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Endometrial CancerPhase 3DOMENICANCT05201547

Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line

A Phase 3 study testing Carboplatin-Paclitaxel and Dostarlimab in people with Endometrial Cancer, run by ARCAGY/ GINECO GROUP at 100 sites in 10 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Phase 3, randomized, multicentre study to evaluate the efficacy and safety of dostarlimab versus carboplatin-paclitaxel in patients with MMR deficient relapse or advanced endometrial cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Cancer
What is being tested?
Carboplatin-Paclitaxel and Dostarlimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
100 sitesin 10 countries
Study dates
15 Apr 2022to Oct 2029
Phase
Phase 3
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must fulfil all the following criteria:
  • Female patient is at least 18 years of age,
  • Patient has signed the Informed Consent (ICF) and is able to comply with protocol requirements.
  • Patient with histologically proven endometrial adenocarcinoma with recurrent or advanced disease.
  • Patient with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • Patient must have primary Stage IIIA to C2 or Stage IV disease or first recurrent endometrial cancer (see International Federation of Gynecology and Obstetrics staging FIGO Staging 18.1) without curative treatment by radiation therapy or surgery alone or in combination, and meet at least one of the following situations:
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  • Patient has patient has primary Stage IIIA-IIIC1 with no amenable curative intent surgery or radiation.
  • Patient has first recurrent disease and is chemotherapy naïve for this 1st recurrence or metastatic setting.
  • Patient has recurrent disease and is chemotherapy naïve for recurrence or advanced /metastatic setting.
  • Patient may have received prior irradiation for advanced endometrial cancer with or without radio-sensitizing chemotherapy if > 3 weeks before the start of the study
  • Patient with evaluable disease (measurable and not measurable disease) according to RECIST 1.1
  • Patient may have received prior neo-adjuvant/adjuvant systemic chemotherapy for the primary cancer and had a recurrence ≥ 6 months after completing treatment (first recurrence only).
  • All histologic subtypes of endometrial adenocarcinoma could be included if MMRd/MSI-H
  • MMRd/MSI-H tumor (first diagnosed by routine local IHC performed either on primitive tumour tissue or on relapse/metastatic tumour sample) is mandatory for inclusion. A central confirmation will be done before inclusion; in case of ambiguous result of central IHC (lack of positive internal control, heterogeneous loss of MMR protein expression), MSI-H status will be assessed by PCR/NGS
  • Availability of 1 block for MMR/MSI status centralized confirmation for IHC or PCR/ NGS
  • . Patient could have been previously treated with hormone therapy, for the metastatic/advanced disease 12) Patient may have received pelvic and lombo-aortic external beam +/- vaginal brachytherapy
  • 13. Patient has adequate organ function, defined as follows:
  • Absolute neutrophil count ≥ 1,500 cells/μL b) Platelets ≥ 100,000 cells/μL c) Haemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L d) Serum creatinine ≤ 1.5× upper limit of normal (ULN) or calculated creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault equation for patients with creatinine levels > 1.5× institutional ULN e) Total bilirubin ≤ 1.5× ULN (≤ 2.0 x ULN in patients with known Gilbert's syndrome) or direct bilirubin ≤ 1× ULN f) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5× ULN unless liver metastases are present, in which case they must be ≤ 5× ULN g) International normalized ratio or prothrombin time (PT) ≤1.5× ULN and activated partial thromboplastin time ≤1.5× ULN. Patients receiving anticoagulant therapy must have a PT or partial thromboplastin within the therapeutic range of intended use of anticoagulants.
  • 14. Patient must have a negative serum pregnancy test within 72 hours of the first dose of study medication, unless they are of nonchildbearing potential. Nonchildbearing potential is defined as follows:
  • Patient is ≥ 45 years of age and has not had menses for > 1 year.
  • A follicle-stimulating hormone value in the postmenopausal range upon screening evaluation if amenorrhoeic for < 2 years without a hysterectomy and oophorectomy.
  • Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation:
  • Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound, MRI, or CT scan.
  • Tubal ligation must be confirmed with medical records of the actual procedure; otherwise, the patient must fulfil the criteria in Inclusion Criterion 14.
  • Information must be captured appropriately within the site's source documents. 15. Patient of childbearing potential must agree to use a highly effective method of contraception (section 18.9) with their partners starting from time of consent through 150 days after the last dose of study treatment. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient (Information must be captured appropriately within the site's source documents).

