A Phase 3 interventional study of Pembrolizumab and Lenvatinib in Metastatic Esophageal Squamous Cell Carcinoma, sponsored by Merck Sharp & Dohme LLC. Terminated at 198 sites in 25 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 3, Interventional, and Treatment
Among 401 studies in Esophageal Squamous Cell Carcinoma with a site in China — 174 open to participants now, 213 under way, 32 of them phase 3. Esophageal Squamous Cell Carcinoma · China.
Among the 401 studies in Esophageal Squamous Cell Carcinoma with a site in China, this one is the 8th largest by enrollment of the 351 interventional ones that give a count, is one of 33 that started in 2021, is one of 52 in phase 3, and was the 161st registered.
676 studies on the registry are indexed under Esophageal Squamous Cell Carcinoma; 267 are open to participants now.
Browse Esophageal Squamous Cell Carcinoma studies →174 of the 401 studies in Esophageal Squamous Cell Carcinoma with a site in China are open now. Recruiting first, the newest first:
Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Sites in China
Ages 18–75
Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Sites in China
Ages 18–80
Second Affiliated Hospital, Zhejiang University, School of Medicine · Sites in China
Ages 18–75
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Sites in China
Ages 18–75
Sun Yat-sen University · Sites in China
Ages 18–75
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 180 Esophageal Squamous Cell Carcinoma studies recruiting now, 83 (46%) set no upper age limit and 76 (42%) stop at 75 or younger; 3 take children under 18; 8 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
401 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 40 · Phase 2 239 · Phase 3 62 · Phase 4 1
First in 1999; this study’s year is marked. 33 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 863 is above the median of 64 across 563 interventional studies indexed under Esophageal Squamous Cell Carcinoma.
Median enrollment 70 across the 351 interventional studies, 205 across the 50 observational. Of the 92 that completed or were terminated, 11 (12%) have results posted.
This tab as a report to print or save as PDF → With an account.
49 of 401 have an industry lead sponsor. The 10 most frequent:
This study is registered under Merck Sharp & Dohme LLC, one of the names counted as Merck & Co., Inc. Under that name alone:
Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 131 are open to participants now.
Of its 502 completed or terminated interventional studies of FDA-regulated products, 370 (74%) have results posted.
Merck & Co., Inc has 6 studies filed under Esophageal Squamous Cell Carcinoma — fewer than ten, so there is no comparison to draw.
45 of the studies in Esophageal Squamous Cell Carcinoma with a site in China that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06194734Phase 3Beijing Konruns Pharmaceutical Co., Ltd.A Study of KC1036 Versus Investigator's Choice of Chemotherapy in Patients With Advanced Esophageal Cancer | 2026-12-30 |
| NCT06907602Phase 3Peking Union Medical College HospitalOptimizing Neoadjuvant Treatment Regimens for Locally Advanced Esophageal Squamous Cell Carcinoma | 2026-12-31 |
| NCT04848753Phase 3Shanghai Junshi Bioscience Co., Ltd.Perioperative Toripalimab (JS001) Combined With Neoadjuvant Chemotherapy in Patients With Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma | 2027-05-12 |
| NCT04550260Phase 3AstraZenecaStudy of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC | 2027-06-30 |
| NCT07016737Phase 3Ye jinjunImmunochemotherapy ± Salvage Chemoradiation for Local Recurrence of Esophageal Squamous Cell Carcinoma After Definitive Chemoradiotherapy | 2027-09-01 |
Add all 45 to your calendar (.ics) → With an account.
Among the 401 studies in Esophageal Squamous Cell Carcinoma with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to assess the efficacy and safety of pembrolizumab plus lenvatinib plus chemotherapy compared with pembrolizumab plus chemotherapy as first-line intervention in participants with metastatic esophageal carcinoma.
The primary hypotheses are that pembrolizumab plus lenvatinib plus chemotherapy is superior to pembrolizumab plus chemotherapy with respect to overall survival (OS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).
As of Amendment 09, Study MK-7902-014 will begin close out activities. Any participant who discontinues study intervention for any reason will be discontinued from the study without further follow-up. Second Course and treatment beyond disease progression will no longer be offered. No safety concerns contributed to the termination of this study.
There will be 2 parts to the study: the cisplatin and 5-fluorouracil (5-FU) (FP) and paclitaxel and cisplatin (TP) Safety Run-in (Part 1) and the Main Study (Part 2). In Part 1 (FP and TP Safety Run-in), participants will be treated with pembrolizumab plus lenvatinib plus FP or TP. Dose-limiting toxicities, safety, and tolerability will be assessed.
