Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005)

Brief summary public domain (ClinicalTrials.gov)

The purpose of this study is to determine the safety and efficacy of combination therapy with pembrolizumab (MK-3475) and lenvatinib (E7080/MK-7902) in participants with triple negative breast cancer (TNBC), ovarian cancer, gastric cancer, colorectal cancer (CRC), glioblastoma (GBM), biliary tract cancers (BTC), or pancreatic cancer.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Disease Control Rate (DCR) Per RECIST 1.1 by Investigator Assessment [Up to approximately 66 months]. Number, Percentage of Participants (95% Confidence Interval). Cohort A: Triple Negative Breast Cancer (Lenva + Pembro) (n=31): 51.6 (33.1 to 69.8); Cohort B: Ovarian Cancer (Lenva + Pembro) (n=31): 77.4 (58.9 to 90.4).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Disease Control Rate (DCR) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR [Up to approximately 66 months]. Number, Percentage of Participants (95% Confidence Interval). Cohort C: Gastric Cancer (Lenva + Pembro) (n=99): 53.5 (43.2 to 63.6); Cohort D1: Colorectal Cancer (Lenva + Pembro) (n=105): 52.4 (42.4 to 62.2); Cohort D2: Colorectal Cancer (Lenva) (n=30): 56.7 (37.4 to 74.5); Cohort E: Glioblastoma Multiforma (Lenva + Pembro) (n=101): 57.4 (47.2 to 67.2); Cohort F: Biliary Tract Cancer (Lenva + Pembro) (n=102): 64.7 (54.6 to 73.9); Cohort G: Pancreatic Cancer (Lenva + Pembro) (n=103): 37.9 (28.5 to 48.0).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Duration of Response (DOR) Per RECIST 1.1 by Investigator Assessment [Up to approximately 66 months]. Median, Months (95% Confidence Interval). Cohort A: Triple Negative Breast Cancer (Lenva + Pembro) (n=7): 22.9 (4.2 to NA) [NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.]; Cohort B: Ovarian Cancer (Lenva + Pembro) (n=8): 15.3 (6.4 to NA) [NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Duration of Response (DOR) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR [Up to approximately 66 months]. Median, Months (95% Confidence Interval). Cohort C: Gastric Cancer (Lenva + Pembro) (n=15): 8.3 (4.2 to NA) [NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.]; Cohort D1: Colorectal Cancer (Lenva + Pembro) (n=15): 8.3 (4.2 to 18.5); Cohort D2: Colorectal Cancer (Lenva) (n=2): NA (NA to NA) [NA = Median, Lower and Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.]; Cohort E: Glioblastoma Multiforma (Lenva + Pembro) (n=22): 4.6 (3.2 to 15.6); Cohort F: Biliary Tract Cancer (Lenva + Pembro) (n=18): 6.2 (4.2 to 7.1); Cohort G: Pancreatic Cancer (Lenva + Pembro) (n=8): 5.8 (2.7 to NA) [NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Progression-Free Survival (PFS) Per RECIST 1.1 by Investigator Assessment [Up to approximately 66 months]. Median, Months (95% Confidence Interval). Cohort A: Triple Negative Breast Cancer (Lenva + Pembro) (n=31): 4.2 (1.7 to 6.3); Cohort B: Ovarian Cancer (Lenva + Pembro) (n=31): 6.1 (4.1 to 9.4).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Progression-Free Survival (PFS) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR [Up to approximately 66 months]. Median, Months (95% Confidence Interval). Cohort C: Gastric Cancer (Lenva + Pembro) (n=99): 3.5 (2.3 to 4.1); Cohort D1: Colorectal Cancer (Lenva + Pembro) (n=105): 3.4 (2.1 to 4.1); Cohort D2: Colorectal Cancer (Lenva) (n=30): 3.4 (2.1 to 4.8); Cohort E: Glioblastoma Multiforma (Lenva + Pembro) (n=101): 3.0 (2.8 to 4.1); Cohort F: Biliary Tract Cancer (Lenva + Pembro) (n=102): 4.1 (3.6 to 5.9); Cohort G: Pancreatic Cancer (Lenva + Pembro) (n=103): 2.1 (2.1 to 3.1).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Overall Survival (OS) [Up to approximately 66 months]. Median, Months (95% Confidence Interval). Cohort A: Triple Negative Breast Cancer (Lenva + Pembro) (n=31): 11.4 (4.1 to 21.7); Cohort B: Ovarian Cancer (Lenva + Pembro) (n=31): 21.3 (11.7 to 32.3); Cohort C: Gastric Cancer (Lenva + Pembro) (n=99): 4.7 (3.8 to 6.1); Cohort D1: Colorectal Cancer (Lenva + Pembro) (n=105): 8.7 (7.0 to 10.0); Cohort D2: Colorectal Cancer (Lenva) (n=30): 7.9 (5.6 to 14.9); Cohort E: Glioblastoma Multiforma (Lenva + Pembro) (n=101): 8.6 (7.4 to 10.8); Cohort F: Biliary Tract Cancer (Lenva + Pembro) (n=102): 7.9 (5.6 to 9.5); Cohort G: Pancreatic Cancer (Lenva + Pembro) (n=103): 4.3 (3.8 to 5.4).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Area Under the Concentration Curve at Steady State (AUCss) of Lenvatinib [Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose and 2-12 hours post-dose; Cycle 2 Day 1: pre-dose, 0.5-4 hours, and 6-10 hours post-dose (up to approximately 23 days). Each cycle is 21 days.]. Mean, ng*hr/mL (Standard Deviation). Cohort A: Triple Negative Breast Cancer (Lenva + Pembro) (n=30): 3253 (1029); Cohort B: Ovarian Cancer (Lenva + Pembro) (n=31): 3145 (984); Cohort C: Gastric Cancer (Lenva + Pembro) (n=93): 2392 (803); Cohort D1: Colorectal Cancer (Lenva + Pembro) (n=104): 2994 (1143); Cohort E: Glioblastoma Multiforma (Lenva + Pembro) (n=100): 2617 (804); Cohort F: Biliary Tract Cancer (Lenva + Pembro) (n=100): 2886 (838).