Who cannot join

  • Patients are to be excluded from the study if they meet any of the following criteria:
  • Patient has received neoadjuvant/adjuvant systemic chemotherapy for primary Stage III or IV disease and has had a recurrence or PD within 6 months of completing this chemotherapy treatment prior to entering the study.
  • Note: Low-dose cisplatin given as a radiation sensitizer or hormonal therapies do not exclude patients from study participation.
  • Patient has had > 1 recurrence of endometrial cancer, treated with chemotherapy. Surgery of the recurrence is allowed.
  • Patient previously treated with systemic chemotherapy for non-curable advanced disease or metastatic disease
  • Patient has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
Show all 27Show fewer
  • Patient has received prior anticancer therapy for (advanced or metastatic disease (targeted therapies, hormonal therapy, radiotherapy) within 21 days or < 5 times the half-life of the most recent therapy prior to Study Day 1, whichever is shorter Note: Palliative radiation therapy to a small field ≥ 1 week prior to Day 1 of study treatment may be allowed.
  • Patient with contraindication to chemotherapy or checkpoint inhibitor treatments
  • Patient has a concomitant malignancy, or patient has a prior non-endometrial invasive malignancy who has been disease-free for < 3 years or who received any active treatment in the last 3 years for that malignancy. Non-melanoma skin cancer is allowed.
  • Patient has known uncontrolled central nervous system metastases, carcinomatosis meningitis, or both. Note: Patients with previously treated brain metastases may participate provided they are stable (without evidence of disease progression by imaging [using the identical imaging modality for each assessment, either MRI or CT scan] for at least 4 weeks prior to the first dose of study treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and have not been using steroids for at least 7 days prior to study treatment. Carcinomatous meningitis precludes a patient from study participation regardless of clinical stability.
  • Patient has a known history of human immunodeficiency virus (HIV; HIV 1 or 2 antibodies).
  • Patient has known active viral infection of hepatitis B (eg, hepatitis B surface antigen reactive) or hepatitis C (eg, hepatitis C virus ribonucleic acid [qualitative] detection).
  • Patient has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is not considered a form of systemic therapy (eg, thyroid hormone or insulin).
  • Patient has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of systemic immunosuppressive therapy within 7 days prior to the first dose of study treatment.
  • Patient has not recovered (ie, to Grade ≤ 1 or to baseline) from cytotoxic therapy-induced adverse events (AEs).
  • Note: Patients with Grade ≤ 2 neuropathy, Grade ≤ 2 alopecia, or Grade ≤ 2 fatigue are an exception to this criterion and may qualify for the study.
  • Patient has not recovered adequately from AEs or complications from any major surgery prior to starting therapy.
  • Patient has a known hypersensitivity to carboplatin, paclitaxel, or dostarlimab components or excipients.
  • Patient is currently participating and receiving study treatment or has participated in a study of an investigational agent and received study treatment or used an investigational device within 4 weeks of the first dose of treatment.
  • Patient is considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or active infection requiring systemic therapy. Specific examples include, but are not limited to, active, non-infectious pneumonitis; uncontrolled ventricular arrhythmia; recent (within 90 days) myocardial infarction; uncontrolled major seizure disorder; unstable spinal cord compression; superior vena cava syndrome; or any psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study (including obtaining informed consent).
  • Use of any of the following immunomodulatory agents within 30 days prior to the first dose of study drug:
  • Systemic corticosteroids (at dose higher than 10 mg/day equivalent prednisone); if systemic corticoid use at higher dose than 10 mg/day, corticoid must be stopped at least 7 days before study treatment start
  • Interferons
  • Interleukins
  • Live vaccine Note: Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, BCG, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed as other killed vaccines, if done at least 2 weeks prior the first dose of study drug; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
  • Patient is pregnant or breastfeeding or is expecting to conceive children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of study treatment, or lactating woman.
  • Patients who had an allogenic tissue/solid organ transplant

Trial locations and contacts

100 sites in 10 countries.

