Table 2.
Pembrolizumab.
| NCT Number | Status | Co-Treatment/Intervention | Phase | Participants | Results/Conclusions | References |
|---|---|---|---|---|---|---|
| NCT04683679 | Recruiting | Olaparib, Radiation | II | 56 | Estimated Primary Completion Date: January 2025 | [110] |
| NCT04095689 | Recruiting | Docetaxel, IL-12 gene therapy, L-NMMA | II | 30 | Estimated Primary Completion Date: January 2024 | [111] |
| NCT04427293 | Recruiting | Lenvatinib, | I | 12 | Estimated Primary Completion Date: July 2026 | [112] |
| NCT04024800 | Active, not recruiting | AE37 Peptide vaccine | II | 29 | Estimated Primary Completion Date: 30 June 2023 | [113] |
| NCT02977468 | Recruiting | Intraoperative radiation therapy (IORT) | I | 15 | Estimated Primary Completion Date: 31 December 2022 | [114] |
| NCT03362060 | Active, not recruiting | PVX-410 | I | 20 | Estimated Primary Completion Date: 31 December 2022 | [115] |
| NCT04191135 | Active, not recruiting | Olaparib, Carboplatin, Gemcitabine | II, III | 1225 | Estimated Primary Completion Date: 26 January 2026 | [116] |
| NCT02768701 | Active, not recruiting | Cyclophosphamide | II | 40 | Estimated Primary Completion Date: 15 March 2023 | [117] |
| NCT02622074 | Completed | Nab-paclitaxel, Anthracycline (doxorubicin), Cyclophosphamide, Carboplatin, Palictaxel | I | 60 | Combination neoadjuvant chemotherapy and pembrolizumab for high-risk, early-stage TNBC showed manageable toxicity and promising antitumor activity. In an exploratory analysis, the pCR rate showed a positive correlation with tumor PD-L1 expression and sTIL levels | [118] |
| NCT03720431 | Active, not recruiting | TTAC-0001 | I | 11 | Estimated Study Completion Date: 26 February 2022 | [119] |
| NCT03121352 | Active, not recruiting | Nac-paclitaxel, Carboplatin | II | 30 | Estimated Primary Completion Date: 6 February 2022 | [120] |
| NCT03036488 | Active, not recruiting | Carboplatin. Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide, Granulocyte colony stimulating factor: Filgrastim or Pegfilgrastim, Placebo for pembrolizumab | III | 1174 | Estimated Primary Completion Date: 30 September 2025 | [121] |
| NCT03145961 | Active, not recruiting | Monotherapy | II | 208 | Estimated Study Completion Date: 1 December 2022 | [122] |
| NCT02819518 | Active, not recruiting | Nab-Paclitaxel, Paclitaxel, Gemcitabine, Carboplatin, Normale Saline Solution (placebo) | III | 882 | Pembrolizumab-chemotherapy showed a significant and clinically meaningful improvement in progression-free survival versus placebo-chemotherapy among patients with metastatic triple-negative breast cancer with CPS of 10 or more. These findings suggest a role for the addition of pembrolizumab to standard chemotherapy for the first-line treatment of metastatic triple-negative breast cancer. | [40] |
| NCT03567720 | Recruiting | Tavokinogene telseplasmid, Immunopulse (electroporation), Nab-paclitaxel | II | 65 | Estimated Primary Completion Date December 2023 | [123] |
| NCT02555657 | Completed | Capecitabine, Eribulin, Gemcitabine, Vinorelbine | III | 622 | Pembrolizumab did not significantly improve overall survival in patients with previously treated metastatic triple-negative breast cancer versus chemotherapy. | [124] |
| NCT03639948 | Recruiting | Carboplatin, Docetaxel, Pegfilgrastim | II | 100 | Estimated Primary Completion Date: November 2021 | [125] |
| NCT03184558 | Terminated | Bemcentinib | II | 29 | Disease Control Rate (DCR): 3.4% of participants Progression-free Survival (PFS): 13.1 weeks Overall Survival (OS): 32.0 weeks |
[126] |
| NCT04986852 | Not yet recruiting | Olinvacimab | II | 36 | Estimated Primary Completion Date: 28 February 2025 | [127] |
| NCT04468061 | Recruiting | Sacituzumab govitecan | II | 110 | Estimated Primary Completion Date: 1 June 2023 | [128] |
| NCT02734290 | Active, not recruiting | Paclitaxel, Capecitabine | I, II | 29 | Estimated Completion Date: May 2022 | [129] |
| NCT03752723 | Recruiting | GX-I7, Cyclophosphamide | I, II | 83 | Estimated Study Completion Date: December 2021 | [130] |
| NCT02981303 | Completed | Imprime PGG | II | 64 | No Study Results Posted | [131] |
| NCT03644589 | Withdrawn | Cisplatin | II | 0 | Withdrawn (No participants enrolled). | [132] |
| NCT02755272 | Recruiting | Carboplatin, Gemcitabine | II | 87 | Estimated Primary Completion Date: October 2022 | [133] |
