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Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-7902-015/E7080-G000-321/LEAP-015) (LEAP-015)
EU CTIS ID: 2023-504834-23-00
What this study is testing
1. Objective (Part 1): To evaluate the safety and tolerability of treatment with lenvatinib plus pembrolizumab plus chemotherapy. 2. Objective (Part 2): To compare the overall survival between treatment groups. 3. Objective (Part 2): To compare the PFS between treatment groups.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Has histologically and/or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic gastroesophageal adenocarcinoma
- Is not expected to require tumor resection during the treatment course
- Has gastroesophageal adenocarcinoma that is not HER-2/neu positive
- Has measurable disease as by RECIST 1.1 by scan with IV contrast as determined by the local site investigator
- Male participants agree to refrain from donating sperm and agree to either remain abstinent from heterosexual intercourse as their preferred and usual lifestyle OR agree to use contraception, during the intervention period and for >7 days after last dose of lenvatinib or 90 days after last dose of chemotherapy-whichever comes last
- Female participants not pregnant or breastfeeding are eligible to participate if not a women of childbearing potential (WOCBP), or if a WOCBP they either use a contraceptive method that is highly effective OR remain abstinent from heterosexual intercourse as their preferred and usual lifestyle, and do not donate eggs (ova,oocytes) to others or freeze/store for their own use, and abstain from breastfeeding during the intervention period through 120 days after last dose of pembrolizumab, 30 days after last dose of lenvatinib, or 180 days after last dose of chemotherapy-whichever occurs last
You likely can't join if
- Has had previous therapy for locally advanced unresectable or metastatic gastric/gastroesophageal junction (GEJ) esophageal adenocarcinoma
- Has received prior therapy with an anti-PD-1, anti-PD-L1 or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
- Has received prior therapy with anti-vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor or anti-VEGF mAb
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study drug
- Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs)
- Has radiographic evidence or encasement or invasion of a major blood vessel, or of intertumoral cavitation
See the full eligibility criteria
Who can join
- Has histologically and/or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic gastroesophageal adenocarcinoma
- Is not expected to require tumor resection during the treatment course
- Has gastroesophageal adenocarcinoma that is not HER-2/neu positive
- Has measurable disease as by RECIST 1.1 by scan with IV contrast as determined by the local site investigator
- Male participants agree to refrain from donating sperm and agree to either remain abstinent from heterosexual intercourse as their preferred and usual lifestyle OR agree to use contraception, during the intervention period and for >7 days after last dose of lenvatinib or 90 days after last dose of chemotherapy-whichever comes last
- Female participants not pregnant or breastfeeding are eligible to participate if not a women of childbearing potential (WOCBP), or if a WOCBP they either use a contraceptive method that is highly effective OR remain abstinent from heterosexual intercourse as their preferred and usual lifestyle, and do not donate eggs (ova,oocytes) to others or freeze/store for their own use, and abstain from breastfeeding during the intervention period through 120 days after last dose of pembrolizumab, 30 days after last dose of lenvatinib, or 180 days after last dose of chemotherapy-whichever occurs last
- Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale within 3 days prior to the first dose of study treatment
- Has adequately controlled blood pressure with or without antihypertensive medications
- Has adequate organ function
What rules you out
- Has had previous therapy for locally advanced unresectable or metastatic gastric/gastroesophageal junction (GEJ) esophageal adenocarcinoma
- Has received prior therapy with an anti-PD-1, anti-PD-L1 or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
- Has received prior therapy with anti-vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor or anti-VEGF mAb
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study drug
- Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs)
- Has radiographic evidence or encasement or invasion of a major blood vessel, or of intertumoral cavitation
- Has inadequate cardiac function
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has poorly controlled diarrhea
- Has accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment
- Has peripheral neuropathy >Grade 2
- Has had major surgery within 28 days prior to first dose of study interventions
- Has a known history of human immunodeficiency virus (HIV) or HIV 1/2 antibodies
- Has a known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection
- Has weight loss of >20% within the last 3 months
- Has had radiotherapy within 14 days of randomization
- Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
- Has known CNS metastases and/or carcinomatous meningitis
- Has severe hypersensitivity (>Grade 3) to treatment with an monoclonal antibody (mAb) or known sensitivity or intolerance to any component of lenvatinib, pembrolizumab, study chemotherapy agents and/or to any excipients, murine proteins, or platinum containing products
- Has had an allogeneic tissue/solid organ transplant
- Has perforation risks or significant gastrointestinal (GI) bleeding
- Has GI obstruction, poor oral intake (CAPOX participants), or difficulty in taking oral medication (CAPOX participants)
The study team makes the final eligibility decision.
Where it's taking place
- Costa Rica
- Canada
- Argentina
- Japan
- Colombia
- Russian Federation
- Israel
- Australia
- Korea, Republic of
- United Kingdom
- Taiwan
- Turkey
- China
- Hong Kong
- Chile
- Guatemala
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Costa Rica; Canada; Argentina; Japan; Colombia; Russian Federation and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.