In Part 2 (Main Study), participants (not including those participating in Part 1) will be treated with pembrolizumab plus lenvatinib plus chemotherapy or pembrolizumab plus chemotherapy. Efficacy, safety, and tolerability will be assessed.
The protocol-specified analysis of the primary outcome measures was completed with a data cut-off of 08-May-2025 (Primary Completion Date) and served as the final analysis of the primary outcome measures. At the time of the protocol-specified analysis, 368 participants were ongoing in the study and will be included in the End of Trial analysis.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In the Induction phase, participants receive pembrolizumab 400mg intravenously (IV) every 6 weeks (Q6W) for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg orally (PO) once daily (QD) plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations at the investigator's discretion (approximately 12 weeks). In the Consolidation phase, participants receive pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks).
Biological: Pembrolizumab · Drug: Lenvatinib · Drug: Cisplatin · Drug: 5-FU · Drug: Paclitaxel
In the Induction phase, participants receive pembrolizumab 400mg intravenously (IV) every 6 weeks (Q6W) for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg orally (PO) once daily (QD) 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) IV every 3 weeks for 4 administrations 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 6 administrations at the investigator's discretion (approximately 12 weeks). In the Consolidation phase, participants receive pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks).
Biological: Pembrolizumab · Drug: Lenvatinib · Drug: Cisplatin · Drug: 5-FU · Drug: Oxaliplatin · Drug: Leucovorin · Drug: Levoleucovorin · Drug: Paclitaxel
Participants receive pembrolizumab 400 mg IV every 6 weeks for 18 cycles (each cycle length = 6 weeks, approximately 2 years) plus 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 \[approximately 2 years\]).
Biological: Pembrolizumab · Drug: 5-FU · Drug: Oxaliplatin · Drug: Leucovorin · Drug: Levoleucovorin · Drug: Paclitaxel
400 mg once every 6-week-cycle, via IV infusion.
Also known as: MK-3475, KEYTRUDA®
8 mg QD (Induction) or 20 mg QD (Consolidation) via oral capsule.
Also known as: MK-7902, E7080, LENVIMA®
80 mg/m\^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy or 75 mg/m\^2 Q3W via infusion, as part of investigator's choice TP chemotherapy.
Also known as: PLATINOL®
4000 mg/m\^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy or 400 mg/m\^2 Q2W via bolus IV infusion followed by 2400 mg/m\^2 Q2W via continuous IV infusion, as part of investigator's choice mFOLFOX6 chemotherapy.
Also known as: ADRUCIL®
85 mg/m\^2 Q2W via IV infusion, as part of investigator's choice mFOLFOX6 chemotherapy.
Also known as: ELOXATIN®
400 mg/m\^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.
Also known as: calcium folinate, folinic acid, WELLCOVORIN®
200 mg/m\^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.
Also known as: calcium levofolinate, levofolinic acid, FUSILEV®
175 mg/m\^2 Q3W via IV infusion, as part of investigator's choice TP chemotherapy.
Also known as: TAXOL®, ONXAL®
Part 1 (FP and TP Safety Run-in): Number of Participants With Dose Limiting Toxicities (DLTs)
A DLT is defined as a specific adverse event graded for toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Hematologic DLTs are defined as Grade 4 neutropenia lasting for ≥7 days, Grade 3 or Grade 4 febrile neutropenia, Grade 3 thrombocytopenia with bleeding, Grade 4 thrombocytopenia, or Grade 4 anemia. Other nonhematologic toxicities considered a DLT include any other Grade 4 or Grade 5 toxicity, Grade 3 toxicities lasting \>3 days (excluding nausea, vomiting, and diarrhea controlled by medical intervention within 72 hours, and Grade 3 rash in the absence of desquamation with no mucosal involvement), Grade 3 hypertension not able to be controlled by medication, ≥Grade 3 gastrointestinal perforation, ≥Grade 3 wound dehiscence requiring medical or surgical intervention, any grade thromboembolic event or any Grade 3 nonhematologic laboratory value requiring medical intervention or hospitalization. The number of participants in Part 1 with DLTs are presented.
Time frame: Up to 21 days
Part 1 (FP and TP Safety Run-in): Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants in Part 1 with AEs will be presented.
Time frame: Up to 43 months
Part 1 (FP and TP Safety Run-in): Number of Participants Who Discontinued Study Treatment Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants in Part 1 who discontinue study treatment due to an AE will be presented.
