400 Participants Needed

Individualized Cancer Therapy for Aggressive Cancers

(MCW I-PREDICT Trial)

MC
Overseen ByMedical College of Wisconsin Cancer Center Clinical Trials Office
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Medical College of Wisconsin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a prospective, open-label navigational investigation designed to evaluate the feasibility of using molecular profile-based evidence to determine individualized cancer therapy for patients with aggressive malignancies. This is a non-randomized, histology-agnostic trial. Although there will be a case mix of histologies, the investigators now know that individual histologies are composed of a heterogeneous mix of molecular alterations. It is not clear whether one case mix is better or worse than another. Thus, the investigators are testing a strategy of molecular matching that may apply across different cancers.

Will I have to stop taking my current medications?

The trial requires that you stop taking other anti-tumor agents for at least five half-lives of the agent or two weeks, whichever is shorter, before enrolling in Group 3. You must not have been treated with anti-tumor agents to enroll in Group 1 or Group 2. Additionally, you must be off prior antibody therapy for at least three half-lives before starting treatment.

How is the drug pembrolizumab (Keytruda) unique in treating aggressive cancers?

Pembrolizumab (Keytruda) is unique because it is an immunotherapy drug that targets the PD-1 receptor, helping the immune system recognize and attack cancer cells. This mechanism is different from traditional chemotherapy, which directly kills cancer cells, and it has shown effectiveness in various cancers, including those with high PD-L1 expression.12345

What data supports the effectiveness of the drug Keytruda (pembrolizumab) for treating aggressive cancers?

Keytruda (pembrolizumab) has shown effectiveness in treating various cancers, including non-small cell lung cancer and melanoma, by helping the immune system attack cancer cells. It is approved for use in advanced melanoma and certain types of lung cancer, indicating its potential benefit in aggressive cancers.12456

Who Is on the Research Team?

HC

Hui-Zi Chen, MD, PhD

Principal Investigator

Medical College of Wisconsin

RK

Razelle Kurzrock, MD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

Adults with aggressive solid tumors, including rare cancers or those without beneficial standard therapies. Eligible participants must have measurable disease, adequate organ function, and not be pregnant or breastfeeding. They should agree to use contraception and have no severe medical conditions that could interfere with the study.

Inclusion Criteria

Patient is either: Treatment naïve for their newly diagnosed malignancy, or Status post one or more systemic therapy regimens. Patient must have measurable disease for malignancy. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2. New York Heart Association (NYHA) Functional Classification I-II. Adequate organ and marrow function as defined. Able to swallow and retain oral medication. If actionable or appropriate molecular profiling has not already been performed, patient must have or provide evaluable tissue and/or blood for molecular profiling. Pregnancy: Female subjects should avoid becoming pregnant, and male subjects should avoid impregnating a female partner. Ability to understand a written informed consent document, and the willingness to sign it. Patients presented at Molecular Tumor Board (MTB) up to two weeks prior to signing consent are eligible to be treated on study based on the MTB recommendations.
I have a serious cancer with limited treatment options or a rare type with no approved treatments.
My condition cannot be treated with surgery, or I am not fit for surgery but expected to live more than three months, or my disease is in a stage where it might benefit from treatment before surgery, or it has spread to other parts of the body, or there is no standard treatment that would extend my life by more than six months.

Exclusion Criteria

I do not have any severe illnesses that could affect the study's results.
I have not had brain radiation within the last 14 days.
Two oncologists disagree on prognosis or resectability
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Molecular Profiling

Tumor tissues/blood are molecularly profiled to determine individualized cancer therapy

4 weeks

Treatment

Participants receive either matched therapy recommended by the Molecular Tumor Board or unmatched therapy based on the treating physician's choice

8 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Standard of care agent
  • Targeted agent
Trial Overview The trial is testing personalized cancer treatments based on molecular profiling of individual tumors against standard care agents. It's a non-randomized study aiming to see if matching therapy to specific molecular changes in different cancers can improve outcomes.
How Is the Trial Designed?
6Treatment groups
Experimental Treatment
Group I: Group 3: Targeted agentExperimental Treatment1 Intervention
Group II: Group 3: Standard of care agentExperimental Treatment1 Intervention
Group III: Group 2: Targeted agentExperimental Treatment1 Intervention
Group IV: Group 2: Standard of care agentExperimental Treatment1 Intervention
Group V: Group 1: Targeted agentExperimental Treatment1 Intervention
Group VI: Group 1: Standard of care agentExperimental Treatment1 Intervention

Standard of care agent is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Keytruda for:
🇪🇺
Approved in European Union as Keytruda for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials
645
Recruited
1,180,000+

Published Research Related to This Trial

In a phase II trial involving 15 patients with resectable non-small cell lung cancer (NSCLC), neoadjuvant treatment with pembrolizumab showed a major pathologic response in 27% of patients, indicating promising antitumor activity before surgery.
The treatment was found to be feasible and safe, with only 33% of patients experiencing moderate adverse events, and no postoperative mortality, suggesting that pembrolizumab does not compromise surgical outcomes.
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience.Eichhorn, F., Klotz, LV., Kriegsmann, M., et al.[2022]
Pembrolizumab, a PD-1 inhibitor used in cancer treatment, can lead to rare but serious immune-related adverse events, including type 1 diabetes mellitus, occurring in about 0.2% of cases.
A review of 42 cases revealed that patients may develop diabetic ketoacidosis during treatment, highlighting the need for blood glucose monitoring and awareness of this potential side effect among clinicians.
Programmed Cell Death-1 Inhibitor-Induced Type 1 Diabetes Mellitus.Clotman, K., Janssens, K., Specenier, P., et al.[2022]
Pembrolizumab (Keytruda) is the first anti-PD-1 therapy approved in the US for treating advanced malignant melanoma, specifically for patients who have progressed after prior treatments.
It is designed to target the PD-1 protein, enhancing the immune system's ability to fight cancer, and is currently under review for approval in the EU.
Pembrolizumab: first global approval.Poole, RM.[2021]

Citations

Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]
Programmed Cell Death-1 Inhibitor-Induced Type 1 Diabetes Mellitus. [2022]
Pembrolizumab: first global approval. [2021]
New Approved Use for Keytruda. [2022]
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. [2017]
FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non-Small Cell Lung Cancer: First-Line Therapy and Beyond. [2022]
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