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Official title Investigation of Profile-related Evidence Determining Individualized Cancer Therapy for Patients With Aggressive Malignancies and Poor Prognoses
ClinicalTrials.gov ID: NCT05674825
What this study is testing
What is Targeted agent?
Targeted agent is an investigational medicine, being studied as a potential treatment for cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years.
- Patient with aggressive solid malignancy must meet at least one of the following:
- Malignancy with ≥30% two-year cancer-associated mortality as estimated by the treating oncologist and one of the study investigators and/or, where...
- Refused standard therapies, OR
- Cancer of unknown primary or a rare tumor (i.e., fewer than 4 cases per 100,000 per year) with no approved therapies.
You likely can't join if
- A potential study subject who meets any of the following exclusion criteria is ineligible to participate in the study.
- Two oncologists disagree on prognosis or resectability.
- Severe or uncontrolled medical disorder that would, in the investigator's opinion, confound study analyses of treatment response (i.e., uncontrolled...
- Is pregnant or breastfeeding or any patient with childbearing potential not using adequate pregnancy prevention.
- Whole brain radiation or stereotactic radiotherapy to CNS metastases within 14 days prior to start of study treatment.
See the full eligibility criteria
- Age ≥18 years.
- Patient with aggressive solid malignancy must meet at least one of the following:
- Malignancy with ≥30% two-year cancer-associated mortality as estimated by the treating oncologist and one of the study investigators and/or, where appropriate, according to accepted data sets in the field (e.g., NCDB)...
- Refused standard therapies, OR
- Cancer of unknown primary or a rare tumor (i.e., fewer than 4 cases per 100,000 per year) with no approved therapies.
- Patient with aggressive solid malignancy irrespective of two-year mortality who, in the opinion of the investigator, has no treatment option expected to yield significant clinical benefit.
- Patient must have at least one of the following for a diagnosis/disease status:
- Unresectable disease, as determined by a disease-appropriate multidisciplinary tumor board.
- Medically unfit for surgical resection but with an expected survival of \> three months.
- Localized disease and are eligible for neoadjuvant treatment.
- Metastatic disease.
- Disease where no conventional therapy leads to a survival benefit \> six months in the respective cohort and line of therapy for which the patient is otherwise eligible.
- Patient is either:
- Treatment naïve for their newly diagnosed malignancy (for enrollment to Groups 1 or 2), or
- Status post one or more systemic therapy regimens, whether matched or unmatched (for enrollment to Group 3). Note: There are no limitations on the number of prior local therapies.
- Patient must have measurable disease for malignancy: defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for...
- 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 below:
- Absolute neutrophil count ≥ 1.0 x 109/L
- Platelet count ≥ 75 x 109/L
- Total bilirubin ≤ 2.0 x institution's upper limit of normal (ULN)
- Patients without underlying liver disease
- alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 3 x institutional ULN
- Serum creatinine ≤ 2.0 x institution's ULN or 24-hour creatinine clearance ≥ 30 ml/min
- At the time of treatment, patient should be off other anti-tumor agents for at least five half-lives of the agent or two weeks from the last day of treatment, whichever is shorter to enroll in Group 3. Patient must not...
- Able to swallow and retain oral medication, if needed.
- If actionable or appropriate molecular profiling has not already been performed, patient must have or provide evaluable tissue and/or blood for molecular profiling. This could be obtained during the standard of care...
- Pregnancy It is not known what effects matched therapy has on human pregnancy or development of the embryo or fetus. Therefore, female people participating in this study should avoid becoming pregnant, and male people...
- Not a female of childbearing potential (FCBP), defined as all female patients that were not in post-menopause for at least one year or are surgically sterile, OR
- An FCBP must have a negative serum pregnancy test and agree to use at least one form of pregnancy prevention during the study for at least one month after treatment discontinuation unless otherwise noted by the agent(s)...
- 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 and do not need to be represented at MTB prior to starting...
- A potential study subject who meets any of the following exclusion criteria is ineligible to participate in the study.
- Two oncologists disagree on prognosis or resectability.
- Severe or uncontrolled medical disorder that would, in the investigator's opinion, confound study analyses of treatment response (i.e., uncontrolled diabetes, chronic renal disease, chronic pulmonary disease or active...
- Is pregnant or breastfeeding or any patient with childbearing potential not using adequate pregnancy prevention.
- Whole brain radiation or stereotactic radiotherapy to CNS metastases within 14 days prior to start of study treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milwaukee, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.