Pembrolizumab for Small Intestinal Cancer

Not currently recruiting at 9 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Academic and Community Cancer Research United

Must not be taking: Steroids, Immunosuppressants, others

Disqualifiers: Autoimmune disease, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 1 year (up to 18 cycles)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests pembrolizumab, a monoclonal antibody, to determine if it can stop small intestinal cancer from growing and spreading. It targets patients with small bowel adenocarcinoma that has spread or cannot be surgically removed. The trial seeks individuals diagnosed with this cancer who have already undergone at least one round of chemotherapy without full success. Participants will receive pembrolizumab through an IV every 21 days, provided their disease does not progress and they do not experience severe side effects. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot be on systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before joining the trial. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that pembrolizumab is likely to be safe for humans?

Research has shown that pembrolizumab, also known as Keytruda, maintains a consistent safety record across various uses. Common side effects include tiredness, muscle pain, rash, diarrhea, fever, and cough, affecting about 20% or more of patients. One study focused on patients with small intestinal cancer found that 59% experienced side effects, which varied in severity.

Keytruda is already approved for treating other types of cancer, indicating it is generally well-tolerated. Side effects can differ from person to person, so discussing potential risks with a healthcare provider is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Pembrolizumab is unique because it is an immunotherapy that harnesses the body's immune system to fight small intestinal cancer. Unlike traditional chemotherapy, which targets cancer cells directly but can also harm healthy cells, pembrolizumab works by blocking the PD-1 pathway. This blockage enables immune cells to better recognize and attack cancer cells. Researchers are excited about pembrolizumab because it has shown promise in other types of cancers and could offer a more targeted and potentially less toxic treatment option for patients with small intestinal cancer.

What evidence suggests that pembrolizumab might be an effective treatment for small intestinal cancer?

Research shows that pembrolizumab, a monoclonal antibody, can help treat some cancers by enabling the body's immune system to identify and attack cancer cells. Studies have found that pembrolizumab significantly improves survival rates in patients with certain genetic traits, such as microsatellite instability-high (MSI-H). In some cases, patients treated with pembrolizumab lived more than twice as long as those receiving traditional chemotherapy. Real-world evidence also supports its effectiveness, particularly in gastrointestinal cancers with specific mutations. Although data on small bowel adenocarcinoma is limited, pembrolizumab's success in similar cancers offers promising hope. Participants in this trial will receive pembrolizumab to evaluate its effectiveness in treating small intestinal cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

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

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.

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?

Group I: Treatment (pembrolizumab) Experimental Treatment 2 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:

Approved in United States as KEYTRUDA for:

• Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
• Melanoma
• Non-small cell lung cancer (NSCLC)
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Hepatocellular carcinoma
• Renal cell carcinoma
• Cervical cancer
• Endometrial carcinoma

Approved in European Union as KEYTRUDA for:

• Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
• Melanoma
• Non-small cell lung cancer (NSCLC)
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Hepatocellular carcinoma
• Renal cell carcinoma
• Cervical cancer
• Endometrial carcinoma

Approved in United Kingdom as KEYTRUDA for:

• Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1

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+

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa2017699

Pembrolizumab in Microsatellite-Instability–High Advanced ... The median progression-free survival of 8.2 months and the overall response of 33.1% observed with chemotherapy are consistent with data ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39631622/

5-year follow-up from the randomized phase III KEYNOTE ... Median OS was more than twice as long in patients treated with pembrolizumab versus chemotherapy in first line despite an effective crossover rate of 62%.

3. keytrudahcp.com keytrudahcp.com/efficacy/

Efficacy Data for KEYTRUDA® (pembrolizumab) The most common adverse reactions (≥20%) were decreased appetite (25%), fatigue (25%), dyspnea (23%), and nausea (20%). In KEYNOTE⁠-⁠671, adverse reactions ...

4. esmoopen.com esmoopen.com/article/S2059-7029(24)01879-9/fulltext

Efficacy of pembrolizumab in microsatellite-stable, tumor ... Pembrolizumab, an immune checkpoint inhibitor (ICI), shows significant survival benefits in patients with microsatellite instability-high (MSI-H) ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.3_suppl.733

Real-world effectiveness and safety of pembrolizumab in ... Conclusions: Our study underscores the real-world effectiveness of pembrolizumab in patients with dMMR Gastrointestinal Non-Colorectal Tumors.

6. keytrudahcp.com keytrudahcp.com/safety/adverse-reactions/msi-h-dmmr-colorectal-cancer/

Adverse Reactions in Patients With Advanced MSI-H/dMMR ... The most common adverse reactions for KEYTRUDA (reported in ≥20% of patients) were fatigue, musculoskeletal pain, rash, diarrhea, pyrexia, cough, decreased ...

7. merck.com merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf

keytruda_pi.pdf Safety data are available for the first 203 patients who received KEYTRUDA and ... Small intestinal cancer. 27. 16 (59%). (39%, 78%). (3.7+, 57.3+). Brain cancer.

8. keytruda.com keytruda.com/side-effects/

Side Effects of KEYTRUDA® (pembrolizumab) Common side effects of KEYTRUDA when used alone include: feeling tired, pain, including pain in muscles, rash, diarrhea, fever, cough, decreased appetite, ...

9. ema.europa.eu ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf

Keytruda, INN-pembrolizumab - European Medicines Agency Safety data of pembrolizumab in the adjuvant melanoma setting in patients ≥ 75 years are limited. Use of pembrolizumab in combination with axitinib for ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S0959804924000066

Safety profile of pembrolizumab monotherapy based on an ... This pooled analysis of 31 clinical trials showed that pembrolizumab has a consistent safety profile across indications.