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Adenocarcinoma - GEJPhase 2DEWINCT06059495

DEWI: Watch-and-Wait With Dostarlimab in Localized dMMR/MSI-H Gastric/GEJ Adenocarcinoma Phase II Study

A Phase 2 study testing Dostarlimab in people with Adenocarcinoma - GEJ and Gastric Adenocarcinoma, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 18 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This phase II study evaluates dostarlimab followed by a watch-and-wait strategy in patients with localized dMMR/MSI-H gastric or gastroesophageal junction (GEJ) adenocarcinoma. The study aims to determine whether surgery can be safely avoided in patients achieving a complete response, defined by negative endoscopy and… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Adenocarcinoma - GEJ, Gastric Adenocarcinoma
What is being tested?
Dostarlimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
89 participants
Where
18 sitesin 2 countries
Study dates
22 Jan 2024to 1 Sep 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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient is eligible to be included in the study only if all the following criteria apply:
  • Is capable of giving signed and dated informed consent,
  • Has an ECOG PS of 0-1,
  • Age ≥18 years old:
  • A patient over 70 years of age is eligible to participate in the main initial cohort if the patient respects all the criteria and has a score G8 of ≥14.
  • A patient over 70 years with a score G8 <14 should have a consultation with an onco-geriatrician to determine the best treatment or therapeutic strategy based on age and co-morbidity. After this consultation, the patient is eligible for main initial cohort if "fits for surgery" with no contraindications to repeated UGI endoscopy with biopsies (no change to the initial protocol) and can follow the study plan and procedures outlined in the study.
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  • If a patient is over 70-year-old, has a G8 score <14, and is unfit for surgery (as determined by onco-geriatric advice and multidisciplinary team [MDT] conclusion), the patient cannot be included in the phase II study (main initial cohort). This patient can be included in the unfit supplemental cohort, with the available Geriatric Core Dataset (G-CODE) test result being mandatory for inclusion (No switching between cohorts is allowed).
  • Has histologically proven non-metastatic gastric or OGJ adenocarcinoma cT2 to T4, Nx, M0 after computed tomography thorax-abdomen-pelvis (TAP-CT) and echo-endoscopy (EUS), performed within 6 weeks before inclusion, according to the 7th Edition of the International Union Against Cancer; NB1: Echo-endoscopy will be performed only if the tumor is not obstructive at UGI endoscopy ± a new UGI endoscopy with 10 biopsies, photos (if not done at the first UGI endoscopy done for diagnosis). If obstructive, the tumor will be classified as cT3 or cT4 (in the situation when the tumor was obstructive and prevented EUS, it was classified T3N+, if it did not invade the adjacent organs on CT scan, because obstructing tumors represented locally advanced disease in the vast majority of cases in previous studies). In this case a new UGI endoscopy must be done with 10 biopsies, photos (if not done at the first GGI endoscopy done for diagnosis).
  • NB2: Echo endoscopy is not mandatory/performed for patient included in additional unfit cohort. TNM stage will be determine by CT scanner.
  • Has no peritoneal carcinomatosis (optional coelioscopy; recommended in case of doubt/ suspicious on CT/ imaging),
  • Has not received prior therapy (chemotherapy, radiotherapy, or immunotherapy) for localized gastric or OGJ adenocarcinoma,
  • Tumor status confirmed to be dMMR/MSI-H as follows:
  • MMR protein expression status will be evaluated by immunohistochemistry (IHC) with four antibodies (anti-hMLH1, anti-hMSH2, anti-hMSH6, anti-hPMS2) according to the local procedures. dMMR will be defined as loss of MLSH1 and PMS2, loss of MSH2 and MSH6, or loss of only one protein with presence of MSI-H.
