Peptide Alarm Therapy for Cancer

Overseen By Cancer Center Clinical Trials Office

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Masonic Cancer Center, University of Minnesota

Must be taking: PD-1/PD-L1 inhibitors

Must not be taking: Anticoagulants, Immunosuppressants

Disqualifiers: Pregnancy, Active CNS metastases, Autoimmune, others

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

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

21 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called Peptide Alarm Therapy (PAT) for individuals with solid tumor cancers that haven't responded to other treatments. The goal is to determine if PAT, when combined with a standard cancer drug, can help control these difficult-to-treat tumors. This trial may suit those who have tried other cancer treatments without success and meet specific health criteria, such as certain blood test results. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

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

Research has shown that pembrolizumab, a type of medication, is usually well-tolerated by patients. In a large study of side effects, many people experienced mild to moderate issues, such as tiredness and skin reactions, while serious side effects were less common. However, concerns exist about using pembrolizumab alone for certain cancers, as it might lead to lower survival rates.

Peptide Alarm Therapy (PAT) remains in the early testing stages. Researchers are working to find the right dose and are closely monitoring for any side effects. Early studies suggest that PAT is tolerable, but more detailed safety information is still being collected. Since PAT is used together with pembrolizumab, doctors are carefully observing for any new side effects that might arise from this combination. ^{1 2 3 4 5}

Why are researchers excited about this study treatment?

Researchers are excited about Peptide Alarm Therapy (PAT) because it offers a unique approach to treating solid tumor cancers. Unlike traditional treatments that rely solely on chemotherapy or radiation, PAT works alongside pembrolizumab, an immune checkpoint inhibitor, to potentially enhance the body's immune response against tumors. This combination aims to activate the immune system more effectively by using a peptide-based method that may increase the tumor's visibility to the immune system. By doing so, PAT could lead to faster and more robust responses compared to existing therapies.

What evidence suggests that this treatment might be an effective treatment for solid tumor cancers?

Research shows that pembrolizumab, which participants in this trial may receive, effectively treats several types of cancer. It is already used for advanced cancers with a protein called PD-L1, enhancing the immune system's ability to fight cancer cells. Early studies with peptide alarm therapy (PAT), another component of the treatment in this trial, suggest that when combined with drugs like pembrolizumab, it can boost the body's immune response against tumors. In animal studies, similar combinations have helped shrink tumors. These findings suggest that PAT could work well with pembrolizumab for treating difficult solid tumors. ^{2 6 7 8 9}

Who Is on the Research Team?

Melissa Geller, MD

Principal Investigator

Masonic Cancer Center, Univeristy of Minnesota

Are You a Good Fit for This Trial?

Inclusion Criteria

I have tested positive for both CMV and EBV.

I have the HLA-A*0201 gene type.

I am fully active or can carry out light work.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive peptide alarm therapy (PAT) administered by intratumoral injection along with a PD-1/PD-L1 inhibitor

6 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Extension

Extension of peptide alarm therapy (PAT) administered by intratumoral injection

What Are the Treatments Tested in This Trial?

Interventions

• PAT

How Is the Trial Designed?

Group I: Peptide Alarm Therapy + Pembrolizumab Experimental Treatment 1 Intervention

Participants receive pembrolizumab 200 mg every 3 weeks (Dose Finding Component) or a disease appropriate PD1/PD-L1 inhibitor (Dose Expansion Component) for 2 treatment courses per standard of care. The first dose of PAT is given on Day 1 and on Day 3 (36 to 48 hours after the 1st PAT dose) A second course of the PD1/PD-L1 inhibitor is given per standard of care on Day 22 (Cycle 2 Day 1).

Who Is Running the Clinical Trial?

Masonic Cancer Center, University of Minnesota

Lead Sponsor

Trials

285

Recruited

15,700+

Citations

1. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-10246

Peptide Alarm Therapy with PD-1/PD-L1 Inhibitor for the ... This phase I trial tests the safety, side effects, and best dose of peptide alarm therapy (PAT) in combination with PD-1/PD-L1 inhibitors (including ...

2. keytrudahcp.com keytrudahcp.com/efficacy/

Efficacy Data for KEYTRUDA® (pembrolizumab) Health care professionals may review efficacy data for KEYTRUDA® (pembrolizumab), browse the indications and select the corresponding KEYNOTE trials for ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11339250/

IL-12 and PD-1 peptide combination gene therapy for ... We demonstrated that the mouse homolog to pembrolizumab was effective at blocking PD-1/PD-L1 in vitro. ... therapy results in enhancement of antitumor effect of ...

4. merck.com merck.com/news/merck-announces-keytruda-pembrolizumab-plus-welireg-belzutifan-met-primary-endpoint-of-disease-free-survival-dfs-in-certain-patients-with-clear-cell-renal-cell-carcinoma-rcc-follow/

Merck Announces KEYTRUDA® (pembrolizumab) Plus ... First combination regimen to demonstrate improvement in DFS compared to KEYTRUDA monotherapy for these patients in the adjuvant setting.

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

Keytruda, INN-pembrolizumab - European Medicines Agency KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung carcinoma in adults whose tumours express PD-L1 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05338658

Study of PAT in Patients With Solid Tumor Cancers Peptide Alarm Therapy + Pembrolizumab. Participants receive pembrolizumab 200 mg every 3 weeks (Dose Finding Component) or a disease appropriate PD1/PD-L1 ...

7. fda.gov fda.gov/drugs/drug-safety-and-availability/fda-alerts-health-care-professionals-and-oncology-clinical-investigators-about-efficacy-issue

Safety Issue in Clinical Trial of Tecentriq and Keytruda FDA is communicating decreased survival associated with the use of Keytruda or Tecentriq as monotherapy in clinical trials to treat patients ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8830697/

Retrospective analysis of clinical trial safety data ... We analyzed over ten thousand adverse event reports from Keynote clinical trials of pembrolizumab for various cancer indications with or without co-occurring ...

9. nanets.net nanets.net/abstracts-archive/2024/2021-c27-fidelman-a-pilot-study-of-pembrolizumab-and-peptide-receptor-radionuclide-therapy-for-patients-with-well-differentiated-neuroendocrine-tumors-and-symptomatic-and-or-progressive-metastases/file

A Pilot Study of Pembrolizumab and Peptide Receptor ... The purpose of this study is to evaluate safety and efficacy of the combination of PRRT and PD1 inhibitor pembrolizumab in high-risk NET. METHODS. In a single ...