Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02054806 | Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-028/KEYNOTE-28) | PHASE1 | COMPLETED | 477 | — | — | Feb 17, 2014 | Apr 30, 2021 | Oct 30, 2023 | - | — |
| NCT01840579 | Study of Pembrolizumab (MK-3475) Monotherapy in Advanced Solid Tumors and Pembrolizumab Combination Therapy in Advanced Non-small Cell Lung Cancer/ Extensive-disease Small Cell Lung Cancer (MK-3475-011/KEYNOTE-011) | PHASE1 | COMPLETED | 57 | — | — | Apr 26, 2013 | Feb 28, 2020 | Jun 22, 2021 | - | — |
Overall response rate (ORR) was defined as the percentage of participants who experienced a complete response (CR; disappearance of all target lesions) or a Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by the investigator.
The following toxicities graded per the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v.4.0) were considered DLTs if judged by the investigator to be related to either study drug: * Grade (G) 4 neutropenia lasting \>7 days * Grade 3 and Grade 4 febrile neutropenia * Grade 4 thrombocytopenia (\<25,000/mm\^3) * Grade 4 anemia * Grade 4 non-hematologic toxicity (not laboratory) * Grade 3 non-hematologic toxicity (not laboratory) lasting \>3 days despite optimal supportive care * Any Grade 3 non-hematologic laboratory value if medical intervention is required to treat the participant or the abnormality persists for \>7 days. * (Part D only) Missing the second dose of pembrolizumab (Cycle1 Day 22) due to drug-related adverse event
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.
| Arm | Type | Description |
|---|---|---|
| Pembrolizumab | EXPERIMENTAL | Participants receive pembrolizumab 10 mg/kg, intravenously (IV), once every 2 weeks (Q2W) for up to \~2 years |
| Pembrolizumab 2 mg/kg | EXPERIMENTAL | In Part A, participants receive intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days). |
| Pembrolizumab 10 mg/kg | EXPERIMENTAL | In Part A, participants receive IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days). |
| Pembrolizumab+Cisplatin/Pemetrexed | EXPERIMENTAL | In Part B, participants receive IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks. |
| Pembrolizumab+Carboplatin/Pemetrexed | EXPERIMENTAL | In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks. |
| Pembrolizumab+Carboplatin/Paclitaxel | EXPERIMENTAL | In Part C, participants receive IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks. |
| Pembrolizumab+Carboplatin/Nab-paclitaxel | EXPERIMENTAL | In Part C, participants receive IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks. |
| Pembrolizumab+Ipilimumab | EXPERIMENTAL | In Part D, participants receive IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab). |
| Pembrolizumab+Cisplatin/Etoposide | EXPERIMENTAL | In Part E, participants receive IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks. |
| Pembrolizumab+Carboplatin/Etoposide | EXPERIMENTAL | In Part E, participants receive IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks. |
| Pembrolizumab+Cisplatin/Etoposide+G-CSF | EXPERIMENTAL | In Part E, participants receive IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks. |
| Name | Type | Description |
|---|---|---|
| Pembrolizumab | BIOLOGICAL | IV infusion |
| Pembrolizumab 2 mg/kg | BIOLOGICAL | Administered as an intravenous (IV) infusion on Day 1 of Cycle 1 (28 days), Cycle 2 (14 days), and Cycle 3 (14 days) |
| Pembrolizumab 10 mg/kg | BIOLOGICAL | Administered as an IV infusion on Day 1 of Cycle 1 (28 days), Cycle 2 (14 days), and Cycle 3 (14 days) |
| Pembrolizumab 200 mg | BIOLOGICAL | Administered as an IV infusion on Day 1 of each 21-day cycle |
| Cisplatin 75 mg/m^2 | DRUG | Administered as an IV infusion on Day 1 of each 21-day cycle |
| Pemetrexed 500 mg/m^2 | DRUG | Administered as an IV infusion on Day 1 of each 21-day cycle |
| Carboplatin AUC 5 mg/mL/min | DRUG | Administered as an IV infusion on Day 1 of each 21-day cycle |
| Carboplatin AUC 6 mg/mL/min | DRUG | Administered as an IV infusion on Day 1 of each 21-day cycle |
| Paclitaxel 200 mg/m^2 | DRUG | Administered as an IV infusion on Day 1 of each 21-day cycle |
| Nab-paclitaxel 100 mg/m^2 | DRUG | Administered as an IV infusion on Days 1, 8, and 15 of each 21-day cycle |
| Ipilimumab 1 mg/kg | BIOLOGICAL | Administered as an IV infusion on Day 1 of every other 21-day cycle (every 42 days) |
| Etoposide 100 mg/m^2 | DRUG | Administered as an IV infusion on Days 1, 2, and 3 of each 21-day cycle |
| G-CSF (pegfilgrastim) 3.6 mg | DRUG | Administered as a subcutaneous injection on Day 4 of Cycle 1 |
Inclusion Criteria: * Histologically or cytologically documented locally-advanced and/or metastatic solid malignancy that is incurable, and has failed prior standard therapy or for which standard therapy is not appropriate * Have biomarker-positive solid tumor * Have measurable disease based on Res...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab, V503, GARDASIL |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| AstraZeneca PLC | AZN | 1 | — | Trastuzumab deruxtecan |