protocolSection identificationModule nctId: NCT06333314, orgStudyIdInfo id: UC-IMM-2302, briefTitle: Dostarlimab for Locally Advanced or Metastatic Cancer (Non-colorectal/Non-endometrial) With Tumor dMMR/MSI, acronym: Pan-MSI-ACSE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2028-10, completionDateStruct date: 2030-09, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: UNICANCER, class: OTHER, collaborators name: National Cancer Institute, France, collaborators name: GlaxoSmithKline, descriptionModule briefSummary: The goal of this open-label randomized, multicenter, comparative phase II trial is to evaluate the efficacy of the immunotherapy, dostarlimab, as first-line treatment for deficient mismatch repair (dMMR)/microsatellite instability (MSI) non-resectable metastatic or locally advanced non-colorectal and non-endometrial cancers compared to the standard of care chemotherapy.Adult patients (aged ≥18 years) with histologically confirmed dMMR/MSI duodenum and small bowel adenocarcinoma, gastric and oeso-gastric junction (OGJ) adenocarcinoma with combined positive score (CPS)\<5, pancreatic adenocarcinoma, ampulla of vater adenocarcinoma, adrenocortical carcinoma, carcinoma of unknown primary site, neuroendocrine carcinoma (Grade3) all primary, and soft tissue sarcoma (except Gastro-Intestinal Stromal Tumor) will be included in this study. They will be randomized and treated with either dostarlimab (experimental arm A), or chemotherapy (control arm B).Patients with documented disease progression following the first line chemotherapy (Arm B) may be eligible for crossover to be treated with dostarlimab, with the same schedule as arm A., conditionsModule conditions: Pancreatic Adenocarcinoma, conditions: Ampulla of Vater Carcinoma, conditions: Adrenocortical Carcinoma, conditions: Neuroendocrine Carcinoma, conditions: Soft Tissue Sarcoma, conditions: Small Bowel Adenocarcinoma, conditions: Duodenum Adenocarcinoma, conditions: Gastric Adenocarcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, multicenter, comparative phase II trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Dostarlimab, interventions name: Chemotherapy, outcomesModule primaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Objective Response Rate, secondaryOutcomes measure: Duration of response, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Progression-Free Survival 2, secondaryOutcomes measure: Objective response rate 2, secondaryOutcomes measure: Progression-Free Survival -crossover, secondaryOutcomes measure: Circulating tumor DNA level, secondaryOutcomes measure: Incidence of treatment-emergent adverse events, secondaryOutcomes measure: Quality of life questionnaire - Core 30 (QLQ-C30), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institut de Cancérologie de l'Ouest, city: Angers, country: France, contacts name: Victor SIMMET, MD, role: CONTACT, geoPoint lat: 47.46667, lon: -0.55, locations facility: Institut du Cancer Avignon-Provence, city: Avignon, country: France, contacts name: Clémence TOULLEC, MD, role: CONTACT, geoPoint lat: 43.94834, lon: 4.80892, locations facility: CHU Jean Minjoz, city: Besançon, country: France, contacts name: Angélique VIENOT, MD, role: CONTACT, geoPoint lat: 47.24878, lon: 6.01815, locations facility: CHU Morvan, city: Brest, country: France, contacts name: Pierre-Guillaume POUREAU, MD, role: CONTACT, geoPoint lat: 48.3903, lon: -4.48628, locations facility: Centre François Baclesse, city: Caen, country: France, contacts name: Elodie COQUAN, MD, role: CONTACT, geoPoint lat: 49.18585, lon: -0.35912, locations facility: Centre Jean Perrin, city: Clermont-Ferrand, country: France, contacts name: Florence OSAER-POLYCARPE, MD, role: CONTACT, geoPoint lat: 45.77966, lon: 3.08628, locations facility: CHU - Henri Mondor, city: Créteil, country: France, contacts name: Christophe TOURNIGAND, MD, role: CONTACT, geoPoint lat: 48.78333, lon: 2.46667, locations facility: Centre Georges François Leclerc, city: Dijon, country: France, contacts name: François GHIRINGHELLI, MD, role: CONTACT, geoPoint lat: 47.31667, lon: 5.01667, locations facility: Centre Léon Bérard, city: Lyon, country: France, contacts name: Clélia COUTZAC, MD, role: CONTACT, geoPoint lat: 45.74848, lon: 4.84669, locations facility: Hôpital la Timone, city: Marseille, country: France, contacts name: Laëtitia DAHAN, MD, role: CONTACT, geoPoint lat: 43.29551, lon: 5.38958, locations facility: Institut Paoli Calmettes, city: Marseille, country: France, contacts name: Christelle DE LA FOUCHARDIERE, MD, role: CONTACT, geoPoint lat: 43.29551, lon: 5.38958, locations facility: Institut de Cancérologie de Lorraine, city: Nancy, country: France, contacts name: Aurélien LAMBERT, MD, role: CONTACT, geoPoint lat: 48.68439, lon: 6.18496, locations facility: Institut Mutualiste Montsouris, city: Paris, country: France, contacts name: Raphaël COLLE, MD, role: CONTACT, geoPoint lat: 48.85341, lon: 2.3488, locations facility: CHU de Bordeaux - Hôpital Haut -Lèvêque, city: Pessac, country: France, contacts name: Denis SMITH, MD, role: CONTACT, geoPoint lat: 44.81011, lon: -0.64129, locations facility: CHU de Poitiers, city: Poitiers, country: France, contacts name: David TOUGERON, MD, role: CONTACT, geoPoint lat: 46.58333, lon: 0.33333, locations facility: Institut Jean Godinot, city: Reims, country: France, contacts name: Damien BOTSEN, MD, role: CONTACT, geoPoint lat: 49.25, lon: 4.03333, locations facility: Centre Eugène Marquis, city: Rennes, country: France, contacts name: Héloïse BOURIEN, MD, role: CONTACT, geoPoint lat: 48.11198, lon: -1.67429, locations facility: CHU de Rouen, city: Rouen, country: France, contacts name: Frédéric DI FIORE, MD, role: CONTACT, geoPoint lat: 49.44313, lon: 1.09932, locations facility: Institut de Cancérologie de l'Ouest, city: Saint-Herblain, country: France, contacts name: Sandrine HIRET, MD, role: CONTACT, geoPoint lat: 47.21765, lon: -1.64841, locations facility: CHU de Toulouse Hôpital Rangueil, city: Toulouse, country: France, contacts name: Rosine GUIMBAUD, MD, role: CONTACT, geoPoint lat: 43.60426, lon: 1.44367, locations facility: Gustave Roussy Grand Paris, city: Villejuif, country: France, contacts name: Cristina SMOLENSCHI, MD, role: CONTACT, geoPoint lat: 48.7939, lon: 2.35992, locations facility: Hôpital Saint-Antoine, city: Paris, state: Île-de-France, country: France, contacts name: Thierry ANDRE, MD, role: CONTACT, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False