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| Therapy Name | Paclitaxel + Pembrolizumab |
| Synonyms | |
| Therapy Description | |
| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| 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). |
| Pembrolizumab | Keytruda | MK-3475 | Immune Checkpoint Inhibitor 150 PD-L1/PD-1 antibody 136 | Keytruda (pembrolizumab) is an antibody against PD-1 that activates T-cell mediated anti-tumor immune response (PMID: 25977344). Keytruda (pembrolizumab) is approved in melanoma, SCLC, HNSCC, classical Hodgkin Lymphoma, PMBL, urothelial carcinoma, HCC, Merkel cell carcinoma, NMIBC, cutaneous SCC, MSI-H or dMMR or TMB high advanced solid tumors, NSCLC and CD274 (PD-L1)-positive NSCLC, esophageal SCC, cervical cancer, HNSCC, and TNBC, in combination with platnum-based chemo in NSCLC, with pemetrexed and platinum in pleural mesothelioma and non-sNSCLC with no EGFR or ALK mutations, with carboplatin and paclitaxel/nab-paclitaxel in sNSCLC, with axitinib or lenvatinib in RCC, with lenvatinib in endometrial carcinoma that is not MSI-H or dMMR, with platinum and fluoropyrimidine-based chemo for esophageal or gastroesophageal carcinoma, with Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemo for CD274 (PD-L1)-positive, HER2-positive gastric or GEJ adenocarcinoma, with fluoropyrimidine- and platinum-containing chemo for HER2-negative gastric or GEJ adenocarcinoma, with platinum-based chemotherapy, with or without bevacizumab, for patients with CD274 (PD-L1)-positive cervical cancer, with gemcitabine and cisplatin for biliary tract cancer, with chemoradiation for cervical cancer, with carboplatin and paclitaxel for endometrial carcinoma, with paclitaxel with or without bevacizumab for epithelial ovarian, Fallopian tube, and peritonium cancer (FDA.gov). |
| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| CD274 positive | ovary epithelial cancer | sensitive | Paclitaxel + Pembrolizumab | FDA approved - On Companion Diagnostic | Actionable | In a Phase III trial (ENGOT-ov65/KEYNOTE-B96) that supported FDA approval, Keytruda (pembrolizumab) plus Taxol (paclitaxel), with or without Avastin (bevacizumab), significantly improved progression-free survival (8.3 vs 7.2 mo, HR 0.72, p=0.0014) and overall survival (18.2 vs 14.0 mo, HR 0.76, p=0.0053) in patients with CD274 (PD-L1)-positive (CPS>/=1) platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (Annals of Oncology, Volume 36, S1582; NCT05116189). | detail... detail... |
| CD274 positive | triple-receptor negative breast cancer | sensitive | Paclitaxel + Pembrolizumab | Guideline | Actionable | Combination of Keytruda (pembrolizumab) and Taxol (paclitaxel) is included in guidelines as preferred first-line therapy for patients with recurrent unresectable or stage IV (M1) CD274 (PD-L1)-positive (CPS >/= 10) triple-receptor negative breast cancer (category 1) (NCCN.org). | detail... |
| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03018080 | Phase II | Paclitaxel + Pembrolizumab | Pilot Study of Paclitaxel Plus Pembrolizumab in Metastatic HER2-Negative Breast Cancer (PePPy) | Completed | USA | 0 |
| NCT05342636 | Phase Ib/II | Irinotecan + Pembrolizumab Irinotecan + MK-4830 + Pembrolizumab MK-4830 + Paclitaxel + Pembrolizumab Lenvatinib + MK-4830 + Pembrolizumab Irinotecan + MK-4280A MK-4280A + Paclitaxel Paclitaxel + Pembrolizumab | A Study of Combination Therapies With Pembrolizumab (MK-3475) in Participants With Advanced Esophageal Cancer (MK-3475-06A) | Completed | TUR | NOR | ITA | FRA | DEU | CHE | BRA | 6 |
| NCT02734290 | Phase Ib/II | Capecitabine + Pembrolizumab Paclitaxel + Pembrolizumab | Standard of Care Chemotherapy Plus Pembrolizumab for Breast Cancer | Active, not recruiting | USA | 0 |
| NCT03136055 | Phase II | Irinotecan + Pembrolizumab Paclitaxel + Pembrolizumab Pembrolizumab | Pembrolizumab-based Therapy in Previously Treated High Grade Neuroendocrine Carcinomas | Completed | USA | 0 |
| NCT05382286 | Phase III | Pembrolizumab + Sacituzumab govitecan-hziy Carboplatin + Gemcitabine + Pembrolizumab Paclitaxel + Pembrolizumab Nab-paclitaxel + Pembrolizumab | Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer (ASCENT-04) | Active, not recruiting | USA | TUR | POL | NLD | ITA | ISR | HUN | GBR | FRA | ESP | DEU | CZE | CHE | CAN | BRA | BEL | AUT | AUS | ARG | 9 |
| NCT07111520 | Phase Ib/II | YL202 BNT327 + YL202 Pembrolizumab + Pemetrexed Disodium BNT327 Pembrolizumab Paclitaxel + Pembrolizumab Carboplatin + Pembrolizumab | A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC) | Recruiting | USA | 1 |
| NCT06492759 | Phase II | Nab-paclitaxel + Pembrolizumab Paclitaxel + Pembrolizumab Carboplatin + Gemcitabine + Pembrolizumab | High Dose Radiation Therapy With Pembrolizumab and Chemotherapy for the Treatment of Patients With PD-L1 Positive Metastatic Triple Negative Breast Cancer | Not yet recruiting | USA | 0 |
| NCT04251169 | Phase II | Paclitaxel + Pembrolizumab | Pembrolizumab + Paclitaxel in Hormone Receptor-positive (HR+)/Human Epidermal Growth Factor Receptor 2-negative (HER2-) Non-luminal (by PAM50) Advanced Breast Cancer After Cyclin-dependent Kinase 4/6 (CDK4/6) Inhibitors Progression (TATEN) | Terminated | ESP | 0 |
| NCT05233696 | Phase II | Nab-paclitaxel + Pembrolizumab Paclitaxel + Pembrolizumab | Radiotherapy in Combo With Chemo and Immunotherapy in Patients With PD-L1 Positive Metastatic TNBC | Withdrawn | USA | 0 |
| NCT06078384 | Phase II | Paclitaxel + Pembrolizumab | Pembrolizumab and Chemotherapy Treatment or no Treatment Guided by the Level of TILs in Resected Early-stage TNBC (ETNA) | Recruiting | FRA | ESP | 0 |
| NCT04964960 | Phase II | Paclitaxel + Pembrolizumab Nab-paclitaxel + Pembrolizumab Pembrolizumab + Pemetrexed Disodium Carboplatin + Pembrolizumab | Pembro+Chemo in Brain Mets | Terminated | USA | 0 |
| NCT04895358 | Phase III | Nab-paclitaxel Nab-paclitaxel + Pembrolizumab Capecitabine + Pembrolizumab Paclitaxel + Pembrolizumab Capecitabine Pegylated liposomal doxorubicin Paclitaxel Pegylated liposomal doxorubicin + Pembrolizumab | Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49) | Active, not recruiting | USA | TUR | SWE | ROU | POL | NLD | ITA | ISR | IRL | HUN | GRC | GBR | FRA | ESP | DEU | CAN | BRA | AUT | AUS | ARG | 11 |