| NCT04373031 | Recruiting | IRX 2 | II | 30 | Estimated Primary Completion Date: June 2024 | [134] |
| NCT02971761 | Active, not recruiting | Enobosarm, Laboratory Biomarker Analysis | II | 29 | Results Submitted—Quality Control (QC) Review Has Not Concluded | [135] |
| NCT02513472 | Completed | Eribulin mesylate | I, II | 258 | ORR 25.8% in participants with mTNBC who were never treated with systemic anticancer therapy in the metastatic setting, 21.8% in participants with mTNBC previously treated with 1 to 2 lines of systemic anticancer therapy in the metastatic setting, 23.4% in participants with mTNBC who were never treated with systemic anticancer therapy and previously treated with 1 to 2 lines of systemic anticancer therapy in the metastatic setting | [136] |
| NCT03310957 | Recruiting | Ladiratuzumab vedotin | I, II | 161 | Estimated Primary Completion Date: 28 February 2022 | [137] |
| NCT02447003 | Completed | Monotherapy | II | 254 | Safe, durable antitumor activity in a subset of patients with previously treated mTNBC. Safe, durable antitumor activity as first-line therapy for patients with PD-L1-positive mTNBC. |
[36,37,38] |
| NCT03599453 | Active, not recruiting | Chemokine Modulation Therapy, Celecoxib, Recombinant Interferon Alfa-2b, Rintatolimod | I | 8 | Estimated Study Completion Date: 6 July 2022 | [138] |
| NCT03106415 | Recruiting | Binimetynib, Laboratory Biomarker Analysis | I, II | 38 | Estimated Primary Completion Date: 15 November 2022 | [139] |
| NCT02730130 | Active, not recruiting | Radiotherapy | II | 17 | Complete Response in 3 participants (17.6%), and Duration of Response: 4.5 months, Time to Response 2.8 months | [140] |
| NCT04634747 | Not yet recruiting | PVX-410 chemotherapy | II | 53 | Estimated Primary Completion Date: 1 April 2023 | [141] |
| NCT03225547 | Active, not recruiting | Mifepristone | II | 74 | Estimated Primary Completion Date: September 2022 | [142] |
| NCT02657889 | Completed | Niraparib | I, II | 122 | Combination niraparib plus pembrolizumab provides promising antitumor activity in patients with advanced or metastatic TNBC, with numerically higher response rates in those with tumor BRCA mutations. The combination therapy was safe with a tolerable safety profile, warranting further investigation. | [143] |
| NCT03012230 | Recruiting | Ruxolitinib Phosphate, Laboratory Biomarker Analysis | I | 18 | Estimated Primary Completion Date: 1 March 2022 | [144] |
| NCT02411656 | Recruiting | Laboratory Biomarker Analysis | II | 35 | Estimated Primary Completion Date: 31 December 2023 | [145] |
| NCT01676753 | Active, not recruiting | Dinaciclib, | I | 32 | Estimated Study Completion Date: 31 December 2022 | [146] |
| NCT04301011 | Recruiting | TBio-6517 | I, II | 114 | Estimated Primary Completion Date: 20 August 2022 | [147] |
| NCT04348747 | Not yet recruiting | Anti-HER2/HER3 Dendritic Cell Vaccine, Celecoxib, Recombinant Interferon Alfa-2b, Rintatolimod | II | 23 | Estimated Primary Completion Date: 1 December 2023 | [148] |
| NCT04879849 | Recruiting | TAK-676, radiotherapy | I | 46 | Estimated Primary Completion Date: 18 January 2024 | [149] |
| NCT05082259 | Not yet recruiting | ASTX660 | I | 48 | Estimated Primary Completion Date: 16 March 2026 | [150] |
| NCT04230109 | Active, not recruiting | Sacituzumab Govitecan | II | 51 | Estimated Primary Completion Date: 30 October 2024 | [151] |
| NCT03197389 | Completed | Monotherapy | I | 54 | Among patients with TNBC, administration of single dose of pembrolizumab was not correlated with PD-1 expression in patients with or without neoadjuvant chemotherapy. | [152] |
| NCT04443348 | Recruiting | Radiation Therapy Boost, Paclitaxel, Carboplatin, Cyclophosphamide, Doxorubicin, Capecitabine | II | 120 | Estimated Primary Completion Date: 1 June 2023 | [153] |
| NCT05112536 | Recruiting | Pembrolizumab, Trilaciclib, Cylophosphamide, Doxorubicin, Paclitaxel, Carboplatin | II | 30 | Estimated Primary Completion Date: 20 August 2022 | [154] |
| NCT03775850 | Completed | EDP1503 | I, II | 69 | No Study Results Posted | [155] |
| NCT03289819 | Completed | Nab-paclitaxel Epirubicin Cyclophosphamide | II | 53 | No Study Results Posted | [156] |
| NCT04432857 | Recruiting | AN0025 | I | 84 | Estimated Primary Completion Date: December 2023 | [157] |
| NCT03396445 | Recruiting | MK-5890, Pemetrexed, Carboplatin, Nab-paclitaxel | I | 202 | Estimated Primary Completion Date: 25 October 2024 | [158] |
