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Therapy Name | Carboplatin + Durvalumab + Paclitaxel |
Synonyms | |
Therapy Description | |
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). |
Durvalumab | Imfinzi | MEDI4736 | Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 121 | Imfinzi (durvalumab) is a monoclonal antibody that binds to and inhibits PD-L1 (CD274), potentially resulting in increased immune response to tumors (PMID: 25943534, PMID: 28214651). Imfinzi (durvalumab) is FDA-approved for use in patients with urothelial carcinoma and unresectable, stage III non-small cell lung cancer, in combination with Imjudo (tremelimumab) and platinum-based chemotherapy in patients with metastatic non-small cell lung cancer (NSCLC) without sensitizing EGFR or ALK mutations, in combination with platinum-based chemotherapy as neoadjuvant therapy followed by surgery and adjuvant Imfinzi (durvalumab) in patients with resectable non-small cell lung cancer, in combination with etoposide and carboplatin or cisplatin in patients with extensive stage small cell lung cancer, in combination with cisplatin and gemcitabine in patients with locally advanced or metastatic biliary tract cancer, in combination with Imjudo (tremelimumab) in adult patients with unresectable hepatocellular carcinoma, and in combination with carboplatin plus paclitaxel followed by single-agent Imfinzi (durvalumab) in adult patients with mismatch repair deficient 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). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
MLH1 negative | endometrial cancer | sensitive | Carboplatin + Durvalumab + Paclitaxel | FDA approved | Actionable | In a Phase III trial (DUO-E) that supported FDA approval, Imfinzi (durvalumab) plus carboplatin and paclitaxel followed by Imfinzi (durvalumab) maintenance improved progression-free survival (PFS) compared to platinum therapy + placebo and placebo maintenance (HR 0.71, p<0.003) in patients with advanced endometrial cancer, with significant PFS benefit (not reached vs 7.0 mo, HR 0.42) observed in the dMMR (as determined by the loss of MLH1, PMS2, MSH2, and MSH6 by IHC) group (PMID: 37864337; NCT04269200). | detail... 37864337 |
MSH6 negative | endometrial cancer | sensitive | Carboplatin + Durvalumab + Paclitaxel | FDA approved | Actionable | In a Phase III trial (DUO-E) that supported FDA approval, Imfinzi (durvalumab) plus carboplatin and paclitaxel followed by Imfinzi (durvalumab) maintenance improved progression-free survival (PFS) compared to platinum therapy + placebo and placebo maintenance (HR 0.71, p<0.003) in patients with advanced endometrial cancer, with significant PFS benefit (not reached vs 7.0 mo, HR 0.42) observed in the dMMR (as determined by the loss of MLH1, PMS2, MSH2, and MSH6 by IHC) group (PMID: 37864337; NCT04269200). | detail... 37864337 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT04269200 | Phase III | Durvalumab Durvalumab + Olaparib Carboplatin + Durvalumab + Paclitaxel Carboplatin + Durvalumab + Olaparib + Paclitaxel Carboplatin + Paclitaxel | Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer (DUO-E) | Active, not recruiting | USA | POL | LTU | ISR | HUN | GRC | EST | ESP | DEU | CAN | BRA | BEL | AUS | 9 |
NCT04585490 | Phase III | Carboplatin + Durvalumab + Pemetrexed Disodium Durvalumab Carboplatin + Durvalumab + Paclitaxel | Personalized Escalation of Consolidation Treatment Following Chemoradiotherapy and Immunotherapy in Stage III NSCLC in Stage III NSCLC | Recruiting | USA | 0 |
NCT04892953 | Phase II | Carboplatin + Durvalumab + Paclitaxel Carboplatin + Durvalumab + Nab-paclitaxel Carboplatin + Durvalumab + Gemcitabine Durvalumab | Local Consolidative Therapy and Durvalumab for Oligoprogressive and Polyprogressive Stage III NSCLC After Chemoradiation and Anti-PD-L1 Therapy | Recruiting | USA | 0 |
NCT03872505 | Phase II | Carboplatin + Durvalumab + Paclitaxel | Pre-operAtive Non-Anthracycline Chemotherapy, Durvalumab +/- RAdiation Therapy in Triple Negative Breast Cancer (PANDoRA) | Withdrawn | USA | 0 |
