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Chemotherapy

Pembrolizumab + Trastuzumab + Chemotherapy for Gastric Cancer

Phase 3

Waitlist Available

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic HER2 positive gastric or GEJ adenocarcinoma

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 trial treatment

Must not have

Has had previous therapy for locally advanced unresectable or metastatic gastric/GEJ cancer

Has a known additional malignancy that is progressing or has required active treatment within the past 5 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 5 years

Awards & highlights

Pivotal Trial

Summary

This trial will compare the efficacy of two different treatments for HER2-positive gastric cancer. The first treatment is pembrolizumab in combination with standard chemotherapy, and the second is trastuzumab in combination with standard chemotherapy. The hypothesis of the study is that pembrolizumab is superior to trastuzumab in terms of progression free survival and overall survival.

Who is the study for?

This trial is for adults with untreated advanced HER2+ gastric or GEJ adenocarcinoma. Participants must have measurable disease, be in good physical condition (ECOG 0-1), and expect to live more than 6 months. They should have proper organ function and agree to use contraception. Exclusions include recent radiotherapy, other active cancers within 5 years, autoimmune diseases treated in the past 2 years, infections needing systemic therapy, poorly controlled diarrhea, significant cardiac issues or hypersensitivities.

What is being tested?

The study tests if pembrolizumab plus trastuzumab with standard chemotherapy works better for HER2+ gastric cancer than just trastuzumab with chemotherapy. It measures how long patients live without their cancer getting worse (PFS) and overall survival (OS). Patients are randomly assigned to receive either the new combination of drugs or the current standard treatment.

What are the potential side effects?

Possible side effects include allergic reactions to medication components, immune system complications that may affect organs like lungs or intestines (pneumonitis/diarrhea), blood disorders from chemotherapy agents used in treatment such as Capecitabine and Cisplatin/Oxaliplatin/5-FU/S-1.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is advanced stomach or GEJ cancer that has not been treated and is HER2 positive.

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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 HER2-positive, confirmed by specific tests on my tumor.

Exclusion Criteria

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

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I have received treatment for advanced stomach cancer that cannot be surgically removed.

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I have another cancer that has gotten worse or needed treatment in the last 5 years.

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I have mild to severe nerve damage.

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I have been diagnosed with HIV.

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I frequently have severe diarrhea that is hard to control.

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I am currently being treated for an infection.

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I am a woman of childbearing potential and my recent pregnancy test was negative.

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

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I have a heart condition that affects my daily life.

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

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I have an active tuberculosis infection.

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

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I have been treated with specific immune therapy for cancer.

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

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I have an immune system disorder or am on long-term steroids.

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I have undergone radiotherapy in the last 14 days.

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I haven't had major surgery or serious injury in the last 28 days and don't expect to need major surgery while on the study treatment.

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I have cancer that has spread to my brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Overall Survival (OS)

Progression Free Survival (PFS) per RECIST 1.1 assessed by BICR

Secondary study objectives

Adverse Events (AE)

Duration of Response (DOR) per RECIST 1.1 assessed by BICR

Objective Response Rate (ORR) per RECIST 1.1 assessed by BICR

+1 more

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Systemic infection

Clostridium difficile colitis

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab + CRT Followed by Pembrolizumab

Placebo + CRT Followed by Placebo

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

Active Control

Group I: Pembrolizumab +Trastuzumab + ChemotherapyExperimental Treatment7 Interventions

Participants receive 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy (Global Cohort) or SOX chemotherapy (Japan cohort).

Group II: Placebo +Trastuzumab + ChemotherapyActive Control7 Interventions

Participants receive matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy (Global Cohort) or SOX chemotherapy (Japan cohort).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

Cisplatin

2013

Completed Phase 3

~3120