RecruitingPhase 1NCT05092373

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


Sponsor

M.D. Anderson Cancer Center

Enrollment

43 participants

Start Date

Apr 29, 2022

Study Type

INTERVENTIONAL

Conditions

Malignant Solid NeoplasmAnatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8Metastatic Breast CarcinomaAnatomic Stage IIIA Breast Cancer AJCC v8Anatomic Stage IIIB Breast Cancer AJCC v8Anatomic Stage IIIC Breast Cancer AJCC v8Metastatic Endometrial CarcinomaMetastatic Hepatocellular CarcinomaMetastatic Renal Cell CarcinomaStage III Hepatocellular Carcinoma AJCC v8Stage III Renal Cell Cancer AJCC v8Stage IIIA Hepatocellular Carcinoma AJCC v8Stage IIIA Uterine Corpus Cancer AJCC v8Stage IIIB Hepatocellular Carcinoma AJCC v8Stage IIIB Uterine Corpus Cancer AJCC v8Stage IIIC Uterine Corpus Cancer AJCC v8Stage IIIC1 Uterine Corpus Cancer AJCC v8Stage IIIC2 Uterine Corpus Cancer AJCC v8Stage IV Hepatocellular Carcinoma AJCC v8Stage IV Renal Cell Cancer AJCC v8Stage IVA Hepatocellular Carcinoma AJCC v8Stage IVA Uterine Corpus Cancer AJCC v8Stage IVB Hepatocellular Carcinoma AJCC v8Stage IVB Uterine Corpus Cancer AJCC v8Metastatic Ovarian CarcinomaStage III Ovarian Cancer AJCC v8Stage IV Ovarian Cancer AJCC v8Prognostic Stage III Breast Cancer AJCC v8Prognostic Stage IIIA Breast Cancer AJCC v8Prognostic Stage IIIB Breast Cancer AJCC v8Prognostic Stage IIIC Breast Cancer AJCC v8Prognostic Stage IV Breast Cancer AJCC v8Stage III Uterine Corpus Cancer AJCC v8Stage IIIA Ovarian Cancer AJCC v8Stage IIIA1 Ovarian Cancer AJCC v8Stage IIIA2 Ovarian Cancer AJCC v8Stage IIIB Ovarian Cancer AJCC v8Stage IIIC Ovarian Cancer AJCC v8Advanced Breast CarcinomaAdvanced Ovarian CarcinomaAdvanced Endometrial CarcinomaAdvanced Fallopian Tube CarcinomaAdvanced Hepatocellular CarcinomaAdvanced Renal Cell CarcinomaStage III Fallopian Tube Cancer AJCC v8Stage IV Fallopian Tube Cancer AJCC v8Advanced Malignant Abdominal NeoplasmAdvanced Malignant Female Reproductive System NeoplasmAdvanced Malignant Thoracic NeoplasmAdvanced Primary Peritoneal CarcinomaMalignant Abdominal NeoplasmMetastatic Fallopian Tube CarcinomaMetastatic Malignant Abdominal NeoplasmMetastatic Malignant Female Reproductive System NeoplasmMetastatic Malignant Thoracic NeoplasmMetastatic Primary Peritoneal CarcinomaStage III Primary Peritoneal Cancer AJCC v8Stage IIIA Fallopian Tube Cancer AJCC v8Stage IIIA Primary Peritoneal Cancer AJCC v8Stage IIIA1 Fallopian Tube Cancer AJCC v8Stage IIIA2 Fallopian Tube Cancer AJCC v8Stage IIIB Fallopian Tube Cancer AJCC v8Stage IIIB Primary Peritoneal Cancer AJCC v8Stage IIIC Fallopian Tube Cancer AJCC v8Stage IIIC Primary Peritoneal Cancer AJCC v8Stage IV Primary Peritoneal Cancer AJCC v8Stage IV Uterine Corpus Cancer AJCC v8Stage IVA Fallopian Tube Cancer AJCC v8Stage IVA Ovarian Cancer AJCC v8Stage IVA Primary Peritoneal Cancer AJCC v8Stage IVB Fallopian Tube Cancer AJCC v8Stage IVB Ovarian Cancer AJCC v8Stage IVB Primary Peritoneal Cancer AJCC v8

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a wearable electric field device (called Tumor Treating Fields or TTFields) to standard cancer drugs (either cabozantinib, or pembrolizumab combined with nab-paclitaxel) can improve treatment for people with advanced cancers in the abdomen or chest area. **You may be eligible if...** - You have been diagnosed with advanced or metastatic liver cancer, kidney cancer, breast cancer, ovarian cancer, or endometrial cancer involving the abdomen or chest - Your cancer has progressed on standard treatment or you cannot tolerate it - You are 18 or older in reasonably good physical health (ECOG 0–1) - Your life expectancy is more than 3 months - Your blood counts, liver, and kidney function are adequate **You may NOT be eligible if...** - You have an active electronic implanted device (like a pacemaker) - You are pregnant or breastfeeding - You have uncontrolled brain metastases - You have had recent major surgery or unhealed wounds - You have autoimmune disease if you are in the pembrolizumab arm Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAtezolizumab

Given IV

DRUGCabozantinib S-malate

Given PO

DRUGNab-paclitaxel

Given IV

PROCEDURETumor Treating Fields Therapy

Receive TTF


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05092373


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