← Back to Search

Fluoropyrimidine-based Chemotherapy

Pembrolizumab + Lenvatinib + Chemo for Esophageal Cancer

Phase 3
Recruiting
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 adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP≤150/90 millimeters of mercury (mm Hg) with no change in antihypertensive medications within 1 week prior to randomization
Has a histologically or cytologically confirmed diagnosis of metastatic squamous cell carcinoma of the esophagus
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~51 months
Awards & highlights

Study Summary

This trial is meant to compare the effects of two different cancer treatments on patients with metastatic esophageal cancer. The first treatment is pembrolizumab plus lenvatinib plus chemotherapy, and the second treatment is pembrolizumab plus chemotherapy. The study will measure overall survival and progression-free survival to see which treatment is more effective.

Who is the study for?
This trial is for adults with metastatic squamous cell carcinoma of the esophagus. Participants must have controlled blood pressure, adequate organ function, and agree to contraception if applicable. Exclusions include adenocarcinoma of the esophagus, significant bleeding risks, recent major surgery or radiotherapy, active infections like Hepatitis B/C or HIV, weight loss over 20% in last 3 months, and certain cardiovascular diseases.Check my eligibility
What is being tested?
The study tests pembrolizumab plus lenvatinib with chemotherapy against pembrolizumab with chemotherapy alone in first-line treatment for metastatic esophageal cancer. The goal is to see which combination improves overall survival (OS) and progression-free survival (PFS) better.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to drugs used; high blood pressure from lenvatinib; immune-related issues such as inflammation in organs due to pembrolizumab; fatigue; digestive problems; increased risk of infection; and possible nerve damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My blood pressure is 150/90 or lower, and my medication hasn't changed in the last week.
Select...
My esophageal cancer is confirmed to be squamous cell and has spread.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~51 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~51 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 (FP and TP Safety Run-in): Number of Participants With Adverse Events (AEs)
Part 1 (FP and TP Safety Run-in): Number of Participants With Dose Limiting Toxicities (DLTs)
Part 1 (FP and TP Safety Run-in): Number of Participants who Discontinued Study Treatment Due to an AE
+2 more
Secondary outcome measures
Part 2 (Main Study): Change From Baseline in HRQoL Score Using EORTC Quality of Life Questionnaire-Oesophageal Module (QLQ-OES18)
Part 2 (Main Study): Change From Baseline in Health-related Quality of life (HRQoL) Score Using European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30)
Part 2 (Main Study): DOR per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS ≥10
+9 more

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680
51%
Neutropenia
47%
Leukopenia
46%
Nausea
43%
Vomiting
35%
Anaemia
31%
Decreased appetite
26%
Haemoglobin decreased
26%
Fatigue
25%
Constipation
25%
White blood cell count decreased
24%
Neutrophil count decreased
19%
Alanine aminotransferase increased
13%
Platelet count decreased
12%
Rash
10%
Aspartate aminotransferase increased
10%
Thrombocytopenia
9%
Blood sodium decreased
8%
Hypokalaemia
7%
Insomnia
7%
Pyrexia
6%
Hyponatraemia
6%
Blood creatinine increased
6%
Lymphopenia
6%
Diarrhoea
6%
Dyspepsia
6%
Red blood cell count decreased
6%
Cough
4%
Dizziness
2%
Bone marrow failure
1%
Cerebral infarction
1%
Ischaemic stroke
1%
Dyspnoea
1%
Pulmonary embolism
1%
Embolism venous
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gemcitabine Plus Cisplatin (GC)
Pemetrexed Plus Cisplatin (PC)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Pembrolizumab + Lenvatinib + ChemotherapyExperimental Treatment8 Interventions
Participants receive pembrolizumab intravenously (IV) plus lenvatinib orally in combination with FP or TP in Part 1, or in combination with investigator's choice of chemotherapy with FP IV or TP IV or oxaliplatin, 5-FU and leucovorin (mFOLFOX6) IV in Part 2. Induction consists of pembrolizumab 400 mg once every 6-weeks (Q6W) for up to ~12 weeks plus lenvatinib 8 mg once daily (QD) for up to ~12 weeks plus chemotherapy with FP (cisplatin 80 mg/m^2 and 5-FU 4000 mg/m^2) or TP (paclitaxel 175 mg/m^2 and cisplatin 75 mg/m^2) once every 3 weeks (Q3W) for up to ~12 weeks or mFOLFOX6 (oxaliplatin 85 mg/m^2, 5-FU 400 mg/m^2 followed by 2400 mg/m^2, and leucovorin 400 mg/m^2 [or levoleucovorin 200 mg/m^2] once every 2 weeks [Q2W] for up to ~12 weeks). This is followed by consolidation with pembrolizumab 400 mg Q6W for up to 16 cycles (each cycle = 6 weeks; total pembrolizumab treatment duration is ~2 years) plus lenvatinib 20 mg QD until progressive disease or discontinuation.
Group II: Pembrolizumab + ChemotherapyActive Control7 Interventions
Participants receive pembrolizumab 400 mg IV Q6W for up to 18 cycles (each cycle = 6 weeks; total pembrolizumab treatment duration is ~2 years) in combination with investigator's choice of chemotherapy with FP (cisplatin 80 mg/m^2 IV Q3W for up to 6 administrations [up to ~18 weeks] and 5-FU 4000 mg/m^2 IV Q3W for up to 35 administrations [up to ~2 years]) or TP (paclitaxel 175 mg/m^2 and cisplatin 75 mg/m^2 Q3W for up 6 administrations [up to ~18 weeks]) or in combination with mFOLFOX6 (oxaliplatin 85 mg/m^2, 5-FU 400 mg/m^2 followed by 2400 mg/m^2 and leucovorin 400 mg/m^2 [or levoleucovorin 200 mg/m^2] IV Q2W for up to 52 administrations [approximately 2 years]), during Part 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Levoleucovorin
2019
Completed Phase 2
~20
Oxaliplatin
2011
Completed Phase 4
~2560
Leucovorin
2005
Completed Phase 4
~5730
Paclitaxel
2011
Completed Phase 4
~5380
Pembrolizumab
2017
Completed Phase 2
~2010
Lenvatinib
2005
Completed Phase 4
~2690
Cisplatin
2013
Completed Phase 3
~1940
5-FU
2014
Completed Phase 3
~3420