  • MSI analysis will be performed by polymerase chain reaction [PCR] using a pentaplex panel (BAT-25, BAT-26, NR-21, NR-24, and NR-27; PROMEGA). MSI-H is defined as instability in two or more of the five studied markers. For this study, samples with 2 unstable markers will also undergo MMR analysis by IHC. Agreement of Sponsor (GERCOR) on a dMMR/MSI status is mandatory to include the patient (the patient's file [an anonymized mail] must be sent to Sponsor). Approval/refusal email for inclusion of the patient will be sent by the Sponsor within 24 hours of receipt of the Investigator email. In case of discrepancy between IHC and PCR, the final decision about the dMMR/MSI status will be taken by GERCOR or coordinating investigator,
  • Has hematological status: absolute neutrophil count (ANC) ≥1.5 x 109/L; platelets ≥100 x 109/L; hemoglobin ≥9 g/dL,
  • Has adequate renal function: serum creatinine level ≤150 µM and clearance ≥30 ml/min (Modification of the Diet in Renal Disease [MDRD] or Cockcroft and Gault),
  • Has adequate liver function: ≤1.5 x upper limit of normal (ULN) of direct bilirubin ≤ ULN for participants with total bilirubin levels >1.5 x ULN (inclusion possible if known Gilbert syndrome), alkaline phosphatase <5 x ULN, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤2.5 x ULN,
  • Has international normalized ratio (INR), prothrombin time (PT), and activated partial thromboplastin time (aPTT) ≤1.5 x ULN, except for the patient on anticoagulant therapy who must have PT-INR-aPTT within therapeutic range is deemed appropriate by the Investigator,
  • Has radiological tumor assessment at screening performed within 6 weeks before inclusion according to RECIST version 1.1 by chest, abdomen, and pelvis CT, showing the absence of metastatic or non-surgical disease,
  • A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
  • Is a woman of non-childbearing potential as defined: i/ ≥ 45 years of age and has not had menses for >1 year, ii/ Amenorrheic for <2 years without a hysterectomy and oophorectomy and have a follicle stimulating hormone (FSH) value in the postmenopausal range upon pre-study (screening) evaluation, iii/ 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, magnetic resonance imaging (MRI), or CT scan. Tubal ligation must be confirmed with medical records of the actual procedure, otherwise the patient must fulfill the criteria in Inclusion criteria 15. Information must be captured appropriately within the site's source documents,
  • Has negative pregnancy blood test within 72 hours before the first dose of dostarlimab, AND
  • If woman of childbearing potential (WOCBP), female patient must be willing to use a highly effective form of contraception from screening throughout the study treatment and 4 months after the last dose of dostarlimab,
  • Male participants are eligible to participate if they agree to the following during the study treatment and for 4 months after the last dose of dostarlimab:
  • Refrain from donating sperm,
  • Must use contraception/barrier as follows:
  • Agree to use a male condom when having sexual intercourse with a WOCBP who is not currently pregnant.
  • Agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person,
  • Provides primary tumor tissue samples (processed as formalin-fixed, paraffin-embedded [FFPE] blocks or freshly frozen) acquired during UGI endoscopy together with images (mandatory), NB: The patient's agreement will be specifically requested for endoscopic images in the patient information note and informed consent for their use as clinical data that may be analyzed and presented in publications. These data will be used in the same manner as other personal data. The confidentiality of these data will be maintained,
  • Is willing and able to comply with scheduled visits, treatment schedule, laboratory tests, tumor biopsies, and other requirements of the study,
  • Is registered in the National Health Care System (PUMa - Protection Universelle Maladie included).

