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Pembrolizumab for Esophageal Cancer

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

Is not expected to require tumor resection during the course of the study

Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 3 days of the first dose of study treatment

Must not have

Has received any prior systemic anticancer therapy for esophageal cancer including investigational agents

Has had major surgery other than for insertion of a feeding tube, open biopsy, or significant traumatic injury within 28 days prior to randomization, or anticipates the need for major surgery during study treatment; participants with gastric or esophageal fistulae are excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to ~72 months

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new cancer treatment that may be more effective and have fewer side effects than the current standard of care.

Who is the study for?

This trial is for adults with esophageal cancer who can't have surgery, are not pregnant or breastfeeding, and agree to use effective contraception. They should be in good physical condition (ECOG 0-1), have proper organ function, and no recent heart attacks or active infections like HIV or hepatitis.

What is being tested?

The study tests if adding pembrolizumab to standard chemoradiotherapy improves survival compared to a placebo plus the same therapy. It focuses on patients whose tumors express certain levels of PD-L1 protein.

What are the potential side effects?

Pembrolizumab may cause immune system-related side effects such as inflammation in various organs, skin reactions, hormone gland problems (like thyroid issues), and infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not expected to need surgery to remove a tumor during the study.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer is confirmed and located in the esophagus or gastroesophageal junction, without distant spread, or it's in the upper esophagus with only neck lymph node spread.

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I am not pregnant or breastfeeding.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had treatment for esophageal cancer before.

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I haven't had major surgery in the last 28 days and don't expect to need any during the study.

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I have been treated for an autoimmune disease in the last 2 years.

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I have had pneumonitis treated with steroids or have it now.

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I have received chemotherapy or radiotherapy for esophageal cancer.

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I have been treated with specific immune system targeting drugs before.

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I have received an organ or tissue transplant from another person.

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I am highly allergic to pembrolizumab or any of the study drugs.

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I have a history of Hepatitis B or active Hepatitis C.

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I have an active tuberculosis infection.

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I have an immune system disorder or have been on steroids or other immune-weakening medicines recently.

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I had a heart attack in the last 6 months.

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My tumor has spread to nearby organs or major blood vessels.

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I am currently being treated for an infection with medication.

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I have recovered from side effects of previous treatments to my normal or mild condition.

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I have symptoms of heart failure.

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I have lost more than 20% of my weight in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to ~72 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to ~72 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~72 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Event-free Survival (EFS)

Overall Survival (OS)

Secondary study objectives

Number of participants discontinuing study treatment due to an adverse event (AE)

Number of participants with an adverse event (AE)

Side effects data

From 2024 Phase 3 trial • 453 Patients • NCT03062358

36%

Aspartate aminotransferase increased

30%

Alanine aminotransferase increased

28%

Blood bilirubin increased

21%

Platelet count decreased

18%

Gamma-glutamyltransferase increased

17%

White blood cell count decreased

17%

Pyrexia

16%

Diarrhoea

15%

Anaemia

15%

Decreased appetite

15%

Rash

14%

Blood alkaline phosphatase increased

14%

Neutrophil count decreased

12%

Hypoalbuminaemia

12%

Pruritus

11%

Cough

11%

Upper respiratory tract infection

10%

Proteinuria

10%

Hypothyroidism

10%

Lymphocyte count decreased

Constipation

Arthralgia

Weight decreased

Abdominal pain

Nausea

Bilirubin conjugated increased

Insomnia

Asthenia

Fatigue

Hyperglycaemia

Hypokalaemia

Hyponatraemia

Hypoproteinaemia

Back pain

Hypertension

Vomiting

Abdominal distension

Blood lactate dehydrogenase increased

Hyperthyroidism

Ascites

Abdominal pain upper

Hepatitis B DNA increased

Malaise

Blood glucose increased

Blood creatinine increased

Upper gastrointestinal haemorrhage

Pneumonia

Dyspepsia

Gastrointestinal haemorrhage

Autoimmune hepatitis

Hepatic failure

Hepatitis E

Influenza

Sepsis

Tumour haemorrhage

Hepatic encephalopathy

Pneumonitis

Dysphonia

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab (First Course) + BSC

Placebo + BSC

Pembrolizumab Second Course

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Pembrolizumab+FP or FOLFOX Therapy+RadiotherapyExperimental Treatment7 Interventions

Participants receive pembrolizumab 200 mg on Day 1 of each 3-week cycle for 8 cycles followed by pembrolizumab 400 mg on Day 1 of each 6-week cycle for 5 cycles PLUS either: * FP therapy: cisplatin 75 mg/m\^2 on Day 1 of Weeks 1, 5, 8 and 11 PLUS 5-fluorouracil (5-FU)\] 1000 mg/m\^2 per day on Days 1-4 of Weeks 1, 5, 8 and 11 OR 800 mg/m\^2/day on each of Days 1-5 at Weeks 1, 5, 8, and 11 PLUS radiotherapy (either 50 Gray \[Gy\] in 25 fractions OR 60 Gy in 30 fractions) on Days 1-5 of each 3-week cycle OR * FOLFOX therapy: oxaliplatin 85 mg/m\^2 AND either leucovorin 400 mg/m\^2 OR levoleucovorin 200 mg/m\^2 on Day 1 of Weeks 1, 3, 5, 7, 9 and 11 PLUS either 5-FU 400 mg/m\^2 on Day 1 of Weeks 1, 3, 5, 7, 9 and 11 OR 5-FU 800 mg/m\^2 per day on Days 1 and 2 of Weeks 1, 3, 5, 7, 9 and 11 PLUS radiotherapy (50 Gy in 25 fractions) on Days 1-5 of each 3-week cycle. All treatments except radiotherapy are given by intravenous (IV) infusion. Total treatment duration is approximately 1 year.

Group II: Placebo+FP or FOLFOX Therapy+RadiotherapyPlacebo Group7 Interventions

Participants receive placebo on Day 1 of each 3-week cycle for 8 cycles followed by placebo on Day 1 of each 6-week cycle for 5 cycles PLUS either: * FP therapy: cisplatin 75 mg/m\^2 on Day 1 of Weeks 1, 5, 8 and 11 PLUS 5-FU 1000 mg/m\^2 per day on Days 1-4 of Weeks 1, 5, 8 and 11 OR 800 mg/m\^2/day on each of Days 1-5 at Weeks 1, 5, 8, and 11 PLUS radiotherapy (either 50 Gy in 25 fractions OR 60 Gy in 30 fractions) on Days 1-5 of each 3-week cycle OR * FOLFOX therapy: oxaliplatin 85 mg/m\^2 AND either leucovorin 400 mg/m\^2 OR levoleucovorin 200 mg/m\^2 on Day 1 of Weeks 1, 3, 5, 7, 9 and 11 PLUS either 5-FU 400 mg/m\^2 on Day 1 of Weeks 1, 3, 5, 7, 9 and 11 OR 5-FU 800 mg/m\^2 per day on Days 1 and 2 of Weeks 1, 3, 5, 7, 9 and 11 PLUS radiotherapy (50 Gy in 25 fractions) on Days 1-5 of each 3-week cycle. All treatments except radiotherapy are given by IV infusion. Total treatment duration is approximately 1 year.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

pembrolizumab

2017

Completed Phase 3

~5890

5-FU

2014

Completed Phase 3

~3100