OncoMatch/Clinical Trials/NCT06333314
Dostarlimab for Locally Advanced or Metastatic Cancer (Non-colorectal/Non-endometrial) With Tumor dMMR/MSI
Is NCT06333314 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Dostarlimab and Chemotherapy for pancreatic adenocarcinoma.
Treatment: Dostarlimab · Chemotherapy — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Pancreatic Cancer
Tumor Agnostic
Neuroendocrine Tumor
Sarcoma
Gastric Cancer
Biomarker criteria
Required: MMR deficient mismatch repair
Histologically proven, dMMR/MSI-H solid tumors
Required: MSI high microsatellite instability
Histologically proven, dMMR/MSI-H solid tumors
Disease stage
Required: Stage III, IV
Documented locally advanced or metastatic disease with no previous systemic anti-cancer treatment in these settings and not suitable for complete surgical resection
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic anti-cancer therapy
Exception: adjuvant therapy for non-metastatic disease completed >6 months before diagnosis of metastatic or recurrent disease
no previous systemic anti-cancer treatment in these settings
Cannot have received: immunotherapy (anti-PD-1, anti-PD-L1, anti-CTLA-4)
Previous exposure to anti-PD-1 or PD-L1 or anti-CTL-4 antibodies or treatment with immunotherapy
Cannot have received: investigational drug
Previous exposure to any investigational drug within 4 weeks (6 weeks for monoclonal antibodies) before the first dose in the study
Cannot have received: systemic anti-cancer therapy or radiation therapy for the cancer for which the patient is being enrolled
Previous exposure to any systemic anti-cancer therapy or radiation therapy for the cancer for which the patient is being enrolled
Lab requirements
Blood counts
anc ≥1.5 x 10⁹/l; platelets ≥100 x 10⁹/l; haemoglobin ≥9 g/dl
Kidney function
serum creatinine level <120 µm, or clearance >50 ml/min (mdrd or cockcroft and gault)
Liver function
serum bilirubin ≤1.5 x uln, alt and ast ≤3.0 x uln, unless liver metastases are present, in which case they must be ≤ 5× uln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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