Alternating Treatment Plans for Participants With Advanced Thoracic/Head & Neck Cancers (ATATcH)
Rutgers, The State University of New Jersey
Summary
The purpose of the research is to evaluate a new schedule of alternating cycles of induction chemoimmunotherapy (chemotherapy plus pembrolizumab) and immunotherapy (pembrolizumab) alone for the initial treatment of patients with advanced lung or head and neck cancers.
Description
This study is looking at the effect of alternating combination chemotherapy plus immunotherapy with immunotherapy alone during the induction phase (resulting in less frequent use of chemotherapy, once every six weeks instead of the usual every three weeks during induction) on the ability to fight your tumor. We expect that less frequent exposure to chemotherapy in this setting will control your cancer effectively while preserving your quality of life. The primary endpoint of this three-arm, parallel phase II study is the percentage of patients receiving one, two, three and four (up to six for…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Lung Cancer (Arms 1 and 2) * Patients must have histologically or cytologically confirmed stage IV NSCLC (includes M1a, M1b, and M1c stage disease, AJCC 8th edition). Patients with Stage IIIB and IIIC disease are eligible if they are not candidates for combined chemotherapy and radiation; such cases should be discussed in a multidisciplinary tumor board. * Eligible NSCLC tissue histologies will include squamous cell carcinoma (enrolled and treated in Arm 1), and nonsquamous histologies (e.g. adenocarcinoma, large cell carincoma, etc.; enrolled and treated in Arm 2). Patients with mixed squamo…
Interventions
- DrugPaclitaxel
Is a chemotherapy drug. Used to treat kinds of cancer, as determined by the doctor
- DrugPemetrexed
Is a chemotherapy drug. Used to treat kinds of cancer, as determined by the doctor
- Drug5Fluorouracil
Is a chemotherapy drug. Used to treat kinds of cancer, as determined by the doctor
- DrugCarboplatin
Is a chemotherapy drug. Used to treat kinds of cancer, as determined by the doctor
- DrugPembrolizumab
It is a type of immunotherapy and works by helping your immune system to kill cancer cells
Locations (11)
- Trinitas Hospital and Comprehensive Cancer CenterElizabeth, New Jersey
- Cancer Institute of New Jersey at HamiltonHamilton, New Jersey
- RWJBarnabas Health - Jersey CityJersey City, New Jersey
- RWJBarnabas Health - Monmouth Medical Center Southern CampusLakewood, New Jersey
- RWJBarnabas Health - Saint Barnabas Medical CenterLivingston, New Jersey
- RWJBarnabas Health - Monmouth Medical CenterLong Branch, New Jersey