Individualized Cancer Therapy for Aggressive Cancers
(MCW I-PREDICT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method for treating aggressive cancers by matching treatments to the unique molecular makeup of each person's cancer. It includes two types of treatments: the standard treatment typically given for the cancer type and a targeted treatment, such as Keytruda (pembrolizumab), which targets specific features of the cancer cells. Participants will be grouped based on their cancer's status and previous treatments. This trial suits individuals with aggressive solid cancers that are difficult to treat, such as those with metastatic disease or cancers with high mortality rates, who may have limited treatment options. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative approach.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that pembrolizumab, the drug tested in this trial, has undergone extensive study. One study found that most patients tolerated it well, with manageable side effects. Common side effects included fatigue and skin rash, but these were not severe for most people. Serious side effects were less common, but they can include immune-related reactions.
Pembrolizumab is already approved for treating other types of cancer, indicating a known safety record. This suggests that while possible side effects exist, doctors are familiar with them and can often manage them. It is crucial to discuss any concerns with a doctor before joining a trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they aim to personalize cancer therapy for individuals with aggressive cancers, tailoring treatments based on the patient's specific disease status and treatment history. Unlike traditional one-size-fits-all approaches, these targeted agents work by specifically attacking cancer cells with certain characteristics, potentially leading to more effective and less toxic outcomes. This approach could significantly improve outcomes for patients who have limited options, offering new hope where conventional therapies may not be effective.
What evidence suggests that this trial's treatments could be effective for aggressive cancers?
Research shows that pembrolizumab, a type of targeted treatment, has promising results for treating some aggressive cancers. In this trial, participants will be grouped based on their disease status and history of prior cancer therapy to receive either a targeted agent or a standard of care agent, both including pembrolizumab. One study found that patients with advanced cancer lived longer when they received pembrolizumab with chemotherapy compared to chemotherapy alone. Another study showed that patients with advanced triple-negative breast cancer lived a median of 23 months with pembrolizumab, which is significant for this difficult-to-treat cancer. Additionally, cases have demonstrated that pembrolizumab can lead to long-term remission in certain cancers, such as high-grade endometrial carcinosarcoma. These findings suggest that pembrolizumab could benefit aggressive cancers, especially when tailored to the patient's specific cancer profile.678910
Who Is on the Research Team?
Hui-Zi Chen, MD, PhD
Principal Investigator
Medical College of Wisconsin
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Molecular Profiling
Tumor tissues/blood are molecularly profiled to determine individualized cancer therapy
Treatment
Participants receive either matched therapy recommended by the Molecular Tumor Board or unmatched therapy based on the treating physician's choice
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Standard of care agent
- Targeted agent
Standard of care agent is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical College of Wisconsin
Lead Sponsor