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,580,958 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,869 Previous Clinical Trials
5,051,047 Total Patients Enrolled
Eisai Inc.Industry Sponsor
515 Previous Clinical Trials
153,223 Total Patients Enrolled

Media Library

5-FU (Fluoropyrimidine-based Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04949256 — Phase 3
Esophageal Cancer Research Study Groups: Pembrolizumab + Lenvatinib + Chemotherapy, Pembrolizumab + Chemotherapy
Esophageal Cancer Clinical Trial 2023: 5-FU Highlights & Side Effects. Trial Name: NCT04949256 — Phase 3
5-FU (Fluoropyrimidine-based Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04949256 — Phase 3

Frequently Asked Questions

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

Are there harmful side effects associated with Cisplatin?

"There is both prior clinical data and multiple rounds of supportive data, so Cisplatin received a score of 3 for safety."

Answered by AI

For what medical condition is Cisplatin most often prescribed?

"Cisplatin is commonly used to treat aggressive cancers. However, it has also been shown to be effective against microsatellite instability high and rectal carcinoma."

Answered by AI

Is there still room for new volunteers in this research project?

"Yes, the trial is ongoing and you can find more information about it on clinicaltrials.gov. This particular research project was posted on July 28th 2021 and updated November 17th of this year. They are looking for 862 participants total from 9 different locations."

Answered by AI

How many people can join this study at most?

"Yes, you're right. The trial was originally posted on 7/28/2021 and is still recruiting patients, as indicated by an update on 11/17/2022. They are looking for 862 individuals total from 9 different locations."

Answered by AI

Does Cisplatin have a history of being tested in other medical studies?

"At present, there are a total of 2144 Cisplatin studies underway. 527 of those trials are currently in Phase 3. While the majority of Cisplatin trials are based in Guangzhou, Guangdong, there are 90871 locations running these sorts of studies."

Answered by AI

At how many facilities can people participate in this clinical trial?

"Across 9 different locations, this trial is currently underway. If you're interested in enrolling and would like to minimize travel, it may be helpful for you to choose a site near Louisville, New york or Seattle."

Answered by AI

What are the goals of this clinical trial?

"The primary outcome for this trial is the number of participants with dose-limiting toxicities (DLTs) over a period of up to 21 days. Secondary outcomes include the duration of response (DOR) in participants with PD-L1 CPS ≥10, time to deterioration (TTD) in HRQoL score using EORTC QLQ-C30, and overall survival (OS) in participants with PD-L1 CPS ≥10."

Answered by AI
~325 spots leftby Dec 2025