Who cannot join

  • The patient is ineligible for the study if any of the following criteria apply:
  • Has received prior concomitant unplanned antitumor therapy (e.g., chemotherapy, molecular targeted therapy, immunotherapy),
  • Has received treatment with any investigational medicinal product within 28 days prior to study entry,
  • Has a treatment anticoagulant or hemostasis disorder contraindicating - biopsies during endoscopy,
  • Has had major surgical procedure within 28 days (4 weeks) prior to the first dose of study treatment,
  • Has other serious and uncontrolled non-malignant disease (including active infection) or is considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant 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,
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  • Has other concomitant or previous malignancy other than the disease under study, except as noted below:
  • i/ adequately treated in-situ carcinoma of the uterine cervix, ii/ basal or squamous cell carcinoma of the skin, iii/ cancer from which the patients was in complete remission for ≥3 years,
  • Has metastases (M stage disease) whatever the location,
  • Is pregnant or breastfeeding,
  • Has human immunodeficiency virus (HIV),
  • Has a documented hepatitis B surface antigen (HBsAg) positive result wither at the pre-inclusion visit or within 3 months prior to the first dose of the study intervention, along with and known active hepatitis, including acute or chronic hepatitis B virus (HBV).
  • Exception: For patients who are HBsAg positive but do not have hepatitis (neither acute nor chronic HBV), antiviral treatment is recommended prior to treatment with dostarlimab:
  • if the HBV DNA level is ≥ 500 IU/mL or 2,500 copies/mL: antiviral treatment is recommended before starting dostarlimab and should be initiated within 3 weeks of starting immunotherapy or, at the latest, concomitantly. This treatment should continue for up to 12 months after the end of treatment with dostarlimab or any other immunosuppressive therapy.
  • if the HBV DNA level is < 500 IU/mL or 2,500 copies/mL: antiviral treatment is recommended before starting dostarlimab and should be initiated concurrently at the latest. This treatment should be continued for up to 12 months after the end of treatment with dostarlimab or any other immunosuppressive therapy.
  • Has hepatitis C virus (HCV) prior to inclusion, Note: Patients positive for HCV antibody are eligible only if PCR testing is negative for HCV RNA.
  • Patient under a legal protection regime (guardianship, curatorship, judicial safeguard) or administrative decision or incapable of giving his/her consent,
  • Impossibility of submitting to the medical follow-up of the study for geographical, social, or psychiatric illness.
  • Non-eligible to immunotherapy:
  • Has pyloric tumor, Note: tumors of the pylorus will be excluded because of the risk of high occlusion in case of pseudo progression and associated surgery,
  • Has any history of autoimmune disease including, but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis, Note: History of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible.
  • Note: Controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible.
  • Has a history of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest imaging,
  • Has received any live, attenuated vaccine within 14 days prior to the firs dose of study treatment or such administration is anticipated during the study,
  • Has received prior therapy with any immune-checkpoint inhibitors, including antibodies or drugs targeting CD137, CTLA-4, PD-1, or PD-L1 or other checkpoint pathways,
  • Has had prior allogeneic bone marrow transplantation or prior solid organ transplantation,
  • Has received treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to the first dose of adjuvant treatment or is required to receive systemic immunosuppressive medications during the study. Inhaled or topical steroids and adrenal replacement doses >10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Note: Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled into the study after approval of Medical Contact. Note: Subjects are permitted the use of topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Adrenal replacement steroid doses including doses >10 mg daily prednisone is permitted. A brief (less than 3 weeks) course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by a contact allergen) is permitted.

Trial locations and contacts

18 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Marie-Line GARCIA LARNICOL, MD contact

+33 (01) 40 20 85 00

gercor@gercor.com.fr

18 sites in 2 countries

France13 sites, 13 recruiting

  • Besancon University Hospital Center

    Besançon

    Christophe BORG, Prof

    Recruiting

  • Centre Hospitalier Universitaire De Bordeaux

    Bordeaux

    Denis SMITH, MD

    Recruiting

  • Centre Hospitalier Regional Et Universitaire De Brest

    Brest

    Jean-Philippe Jean-Philippe METGES, MD

    Recruiting

  • Henri Mondor Hospital

    Créteil

    Christophe TOURNIGAND, Prof, MD

    Recruiting

  • CHRU Lille

    Lille

    Guillaume PIESSEN, MD

    Guillaume PIESSEN, MD

    Recruiting

  • Centre Leon Berard

    Lyon

    Clélia COUTZAC, MD

    Recruiting

  • Institut Paoli Calmettes

    Marseille

    Christelle DE LA FOUCHARDIERE, Prof, MD

    Recruiting

  • Institut régional du Cancer de Montpellier - ICM Val d'Aurelle Oncologie Médicale