Time frame: Up to 22 months
Part 2 (Main Study): Overall Survival (OS) in All Participants
OS is defined as the time from randomization to death due to any cause. OS in Part 2 for all randomized participants are presented based on the Kaplan-Meier method for censored data.
Time frame: Up to 42 months
Part 2 (Main Study): Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in All Participants
PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. RECIST 1.1 has been adjusted to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. PFS in Part 2 for all randomized participants are presented based on the Kaplan-Meier method for censored data.
Time frame: Up to 42 months
Part 2 (Main Study): Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR in All Participants
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions), per RECIST 1.1 adjusted to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, as assessed by BICR. ORR in Part 2 for all randomized participants are presented.
Time frame: Up to 42 months
Part 2 (Main Study): Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR in All Participants
For participants who demonstrate a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), per RECIST 1.1 by BICR, DOR is defined as the time from first documented evidence of CR or PR until PD or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. RECIST 1.1 has been adjusted to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. DOR in Part 2 for all randomized participants are presented based on the Kaplan-Meier method for censored data.
Time frame: Up to 42 months
Part 2 (Main Study): OS in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10
OS is defined as the time from randomization to death due to any cause. OS in Part 2 for randomized participants with PD-L1 CPS ≥10 are presented based on the Kaplan-Meier method for censored data.
Time frame: Up to 42 months
Part 2 (Main Study): PFS Per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS ≥10
PFS is defined as the time from randomization to the first documented PD per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. RECIST 1.1 has been adjusted to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. PFS in Part 2 for randomized participants with PD-L1 CPS ≥10 are presented based on the Kaplan-Meier method for censored data.
Time frame: Up to 42 months
Part 2 (Main Study): ORR Per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS ≥10
ORR is defined as the percentage of participants with CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), per RECIST 1.1 adjusted to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, as assessed by BICR. ORR in Part 2 for randomized participants with PD-L1 CPS ≥10 are presented.
Time frame: Up to 42 months
Part 2 (Main Study): DOR Per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS ≥10
For participants who demonstrate a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), per RECIST 1.1 by BICR, DOR is defined as the time from first documented evidence of CR or PR until PD or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. RECIST 1.1 has been adjusted to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. DOR in Part 2 for randomized participants with PD-L1 CPS ≥10 are presented based on the Kaplan-Meier method for censored data.
Time frame: Up to 42 months
Part 2 (Main Study): Number of Participants With AEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants in Part 2 with AEs are presented.
Time frame: Up to 43 months
Part 2 (Main Study): Number of Participants Who Discontinued Study Treatment Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants in Part 2 who discontinue study treatment due to an AE are presented.
Time frame: Up to 22 months
Participants with the following conditions were included in the study: if they had a confirmed diagnosis of metastatic squamous cell carcinoma of the esophagus and measurable disease; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; submitted a tumor tissue sample; had adequately controlled blood pressure; and had adequate organ function.
| Milestone | Part 1: Pembrolizumab + Lenvatinib + Chemotherapy | Part 2: Pembrolizumab + Lenvatinib + Chemotherapy | Part 2: Pembrolizumab + Chemotherapy |
|---|---|---|---|
| Started | 13 | 423 | 427 |
| First course | 13 | 421 | 426 |
| Second course | 0 | 1 | 0 |
| Completed | 0 | 0 | 0 |
| Not completed | 13 | 423 | 427 |
| Withdrew: Death | 12 | 234 | 240 |
| Withdrew: Physician decision | 0 | 0 | 2 |
| Withdrew: Withdrawal by subject | 0 | 3 | 4 |
| Withdrew: Ongoing | 1 | 186 | 181 |
A DLT is defined as a specific adverse event graded for toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Hematologic DLTs are defined as Grade 4 neutropenia lasting for ≥7 days, Grade 3 or Grade 4 febrile neutropenia, Grade 3 thrombocytopenia with bleeding, Grade 4 thrombocytopenia, or Grade 4 anemia. Other nonhematologic toxicities considered a DLT include any other Grade 4 or Grade 5 toxicity, Grade 3 toxicities lasting \>3 days (excluding nausea, vomiting, and diarrhea controlled by medical intervention within 72 hours, and Grade 3 rash in the absence of desquamation with no mucosal involvement), Grade 3 hypertension not able to be controlled by medication, ≥Grade 3 gastrointestinal perforation, ≥Grade 3 wound dehiscence requiring medical or surgical intervention, any grade thromboembolic event or any Grade 3 nonhematologic laboratory value requiring medical intervention or hospitalization. The number of participants in Part 1 with DLTs are presented.
