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Monoclonal Antibodies

Pembrolizumab for Small Intestinal Cancer

Phase 2

Waitlist Available

Led By Robert McWilliams

Research Sponsored by Academic and Community Cancer Research United

Eligibility Criteria Checklist

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

Must have

Female subjects of childbearing potential must have a negative pregnancy test and agree to use birth control methods or abstain from heterosexual activity during the study and for 120 days after the last dose of study medication

Must have Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Must not have

Diagnosis of immunodeficiency or receiving systemic steroid therapy or immunosuppressive therapy within 7 days prior to registration

Known additional malignancy that is progressing or requires active treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year (up to 18 cycles)

Awards & highlights

No Placebo-Only Group

Summary

This trial will test how well pembrolizumab works on patients with small bowel adenocarcinoma that has spread or can't be removed by surgery.

Who is the study for?

This trial is for patients with small bowel adenocarcinoma that has spread or can't be surgically removed. Participants must have had prior chemotherapy, adequate organ function, and no recent use of other investigational drugs. They should not have autoimmune diseases, active infections, or a history of certain cancers.

What is being tested?

The effectiveness of pembrolizumab, a monoclonal antibody designed to block cancer growth by interfering with tumor cells' ability to evade the immune system. This phase II trial will assess its impact on advanced small bowel adenocarcinoma.

What are the potential side effects?

Pembrolizumab may cause immune-related side effects such as inflammation in various organs including lungs (pneumonitis), liver problems, skin reactions, hormone gland issues (like thyroid dysfunction), 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 pregnant, will use birth control, or abstain from sex during and for 120 days after 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 in the small bowel and cannot be removed or has spread.

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My liver and kidney tests are within the required ranges.

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My cancer is a type of small bowel adenocarcinoma, not related to the ampulla of Vater or appendix.

Exclusion Criteria

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

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I have an immune system disorder or have been on steroids or immune-suppressing drugs in the last week.

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I have another cancer that is getting worse or needs treatment.

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My cancer started in the ampulla or appendix.

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I have or had lung inflammation not caused by an infection.

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I have not received a live vaccine in the last 30 days.

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My cancer is not adenocarcinoma.

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

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I have had active tuberculosis in the past.

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I am currently on medication for an infection.

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

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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 ~ 1 year (up to 18 cycles)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year (up to 18 cycles)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year (up to 18 cycles) 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 Confirmed Response Rate

Secondary study objectives

Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Events Regardless of Attribution

Overall Survival

Progression Free Survival

Other study objectives

Tumor Markers

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

Clostridium difficile colitis

Systemic infection

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

Placebo + CRT Followed by Placebo

Pembrolizumab + CRT Followed by Pembrolizumab

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)Experimental Treatment2 Interventions

Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~2810

0 / 16Eligibility criteria met