Dostarlimab for Locally Advanced or Metastatic Cancer (Non-colorectal/Non-endometrial) With Tumor dMMR/MSI
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.
Timeline
- Start
- 2024-07-23
- Primary completion
- 2028-10
- Completion
- 2030-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Carboplatin | Small molecule | — | — |
| Comparator | Cisplatin | Other / unclassified | — | — |
| Subject | Dostarlimab | Monoclonal antibody | 1000 mg | Intravenous |
| Comparator | Doxorubicin | Other / unclassified | — | — |
| Comparator | Etoposide | Small molecule | — | — |
| Comparator | Gemcitabine | Small molecule | — | — |
| Comparator | Ifosfamide | Small molecule | — | — |
| Comparator | Mitotane | Small molecule | — | — |
| Comparator | Paclitaxel | Small molecule | — | — |
| Comparator | Trabectedin | Small molecule | — | — |