| Participants | Part 1: Pembrolizumab + Lenvatinib + Chemotherapy | Part 2: Pembrolizumab + Lenvatinib + Chemotherapy | Part 2: Pembrolizumab + Chemotherapy |
|---|---|---|---|
| Part 1 (FP and TP Safety Run-in): Number of Participants With Dose Limiting Toxicities (DLTs) | 2 | — | — |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants in Part 1 with AEs will be presented.
| Participants | Part 1: Pembrolizumab + Lenvatinib + Chemotherapy | Part 2: Pembrolizumab + Lenvatinib + Chemotherapy | Part 2: Pembrolizumab + Chemotherapy |
|---|---|---|---|
| Part 1 (FP and TP Safety Run-in): Number of Participants With Adverse Events (AEs) | 13 | — | — |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants in Part 1 who discontinue study treatment due to an AE will be presented.
| Participants | Part 1: Pembrolizumab + Lenvatinib + Chemotherapy | Part 2: Pembrolizumab + Lenvatinib + Chemotherapy | Part 2: Pembrolizumab + Chemotherapy |
|---|---|---|---|
| Part 1 (FP and TP Safety Run-in): Number of Participants Who Discontinued Study Treatment Due to an AE | 7 | — | — |
OS is defined as the time from randomization to death due to any cause. OS in Part 2 for all randomized participants are presented based on the Kaplan-Meier method for censored data.
| Months | Part 1: Pembrolizumab + Lenvatinib + Chemotherapy | Part 2: Pembrolizumab + Lenvatinib + Chemotherapy | Part 2: Pembrolizumab + Chemotherapy |
|---|---|---|---|
| Part 2 (Main Study): Overall Survival (OS) in All Participants | — | 17.6 (15.5 to 19.1) | 15.5 (13.5 to 17.2) |
PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. RECIST 1.1 has been adjusted to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. PFS in Part 2 for all randomized participants are presented based on the Kaplan-Meier method for censored data.
| Months | Part 1: Pembrolizumab + Lenvatinib + Chemotherapy | Part 2: Pembrolizumab + Lenvatinib + Chemotherapy | Part 2: Pembrolizumab + Chemotherapy |
|---|---|---|---|
| Part 2 (Main Study): Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in All Participants | — | 7.2 (6.8 to 8.4) | 6.9 (5.8 to 7.0) |
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions), per RECIST 1.1 adjusted to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, as assessed by BICR. ORR in Part 2 for all randomized participants are presented.
| Percentage of participants | Part 1: Pembrolizumab + Lenvatinib + Chemotherapy | Part 2: Pembrolizumab + Lenvatinib + Chemotherapy | Part 2: Pembrolizumab + Chemotherapy |
|---|---|---|---|
| Part 2 (Main Study): Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR in All Participants | — | 62.2 (57.4 to 66.8) | 54.8 (49.9 to 59.6) |
For participants who demonstrate a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), per RECIST 1.1 by BICR, DOR is defined as the time from first documented evidence of CR or PR until PD or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. RECIST 1.1 has been adjusted to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. DOR in Part 2 for all randomized participants are presented based on the Kaplan-Meier method for censored data.
| Months | Part 1: Pembrolizumab + Lenvatinib + Chemotherapy | Part 2: Pembrolizumab + Lenvatinib + Chemotherapy | Part 2: Pembrolizumab + Chemotherapy |
|---|---|---|---|
| Part 2 (Main Study): Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR in All Participants | — | 8.1 (6.9 to 9.7) | 6.8 (5.8 to 8.3) |
OS is defined as the time from randomization to death due to any cause. OS in Part 2 for randomized participants with PD-L1 CPS ≥10 are presented based on the Kaplan-Meier method for censored data.
| Months | Part 1: Pembrolizumab + Lenvatinib + Chemotherapy | Part 2: Pembrolizumab + Lenvatinib + Chemotherapy | Part 2: Pembrolizumab + Chemotherapy |
|---|---|---|---|
| Part 2 (Main Study): OS in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10 | — | 18.0 (16.4 to 20.4) | 15.8 (13.1 to 17.4) |
PFS is defined as the time from randomization to the first documented PD per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. RECIST 1.1 has been adjusted to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. PFS in Part 2 for randomized participants with PD-L1 CPS ≥10 are presented based on the Kaplan-Meier method for censored data.