| NCT01986426 | Completed | LTX-315 | I | 80 | No Study Results Posted | [159] |
| NCT03761914 | Recruiting | Galinpepimut-S | I, II | 90 | Estimated Primary Completion Date: 31 January 2024 | [160] |
| NCT03797326 | Active, not recruiting | Lenvatinib | II | 590 | Estimated Primary Completion Date: 22 December 2023 | [161] |
| NCT04265872 | Recruiting | Bortezomib, and cisplatin injections--bortezomib followed by pembro/cis | Early phase I | 20 | Estimated Primary Completion Date: 1 October 2023 | [162] |
| NCT04332653 | Recruiting | Efineptakin alfa | I, II | 178 | Estimated Primary Completion Date: 30 June 2022 | [163] |
| NCT04429542 | Recruiting | BCA101 | I | 292 | Estimated Primary Completion Date: 31 December 2022 | [164] |
| NCT05082610 | Not yet recruiting | HMBD-002 | I | 240 | Estimated Primary Completion Date: October 2024 | [165] |
| NCT02644369 | Active, not recruiting | Monotherapy | II | 100 | No Study Results Posted | [166] |
| NCT05094804 | Recruiting | OR2805, Nivolumab | I, II | 130 | Estimated Primary Completion Date: 15 April 2024 | [167] |
| NCT05070247 | Not yet recruiting | TAK-500 | I | 106 | Estimated Primary Completion Date: 8 April 2025 | [168] |
| NCT04725331 | Recruiting | BT-001 | I, II | 48 | Estimated Primary Completion Date: 30 November 2024 | [169] |
| NCT03454451 | Recruiting | Ciforadenant, CPI-006 | I | 378 | Estimated Primary Completion Date: March 2022 | [170] |
| NCT03849469 | Recruiting | XmAb®22841 | I | 242 | Estimated Primary Completion Date: June 2024 | [171] |
| NCT04234113 | Recruiting | SO-C101 | I | 96 | Estimated Primary Completion Date: December 2023 | [172] |
| NCT02178722 | Completed | Epacadostat | I, II | 444 | Ammong patients with TNBC Safety, ORR: 11.1% | [173] |
| NCT05007106 | Recruiting | Vibostolimab Co-Formulation, Lenvatinib, 5-Fluorouracil, Cisplatin, Paclitaxel | II | 480 | Estimated Primary Completion Date: 19 February 2025 | [174] |
| NCT03621982 | Recruiting | ADCT-301 | I | 95 | Estimated Primary Completion Date: 15 November 2022 | [175] |
| NCT04348916 | Recruiting | ONCR-177 | I | 132 | Estimated Primary Completion Date: January 2025 | [176] |
| NCT01042379 | Recruiting | Standard Therapy, AMG 386 with or without Trastuzumab, AMG 479 (Ganitumab) plus Metformin, MK-2206 with or without Trastuzumab, AMG 386 and Trastuzumab, T-DM1 and Pertuzumab, Pertuzumab and Trastuzumab, Ganetespib, ABT-888, Neratinib, PLX3397, Pembrolizumab- 4 cycle, Talazoparib plus Irinotecan, Patritumab and Trastuzumab, Pembrolizumab-8 cycle, SGN-LIV1A, Durvalumab plus Olaparib, SD-101 + Pembrolizumab, Tucatinib plus trastuzumab and pertuzumab, Cemiplimab, Cemiplimab plus REGN3767, Trilaciclib with or without trastuzumab + pertuzumab, SYD985 ([vic-]trastuzumab duocarmazine), Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab, Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab, Amcenestrant, Amcenestrant + Abemaciclib Amcenestrant + Letrozole |
II | 4000 | Estimated Primary Completion Date: December 2030 | [177] |
| NCT04060342 | Recruiting | GB1275D, Nab-paclitaxel and gemcitabine |
I, II | 242 | Estimated Primary Completion Date: March 2023 | [178] |
| NCT03366844 | Recruiting | Radiotherapy | I, II | 60 | Estimated Primary Completion Date: 21 January 2022 | [179] |
| NCT04148937 | Active, not recruiting | LY3475070 | I | 150 | Estimated Primary Completion Date: 20 December 2021 | [180] |
| NCT03277352 | Terminated | Epacadostat | I, II | 10 | The study was terminated due to emergent data from another study and unrelated to safety. Treatment-Emergent Adverse Events: 100% ORR: 30% |
[181] |
| NCT05069935 | Not yet recruiting | FT538, Cyclophosphamide, Fludarabine, Monoclonal antibody including pembrolizumab—Dose Escalation, Monoclonal antibody (including pembrolizumab)—Dose Expansion | I | 189 | Estimated Primary Completion Date 5 September 2023 | [109] |
| NCT03952325 | Terminated (The Sponsor has discontinued the development of tesetaxel) | Atezolizumab, Nivolumab, Tesetaxel | II | 294 | The study has stopped early and will not start again. Participants are no longer being examined or treated. | [106] |
| NCT04954599 | Not yet recruiting | CP-506 Carboplatin Immune checkpoint inhibitor (including pembrolizumab) | I, II | 126 | Estimated Primary Completion Date: September 2024 | [108] |