    Montpellier

    Antoine ADENIS, Prof, MD

    Recruiting

  • Institut Mutualiste Montsouris

    Paris

    Emilie SOULARUE, MD

    Recruiting

  • Saint Antoine Hospital

    Paris

    Thierry ANDRE, Prof, MD

    Thierry ANDRE, MD

    Recruiting

  • Centre Hospitalier Universitaire De Poitiers

    Poitiers

    David TOUGERON, Prof, MD

    Recruiting

  • Centre Hospitalier Universitaire Reims

    Reims

    Olivier BOUCHE, Prof, MD

    Recruiting

  • Centre Hospitalier De Saint Malo

    St-Malo

    Romain DESGRIPPES, MD

    Not yet recruiting

Other trials in France

Italy5 sites, 5 recruiting

  • Fondazione. IRCCS Istituto Nazionale dei Tumori di Milano

    Milan

    Alessandra RAIMONDI, MD

    Recruiting

  • Fondazione I.R.C.C.S. Istituto Oncologico Veneto

    Padova

    Sabina MURGIONI, MD

    Recruiting

  • Azienda USL della Romagna OSPEDALE DI RAVENNA

    Ravenna

    Stefano TAMBERI, MD

    Recruiting

  • Istituto Clinico Humanitas

    Rozzano

    Alberto PUCCINI, MD

    Recruiting

  • Azienda Sanitaria Universitaria friuli Centrale Presidio Ospedaliero Santa Maria della Misericordia di Udine

    Udine

    Silvo Ken GARATTINI, MD

    Recruiting

Other trials in Italy

About this study

Official title: Watch-and-wait Strategy to Initiate Dostarlimab-based Immunotherapy in Localized Deficient Mismatch Repair (dMMR) and/or Microsatellite Instability High (MSI-H) oEso-gastric Junction and Gastric Adenocarcinoma: An Open-label GERCOR Phase II Study

This phase II study evaluates dostarlimab followed by a watch-and-wait strategy in patients with localized dMMR/MSI-H gastric or gastroesophageal junction (GEJ) adenocarcinoma. The study aims to determine whether surgery can be safely avoided in patients achieving a complete response, defined by negative endoscopy and tumor-free biopsies after treatment.

Read the detailed description

Patients with localized, resectable gastric or gastroesophageal junction (GEJ) adenocarcinoma are currently treated with radical surgery, the only curative option, typically combined with perioperative chemotherapy. However, surgery is associated with substantial morbidity and a significant impact on quality of life. Given the high efficacy of immune checkpoint inhibitors in localized dMMR/MSI-H tumors, surgery omission may be a potential strategy for selected patients.

This national, multicenter, open-label phase II study will evaluate dostarlimab in patients with localized dMMR/MSI-H gastric or GEJ adenocarcinoma. The primary objective is to determine whether a watch-and-wait approach can safely replace surgery in patients achieving a complete response after treatment, defined by negative endoscopy and tumor-free biopsies.

Study aims Main cohort: To evaluate dostarlimab followed by a watch-and-wait approach in patients with localized dMMR/MSI-H gastric or GEJ adenocarcinoma.

Additional unfit cohort (patients unfit for surgery): To evaluate the efficacy of dostarlimab in patients aged >70 years with localized dMMR/MSI-H gastric or GEJ adenocarcinoma who are deemed unfit for surgical resection.

Sample size Main initial cohort study (phase II): A total of 89 patients will be included (59 patients in the original protocol conducted in France and Italy, and an additional 30 patients to be enrolled exclusively in France).

Additional unfit cohort: A total of 39 patients will be included (20 patients in the original protocol conducted in France and Italy, and an additional 19 patients to be enrolled exclusively in France).

