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Study identifier: NCT03797326 Synced from ClinicalTrials.gov · August 07, 2026
● Study status: Completed

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)

Condition: Advanced Solid Tumors · Triple Negative Breast Cancer · Ovarian Cancer  ·  Sponsor: Merck Sharp & Dohme LLC

PhasePhase 2
Planned participants611
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNoCheck eligibility criteria ↓
Where88 locations · 17 countries

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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 fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment (applies to all cohorts except the ovarian cancer cohort) * Has radiographic evidence of encasement or invasion of a major blood vessel or of intratumoral cavitation. Participants with portal vein invasion (Vp4), inferior vena cava, or cardiac involvement based on imaging in the BTC cohort are not eligible for enrollment * Has clinical significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study treatment * Has significant cardiovascular impairment within 12 months of the first dose of study treatment, such as history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular accident (CVA), or cardiac arrhythmia associated with hemodynamic instability * Has a history of arterial thromboembolism within 12 months of start of study treatment * Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. * Has a serious nonhealing wound, ulcer or bone fracture * Has had major surgery within 3 weeks prior to first dose of study interventions * Has biologic response modifiers therapy (e.g. granulocyte colony-stimulating factor) within 4 weeks before study entry * Has preexisting ≥Grade 3 gastrointestinal (GI) or non-gastrointestinal fistula * Has received prior therapy with lenvatinib, an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], Tumor necrosis factor receptor superfamily, member 4 \[OX 40\], tumor necrosis factor receptor superfamily member 9 \[CD137\]) * Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to study treatment start * If participant received major surgery, they must have recovered adequately from the toxicity and/or complic…

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (88)

City of Hope ( Site 0002)Duarte, California, United States
Cedars Sinai Medical Center ( Site 0003)Los Angeles, California, United States
University of California Davis Comprehensive Cancer Center ( Site 0005)Sacramento, California, United States
University of Colorado, Anschutz Cancer Pavilion ( Site 0007)Aurora, Colorado, United States
University of Florida-Health Cancer Center-Orlando ( Site 0015)Orlando, Florida, United States
Rutgers Cancer Institute of New Jersey ( Site 0009)New Brunswick, New Jersey, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0023)New York, New York, United States
Sanford Fargo Medical Center ( Site 0059)Fargo, North Dakota, United States
Lehigh Valley Hospital- Cedar Crest ( Site 0047)Allentown, Pennsylvania, United States
Sanford Cancer Center ( Site 0058)Sioux Falls, South Dakota, United States
West Cancer Center - East Campus ( Site 0018)Germantown, Tennessee, United States
Mary Crowley Cancer Research Centers - Medical City Hospital ( Site 0049)Dallas, Texas, United States

+ 76 more locations — full list on the registry record.

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