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Investigator Assessment [Up to approximately 66 months]. Number, Percentage of Participants (95% Confidence Interval). Cohort A: Triple Negative Breast Cancer (Lenva + Pembro) (n=31): 22.6 (9.6 to 41.1); Cohort B: Ovarian Cancer (Lenva + Pembro) (n=31): 25.8 (11.9 to 44.6).

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria (for Glioblastoma Multiforma [GBM] Only), by Blinded Independent Central Review (BICR) [Up to approximately 66 months]. Number, Percentage of Participants (95% Confidence Interval). Cohort C: Gastric Cancer (Lenva + Pembro) (n=99): 15.2 (8.7 to 23.8); Cohort D1: Colorectal Cancer (Lenva + Pembro) (n=105): 14.3 (8.2 to 22.5); Cohort D2: Colorectal Cancer (Lenva) (n=30): 6.7 (0.8 to 22.1); Cohort E: Glioblastoma Multiforma (Lenva + Pembro) (n=101): 21.8 (14.2 to 31.1); Cohort F: Biliary Tract Cancer (Lenva + Pembro) (n=102): 17.6 (10.8 to 26.4); Cohort G: Pancreatic Cancer (Lenva + Pembro) (n=103): 7.8 (3.4 to 14.7).

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Number of Participants With One or More Adverse Events (AEs) [Up to approximately 66 months]. Count Of Participants, Participants. Cohort A: Triple Negative Breast Cancer (Lenva + Pembro) (n=31): 31; Cohort B: Ovarian Cancer (Lenva + Pembro) (n=31): 31; Cohort C: Gastric Cancer (Lenva + Pembro) (n=99): 97; Cohort D1: Colorectal Cancer (Lenva + Pembro) (n=105): 104; Cohort D2: Colorectal Cancer (Lenva) (n=30): 30; Cohort E: Glioblastoma Multiforma (Lenva + Pembro) (n=101): 101; Cohort F: Biliary Tract Cancer (Lenva + Pembro) (n=102): 102; Cohort G: Pancreatic Cancer (Lenva + Pembro) (n=103): 103.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Number of Participants Who Discontinued From Study Treatment Due to an AE [Up to approximately 62 months]. Count Of Participants, Participants. Cohort A: Triple Negative Breast Cancer (Lenva + Pembro) (n=31): 5; Cohort B: Ovarian Cancer (Lenva + Pembro) (n=31): 11; Cohort C: Gastric Cancer (Lenva + Pembro) (n=99): 23; Cohort D1: Colorectal Cancer (Lenva + Pembro) (n=105): 19; Cohort D2: Colorectal Cancer (Lenva) (n=30): 4; Cohort E: Glioblastoma Multiforma (Lenva + Pembro) (n=101): 11; Cohort F: Biliary Tract Cancer (Lenva + Pembro) (n=102): 20; Cohort G: Pancreatic Cancer (Lenva + Pembro) (n=103): 19.