RecruitingPhase 2NCT06333314

Dostarlimab for Locally Advanced or Metastatic Cancer (Non-colorectal/Non-endometrial) With Tumor dMMR/MSI

Dostarlimab as First-line Treatment for Patients With dMMR/MSI (Non-colorectal/Non-endometrial) Locally Advanced or Metastatic Cancer: a Randomized Phase 2 Trial (Cohort Pan-MSI ACSE) With Crossover in the Standard Arm at Progression


Sponsor

UNICANCER

Enrollment

120 participants

Start Date

Jul 23, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing dostarlimab — an immunotherapy drug that helps the immune system recognize and attack cancer — as a first-line treatment for people with certain rare, advanced cancers that have a specific genetic feature called dMMR/MSI-H (meaning the cancer cells have a defect in their DNA repair system). This type of cancer tends to respond well to immunotherapy. The study includes several rare cancer types not usually covered in other dostarlimab trials. **You may be eligible if:** - You are 18 or older - You have a confirmed advanced or metastatic cancer with dMMR/MSI-H (deficient mismatch repair / microsatellite instability-high) that is NOT colorectal or endometrial cancer - Eligible cancer types include: small bowel adenocarcinoma, gastric/esophagogastric junction cancer (with low immune marker), pancreatic cancer, ampullary cancer, adrenocortical carcinoma, cancer of unknown primary, high-grade neuroendocrine carcinoma, or soft tissue sarcoma (not GIST) - You have not yet received systemic treatment for your advanced cancer - Tumor tissue is available for testing to confirm the dMMR/MSI-H status **You may NOT be eligible if:** - Your cancer is colorectal or endometrial cancer - You have already received chemotherapy or immunotherapy for your advanced disease - You do not have dMMR/MSI-H confirmed on testing - Adequate tumor tissue is not available Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDostarlimab

Anti-PD-1 monoclonal antibody

DRUGChemotherapy

* mFOLFOX6 or FOLFIRI or XELOX regimen * FOLFOX or XELOX or TFOX regimen * FOLFIRINOX or gemcitabine-nab-paclitaxel or gemcitabine monotherapy. * Cisplatin and gemcitabine cisplatin or CAPOX or mFOLFOX6. * Etoposide-cisplatin-doxorubicin or mitotane * Cisplatin and gemcitabine or carboplatin and paclitaxel * Etoposide-cisplatin or etoposide-carboplatin * Doxorubicin and ifosfamide or doxorubicin monotherapy or doxorubicin and trabectedin.


Locations(22)

Institut de Cancérologie de l'Ouest

Angers, France

Institut du Cancer Avignon-Provence

Avignon, France

CHU Jean Minjoz

Besançon, France

CHU Morvan

Brest, France

Centre François Baclesse

Caen, France

Centre Jean Perrin

Clermont-Ferrand, France

CHU - Henri Mondor

Créteil, France

Centre Georges François Leclerc

Dijon, France

Centre Léon Bérard

Lyon, France

Hôpital la Timone

Marseille, France

Institut Paoli Calmettes

Marseille, France

Institut de Cancérologie de Lorraine

Nancy, France

Institut Mutualiste Montsouris

Paris, France

CHU de Bordeaux - Hôpital Haut -Lèvêque

Pessac, France

CHU de Poitiers

Poitiers, France

Institut Jean Godinot

Reims, France

Centre Eugène Marquis

Rennes, France

CHU de Rouen

Rouen, France

Institut de Cancérologie de l'Ouest

Saint-Herblain, France

CHU de Toulouse Hôpital Rangueil

Toulouse, France

Gustave Roussy Grand Paris

Villejuif, France

Hôpital Saint-Antoine

Paris, Île-de-France Region, France

View Full Details on ClinicalTrials.gov

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NCT06333314


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