Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Breast Neoplasms

Carcinoma, Hepatocellular

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma, Renal Cell

Abdominal Neoplasms

Thoracic Neoplasms

Genital Neoplasms, Female

Fallopian Tube Neoplasms

Peritoneal Neoplasms

Endometrial Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Kidney Neoplasms

Urologic Neoplasms

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Fallopian Tube Diseases

Peritoneal Diseases

Uterine Neoplasms

Uterine Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Fallopian Tube Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Pembrolizumab

Albumin-Bound Paclitaxel

Atezolizumab

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Immunologic Factors

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.

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.

Cabozantinib S-malate

Nab-paclitaxel

Tumor Treating Fields Therapy

Apostolia M. Tsimberidou

Apostolia M Tsimberidou

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.

PRIMARY OBJECTIVE:

I. To assess the safety and tolerability of TTF, including the maximum tolerated dose (MTD), in combination with cabozantinib (Cohort 1) with nab-paclitaxel and pembrolizumab (Cohort 2) in patients with advanced solid tumors involving the abdomen or thorax to the 4 prespecified tumor types.

SECONDARY OBJECTIVE:

I. To assess the objective response rate, progression-free survival and overall survival of TTF in combination with cabozantinib (Cohort 1) with nab-paclitaxel and pembrolizumab (Cohort 2) in patients with advanced solid tumors involving the abdomen or thorax to the 4 prespecified tumor types.

OUTLINE: Patients are assigned to 1 of 2 cohorts.

COHORT 1: Patients receive TTF continuously for at least 18 hours per day on days 1-21 of each cycle. Patients also receive cabozantinib orally (PO) once daily (QD) on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

COHORT 2: Patients receive TTF continuously for at least 18 hours per day on days 1-28 of each cycle. Patients also receive nab-paclitaxel intravenously (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.

After completion of study treatment, patients are followed for 6 weeks.

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

To assess the safety and tolerability of TTF, including the maximum tolerated dose (MTD),in combination with cabozantinib (Cohort 1) or with nab-paclitaxel and atezolizumab (Cohort 2) in patients with advanced solid tumors involving the abdomen or thorax to the 4 prespecified tumor types. 1st cycle with at least 6 evaluable patients treated at the dose.

To assess the objective response rate, progression-free survival and overall survival of TTF in combination with cabozantinib (Cohort 1) or with nab-paclitaxel and atezolizumab (Cohort 2) in patients with advanced solid tumors involving the abdomen or thorax to the 4 prespecified tumor types.sion 1.1. Will be estimated along with its exact 95% confidence interval (CI). Patients who were replaced without tumor evaluation will not be included in ORR estimation.

M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for metastatic malignant abdominal neoplasm