GYNECOLOGIC CANCER

22.0087: A Phase I, Open-Label, Multicenter Study of FT538 in Combination with Monoclonal Antibodies in Subjects with Advanced Solid Tumors

Principal Investigator: Jason Chesney, MD, PhD

Phase: I

Description: Primary:• To define the RP2D of FT538 in combination with the following mAbs in subjects with advanced solid tumors: avelumab, trastuzumab (including biosimilars), cetuximab, atezolizumab, nivolumab, and pembrolizumab• To evaluate the safety and tolerability of FT538 in combination with the following mAbs in subjects with advanced solid tumors: avelumab, trastuzumab (including biosimilars), cetuximab, atezolizumab, nivolumab, and pembrolizumabSecondary:• To evaluate the anti-tumor activity of FT538 in combination with the following mAbs in subjects with advanced solid tumors: avelumab, trastuzumab (including biosimilars), cetuximab, atezolizumab, nivolumab, and pembrolizumab, using RECIST v1.1• To characterize the PK of FT538 in combination with the following mAbs in subjects with advanced solid tumors: avelumab, trastuzumab (including biosimilars), cetuximab, atezolizumab, nivolumab, and pembrolizumab

More Info: https://clinicaltrials.gov/ct2/show/NCT05069935?term=NCT05069935&draw=2&rank=1


19.0698:  Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination with Pembrolizumab in Advanced Cancer

Principal Investigator: Rebecca Redman, M.D.

Phase:  I

Description: This clinical trial is a Phase 1/2, open-label, sequential-group, dose-escalation and cohort expansion study to determine the safety and preliminary anti-tumor activity of FLX475 as monotherapy and in combination with pembrolizumab. The study will be conducted in two parts, a dose-escalation phase (Part 1) and a cohort expansion phase (Part 2). In Part 1 of the study, subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy or in combination with pembrolizumab. In Part 2 of the study, subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 as monotherapy or in combination with pembrolizumab.

More Info:  https://clinicaltrials.gov/ct2/show/NCT03674567?term=NCT03674567&draw=2&rank=1

 

16.0568 - Molecular Analysis for Therapy Choice (MATCH).

Principal Investigator: Vivek Sharma, M.D., F.A.C.P.

Description: This phase II trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors or lymphomas.

Phase: II

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02465060?term=eay131&rank=1

 

08.0388 - Protocol for the Cancer Database and Specimen Repository (CDSR) at the Brown Cancer Center (Previous Lung Repository).

Principal Investigator: Rebecca Redman, M.D.

Description: The mission of the Cancer Database and Specimen Repository (CDSR) is to collect clinical information and samples of human specimens from cancer patients and from control patients for research, and to distribute specimens to researchers for the advancement of science.

 

18.0160:  A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety Using Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients with Recurrent, Metastatic or Persistent Cervical Carcinoma    

Principal Investigator:  Jason A Chesney, M.D., Ph.D.    

Description: LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI, for the treatment of patients with recurrent, metastatic, or persistent cervical carcinoma. The cell transfer therapy used in this study involves patients receiving a NMA lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2.     

Phase:  II    

Additional Information: https://clinicaltrials.gov/ct2/show/NCT03108495?term=NCT03108495&rank=1  
 

20.0685:  NCI COVID-19 in Cancer Patients Study (N-CCaPS): A Longitudinal Natural History Study

Principal Investigator: Rebecca Redman, MD

Description:  This study collects blood samples, medical information, and medical images from patients who are being treated for cancer and have a positive test for SARS CoV-2, the new coronavirus that causes the disease called COVID-19. Collecting blood samples, medical information, and medical images may help researchers determine how COVID-19 affects the outcomes of patients undergoing cancer treatment and how having cancer affects COVID-19.

More info:  https://clinicaltrials.gov/ct2/show/NCT04387656?term=NCT04387656&draw=2&rank=1