← Back to Search

Antimetabolites

Lenvatinib + Pembrolizumab + Chemotherapy for Gastroesophageal Cancer (LEAP-015 Trial)

Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has measurable disease as defined by RECIST 1.1 by scan with IV contrast as determined by the local site investigator
Has histologically and/or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic gastroesophageal adenocarcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~41 months
Awards & highlights

LEAP-015 Trial Summary

This trial is testing whether adding lenvatinib and pembrolizumab to chemotherapy can help people with gastroesophageal cancer live longer and have less cancer growth compared to chemotherapy alone.

Who is the study for?
This trial is for adults with advanced or metastatic gastroesophageal adenocarcinoma who haven't had treatment for it before. They should have a good performance status, not be pregnant or breastfeeding, and willing to use effective contraception. People can't join if they've had certain treatments, surgeries recently, other cancers within 5 years, severe allergies to study drugs, uncontrolled health issues like high blood pressure or diarrhea.Check my eligibility
What is being tested?
The trial tests the combination of Lenvatinib plus Pembrolizumab with chemotherapy against chemotherapy alone in patients with gastroesophageal cancer. It aims to see if this combo improves overall survival and slows disease progression compared to just chemo.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation (like inflammation), infusion-related reactions from the drugs being given through veins, fatigue, digestive problems such as diarrhea or constipation, skin rash and potential increase in blood pressure.

LEAP-015 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer can be measured on scans.
Select...
My cancer is a type that started in the stomach or esophagus and has spread.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My organs are functioning well.
Select...
My stomach cancer is not HER2 positive.
Select...
My cancer is a type that started in the stomach or esophagus and has spread.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I am not expected to need surgery to remove a tumor during my treatment.
Select...
I am not pregnant, breastfeeding, and if able to have children, I use or will use effective birth control or practice abstinence.
Select...
I agree to not donate sperm and to either not have sex or use birth control during and up to 90 days after treatment.
Select...
My stomach cancer is not HER2 positive.
Select...
I am not expected to need surgery to remove my tumor during treatment.
Select...
My blood pressure is under control, with or without medication.

LEAP-015 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~41 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~41 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1: Number of Participants who Discontinued Study Treatment Due to an AE
Part 1: Number of Participants with Adverse Events (AEs)
Part 1: Number of Participants with Dose Limiting Toxicities (DLTs)
+4 more
Secondary outcome measures
Part 2: DOR Per RECIST 1.1 as Assessed by BICR in All Participants
Part 2: Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR in Participants with PD-L1 CPS ≥1
Part 2: Number of Participants who Discontinued Study Treatment Due to an AE
+3 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

LEAP-015 Trial Design

2Treatment groups
Experimental Treatment
Group I: Lenvatinib + Pembrolizumab + ChemotherapyExperimental Treatment6 Interventions
Participants receive lenvatinib administered orally (PO) every day (QD) in combination with pembrolizumab intravenously (IV) every 6 weeks (Q6W) plus chemotherapy with either capecitabine and oxaliplatin (CAPOX) or chemotherapy with 5-FU, leucovorin, and oxaliplatin (mFOLFOX6). Induction with lenvatinib 8 mg QD plus pembrolizumab (400 mg Q6W) plus chemotherapy (CAPOX or mFOLFOX6) will be administered for 2 cycles (approximately 12 weeks), followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab (400 mg Q6W) for 16 cycles. A cycle is 6 weeks (42 days).
Group II: ChemotherapyExperimental Treatment4 Interventions
Participants receive chemotherapy with either CAPOX Q3W or mFOLFOX6 Q2W. A cycle is 6 weeks (42 days).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxaliplatin
2011
Completed Phase 4
~2560
5-FU
2014
Completed Phase 3
~3420
Pembrolizumab
2017
Completed Phase 2
~1950
Lenvatinib
2005
Completed Phase 4
~2690
Capecitabine
2013
Completed Phase 3
~3420

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,021 Total Patients Enrolled
Eisai Inc.Industry Sponsor
515 Previous Clinical Trials
153,209 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,862 Previous Clinical Trials
5,048,810 Total Patients Enrolled

Media Library

5-FU (Antimetabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04662710 — Phase 3
Gastroesophageal Adenocarcinoma Research Study Groups: Lenvatinib + Pembrolizumab + Chemotherapy, Chemotherapy
Gastroesophageal Adenocarcinoma Clinical Trial 2023: 5-FU Highlights & Side Effects. Trial Name: NCT04662710 — Phase 3
5-FU (Antimetabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04662710 — Phase 3
Gastroesophageal Adenocarcinoma Patient Testimony for trial: Trial Name: NCT04662710 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other research has Pembrolizumab been used in?

"Pembrolizumab is being trialed in 1726 different medical studies that are still ongoing. Phase 3 trials, which are the most advanced, make up 352 of these investigations. The epicentre for Pembrolizumab clinical trials is Guangzhou, Guangdong; however, the drug is being tested in 62511 different hospitals and research centres."

Answered by AI

Pembrolizumab is most commonly used for which type of patient?

"Pembrolizumab is indicated for the treatment of malignant neoplasms. Additionally, it has shown efficacy in treating unresectable melanoma, microsatellite instability high, and patients with a high risk of recurrence."

Answered by AI

What are the researchers working to find out through this clinical trial?

"The primary outcome of this study, which will be assessed over a Up to ~34 months time frame is to Part 2: Overall Survival in All Participants. Secondary outcomes include Part 2: Number of Participants with Adverse Events which is defined as An Adverse Event is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Part 2 with Adverse Events will be reported by treatment arm., Part 2: Number of Participants who Discontinued Study Treatment Due to an Adverse Event which is defined as An Adverse Event is"

Answered by AI

Are patients being actively enrolled in this experiment at this time?

"Yes, this trial is still looking for volunteers according to the information on clinicaltrials.gov. The listing for the trial was first posted on December 30th 2020 and was last edited on November 7th 2022."

Answered by AI

What is the Pembrolizumab patient safety profile?

"Pembrolizumab has undergone multiple rounds of testing and has been found to be effective in prior clinical trials. As a result, it has been given a safety score of 3."

Answered by AI

How many sites are currently conducting this clinical trial?

"12 hospitals are running this trial, which are Memorial Sloan Kettering Cancer Center ( Site 0032) in New york, Hamilton Health Sciences - Juravinski Site ( Site 0106) in Hamilton, and CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0103) in Sherbrooke. There are 9 other locations running this trial."

Answered by AI

Who else is applying?

What site did they apply to?
Queen Elizabeth II Health Sciences Centre ( Site 0101)
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Have not had any effective drug since I reside in Africa.
PatientReceived 1 prior treatment
~321 spots leftby Feb 2026