Being tested
Dostarlimab
Keywords
dMMR, MSI-H, dostarlimab, watch-and-wait, surgery, immunotherapy

What participants receive

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

  • DostarlimabDrug

    Also called Jemperli

    Post-Inclusion: Dostarlimab 500mg IV q3wx4 cycles (Cs). Week 12 (W12)

    • cCR (both cohorts): Dostarlimab 1,000mg q6w×2 cycles.
    • Downstaging (Stage 2-3), no PD/mets: Dostarlimab 500mg q3w×4Cs.
    • Main cohort: SD/PD, Stage 1, positive(+), no cCR→Surgery. Post-surgery: Becker-TRG 1a/1b/2→Dostarlimab 1,000mg q6w×6Cs; Becker-TRG 3→Stop Trt.
    • Additional unfit cohort: SD/PD, Stage 1, biopsy(+) ± mets→Stop dostarlimab, withdraw from Trt, investigator-directed care, remain in FU.

    W24

    • cCR at W12\&W24: Dostarlimab 1,000mg q6w×4Cs.
    • cCR at W12 but not W24:
    • Main cohort: Stop dostarlimab; surgery/adjuvant Trt per investigator.
    • Additional unfit cohort: Stop dostarlimab; withdraw from Trt; FU only.
    • Downstaging at W12 + cCR at W24: Dostarlimab 1,000mg q6w×4Cs.
    • Downstaging at W12 but no cCR at W24:
    • Main cohort: Surgery; if Becker-TRG 1a/1b/2, dostarlimab 1,000mg q6w×4Cs.
    • Additional unfit cohort: Stop dostarlimab, withdraw from Trt, investigator-directed care, remain in FU.
Study groups in NCT06059495
Study groupRoleWhat they receive
Dostarlimab-based treatmentExperimentalAfter inclusion patients will receive dostarlimab at 500 mg q3w (± 2-3 days) for 4 cycles (C1-C4). Then, an adaptive treatment strategy will be determined based on clinical assessment of the patient.
Receives: Drug: Dostarlimab

What is being measured

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

  1. Clinical complete response (cCR)

    Main initial cohort: To evaluate clinical complete response (cCR) at 1 year defined as the rate of patients who at 1 year from the start of therapy with dostarlimab are alive, were not operated for tumor resection, are free of disease progression (locoregional or metastases), have all negative biopsies, and show endoscopy downstaging stage 3 or 4 (endoscopic grade).

    Additional unfit cohort: To evaluate cCR at 1 year defined as the rate of patients who at 1 year from the start of therapy with dostarlimab are alive, are free of disease progression (locoregional or metastases), have all negative biopsies, and show endoscopy downstaging stage 3 or 4 (endoscopic grade).

    Measured: At 1 year from the start of treatment with dostarlimab.

Secondary outcomes (14)

  1. Pathological complete response (pCR)

    Pathological complete response is defined as 100% fibrosis or fibro-inflammation or necrosis or granulomatous reaction within an entire gross lesion without microscopic evidence of carcinoma, and no positive lymph nodes, after examination of the complete macroscopic surgical specimen equivalent to a Becker TRG Grade 1a (complete regression).

    Measured: up to 5 years

  2. Loco/loco-regional and distant recurrence

    Loco/loco-regional recurrence is defined as cancer recurrence within the regional resection area or local anastomotic site.

    Distant recurrence is defined as peritoneal recurrence, liver metastasis or metastasis at other extra-abdominal sites as well as nodal metastasis beyond the regional nodes

    Measured: up to 5 years

  3. Event-free survival (EFS)

    Event-free survival is defined as time from first dose of treatment to surgery for tumoral resection, first progression of disease local or distant recurrence, or death due to any cause. Alive patients without event will be censored at the last follow-up.

    Measured: up to 5 years

  4. Time to treatment failure (TTF)

    Time to treatment failure is defined as the interval between initiating therapy (first dose of dostarlimab) and the earliest of clinical progression, depending on whether the patient had surgery for tumoral resection or not, or death.

