Targeted Therapy for Cancer
(StrataPATH Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the effectiveness and safety of various cancer treatments guided by specific biomarkers (unique biological indicators). It includes treatments such as Encorafenib + Binimetinib and Enhertu (Fam-Trastuzumab Deruxtecan-Nxki, an antibody-drug conjugate), among others, targeting individuals with solid tumors. The trial seeks participants with a confirmed solid tumor who can attend study visits and are willing to provide blood samples. Eligible participants must be biomarker-positive and have experienced no worsening of brain metastases (if applicable) for at least four weeks. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important cancer research.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the treatments in this trial have different safety levels based on past studies.
1. **Encorafenib + Binimetinib**: Studies indicate that this combination is generally well-tolerated, meaning most people can handle it without stopping. It has a low dropout rate in patients with certain types of melanoma, a skin cancer. However, there is a risk of developing new cancers.
2. **Enfortumab Vedotin**: This treatment is mostly safe but can have serious side effects. About 3.9% of patients experienced severe reactions, such as lung problems or infections. Common side effects include nerve issues, skin problems, and fatigue.
3. **Enhertu (fam-trastuzumab deruxtecan-nxki)**: Enhertu can lower white blood cells, which help fight infections, in 65% of patients. There is also a risk of severe lung disease, which can be life-threatening.
4. **Lorlatinib**: This drug may cause serious lung inflammation, which can be dangerous. It's used for a type of lung cancer, but patients need to monitor for lung-related symptoms.
5. **Talazoparib**: Known side effects include fatigue, anemia (low red blood cells), and nausea. Rarely, it can cause serious bone marrow problems, affecting blood cells.
Each treatment has its own risks and benefits. Consulting with a doctor is important to understand what they mean for individual patients.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they offer new ways to target cancer cells more precisely. For example, Encorafenib + Binimetinib is unique because it targets specific mutations in cancer cells, potentially leading to better outcomes for patients with those mutations. Enfortumab Vedotin stands out with its novel antibody-drug conjugate mechanism, directly delivering chemotherapy to cancer cells while minimizing impact on healthy cells. Enhertu and Fam-Trastuzumab Deruxtecan-Nxki are also antibody-drug conjugates, but they target HER2, a protein often overexpressed in certain cancers, offering hope for those resistant to standard therapies. These innovations hold promise for more effective and personalized cancer treatment options.
What evidence suggests that this trial's treatments could be effective for cancer?
Research has shown that combining Encorafenib and Binimetinib, one of the treatment options in this trial, holds promise for certain cancer patients. One study found that patients lived for a median of 47.6 months, significantly longer than with other treatments. Enfortumab Vedotin, another option in this trial, effectively helped patients with advanced bladder cancer live longer by reducing the risk of death by 30% compared to chemotherapy. Enhertu, also under study, lowered the chance of breast cancer recurrence or death by 53%. Lorlatinib, another treatment arm, impacted lung cancer, with 60% of patients living without disease progression after five years. Talazoparib, also tested in this trial, showed a 50% response rate in patients with advanced breast cancer, providing significant benefits. These treatments demonstrate strong potential in targeting specific cancer types.678910
Who Is on the Research Team?
Kat Kwiatkowski, PhD
Principal Investigator
Strata Oncology
Are You a Good Fit for This Trial?
Adults with confirmed solid tumors who can provide blood samples and have specific biomarkers as per the trial's requirements. They must be able to follow the study schedule, have adequate organ function, and not be pregnant or nursing. Excluded are those on other cancer treatments, recent major surgery patients, individuals with primary brain tumors or uncontrolled medical conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive FDA-approved cancer therapies based on biomarker profiles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- Encorafenib + Binimetinib
- Enfortumab Vedotin
- Enhertu
- Fam-Trastuzumab Deruxtecan-Nxki
- Lorlatinib
- PADCEV
- Talazoparib
Find a Clinic Near You
Who Is Running the Clinical Trial?
Strata Oncology
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
Pfizer
Industry Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University
Gilead Sciences
Industry Sponsor
Daniel O'Day
Gilead Sciences
Chief Executive Officer since 2019
MBA from Columbia University
Dietmar Berger
Gilead Sciences
Chief Medical Officer
MD and PhD from Albert-Ludwigs University School of Medicine