100 sites in 10 countries

France54 sites

  • CHU d'Amiens - Hôpital Sud

    Amiens, 80054

  • Clinique de l'Europe

    Amiens, 80090

  • ICO Paul Papin

    Angers, 49055

  • Centre Hospitalier d'Auxerre

    Auxerre, 89011

  • Institut Sainte Catherine

    Avignon

  • CH Simone Veil de Beauvais

    Beauvais, 60000

  • CHRU Jean Minjoz

    Besançon, 25000

  • Institut Bergonié

    Bordeaux, 33076

  • CHU Brest

    Brest

  • Centre François Baclesse

    Caen, 14000

  • Centre Hospitalier William Morey

    Chalon-sur-Saône, 71100

  • ROC 37

    Chambray-lès-Tours

  • Centre Jean Perrin

    Clermont-Ferrand, 63000

  • GHPSO

    Creil, 60109

  • Centre Hospitalier Intercommunal de Créteil

    Créteil, 21079

  • Centre Georges François Leclerc

    Dijon, 21000

  • CHU de Dijon

    Dijon, 21079

  • Clinique Victor Hugo

    Le Mans, 72000

  • Centre Oscar Lambret

    Lille, 59020

  • Centre Hospitalier Lyon Sud

    Lyon, 69310

  • Centre Léon Bérard

    Lyon, 69373

  • APHM - Hôpital de la Timone

    Marseille, 13005

  • Institut Paoli Calmettes

    Marseille, 13273

  • Hôpital Saint-Joseph

    Marseille, 13285

  • Hôpital de Mont-de-Marsan

    Mont-de-Marsan

  • ICM Val d'Aurelle

    Montpellier, 34298

  • Centre Azuréen de Cancérologie

    Mougins, 06250

  • Médipôle de NANCY SAS

    Nancy

  • Hôpital Privé du Confluent S.A.S.

    Nantes, 44000

  • Centre Antoine Lacassagne

    Nice, 06100

  • Institut de cancérologie du gard

    Nîmes, 30029

  • CHU d'ORLEANS

    Orléans

  • Institut Curie

    Paris, 75005

  • AP-HP Hôpital Pitié-Salpêtrière

    Paris, 75013

  • Hôpital Cochin

    Paris, 75014

  • Groupe Hospitalier Diaconesses-Croix Saint-Simon

    Paris, 75020

  • Hôpital Européen Georges Pompidou

    Paris

  • Institut Mutualiste Montsouris

    Paris

  • Centre Hospitalier Général de Pau

    Pau, 64046

  • Centre CARIO - HPCA

    Plérin, 22190

  • CHU de Poitiers - Hôpital de la Milétrie

    Poitiers, 86021

  • CHI de Cornouaille

    Quimper

  • Institut Jean Godinot

    Reims

  • Centre Eugène Marquis

    Rennes, 35042

  • Centre Henri Becquerel

    Rouen, 76038

  • CHU Saint-Etienne - Pôle de Cancérologie

    Saint-Etienne, 42055

  • Centre Hospitalier Privé de Saint-Grégoire

    Saint-Grégoire, 35760

  • ICO - Centre René Gauducheau

    Saint-Herblain, 44805

  • Institut de Cancérologie de Strasbourg Europe - ICANS

    Strasbourg, 67200

  • CHU Strasbourg - Hôpital de Hautepierre

    Strasbourg

  • Oncopole Claudius Regaud - IUCT Oncopole

    Toulouse, 31059

  • CHU Bretonneau

    Tours

  • ICL - Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Italy14 sites

  • Centro di Riferimento Oncologico

    Aviano, 3308

  • IRCCS Istituto Oncologico Giovanni Paolo II

    Bari, 70124

  • Ospedale degli Infermi

    Biella, 13875

  • Spedali Civili-Università di Brescia

    Brescia, 25123

  • Ospedale Civile degli Infermi

    Faenza, 48018

  • Ospedale San Luca

    Lucca, 55100

  • Ospedale "Umberto I"

