Miami, FLNCT05503797Now EnrollingIRB Ready

Cancer Clinical Trial in Miami, FL

Access cutting-edge cancer treatment through this phase 2 clinical trial at a research site in Miami. Study-provided care at no cost to qualified participants.

Sponsored by Fore Biotherapeutics

Quick Self-Assessment

See if you qualify for this Miami location

Preparing your pre-screening questions…

Expert Care in Miami

Access cancer specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related cancer treatment provided free

Apply for This Miami Location

Check if you qualify for this cancer clinical trial in Miami, FL

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Miami

    Convenient for FL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Miami site if eligible
  4. 4Begin participation

About This Cancer Study in Miami

The objective of this Master Protocol is to evaluate the efficacy and safety of plixorafenib in participants with locally advanced or metastatic solid tumors, or recurrent or progressive primary central nervous system (CNS) tumors harboring BRAF fusions, or in participants with rare BRAF V600-mutated solid tumors, melanoma, thyroid, or recurrent primary CNS tumors.

Sponsor: Fore Biotherapeutics

Who Can Participate

Inclusion Criteria

Subprotocol A:
Male and female, ≥8 years of age, and weighing ≥25 kg.
Histologic diagnosis of a solid tumor or primary CNS tumor.
Documentation of BRAF gene fusion in tumor and/or blood detected by an analytically validated test by DNA sequencing or RNA (transcriptome) sequencing.
Have an archival tissue sample available meeting protocol requirements.
Consent to provide scan(s) prior to baseline to assess change in tumor trajectory.
Received all available standard therapy, is intolerant to available therapies, or the investigator has determined that treatment with standard therapy is not appropriate.
All adverse events related to prior therapies (chemotherapy; radiotherapy; surgery) must have resolved to Grade 1 or baseline. Subprotocol B:
Male and female, ≥8 years of age, and weighing ≥25 kg.
Histological diagnosis of a primary CNS tumor, including but not limited to the following:
Adults (≥18 years) with Grade 1-4 glioma or glioneuronal tumor (including glioblastoma, anaplastic astrocytoma, high grade astrocytoma with piloid features, pilocytic astrocytoma, gliosarcoma, anaplastic pleomorphic xanthoastrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma, not otherwise specified \[NOS\], ganglioglioma, or recurrent LGG). OR
Pediatric patients (8-17 years of age) with a Grade 3 or 4 glioma or glioneuronal tumor, including those with a prior, histologically confirmed, diagnosis of a low-grade glioma or glioneuronal tumor and now have radiographic or histopathological findings consistent with WHO \[2021\] Grade 3 or 4 primary CNS tumor.
Participants must have unresectable, locally advanced or metastatic disease that: i. Had prior treatment with radiotherapy and/or first-line chemotherapy or concurrent chemoradiation therapy OR
Note: Participants who have a WHO Grade 3 or 4 glioma for whom chemotherapy and/or radiotherapy is not considered standard of care may remain eligible for the study. ii. Is intolerant to available therapies OR iii. The investigator has determined that treatment with standard therapy is not appropriate.
Documented BRAF V600E mutation in tumor and/or liquid biopsy detected by an analytically validated test at CLIA or CLIA-equivalent laboratory approved by sponsor or sponsor-designated central test.
An archival tissue sample available meeting protocol requirements, or fresh biopsy is required if the archival sample is not available for retrospective confirmation test.
Consent to provide scan(s) prior to baseline to assess change in tumor trajectory.
Measurable disease based upon specified response criteria, as determined by the radiographic BICR.
All adverse events related to prior therapies (eg, chemotherapy, radiotherapy, surgery) must have resolved to Grade 1 or baseline.
Participants who are receiving corticosteroid treatment must be on a stable or decreasing dose of ≤8 mg/day of dexamethasone or equivalent corticosteroid treatment for 7 days prior to first dose of study treatments. Subprotocol C:
Male and female, ≥8 years of age, and weighing ≥25 kg.
Histologic diagnosis of a rare BRAF V600E-mutated solid tumor that is unresectable, locally advanced or metastatic.
Measurable disease on CT, MRI, or physical exam
Documented BRAF V600E mutation in tumor and/or liquid biopsy detected by an analytically validated test.
Have an archival tissue sample available meeting protocol requirements.
Consent to provide scan(s) prior to baseline to assess change in tumor trajectory
Received all available standard therapy, is intolerant to available therapies, or the investigator has determined that treatment with standard therapy is not appropriate. Subprotocol D:
Male and female, ≥8 years of age, and weighing ≥25 kg.
Histologic diagnosis of a solid tumor harboring a BRAF V600E mutation and not eligible for other subprotocols.
Measurable disease on CT, MRI, or physical exam.
Evidence of BRAF V600E mutation in tumor and/or blood detected by genomic tests.
Consent to provide a tumor biopsy.
Willingness to comply with the ECG substudy procedures.
All adverse events related to prior therapies (chemotherapy; radiotherapy; surgery) must have resolved to Grade 1 or baseline.

