Gynecologic Clinical Trials

25.0299:  :  A PHASE III TRIAL OF ONE VS. TWO YEARS OF MAINTENANCE OLAPARIB, WITH OR WITHOUT BEVACIZUMAB, IN PATIENTS WITH BRCA1/2 MUTATED OR HOMOLOGOUS RECOMBINATION DEFICIENT (HRD+) OVARIAN CANCER FOLLOWING RESPONSE TO FIRST LINE PLATINUM-BASED CHEMOTHERAPY

Principal Investigator

Jason Chesney, MD, PhD

Phase

III

Description

This phase III trial compares the effect of olaparib for one year versus two years, with or without bevacizumab, for the treatment of BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer. Olaparib is a polyadenosine 5'-diphosphoribose polymerase (PARP) enzyme inhibitor and may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving olaparib for one year with or without bevacizumab may be effective in treating patients with BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer, when compared to two years of olaparib.

Find more information at ClinicalTrials.gov

25.0168:  A Randomized Phase II Trial of Nivolumab and Ipilimumab Compared to Nivolumab Monotherapy in Patients with Deficient Mismatch Repair System Recurrent Endometrial Carcinoma

Principal Investigator

Jason Chesney, MD, PhD

Phase

II

Description

This phase II trial tests whether the combination of nivolumab and ipilimumab is better than nivolumab alone to shrink tumors in patients with deficient mismatch repair system (dMMR) endometrial carcinoma that has come back after a period of time during which the cancer could not be detected (recurrent). Deoxyribonucleic acid (DNA) mismatch repair (MMR) is a system for recognizing and repairing damaged DNA. In 2-3% of endometrial cancers this may be due to a hereditary condition resulted from gene mutation called Lynch Syndrome (previously called hereditary nonpolyposis colorectal cancer or HNPCC). MMR deficient cells usually have many DNA mutations. Tumors that have evidence of mismatch repair deficiency tend to be more sensitive to immunotherapy. There is some evidence that nivolumab with ipilimumab can shrink or stabilize cancers with deficient mismatch repair system. However, it is not known whether this will happen in endometrial cancer; therefore, this study is designed to answer that question. Monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab in combination with ipilimumab may be better than nivolumab alone in treating dMMR recurrent endometrial carcinoma.

Find more information at ClinicalTrials.gov

25.0110:  A Phase 1b/2 Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Raludotatug Deruxtecan With or Without Other Anticancer Investigational Agents in Participants With High-grade Serous Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Who Have Relapsed After Prior Platinum-based Chemotherapy  (REJOICE-Ovarian02)

Principal Investigator

Rebecca Redman, MD

Phase

1b/2

Description

Researchers are looking for other ways to treat relapsed high-grade serous ovarian cancer. Relapsed means the cancer came back after treatment. High-grade means the cancer cells grow and spread quickly. Serous means the cancer started in the cells that cover the ovaries, the lining of the belly, or in the fallopian tubes.Standard treatment (usual treatment) for people with relapsed high-grade serous ovarian cancer may include:Chemotherapy, which is a treatment that uses medicine to destroy cancer cells or stop them from growingTargeted therapy, which is a treatment that works to control how specific types of cancer cells grow and spreadRaludotatug deruxtecan (R-DXd) is a study treatment that is an antibody drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. Researchers want to know if R-DXd is safe to take with standard treatment and if people tolerate them together.

Find more information at ClinicalTrials.gov

24.0766:  A Phase 1/1b Open-label, Multicenter Clinical Study of MK-0472 as Monotherapy and Combination Therapy in Participants with Advanced/Metastatic Solid Tumors.

Principal Investigator

Rebecca Redman, MD

Phase

1/1b

Description

The purpose of this study is to assess the efficacy, safety, and tolerability of MK-0472 administered as monotherapy and in combination with pembrolizumab (MK-3475) or MK-1084 in participants with histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumors.

Find more information at ClinicalTrials.gov

24.0590:  A Phase 2, multicenter, open-label study of lifileucel (tumor-infiltrating lymphocytes [TIL]) in participants with previously treated advanced endometrial cancer 

Principal Investigator

Jason Chesney, MD, PhD 

Phase

II 

Description

The purpose of this study is to investigate the efficacy and safety of the lifileucel regimen in participants with previously treated endometrial cancer.

Find more information at ClinicalTrials.gov

22.0392:  Combination Therapy with Liposomal Doxorubicin and Withaferin A (Ashwagandha, ASWD) in Recurrent Ovarian Cancer 

Principal Investigator

Whitney Goldsberry 

Phase

I 

Description

This is a two-part open-label clinical trial of ASWD (Ashwagandha) administered to patients with recurrent platinum resistant ovarian cancer in combination with liposomal doxorubicin, following at least two previous lines of chemotherapy. Patients will initially be enrolled in part 1 of the study, which is the feasibility/tolerability evaluation. Once the part 1enrollment is completed, the patients will be enrolled in part 2 of the study. 

Find more information at ClinicalTrials.gov

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.