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

Conditions

• Advanced Breast Carcinoma
• Advanced Endometrial Carcinoma
• Advanced Fallopian Tube Carcinoma
• Advanced Hepatocellular Carcinoma
• Advanced Malignant Abdominal Neoplasm
• Advanced Malignant Female Reproductive System Neoplasm
• Advanced Malignant Thoracic Neoplasm
• Advanced Ovarian Carcinoma
• Advanced Primary Peritoneal Carcinoma
• Advanced Renal Cell Carcinoma
• Anatomic Stage III Breast Cancer AJCC v8
• Anatomic Stage IIIA Breast Cancer AJCC v8
• Anatomic Stage IIIB Breast Cancer AJCC v8
• Anatomic Stage IIIC Breast Cancer AJCC v8
• Anatomic Stage IV Breast Cancer AJCC v8
• Malignant Abdominal Neoplasm
• Malignant Solid Neoplasm
• Metastatic Breast Carcinoma
• Metastatic Endometrial Carcinoma
• Metastatic Fallopian Tube Carcinoma
• Metastatic Hepatocellular Carcinoma
• Metastatic Malignant Abdominal Neoplasm
• Metastatic Malignant Female Reproductive System Neoplasm
• Metastatic Malignant Thoracic Neoplasm
• Metastatic Ovarian Carcinoma
• Metastatic Primary Peritoneal Carcinoma
• Metastatic Renal Cell Carcinoma
• Prognostic Stage III Breast Cancer AJCC v8
• Prognostic Stage IIIA Breast Cancer AJCC v8
• Prognostic Stage IIIB Breast Cancer AJCC v8
• Prognostic Stage IIIC Breast Cancer AJCC v8
• Prognostic Stage IV Breast Cancer AJCC v8
• Stage III Fallopian Tube Cancer AJCC v8
• Stage III Hepatocellular Carcinoma AJCC v8
• Stage III Ovarian Cancer AJCC v8
• Stage III Primary Peritoneal Cancer AJCC v8
• Stage III Renal Cell Cancer AJCC v8
• Stage III Uterine Corpus Cancer AJCC v8
• Stage IIIA Fallopian Tube Cancer AJCC v8
• Stage IIIA Hepatocellular Carcinoma AJCC v8
• Stage IIIA Ovarian Cancer AJCC v8
• Stage IIIA Primary Peritoneal Cancer AJCC v8
• Stage IIIA Uterine Corpus Cancer AJCC v8
• Stage IIIA1 Fallopian Tube Cancer AJCC v8
• Stage IIIA1 Ovarian Cancer AJCC v8
• Stage IIIA2 Fallopian Tube Cancer AJCC v8
• Stage IIIA2 Ovarian Cancer AJCC v8
• Stage IIIB Fallopian Tube Cancer AJCC v8
• Stage IIIB Hepatocellular Carcinoma AJCC v8
• Stage IIIB Ovarian Cancer AJCC v8
• Stage IIIB Primary Peritoneal Cancer AJCC v8
• Stage IIIB Uterine Corpus Cancer AJCC v8
• Stage IIIC Fallopian Tube Cancer AJCC v8
• Stage IIIC Ovarian Cancer AJCC v8
• Stage IIIC Primary Peritoneal Cancer AJCC v8
• Stage IIIC Uterine Corpus Cancer AJCC v8
• Stage IIIC1 Uterine Corpus Cancer AJCC v8
• Stage IIIC2 Uterine Corpus Cancer AJCC v8
• Stage IV Fallopian Tube Cancer AJCC v8
• Stage IV Hepatocellular Carcinoma AJCC v8
• Stage IV Ovarian Cancer AJCC v8
• Stage IV Primary Peritoneal Cancer AJCC v8
• Stage IV Renal Cell Cancer AJCC v8
• Stage IV Uterine Corpus Cancer AJCC v8
• Stage IVA Fallopian Tube Cancer AJCC v8
• Stage IVA Hepatocellular Carcinoma AJCC v8
• Stage IVA Ovarian Cancer AJCC v8
• Stage IVA Primary Peritoneal Cancer AJCC v8
• Stage IVA Uterine Corpus Cancer AJCC v8
• Stage IVB Fallopian Tube Cancer AJCC v8
• Stage IVB Hepatocellular Carcinoma AJCC v8
• Stage IVB Ovarian Cancer AJCC v8
• Stage IVB Primary Peritoneal Cancer AJCC v8
• Stage IVB Uterine Corpus Cancer AJCC v8

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Atezolizumab — BIOLOGICAL
  Given IV
• Cabozantinib S-malate — DRUG
  Given PO
• Nab-paclitaxel — DRUG
  Given IV
• Tumor Treating Fields Therapy — PROCEDURE
  Receive TTF

Study Details

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.

Key Dates

Start date

Apr 29, 2022

Status verified

Jan 2026

Primary completion

Sep 1, 2026

Completion

Sep 1, 2026

Study Design

Enrollment

43 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1 (TTF, cabozantinib)
  Patients receive TTF continuously for at least 18 hours per day on days 1-21 of each cycle. Patients also receive cabozantinib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
• Experimental: Cohort 2 (TFF, atezolizumab, nab-paclitaxel)
  Patients receive TTF continuously for at least 18 hours per day on days 1-28 of each cycle. Patients also receive nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 of each cycle and atezolizumab IV over 30-60 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

To assess the safety and tolerability of TTF, including the maximum tolerated dose (MTD). [ Time Frame: through study completion, an average of 2 to 3 years ]

Central Contacts

• Apostolia M Tsimberidou
  713-792-4259
  [email protected]

Locations (1)

Find similar trials in Houston, TX

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