Therapy Detail
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| Therapy Name | Carboplatin + Dostarlimab-gxly + Paclitaxel |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Carboplatin | Paraplatin | CBDCA | Chemotherapy - Platinum 7 | Paraplatin (carboplatin) is a second-generation platinum compound and is activated intracellularly to form reactive platinum complexes that cross link DNA with DNA and with proteins. This induces apoptosis and inhibits cell growth (NCI Drug Dictionary). |
| Dostarlimab-gxly | Jemperli | TSR-042 | Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 121 | Jemperli (dostarlimab-gxly) is a monoclonal antibody that targets PD-1 (PDCD1) and inhibits binding of the PD-L1 (CD274) ligand, potentially resulting in enhanced anti-tumor immune response (PMID: 34313545). Jemperli (dostarlimab-gxly) is FDA approved for use in patients with recurrent or advanced endometrial cancer or solid tumors harboring mismatch repair deficient (dMMR), as determined by an FDA-approved test, who have progressed on prior treatments, and in combination with Paraplatin (carboplatin) and Taxol (paclitaxel), followed by Jemperli (dostarlimab-gxly) monotherapy, in patients with primary advanced or recurrent endometrial cancer (FDA.gov). |
| Paclitaxel | Taxol | 7-Epipaclitaxel | Antimicrotubule Agent 14 BCL2 Family Inhibitor 6 | Taxol (paclitaxel) binds to tubulin to inhibit microtubule disassembly, which results in decreased cell division, and also binds to the anti-apoptotic factor Bcl-2, promoting apoptosis (NCI Drug Dictionary). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| MSH6 negative | endometrial cancer | sensitive | Carboplatin + Dostarlimab-gxly + Paclitaxel | Phase III | Actionable | In a Phase III trial (RUBY), Jemperli (dostarlimab-gxly) plus carboplatin and paclitaxel followed by Jemperli (dostarlimab-gxly) improved 24-month progression-free survival (61.4% vs 15.7%, HR 0.28, p<0.001) compared to placebo in patients with advanced or recurrent mismatch repair-deficient (dMMR, as indicated by a loss of MLH1, PMS2, MSH2, or MSH6 expression in an FDA-approved IHC test) or microsatellite instability-high (MSI-H) endometrial cancer (PMID: 36972026; NCT03981796). | 36972026 |
| MLH1 negative | endometrial cancer | sensitive | Carboplatin + Dostarlimab-gxly + Paclitaxel | Phase III | Actionable | In a Phase III trial (RUBY), Jemperli (dostarlimab-gxly) plus carboplatin and paclitaxel followed by Jemperli (dostarlimab-gxly) improved 24-month progression-free survival (61.4% vs 15.7%, HR 0.28, p<0.001) compared to placebo in patients with advanced or recurrent mismatch repair-deficient (dMMR, as indicated by a loss of MLH1, PMS2, MSH2, or MSH6 expression in an FDA-approved IHC test) or microsatellite instability-high (MSI-H) endometrial cancer (PMID: 36972026; NCT03981796). | 36972026 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03981796 | Phase III | Carboplatin + Paclitaxel Carboplatin + Dostarlimab-gxly + Paclitaxel | A Study of Dostarlimab (TSR-042) Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Patients With Recurrent or Primary Advanced Endometrial Cancer (RUBY) | Active, not recruiting | USA | TUR | SWE | POL | NOR | NLD | ITA | ISR | HUN | GRC | GBR | FIN | ESP | DNK | DEU | CZE | CAN | BEL | 2 |
| NCT05819892 | Phase I | Cisplatin + Dostarlimab-gxly + Paclitaxel Carboplatin + Dostarlimab-gxly + Paclitaxel | Phase I Trial Testing the Safety and Tolerability of Chemoradiation Followed by Chemotherapy + Dostarlimab for Stage IIIC, Node Positive, Endometrial Cancer | Recruiting | USA | 0 |
| NCT03307785 | Phase I | Carboplatin + Dostarlimab-gxly + Paclitaxel Dostarlimab-gxly + Niraparib | Study of Niraparib or Carboplatin-Paclitaxel in Combination With TSR-042 | Active, not recruiting | USA | 0 |
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