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Phase 2 Completed N=611 Treatment

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)

Advanced Solid Tumors · Triple Negative Breast Cancer · Ovarian Cancer · Gastric Cancer
Source: ClinicalTrials.gov NCT03797326 ↗
Enrolled (actual)
611
Serious AEs
49.8%
Results posted
Nov 2025
Primary outcomePrimary: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Investigator Assessment — 22.6; 25.8 Percentage of Participants

Summary

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Investigator Assessment
22.6; 25.8
PRIMARY
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)
15.2; 14.3; 6.7; 21.8; 17.6; 7.8
PRIMARY
Number of Participants With One or More Adverse Events (AEs)
31; 31; 97; 104; 30; 101
PRIMARY
Number of Participants Who Discontinued From Study Treatment Due to an AE
5; 11; 23; 19; 4; 11
SECONDARY
Disease Control Rate (DCR) Per RECIST 1.1 by Investigator Assessment
51.6; 77.4
SECONDARY
Disease Control Rate (DCR) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR
53.5; 52.4; 56.7; 57.4; 64.7; 37.9
SECONDARY
Duration of Response (DOR) Per RECIST 1.1 by Investigator Assessment
22.9; 15.3
SECONDARY
Duration of Response (DOR) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR
8.3; 8.3; NA; 4.6; 6.2; 5.8
SECONDARY
Progression-Free Survival (PFS) Per RECIST 1.1 by Investigator Assessment
4.2; 6.1
SECONDARY
Progression-Free Survival (PFS) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR
3.5; 3.4; 3.4; 3.0; 4.1; 2.1
SECONDARY
Overall Survival (OS)
11.4; 21.3; 4.7; 8.7; 7.9; 8.6
SECONDARY
Area Under the Concentration Curve at Steady State (AUCss) of Lenvatinib
3253; 3145; 2392; 2994; 2617; 2886

Eligibility Criteria

Inclusion Criteria

  • Has a histologically or cytologically-documented, advanced (metastatic and/or unresectable) solid tumor that is incurable and for which prior standard systemic therapy has failed in one of the following cohorts: TNBC, Ovarian Cancer, Gastric Cancer, Colorectal Cancer, GBM, BTC (intrahepatic, extrahepatic cholangiocarcinoma and gall bladder cancer; excludes Ampulla of Vater), Pancreatic Cancer
  • Must have progressed on or since the last treatment
  • Has measurable disease per RECIST 1.1 (RANO for the GBM cohort) as assessed by the local site investigator/radiology and confirmed by BICR
  • Has provided a PD-L1 evaluable archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
  • Male participants agree to use approved contraception during the treatment period for at least 7 days after the last dose of lenvatinib, or refrain from heterosexual intercourse during this period
  • Female participants are not pregnant or breastfeeding, and are not a woman of childbearing potential (WOCBP), OR are a WOCBP that agrees to use contraception during the treatment period (or 14 days prior to the initiation of study treatment for oral contraception) and for at least 120 days post pembrolizumab, or 30 days post lenvatinib, whichever occurs last
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 3 days of study treatment initiation
  • Has adequate organ function

For Triple Negative Breast Cancer Participants:

  • Has received one or 2 prior lines of therapy
  • Has Lactate Dehydrogenase (LDH) <2.0 x Upper Limit of Normal (ULN)
  • Has locally determined results for estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 tumor analyses

For Ovarian Cancer Participants:

  • Has primary ovarian cancer and has received 3 prior lines of therapy.

For Gastric Cancer Participants:

  • Has received 2 prior lines of therapy. Note: Gastric cancer will include participants with both gastric and gastroesophageal junction (GEJ) adenocarcinoma. Participants with squamous cell carcinoma histology are not eligible

For Colorectal Cancer Participants:

  • Has received 2 prior lines of therapy

For GBM Participants:

  • Has failed initial systemic therapy for newly diagnosed GBM
  • Have the following time periods elapsed before the projected start of scheduled study treatment: 1) at least 3 weeks from prior surgical resection, 2) at least 1 week from stereotactic biopsy, 3) at least 6 months from completion of prior radiotherapy, 4) at least 4 weeks (or 5 half-lives, whichever is shorter) from any investigational agent, 5) at least 4 weeks from cytotoxic therapy, 6) at least 6 weeks from antibodies, 7) at least 4 weeks (or 5 half-lives, whichever is shorter) from other antitumor therapies and 1 week for cancer vaccines
  • Be neurologically stable (e.g. without a progression of neurologic symptoms or requiring escalating doses of systemic steroid therapy within last 2 weeks) and clinically stable
  • Has histologically confirmed World Health Organization (WHO) Grade IV GBM
  • Has locally determined result for O^6-methylguanine-DNA methyltransferase (MGMT) analysis

For Biliary Tract Cancer Participants:

  • Has received 1 prior line of therapy
  • Child-Pugh Score, Class A: well-compensated disease. Child-Pugh Score of 5-6

For Pancreatic Cancer Participants:

  • Has pathologically (histologically or cytologically) confirmed pancreatic ductal adenocarcinoma that is metastatic at enrollment
  • Has received one or 2 prior lines of therapy
  • Has received prior therapy with at least 1 (platinum-containing regimen or gemcitabine-containing regimen) but no more than 2 prior systemic therapies for unresectable or metastatic pancreatic cancer

Exclusion Criteria

  • Has gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib
  • Has present or progressive accumulation of pleural, ascitic, or pericardial f
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03797326). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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