Actively Recruiting
Phase I Study of Tumor Treating Fields (TTF) in Combination With Cabozantinib or With Pembrolizumab and Nab-Paclitaxel in Patients With Advanced Solid Tumors Involving the Abdomen or Thorax
Led by M.D. Anderson Cancer Center · Updated on 2026-01-14
43
Participants Needed
1
Research Sites
226 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase Ib trial tests the safety, side effects, and best dose of tumor treating fields therapy in combination with either cabozantinib or nab-paclitaxel and atezolizumab in treating patients with solid tumors involving the abdomen or thorax that have spread to other parts of the body (advanced). Tumor treating fields therapy on this study utilizes NovoTTF systems that are wearable devices that use electrical fields at different frequencies that may help stop the growth of tumor cells by interrupting cancer cells' ability to divide. Cabozantinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Chemotherapy drugs, such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving tumor treating fields therapy in combination with either cabozantinib, or with nab-paclitaxel and atezolizumab may help control advanced solid tumors involving the abdomen or thorax.
CONDITIONS
Official Title
Phase I Study of Tumor Treating Fields (TTF) in Combination With Cabozantinib or With Pembrolizumab and Nab-Paclitaxel in Patients With Advanced Solid Tumors Involving the Abdomen or Thorax
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have a confirmed diagnosis of advanced or metastatic solid cancer involving the abdomen or thorax, including hepatocellular carcinoma, renal cell carcinoma, breast cancer, ovarian/fallopian tube cancer, or endometrial/primary peritoneal tumors
- Unable to tolerate standard therapy or have tumor progression after standard treatment
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy greater than 3 months
- Normal bone marrow function with specific blood count levels
- Adequate liver function with defined bilirubin and liver enzyme levels
- For hepatocellular carcinoma patients: Child Pugh status A, no significant ascites, and no history or risk of bleeding or wound healing problems
- Kidney function with creatinine clearance 50 mL/min or higher
- Measurable or evaluable disease according to RECIST criteria
- Women of childbearing potential must use effective contraception during the study
- Male participants must agree to use effective contraception or abstinence
- Ability to operate the tumor treating fields device independently or with caregiver help
You will not qualify if you...
- Prior anticancer or radiation therapy within 2 weeks before study start; no major surgery within 4 weeks prior
- Must have recovered to Grade 0-1 toxicity from previous treatments
- Active brain metastasis or leptomeningeal disease unless stable and off steroids as specified
- Uncontrolled serious heart conditions such as hypertension, angina, arrhythmias, heart failure, or recent heart attack
- Severe or uncontrolled medical conditions that could affect participation
- Pregnant or breastfeeding women
- History of allergy or contraindication to tumor treating fields therapy
- Implanted pacemaker, defibrillator, or other electrical medical devices
- Allergy or intolerance to cabozantinib, nab-paclitaxel, pembrolizumab, or study adhesives
- Conditions contraindicating study participation as judged by investigators
- Cabozantinib cohort specific exclusions: recent significant bleeding, certain lung lesions, abnormal blood clotting tests, inability to swallow capsules, and others
- Atezolizumab cohort specific exclusions: recent immunotherapy as last treatment, active infections, recent live vaccines, serious autoimmune diseases, and immune system disorders
- Concurrent malignancies only allowed under specific conditions and with investigator agreement
AI-Screening
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Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Apostolia M Tsimberidou
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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