| Months | Part 1: Pembrolizumab + Lenvatinib + Chemotherapy | Part 2: Pembrolizumab + Lenvatinib + Chemotherapy | Part 2: Pembrolizumab + Chemotherapy |
|---|---|---|---|
| Part 2 (Main Study): PFS Per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS ≥10 | — | 8.1 (6.9 to 9.5) | 6.9 (6.3 to 7.2) |
ORR is defined as the percentage of participants with CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), per RECIST 1.1 adjusted to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, as assessed by BICR. ORR in Part 2 for randomized participants with PD-L1 CPS ≥10 are presented.
| Percentage of participants | Part 1: Pembrolizumab + Lenvatinib + Chemotherapy | Part 2: Pembrolizumab + Lenvatinib + Chemotherapy | Part 2: Pembrolizumab + Chemotherapy |
|---|---|---|---|
| Part 2 (Main Study): ORR Per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS ≥10 | — | 62.5 (56.5 to 68.2) | 57.0 (51.0 to 62.9) |
For participants who demonstrate a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), per RECIST 1.1 by BICR, DOR is defined as the time from first documented evidence of CR or PR until PD or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. RECIST 1.1 has been adjusted to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. DOR in Part 2 for randomized participants with PD-L1 CPS ≥10 are presented based on the Kaplan-Meier method for censored data.
| Months | Part 1: Pembrolizumab + Lenvatinib + Chemotherapy | Part 2: Pembrolizumab + Lenvatinib + Chemotherapy | Part 2: Pembrolizumab + Chemotherapy |
|---|---|---|---|
| Part 2 (Main Study): DOR Per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS ≥10 | — | 9.7 (6.9 to 13.6) | 6.9 (5.7 to 8.3) |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants in Part 2 with AEs are presented.
Results for this outcome have not been posted.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants in Part 2 who discontinue study treatment due to an AE are presented.
Results for this outcome have not been posted.
Collected over All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part 1 Pembrolizumab + Lenvatinib + Chemotherapy First Course | 12/13 (92.3%) | 7/13 (53.8%) | 13/13 (100%) |
| Part 2 Pembrolizumab + Lenvatinib + Chemotherapy First Course | 236/423 (55.8%) | 224/421 (53.2%) | 412/421 (97.9%) |
| Part 2 Pembrolizumab + Chemotherapy First Course | 246/427 (57.6%) | 201/426 (47.2%) | 417/426 (97.9%) |
| Part 2 Pembrolizumab + Lenvatinib + Chemotherapy Second Course | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Part 2 Pembrolizumab + Chemotherapy Second Course | — | — | — |
| Event | Part 1 Pembrolizumab + Lenvatinib + Chemotherapy First Course | Part 2 Pembrolizumab + Lenvatinib + Chemotherapy First Course | Part 2 Pembrolizumab + Chemotherapy First Course | Part 2 Pembrolizumab + Lenvatinib + Chemotherapy Second Course | Part 2 Pembrolizumab + Chemotherapy Second Course |
|---|---|---|---|---|---|
| PneumoniaInfections and infestations | 0/13 | 50/421 | 36/426 | 0/1 | — |
| Cardiac arrestCardiac disorders | 1/13 | 0/421 | 1/426 | 0/1 | — |
| Oesophageal fistulaGastrointestinal disorders | 1/13 | 4/421 | 2/426 | 0/1 | — |
| Enterocolitis infectiousInfections and infestations | 1/13 | 0/421 | 1/426 | 0/1 | — |
| Stoma site infectionInfections and infestations | 1/13 | 0/421 | 0/426 | 0/1 | — |
| Streptococcal bacteraemiaInfections and infestations | 1/13 | 0/421 | 0/426 | 0/1 | — |
| HyponatraemiaMetabolism and nutrition disorders | 1/13 | 1/421 | 1/426 | 0/1 | — |
| SyncopeNervous system disorders | 1/13 | 0/421 | 0/426 | 0/1 | — |
| Acute kidney injuryRenal and urinary disorders | 1/13 | 6/421 | 4/426 | 0/1 | — |
