks Cycle 2 : carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV + durvalumab 1125 mg IV (day1) Cycle 3 : carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV + durvalumab 1125 mg IV (day1) ADJUVANT : 1. If complete surgical resection at interval debulking surgery : 3 cycles of durvalumab 1125 mg IV + carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV at day1, every 3 weeks. 2. If residual tumor at interval debulking surgery : the tremelimumab 75 mg IV will be added to the durvalumab-chemotherapy combination at day 1 of cycle 2 before a salvage surgery. Durvalumab 1125 mg IV (with one cycle of tremelimumab 75 mg IV post S3) will be pursued in maintenance treatment, up to 1 year or until disease progression, unacceptable toxicity or patient withdrawn.	Drug	ARM A Durvalumab/chemotherapy association
ARM B Durvalumab/Tremelimumab/chemotherapy associationNEO-ADJUVANT Cycle 1 : carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV alone (day1), every 3 weeks Cycle 2 : carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV + durvalumab 1125 mg IV + tremelimumab 75 mg IV (day1) Cycle 3 : carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV + durvalumab 1125 mg IV (day1) ADJUVANT : 1. If complete surgical resection at interval debulking surgery : 3 cycles of durvalumab 1125 mg IV + carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV at day1, every 3 weeks. 2. If residual tumor at interval debulking surgery : patients will be treated according to investigator choice.	Drug	ARM B Durvalumab/Tremelimumab/chemotherapy association

Primary outcome

Toxicity after neo-adjuvant treatment
Time frame: At the end of cycle 3 (each cycle is 21 days)
frequency of adverse events according to CTCAE v4.03 criteria

7 secondary outcomes

Toxicity after adjuvant treatment
Time frame: At the end of cycle 6 (each cycle is 21 days)
Toxicity after maintenance therapy
Time frame: Up to 18 months
Safety after interval debulking surgery
Time frame: Up to 6 months
Progression Free Survival (PFS) based on investigator assessment using the RECIST version 1.1
Time frame: From date of randomisation until the date of progression or death, which ever occurs earlier, assessed up to 36 months
Sugarbaker Peritoneal Index Score (PCI)
Time frame: Up to 6 months
Time to start of first subsequent therapy or death
Time frame: Up to 36 months
overall survival
Time frame: from date of randomisation to death, assessed up to 36 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
Individual participant dataSharing planned: No

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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. This study is not recruiting at the moment.

Alexandra LEARY, MD, PhD principal investigator

Gustave Roussy, Cancer Campus, Grand Paris

11 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 5 inclusion and 34 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: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Toxicity after neo-adjuvant treatment (time frame: At the end of cycle 3 (each cycle is 21 days)). 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 NCT03249142.

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 3 Dec 2025.