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Anti-metabolites

Pembrolizumab + Capecitabine + Radiation for Gastric Cancer

Phase 2

Recruiting

Led By Salma Jabbour

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

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

Must have

Mismatch repair deficiency as identified by immunohistochemistry or Epstein-Barr virus positivity

Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion

Must not have

Immunodeficiency, systemic steroid therapy, or immunosuppressive therapy within 7 days prior to treatment

History of pneumonitis requiring steroids or current pneumonitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing pembrolizumab with capecitabine and radiation therapy to treat gastric cancer.

Who is the study for?

This trial is for adults with operable gastric cancer that's mismatch repair deficient or Epstein-Barr virus positive. They must have certain blood and organ function levels, not be pregnant or breastfeeding, agree to use contraception, and have no history of specific treatments or conditions that could affect the trial.

What is being tested?

The study tests pembrolizumab (a monoclonal antibody) combined with capecitabine (chemotherapy) and radiation therapy. It aims to see if this combination is more effective in stopping the growth of tumor cells compared to current standard treatments.

What are the potential side effects?

Potential side effects include immune system reactions, fatigue, nausea from chemotherapy, skin irritation from radiation, as well as possible liver and kidney function changes. The severity can vary among patients.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is mismatch repair deficient or EBV positive.

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I am willing to undergo a biopsy to provide a tissue sample.

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My stomach cancer is at a stage that can be operated on.

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

Exclusion Criteria

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

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I have not taken steroids or immunosuppressants in the last week.

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

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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.

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My cancer has spread to other parts of my body.

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I have received treatments like chemotherapy or radiotherapy for stomach cancer before.

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I haven't had chemotherapy, targeted therapy, or radiation in the last 2 weeks.

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I have been diagnosed with active tuberculosis.

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I have a history of HIV or active hepatitis B or C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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

Recurrence-free survival (RFS) rate

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

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (pembrolizumab, capecitabine, radiation therapy)Experimental Treatment4 Interventions

Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Within 2-6 weeks, patients undergo surgery. Beginning up to 56 days after surgery, patients receive pembrolizumab IV over 30 minutes on day 1 and capecitabine PO BID on days 1-14. Treatment repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Within 2-6 weeks of resting, patients continue to receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 11 courses in the absence of disease progression or unacceptable toxicity. Beginning course 4, patients undergo radiation therapy over 15-30 minutes on days 1-5 for up to 5 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Capecitabine

2013

Completed Phase 3

~4280

Pembrolizumab

2017

Completed Phase 3

~3130

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor

455 Previous Clinical Trials

69,911 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,957 Previous Clinical Trials

41,112,047 Total Patients Enrolled

Salma Jabbour4.413 ReviewsPrincipal Investigator - Rutgers Cancer Institute of New Jersey

Rutgers Cancer Institute of New Jersey

2 Previous Clinical Trials

46 Total Patients Enrolled

5Patient Review

Dr. Jabbour is an attentive, considerate, and comprehensive physician who always puts her patients first. She is always available and provides top-notch care.