| DysphagiaGastrointestinal disorders | 0/13 | 26/421 | 20/426 | 0/1 | — |
| Event | Part 1 Pembrolizumab + Lenvatinib + Chemotherapy First Course | Part 2 Pembrolizumab + Lenvatinib + Chemotherapy First Course | Part 2 Pembrolizumab + Chemotherapy First Course | Part 2 Pembrolizumab + Lenvatinib + Chemotherapy Second Course | Part 2 Pembrolizumab + Chemotherapy Second Course |
|---|---|---|---|---|---|
| ColitisGastrointestinal disorders | 0/13 | 3/421 | 0/426 | 1/1 | — |
| DiarrhoeaGastrointestinal disorders | 8/13 | 161/421 | 95/426 | 0/1 | — |
| Neutrophil count decreasedInvestigations | 8/13 | 228/421 | 261/426 | 0/1 | — |
| AnaemiaBlood and lymphatic system disorders | 7/13 | 158/421 | 178/426 | 0/1 | — |
| HypothyroidismEndocrine disorders | 7/13 | 141/421 | 48/426 | 0/1 | — |
| FatigueGeneral disorders | 6/13 | 131/421 | 119/426 | 0/1 | — |
| HyponatraemiaMetabolism and nutrition disorders | 6/13 | 66/421 | 46/426 | 0/1 | — |
| NauseaGastrointestinal disorders | 5/13 | 189/421 | 193/426 | 0/1 | — |
| StomatitisGastrointestinal disorders | 5/13 | 129/421 | 70/426 | 0/1 | — |
| Decreased appetiteMetabolism and nutrition disorders | 5/13 | 137/421 | 115/426 | 0/1 | — |
| Age, Continuous(Years) | Part 1: Pembrolizumab + Lenvatinib + Chemotherapy | Part 2: Pembrolizumab + Lenvatinib + Chemotherapy | Part 2: Pembrolizumab + Chemotherapy | Total |
|---|---|---|---|---|
| Mean | 62.7 ± 10.0 | 63.5 ± 9.0 | 65.0 ± 8.2 | 64.2 ± 8.7 |
| Sex: Female, Male(Participants) | Part 1: Pembrolizumab + Lenvatinib + Chemotherapy | Part 2: Pembrolizumab + Lenvatinib + Chemotherapy | Part 2: Pembrolizumab + Chemotherapy | Total |
|---|---|---|---|---|
| Female | 0 | 92 | 93 | 185 |
| Male | 13 | 331 | 334 | 678 |
| Ethnicity (NIH/OMB)(Participants) | Part 1: Pembrolizumab + Lenvatinib + Chemotherapy | Part 2: Pembrolizumab + Lenvatinib + Chemotherapy | Part 2: Pembrolizumab + Chemotherapy | Total |
|---|---|---|---|---|
| Hispanic or Latino | 1 | 39 | 56 | 96 |
| Not Hispanic or Latino | 12 | 378 | 368 | 758 |
| Unknown or Not Reported | 0 | 6 | 3 | 9 |
| Race (NIH/OMB)(Participants) | Part 1: Pembrolizumab + Lenvatinib + Chemotherapy | Part 2: Pembrolizumab + Lenvatinib + Chemotherapy | Part 2: Pembrolizumab + Chemotherapy | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 6 | 8 | 14 |
| Asian | 11 | 279 | 285 | 575 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 3 | 4 |
| White | 2 | 131 | 130 | 263 |
| More than one race | 0 | 3 | 1 | 4 |
| Unknown or Not Reported | 0 | 3 | 0 | 3 |
| Region of Enrolling Site(Participants) | Part 1: Pembrolizumab + Lenvatinib + Chemotherapy | Part 2: Pembrolizumab + Lenvatinib + Chemotherapy | Part 2: Pembrolizumab + Chemotherapy | Total |
|---|---|---|---|---|
| East Asia | 11 | 278 | 281 | 570 |
| North America +Western Europe | 1 | 69 | 66 | 136 |
| Rest of World | 1 | 76 | 80 | 157 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status(Participants) | Part 1: Pembrolizumab + Lenvatinib + Chemotherapy | Part 2: Pembrolizumab + Lenvatinib + Chemotherapy | Part 2: Pembrolizumab + Chemotherapy | Total |
|---|---|---|---|---|
| ECOG 0 | 3 | 147 | 168 | 318 |
| ECOG 1 | 10 | 273 | 257 | 540 |
| Missing | 0 | 3 | 2 | 5 |
Showing the first 100 of 198 sites across 25 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Data sharing details ↗ · externaldatasharing-msd.com
Ran from Jul 2021 to primary completion in May 2025, 45 months.
Results were first posted in Jul 2026, 1 year 2 months after primary completion.
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Studies of the drug tested here: Lenvatinib
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