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.

ClinicalTrials.gov:  https://clinicaltrials.gov/study/NCT05112601?term=NCT05112601&rank=1

24.0832:  NCI Cervical Cancer ‘Last Mile’ Initiative ‘Self-collection for HPV testing to Improve Cervical Cancer Prevention’ (SHIP) Trial 

Principal Investigator: Tanya Franklin, MD 

Phase:  NA 

Description:  This clinical trial evaluates the use of self-collected vaginal samples for human papillomavirus (HPV) testing in patients referred for a colposcopy and/or cervical excisional procedures to improve cervical cancer prevention. HPV is a common virus which usually causes infections that last only a few months, but sometimes can last longer. It is known to cause a variety of cancers including cancer of the cervix. Even though there are ways to detect cervical cancer early, many individuals do not undergo screening that involves pelvic exams. Over half of all new cervical cancer cases are among those who have either never been screened or who are not screened enough. Without appropriate screening and care, preventable pre-cancers may turn into cancer. A new way to detect cervical cancer is to have individuals collect their own vaginal sample for HPV testing to know their risk for cervical cancer. This may give individuals more flexibility and comfort having the ability to collect samples themselves, compared to a doctor performing a speculum examination and collecting the samples in a clinic. This study compares clinical accuracy of HPV testing on self-collected vaginal samples versus cervical samples collected by clinician.The Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial is part of the National Cancer Institute (NCI)'s Cervical Cancer 'Last Mile' Initiative, a public private partnership that seeks to increase access to cervical cancer screening. The SHIP Trial focuses on developing clinical evidence to inform the US Food and Drug Administration (FDA)'s regulatory reviews of self-collection approaches as alternative sample collection approaches for cervical cancer screening. Several industry partner-specific self-collection device and assay combinations will be non-competitively and independently evaluated with a similar study design framework to inform pre-approval and/or post-approval regulatory requirements. 

ClinicalTrials.gov:  https://clinicaltrials.gov/study/NCT06498661?term=NCT06498661&rank=1

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.

ClinicalTrials.gov:  https://clinicaltrials.gov/study/NCT05853367?term=NCT05853367&rank=1

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.

 ClinicalTrials.gov:  https://clinicaltrials.gov/study/NCT06481592?term=NCT06481592&rank=1

22.0392:  COMBINATION THERAPY WITH LIPOSOMAL DOXORUBICIN AND WITHAFERIN A (ASHWAGANDHA, ASWD) IN RECCURENT 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. 

More Info:  https://clinicaltrials.gov/study/NCT05610735?term=NCT05610735&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.