    Lugo, 48022

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • Istituto Europeo di Oncologia

    Milan, 20141

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

  • Ospedale "Santa Maria delle Croci"

    Ravenna, 48121

  • Policlinco Umberto I

    Roma, 00161

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00168

  • Azienda Sanitaria Universitaria Friuli Centrale

    Udine, 33100

Other trials in Italy

Spain9 sites

  • Hospital Germans Trias i Pujol / ICO Badalona

    Badalona, 08916

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital General Universitario de Elche

    Elche, Alicante, 30203

  • Hospital Universitario de León

    León, 24008

  • Hospital Universitario Son Espases

    Palma, 07120

  • Hospital Son Llátzer

    Palma de Mallorca, 07198

  • Hospital Clínico Universitario Santiago de Compostela

    Santiago de Compostela, 15706

  • Hospital Universitario y Politécnico La Fe

    Valencia, 46026

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

South Korea7 sites

  • National Cancer Center

    Gyeonggi-do, 10408

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Yonsei Medical Center Severance Hospital

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • Korea University Guro Hospital

    Seoul, 08308

Other trials in South Korea

United Kingdom6 sites

  • Queen Elizabeth Hospital

    Birmingham, B15 2GW GB

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ GB

  • Western General Hospital

    Edinburgh, EH42XU

  • University College London Hospital

    London, NW1 2PG GB

  • Northampton General Hospital NHS Trust

    Northampton, NN1 5BD GB

  • Royal Cornwall Hospital

    Truro, 3LJ GB

Other trials in United Kingdom

Japan4 sites

  • Kurume University Hospital

    Fukuoka, 830-0011

  • Fukushima Medical University Hospital

    Fukushima, 960-1295

  • The Cancer Institute Hospital Of JFCR

    Kōtoku, 135-8550

  • Saitama Medical University International Medical Center

    Saitama, 350-1298

Other trials in Japan

Australia2 sites

  • Canberra Hospital

    Garran, 2605

  • Calvary Mater Newcastle

    Waratah, 2298

Other trials in Australia

Singapore2 sites

  • National University Hospital (NUH)

    Singapore, 119074

  • National Cancer Centre Singapore (NCCS)

    Singapore, 169610

Other trials in Singapore

Canada1 site

  • Princess Margaret Cancer Centre

    Toronto, M5G2M9

Other trials in Canada

New Zealand1 site

  • Auckland City Hospital

    Auckland, 1023

Other trials in New Zealand

About this study

Official title: Randomized Phase III Trial in MMR Deficient Endometrial Cancer Patients Comparing Chemotherapy Alone Versus Dostarlimab in First Line Advanced/Metastatic Setting

Phase 3, randomized, multicentre study to evaluate the efficacy and safety of dostarlimab versus carboplatin-paclitaxel in patients with MMR deficient relapse or advanced endometrial cancer.

Read the detailed description

Phase III, randomized, open label, multi-centre study.

Randomization on a 1:1 ratio, stratification performed according to:

  • Prior adjuvant chemotherapy (yes or no)
  • Prior pelvic radiotherapy (yes or no)
  • Disease status: newly diagnosed advanced / metastatic disease versus relapse
Being tested
Carboplatin-Paclitaxel, Dostarlimab
Keywords
MMR, first line, metastatic, dostarlimab
Medical subject headings
Endometrial Neoplasms, Neoplasm Metastasis

What participants receive

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

  • Carboplatin-PaclitaxelDrug

    Chemotherapy will be administered by intravenous infusion. Carboplatin AUC 5-6 + Pacltaxel 175 mg/m² every 3 weeks. Total duration of treatment: 6 cycles

  • DostarlimabDrug

    Dostarlimab will be administered through a 30-minute infusion at a dose of 500 mg Q3W from Cycle 1 through Cycle 4 and at a dose of 1,000 mg Q6W thereafter, beginning at Cycle 5 Day 1 up to a maximum of 2 years.

