41 Participants Needed

Pembrolizumab for Small Intestinal Cancer

Recruiting at 7 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Academic and Community Cancer Research United
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase II trial studies how well pembrolizumab works in treating patients with small bowel adenocarcinoma that has spread to other places in the body or that cannot be removed by surgery. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.

Who Is on the Research Team?

RM

Robert McWilliams

Principal Investigator

Academic and Community Cancer Research United

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.
I am not pregnant, will use birth control, or abstain from sex during and for 120 days after the study.
Must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
See 7 more

Exclusion Criteria

My cancer started in the ampulla or appendix.
I have an immune system disorder or have been on steroids or immune-suppressing drugs in the last week.
I have recently used specific therapies or treatments.
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pembrolizumab intravenously over 30 minutes on day 1, with courses repeating every 21 days in the absence of disease progression or unacceptable toxicity

Up to 1 year (up to 18 cycles)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-ups every 3 months until disease progression, and then every 6 months for up to 5 years

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Pembrolizumab
Trial Overview 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.
How Is the Trial Designed?
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.

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

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Approved in United States as KEYTRUDA for:
  • Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS β‰₯1
  • Melanoma
  • Non-small cell lung cancer (NSCLC)
  • Urothelial carcinoma
  • Colorectal cancer
  • Gastric cancer
  • Hepatocellular carcinoma
  • Renal cell carcinoma
  • Cervical cancer
  • Endometrial carcinoma
πŸ‡ͺπŸ‡Ί
Approved in European Union as KEYTRUDA for:
  • Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS β‰₯1
  • Melanoma
  • Non-small cell lung cancer (NSCLC)
  • Urothelial carcinoma
  • Colorectal cancer
  • Gastric cancer
  • Hepatocellular carcinoma
  • Renal cell carcinoma
  • Cervical cancer
  • Endometrial carcinoma
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Approved in United Kingdom as KEYTRUDA for:
  • Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS β‰₯1

Find a Clinic Near You

Who Is Running the Clinical Trial?

Academic and Community Cancer Research United

Lead Sponsor

Trials
54
Recruited
4,900+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+
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