    Measured in both cohorts.

    Measured: up to 5 years

  5. Disease-free survival (DFS)

    Disease-free survival is defined only for patient with surgery (partial or complete gastrectomy or oesogastrectomy) as the time between the date of surgery and the date either of recurrence or death from any cause.

    Measured: up to 5 years

  6. Overall survival (OS)

    Overall survival is defined as the time between the date of the first dose of study treatment and the death date.

    Measured in both cohorts.

    Measured: up to 5 years

  7. The number of patients who did not undergo surgery for tumor resection without distant metastases

    The number of patients who did not undergo surgery for tumor resection without distant metastases at 12 and 24 months,

    Measured: up to 5 years

  8. The number of patients who did not undergo surgery for tumor resection with distant metastases

    The number of patients who did not undergo surgery for tumor resection with distant metastases at 12 and 24 months,

    Measured: up to 5 years

  9. Progression-free survival (PFS) in additional cohort

    Progression-free survival is defined as time from first dose of treatment to first progression of disease local or distant recurrence, or death due to any cause. Alive patients without event will be censored at the last follow-up.

    Measured: up to 5 years

  10. Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) following dostarlimab treatment

    Patients will be assessed for AEs and SAEs throughout the study using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

    Measured in both cohorts.

    Measured: up to 5 years; from the date of dostarlimab initiation to the date of death

  11. Health-related quality of life (HRQoL) by the EORTC Core Quality of Life questionnaire (EORTC QLQ-C30)

    HRQoL assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The EORTC QLQ-C30 generates scores transformed to a 0 to 100 scale. For the Global Health Status/Quality of Life scale and functional scales, higher scores indicate better HRQoL and functioning. For symptom scales/items, higher scores indicate greater symptom burden and worse quality of life. Measured in both cohorts.

    Measured: up to 5 years

  12. Health-related quality of life (HRQoL) by the EORTC oesophago-gastric (EORTC QLQ-OG25) questionnaire

    HRQoL assessed using the European Organisation for Research and Treatment of Cancer Oesophago-Gastric Cancer Questionnaire (EORTC QLQ-OG25). The EORTC QLQ-OG25 consists of symptom scales and single-item measures that are transformed to scores ranging from 0 to 100. Higher scores indicate greater symptom burden, more problems, and worse health-related quality of life. Measured in both cohorts.

    Measured: up to 5 years

  13. Number of days spent in the hospital (DIH)

    Number of days spent in the hospital (DIH) measured in additional unfit cohort.

    Measured: up to 5 years

  14. Morbidity in case of surgery

    Morbidity in case of surgery (complication or death occurring within 90 postoperative days according to the Clavien Dindo's classification) measured in main cohort only.

    Measured: up to 5 years

Timeline

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

  1. First posted28 Sep 2023
  2. Study start22 Jan 2024
  3. Primary completion1 Sep 2028 (estimated)
  4. Study completion1 Sep 2028 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
After inclusion all patients will receive dostarlimab at 500 mg q3w (± 2-3 days) for 4 cycles (C1-C4). An adaptive treatment strategy will be determined based on clinical assessment of the patient at weeks 12 (±1 week) and week 24 (±1 week).
Masking
None (open label)
Enrolment
89 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06059495
Sponsor's protocol ID
DEWI G-123
Other IDs
2023-506102-39-00, 2023
Acronym
DEWI
Status last verified
Aug 2026
First submitted
20 Jul 2023
Last updated
26 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dostarlimab in people with Adenocarcinoma - GEJ and Gastric Adenocarcinoma, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 18 sites in 2 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 31 inclusion and 28 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: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in France, Italy. 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 Marie-Line GARCIA LARNICOL, MD (+33 (01) 40 20 85 00, gercor@gercor.com.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical complete response (cCR) (time frame: At 1 year from the start of treatment with dostarlimab.). 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 NCT06059495.

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 26 Aug 2026.

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