Exclusion Criteria

Subprotocol A:
Prior treatment with RAF/BRAF inhibitors active for Class 2 BRAF alterations for advanced unresectable or metastatic disease.
Prior treatment with a MEK inhibitor.
Tyrosine kinase inhibitor(s) and/or targeted therapies are allowed (other than BRAF/MAPK pathway inhibitors per Exclusion Criteria 3 and 4) and will be restricted to no more than the number of lines of therapy that are consistent with standard treatment guidelines.
Malignancy with co-occurring activating RAS mutation(s) at any time.
Uncontrolled intercurrent illness that would limit compliance with study requirements.
HIV infection with exceptions; discuss with treating physician.
Have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral plixorafenib or cobicistat (such as ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, and small bowel resection).
Grade ≥2 changes in AST, ALT, GGT, or bilirubin attributed to prior immune checkpoint inhibitor treatment are exclusionary, even if resolved. Subprotocol B:
Prior treatment with BRAF, ERK, and/or MEK inhibitor(s).
Known or suspected neurofibromatosis-1 (NF-1) and/or RAS related gene alterations.
Uncontrolled intercurrent illness that would limit compliance with study requirements.
Active infection requiring systemic therapy.
HIV infection with exceptions; discuss with treating physician.
Have impairment of GI function or GI disease that may significantly alter the absorption of oral plixorafenib (such as ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection).
Grade ≥ 2 changes in AST, ALT, gamma-glutamyl transaminase (GGT), or bilirubin attributed to prior immune checkpoint inhibitor treatment are exclusionary, even if resolved. Subprotocol C:
Diagnosis of colorectal adenocarcinoma or pancreatic ductal adenocarcinoma (neuroendocrine or acinar tumors are eligible).
Diagnosis of BRAF V600E-mutated cutaneous melanoma, papillary thyroid cancer, or NSCLC.
Participant has CNS metastases.
Prior treatment with BRAF, ERK, and/or MEK inhibitor(s), unless otherwise specified for specific tumor types (i.e. low grade serous or borderline ovarian cancer).
Known or suspected neurofibromatosis-1 (NF-1) and/or RAS related gene alterations.
Participants with prostate, breast, or gynecologic cancers with known activating mutations that lead to constitutive hormone receptor activation (AR-V7, ESR1).
Uncontrolled intercurrent illness that would limit compliance with study requirements.
Active infection requiring systemic therapy.
HIV infection with exceptions; discuss with treating physician. Subprotocol D:
Known or suspected neurofibromatosis-1 (NF-1) and/or RAS related gene alterations or other co-occurring driver mutations.
Participant has a non-CNS solid tumor with CNS metastases.
Uncontrolled intercurrent illness that would limit compliance with study requirements.
Active infection requiring systemic therapy.
HIV infection with exceptions; discuss with treating physician.
Use or anticipate the need for medications with known risk for QT-prolonging potential and Torsades de Pointes.
History of acute or chronic cardiovascular disease or surgery, hypertension, with systolic blood pressure \>160mm HG, history of QTc abnormalities, or clinical significantly ECG abnormalities (for participants in the ECG substudy).

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Miami?

Yes, this clinical trial (NCT05503797) has an active research site in Miami, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Cancer Treatment Options in Miami, FL

If you're searching for cancer treatment options in Miami, FL, this clinical trial (NCT05503797) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Miami research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all cancer clinical trials near you to find additional studies recruiting in your area.

More Breast Cancer Trials in Miami, FL

See all breast cancer clinical trials recruiting in Miami — not just this study.

Browse Breast Cancer Trials in Miami →

Browse More Trials by Condition

Breast Cancer TrialsLung Cancer TrialsProstate Cancer TrialsColorectal Cancer TrialsMelanoma TrialsPancreatic Cancer TrialsOvarian Cancer TrialsBladder Cancer TrialsAll Conditions →

Ready to Join in Miami?

Take the first step toward participating in this groundbreaking clinical trial

Secure · Expert Care · Miami, FL