Study groups in NCT05201547
Study groupRoleWhat they receive
Arm A: Dostarlimab 500 mg, every 3 weeks, 4 cycles and then 1000 mg every 6 weeksExperimentalNot described
Receives: Drug: Dostarlimab
Arm B: Carboplatin AUC 5 or 6 plus Paclitaxel 175 mg/m2, every 3 weeks, 6 cycles.ExperimentalNot described
Receives: Drug: Carboplatin-Paclitaxel

What is being measured

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

  1. Progression Free Survival (PFS)

    Defined as the time from the date of randomization until objective tumor progression based on RECIST 1.1, by BICR (Blinded Independent Central Review), or death due to any cause, whichever occurs first. Patients alive and free of progression will be censored at the last disease assessment date.

    Measured: from the date of randomization until objective tumor progression based on RECIST 1.1, or death due to any cause, whichever occurs first assessed up to 5 years.

Secondary outcomes (15)

  1. Overall Survival (OS) (key secondary endpoint)

    Measured as the time from the date of randomization to the date of death due to any cause. Patients alive at the cut-off date will be censored at the last date they are known to be alive.

    Measured: from the date of randomization until death due to any cause, assessed up to 5 years

  2. Progression Free Survival 2 (PFS2)

    Defined by the time from initial randomization to the second objective disease progression (ie, after the first subsequent therapy) as assessed by the investigator or death due to any cause, whoever occurs first. Patients alive and free of second progression (including patients without any progression), will be censored at the last disease assessment date.

    Measured: from the date of randomization until second objective tumor progression based on RECIST 1.1, or death due to any cause, whichever occurs first assessed up to 5 years

  3. Quality Of Life evaluation based on Quality of Life Questionnaire EQ5D5L (The 5-level EQ-5D version)

    The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems

    Measured: through study completion, an average of 5 years

  4. To assess the effects of Dostarlimab on Health related quality of Life (QoL) based on EORTC QLQ C30 (Quality of Life questionnaire-core 30) (with a focus of role functionning dimension)

    Health related quality of life of the patient. For all scales a high score is equivalent to worse or more problems. Range is the difference between the maximum and minimum possible value of the raw score. All items are scored from1 to 4, giving a range=3. For each scale, calculate the raw score by the addition of item responses divided by the number of items. Then a linear transformation is used to standardise the raw score, so that scores range from 0 to 100. Score= (raw score-1)/rangex100

    Measured: Defined as the Global Health Status score from the EORTC QLQ C30 at 18 weeks, assessed up to 5 years

  5. To assess the quantity of peripheral neuropathy event induced by chemotherapy based on EORTC QLQ-CIPN 20 (Quality of Life questionnaire-Chemotherapy induced peripheral neuropathy 20)

    Chemotherapy induced peripheral neuropathy assessed by QLQ-CIPN20 at 18 weeks for each problems or symptoms there are a scales with a high score which is equivalent to worse or more. All items are scored from1 to 4, giving a range=3. 1 = Not at all and 4 = Very much. For each scale, calculate the raw score by the addition of item responses divided by the number of items.

    Measured: Defined as the Global Health Status score from the EORTC QLQ-CIP20 at 18 weeks, assessed up to 5 years

  6. To assess the effects of treatment on health-related quality of life (HRQoL) as measure by determining time to deterioration in Quality of life, based EORTC QLQ-EN24 (Quality of Life Questionnaire - Endometrial Cancer Module)

    To assess disease and treatment specific aspects of the quality of life of patients with endometrial cancer. A high score for the functional scales represents a high level of functioning, while a high score for the symptom scales represents a high level of symptoms or problems. Symptoms related to sexual/vaginal problems (EMSXV including item 51-53) are optional.

