Actively Recruiting
Phase I Study of Tumor Treating Fields (TTF) 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 ยท Updated on 2026-01-14
43
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, side effects, and best dose of tumor treating fields (TTF) therapy combined with either cabozantinib or nab-paclitaxel and atezolizumab in patients with advanced solid tumors involving the abdomen or thorax that have spread to other parts of the body. This phase Ib trial focuses on patients with specific tumor types who have progressed on or cannot tolerate standard therapy. The study aims to assess the tolerability and effectiveness of these combinations in controlling tumor growth. Participants are assigned to one of two groups. In Cohort 1, patients receive TTF continuously for at least 18 hours per day on days 1-21 of each 21-day cycle, alongside daily oral cabozantinib. In Cohort 2, patients receive TTF continuously for at least 18 hours per day on days 1-28 of each 28-day cycle, combined with intravenous nab-paclitaxel on days 1, 8, and 15 and atezolizumab on days 1 and 15. Treatment cycles continue until disease progression or unacceptable side effects. After treatment ends, patients are followed for 6 weeks. During the study, patients are closely monitored for safety, tolerability, and response to treatment. Researchers will evaluate objective tumor response, progression-free survival, and overall survival over approximately 2 to 3 years. Patients undergo regular assessments including physical exams, laboratory tests, and imaging to measure disease status. Participants must be able to operate the TTF device independently or with caregiver help. The study provides detailed observation of how these combined treatments affect advanced solid tumors in the abdomen or thorax.
CONDITIONS
Brief 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...
- Pathologically confirmed advanced or metastatic solid cancer involving the abdomen or thorax (hepatocellular carcinoma, renal cell carcinoma, breast cancer, ovarian/fallopian, or endometrial/primary peritoneal tumors)
- Cannot tolerate standard therapy or have tumor progression on standard therapy
- Age 18 years or older
- ECOG performance status 0 to 1
- Life expectancy greater than 3 months
- Normal bone marrow function with specific minimum blood counts
- Adequate liver function within defined limits
- For hepatocellular carcinoma, Child Pugh status A and no significant ascites or bleeding risk
- Serum creatinine clearance 50 mL/min or higher
- Measurable or evaluable disease by RECIST
- Women of childbearing potential must use effective contraception; men must agree to contraception or abstinence
- Able 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 or major surgery within 4 weeks before treatment start
- Not recovered to Grade 0-1 toxicity from prior therapy
- Active brain metastasis or leptomeningeal disease unless stable and off steroids
- Uncontrolled heart conditions including hypertension, angina, arrhythmias, heart failure, or ischemic disease
- Severe uncontrolled medical diseases that could affect study participation
- Pregnant or breastfeeding
- Hypersensitivity to tumor treating fields therapy or related study drugs
- Implanted electrical medical devices such as pacemakers or defibrillators
- Prior treatment discontinuation due to unacceptable toxicity with cabozantinib
- Specific additional exclusions for cabozantinib cohort including bleeding risks, pulmonary lesions, coagulation abnormalities, and inability to swallow capsules
- Specific exclusions for atezolizumab cohort including recent live vaccines, active infections, serious autoimmune diseases, and compromised immune function
- Any other condition judged unsafe or noncompliant by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles for Cohort 1 and 28-day cycles for Cohort 2 until disease progression or unacceptable toxicity
Participants receive Tumor Treating Fields (TTF) therapy daily along with assigned drug treatments depending on their cohort. Cohort 1 participants take cabozantinib orally daily for 21 days per cycle with cycles repeating every 21 days. Cohort 2 participants receive TTF daily for 28 days per cycle and receive intravenous nab-paclitaxel on days 1, 8, and 15 and atezolizumab on days 1 and 15 with cycles repeating every 28 days. Treatment continues unless disease progresses or unacceptable side effects occur.
Multiple visits depending on treatment schedule and assessments during each cycle
Duration - 6 weeks
After completing treatment, participants are followed for safety and outcome monitoring for 6 weeks.
Approximately 1 to 2 visits during follow-up
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here