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

ConditionsAdvanced Breast CarcinomaAdvanced Endometrial CarcinomaAdvanced Fallopian Tube CarcinomaAdvanced Hepatocellular CarcinomaAdvanced Malignant Abdominal NeoplasmAdvanced Malignant Female Reproductive System NeoplasmAdvanced Malignant Thoracic NeoplasmAdvanced Ovarian CarcinomaAdvanced Primary Peritoneal CarcinomaAdvanced Renal Cell CarcinomaAnatomic Stage III Breast Cancer AJCC v8Anatomic Stage IIIA Breast Cancer AJCC v8Anatomic Stage IIIB Breast Cancer AJCC v8Anatomic Stage IIIC Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8Malignant Abdominal NeoplasmMalignant Solid NeoplasmMetastatic Breast CarcinomaMetastatic Endometrial CarcinomaMetastatic Fallopian Tube CarcinomaMetastatic Hepatocellular CarcinomaMetastatic Malignant Abdominal NeoplasmMetastatic Malignant Female Reproductive System NeoplasmMetastatic Malignant Thoracic NeoplasmMetastatic Ovarian CarcinomaMetastatic Primary Peritoneal CarcinomaMetastatic Renal Cell CarcinomaPrognostic 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 Fallopian Tube Cancer AJCC v8Stage III Hepatocellular Carcinoma AJCC v8Stage III Ovarian Cancer AJCC v8Stage III Primary Peritoneal Cancer AJCC v8Stage III Renal Cell Cancer AJCC v8Stage III Uterine Corpus Cancer AJCC v8Stage IIIA Fallopian Tube Cancer AJCC v8Stage IIIA Hepatocellular Carcinoma AJCC v8Stage IIIA Ovarian Cancer AJCC v8Stage IIIA Primary Peritoneal Cancer AJCC v8Stage IIIA Uterine Corpus Cancer AJCC v8Stage IIIA1 Fallopian Tube Cancer AJCC v8Stage IIIA1 Ovarian Cancer AJCC v8Stage IIIA2 Fallopian Tube Cancer AJCC v8Stage IIIA2 Ovarian Cancer AJCC v8Stage IIIB Fallopian Tube Cancer AJCC v8Stage IIIB Hepatocellular Carcinoma AJCC v8Stage IIIB Ovarian Cancer AJCC v8Stage IIIB Primary Peritoneal Cancer AJCC v8Stage IIIB Uterine Corpus Cancer AJCC v8Stage IIIC Fallopian Tube Cancer AJCC v8Stage IIIC Ovarian Cancer AJCC v8Stage IIIC Primary Peritoneal Cancer AJCC v8Stage IIIC Uterine Corpus Cancer AJCC v8Stage IIIC1 Uterine Corpus Cancer AJCC v8Stage IIIC2 Uterine Corpus Cancer AJCC v8Stage IV Fallopian Tube Cancer AJCC v8Stage IV Hepatocellular Carcinoma AJCC v8Stage IV Ovarian Cancer AJCC v8Stage IV Primary Peritoneal Cancer AJCC v8Stage IV Renal Cell Cancer AJCC v8Stage IV Uterine Corpus Cancer AJCC v8Stage IVA Fallopian Tube Cancer AJCC v8Stage IVA Hepatocellular Carcinoma AJCC v8Stage IVA Ovarian Cancer AJCC v8Stage IVA Primary Peritoneal Cancer AJCC v8Stage IVA Uterine Corpus Cancer AJCC v8Stage IVB Fallopian Tube Cancer AJCC v8Stage IVB Hepatocellular Carcinoma AJCC v8Stage IVB Ovarian Cancer AJCC v8Stage IVB Primary Peritoneal Cancer AJCC v8Stage IVB Uterine Corpus Cancer AJCC v8
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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 criteria

Qualifiers

Participants must have pathologically confirmed advanced/metastatic solid cancer (hepatocellular carcinoma, renal cell carcinoma, breast cancer, ovarian/fallopian, or endometrial/primary peritoneal tumors) involving the abdomen or thorax, cannot tolerate standard therapy or have experienced tumor progression on standard therapy.

Age: ≥18 years.

Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

Life expectancy >3 months.

Disqualifiers

Participants must not receive prior anticancer therapy or radiation therapy within 2 weeks and must not undergo major surgery within 4 weeks prior to initiation of treatment on protocol. Participants who are already on cabozantinib and have progressive disease are allowed to transition to treatment with tumor treating fields and cabozantinib. Participants in both cohorts who already started treatments as standard of care (Cohort 1: Cabozantinib and Cohort 2: nab-paclitaxel and Pembrolizumab) are allowed to start on protocol within the first 2-3 weeks of treatment initiation. Palliative radiation therapy is allowed.

Participants must have recovered to Grade 0-1 toxicity from prior therapy.

Active brain metastasis or leptomeningeal disease. Patients with treated brain metastasis must have stable disease, evidenced by brain imaging for at least 4 weeks and the patient must have been off steroids for at least 2 weeks.

The patient has cardiac conditions as follows: uncontrolled: hypertension (blood pressure [BP] > 160/100) despite optimal therapy, uncontrolled angina, ventricular arrhythmias, congestive heart failure (New York Heart Association Class II or above), prior or current cardiomyopathy, uncontrolled atrial fibrillation with heart rate > 100 beats per minute (bpm), unstable ischemic heart disease (myocardial infarction within 6 months prior to starting treatment or angina requiring use of nitrates more than once weekly).

Trial design

Treatments tested in this trial

  • Atezolizumab
  • Cabozantinib S-malate
  • Nab-paclitaxel
  • Tumor Treating Fields Therapy

Treatment groups

43 Participants
are divided into 2 treatment groups

Sponsors and collaborators