    Measured: Defined as the Global Health Status score from the EORTC QLQ-EN24 at 18 weeks, assessed up to 5 years

  7. To assess the status of health for patients with endometrial cancer based on EUROQOL EQ-5D (Descriptive system)

    Deterioration and impact on patients' life of endometrial cancer assessed by the questionnaire EUROQOL EQ-5D

    Measured: Defined as the Global Health Status score from the EUROQOL EQ-5D at 18 weeks, assessed up to 5 years

  8. Best Objective Response Rate (ORR)

    Defined as the proportion of patients with unconfirmed complete or partial response as per RECIST 1.1 according to the investigators assessement

    Measured: from the date of randomization until best objective response based on RECIST 1.1, assessed up to 5 years

  9. Disease Control Rate (DCR)

    Defined as the proportion of participants who have achieved unconfirmed CR or PR or have demonstrated SD for at least 24 weeks; per RECIST 1.1 according to the investigators assessment as in patients with evaluable according to the investigators assessment as in patients with evaluable disease at entry

    Measured: from the date of randomization until response or stable disease per RECIST 1.1, assessed up to 5 years

  10. Duration of Response Rate (DoR)

    Measured from the time of initial response until documented tumor progression as per investigators assessment.

    Measured: from the time of initial response until documented tumor progression ,assessed up to 5 years

  11. Safety and number of adverse events

    Measured from the time of initial response until documented tumor progression.

    Measured: From date of randomization until end of study, assessed up to 6 years

  12. Tolerability to the treatment

    Assessed by CTCAE v5.0 (by investigators) Assessed by NCI PRO-CTCAE (by patients)

    Measured: From date of randomization until end of study, assessed up to 6 years

  13. Time to first and second Subsequent Treatment

    Defined as the time from the date of randomization to date of respectively the first and second subsequent anticancer therapy or death.

    Measured: from the date of randomization to date of event, assessed up to an average of 5 years

  14. To determine the immunogenicity of dostarlimab

    Incidence of ADA against dostarlimab

    Measured: from randomisation to 12 weeks after end of treatment, assessed at study end

  15. PRO-CTCAE Average composite score

    Change from baseline in the PRO-CTCAE Average Composite Score and interference score derived from 16 items measuring usual/daily activities

    Measured: up to 12 weeks and up to 24 weeks

Timeline

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

  1. First posted21 Jan 2022
  2. Study start15 Apr 2022
  3. Primary completion1 Oct 2026
  4. Study completionOct 2029 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05201547
Sponsor's protocol ID
GINECO-EN105b
Acronym
DOMENICA
Status last verified
Nov 2026
First submitted
22 Nov 2021
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Secord AA, Powell MA, McAlpine J. Molecular Characterization and Clinical Implications of Endometrial Cancer. Obstet Gynecol. 2025 Nov 1;146(5):660-671. doi: 10.1097/AOG.0000000000006080. Epub 2025 Sep 18.

    PubMed 40966692

  • Cherifi F, Ray-Coquard I, Rubio MJ, Paoletti X, Lorusso D, Choi CH, Hasegawa K, Tan DSP, Hudson E, Davis A, Tognon G, Lheureux S, Vardar Key MA, Kurtz JE, Alexandre J, Joly F. DOMENICA: dostarlimab versus chemotherapy alone in first-line MMR-deficient advanced endometrial cancer patients. Future Oncol. 2025 Jun;21(13):1613-1623. doi: 10.1080/14796694.2025.2496133. Epub 2025 May 5.

    PubMed 40323277

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Carboplatin-Paclitaxel and Dostarlimab in people with Endometrial Cancer, run by ARCAGY/ GINECO GROUP at 100 sites in 10 countries.

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 25 inclusion and 27 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: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 100 sites in France, Italy, Spain, South Korea, United Kingdom and 5 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

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?

Progression Free Survival (PFS) (time frame: from the date of randomization until objective tumor progression based on RECIST 1.1, or death due to any cause, whichever occurs first assessed up to 5 years.). 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 NCT05201547, which also lists 2 linked publications.

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 6 Nov 2026.

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