NCT05298423 | Phase III | Cisplatin + MK-7684A + Pemetrexed Disodium Cisplatin + Durvalumab + Paclitaxel Carboplatin + MK-7684A + Paclitaxel Cisplatin + Etoposide + MK-7684A Carboplatin + Durvalumab + Paclitaxel Cisplatin + Durvalumab + Etoposide | Study of Pembrolizumab/Vibostolimab (MK-7684A) in Combination With Concurrent Chemoradiotherapy Followed by Pembrolizumab/Vibostolimab Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Stage III Non-small Cell Lung Cancer (MK-7684A-006/KEYVIBE-006) | Recruiting | USA | TUR | ROU | ITA | ISR | GRC | ESP | DEU | CZE | BRA | AUS | 13 |
NCT03800134 | Phase III | Cisplatin + Durvalumab + Gemcitabine Carboplatin + Paclitaxel Cisplatin + Pemetrexed Disodium Carboplatin + Pemetrexed Disodium Carboplatin + Durvalumab + Pemetrexed Disodium Carboplatin + Durvalumab + Paclitaxel Cisplatin + Durvalumab + Pemetrexed Disodium Cisplatin + Gemcitabine | A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer | Active, not recruiting | USA | ROU | POL | NLD | ITA | HUN | FRA | ESP | DEU | CAN | BRA | BGR | BEL | AUT | ARG | 13 |
NCT02726997 | Phase Ib/II | Carboplatin + Durvalumab + Paclitaxel | Matched Paired Pharmacodynamics and Feasibility Study of Durvalumab in Combination With Chemotherapy in Frontline Ovarian Cancer | Active, not recruiting | USA | 0 |
NCT05856695 | Phase II | Carboplatin + Durvalumab + Paclitaxel | A Phase II Study Assessing the Efficacy of Etoposide Free Chemotherapy Plus Durvalumab (MEDI4736) in First Line Extensive Disease Small Cell Lung Cancer (SCLC) (TAXIO) | Recruiting | FRA | 0 |
NCT05624996 | Phase III | Cisplatin + Durvalumab + Etoposide Carboplatin + Durvalumab + Pemetrexed Disodium Cisplatin + Durvalumab + Pemetrexed Disodium Carboplatin + Durvalumab + Paclitaxel | Testing the Addition of High Dose, Targeted Radiation to the Usual Treatment for Locally-Advanced Inoperable Non-small Cell Lung Cancer | Recruiting | USA | 0 |
NCT03965468 | Phase II | Carboplatin + Durvalumab + Paclitaxel | Immunotherapy, Chemotherapy, Radiotherapy and Surgery for Synchronous Oligo-metastatic NSCLC (CHESS) | Recruiting | NLD | ITA | ESP | CHE | 0 |
NCT04262869 | Phase II | Durvalumab + Pemetrexed Disodium Carboplatin + Durvalumab + Pemetrexed Disodium Carboplatin + Durvalumab + Paclitaxel Durvalumab | Platinum-Based Chemotherapy and Durvalumab for the Treatment of Stage IIIB or IV Non-small Cell Lung Cancer | Withdrawn | 0 | |
NCT03509012 | Phase I | Carboplatin + Cisplatin + Durvalumab + Etoposide + Tremelimumab Carboplatin + Cisplatin + Durvalumab + Pemetrexed Disodium Cisplatin + Durvalumab + Etoposide Cisplatin + Durvalumab Carboplatin + Durvalumab + Paclitaxel Carboplatin + Cisplatin + Durvalumab + Etoposide | Immunotherapy in Combination With Chemoradiation in Patients With Advanced Solid Tumors (CLOVER) | Active, not recruiting | USA | ESP | 3 |
NCT04092283 | Phase III | Carboplatin + Paclitaxel Cisplatin + Etoposide Cisplatin + Durvalumab + Etoposide Carboplatin + Durvalumab + Paclitaxel Durvalumab Cisplatin + Durvalumab + Pemetrexed Disodium Cisplatin + Pemetrexed Disodium | Testing the Addition of an Antibody to Standard Chemoradiation Followed by the Antibody for One Year to Standard Chemoradiation Followed by One Year of the Antibody in Patients With Unresectable Stage III Non-Small Cell Lung Cancer | Active, not recruiting | USA | 1 |
NCT02962063 | Phase Ib/II | Carboplatin + Durvalumab + Paclitaxel | Durvalumab, an Anti-PD-L1 Antibody, and Chemoradiation Before Surgery for Esophageal Cancer | Recruiting | USA | 0 |
NCT03616886 | Phase Ib/II | Carboplatin + Durvalumab + Oleclumab + Paclitaxel Carboplatin + Durvalumab + Paclitaxel | Paclitaxel + Carboplatin + Durvalumab With or Without Oleclumab for Previously Untreated Locally Recurrent Inoperable or Metastatic TNBC (SYNERGY) | Active, not recruiting | FRA | BEL | 0 |
NCT03174275 | Phase II | Carboplatin + Cisplatin + Durvalumab + Paclitaxel Carboplatin + Durvalumab + Paclitaxel | Carboplatin, Nab-Paclitaxel, Durvalumab Before Surgery and Adjuvant Therapy in Head and Neck Squamous Cell Carcinoma | Active, not recruiting | USA | 0 |
NCT03723967 | Phase II | Carboplatin + Durvalumab + Paclitaxel | FRAIL-IMMUNE (GORTEC 2018-03) - Combination of Durvalumab With Carboplatin/Paclitaxel (FRAIL-IMMUNE) | Completed | FRA | 0 |