Protocol Title: A Randomized Phase 2 Study of CBX-12 in Subjects with Platinum Resistant or Refractory Ovarian Cancer

Enrollment Closed

The purpose of this study is to assess the safety, tolerability, and efficacy of CBX-12 in female subjects with platinum-resistant or refractory ovarian cancer at 2 doses; 125 mg/m2 every 21 days or 100 mg/m2 every 21 days. 

For more information, please visit the website at https://clinicaltrials.gov/study/NCT06315491. 

If you have any questions, please contact Kathleen Richman at (813) 844-4151.

Protocol Title: EASE Study: A randomized, controlled study to EvAluate the Safety and Effectiveness of the Materna Prep Device to pre-stretch the vaginal canal and pelvic floor muscles in preparation for vaginal delivery

Enrollment Closed

This study aims to evaluate the safety and effectiveness of the Materna Prep Device to pre-stretch the vaginal canal and pelvic floor muscles in preparation for vaginal delivery. For more information, please visit https://easestudy.org/  

If you have any questions, please contact Maha Al Jumaily at 813-259-8680 or at mahaaljumaily@usf.edu

Protocol Title: Phase 2 Study of Alpelisib and Fulvestrant for PIK3CA-mutated Estrogen Receptor (ER)-positive Endometrioid Endometrial Cancers

Currently Enrolling

This is a 2 stage multi-center study designed to evaluate the efficacy of the combination of alpelisib and fulvestrant in patients with PIK3CA-mutated ER-positive endometrioid endometrial cancers by estimating the objective response rate (ORR).

For more information please visit https://clinicaltrials.gov/study/NCT05154487.

To enroll in this study at USF/TGH, please contact Kathleen Murillo at (813) 844-415.

Protocol Title: Gastroschisis Outcomes of Delivery (GOOD)

Currently Enrolling

This study is a prospective, multi-institutional trial that aims to determine the clinical risks of infants with gastroschisis who were delivered at 35 weeks compared with those of infants who were expectantly managed to observed delivery with a goal of 38 weeks. Patients may be enrolled in the study any time prior to 33 weeks but will be randomized at 33 weeks to delivery at 35 weeks or observation with a goal of 38 weeks. 

For more information please visit  https://www.thegoodstudy.org/ or https://clinicaltrials.gov/study/NCT02774746. 

To enroll in this study at USF Health, please contact Maha Al Jumaily at 813-259-8680 or at mahaaljumaily@usf.edu

Protocol Title: A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy

Currently Enrolling 

The primary objectives of this study are to evaluate the effect of sacituzumab govitecan (SG) compared to treatment of physician's choice (TPC) on progression-free survival (PFS) as assessed by blinded independent central review (BICR) and overall survival (OS).

For more information, please visit  https://clinicaltrials.gov/study/NCT06486441?term=GS-US-682-6769&rank=1. 

To enroll in this study at USF/TGH, please contact Kathleen Richman at (813) 844-4151.

Protocol Title: Feasibility of pelvic floor muscle training with a digital therapeutic motion-based device (Leva Device) in a postpartum population

Currently Enrolling

This prospective study aims to assess the feasibility of postpartum use of a digital therapeutic motion-based device for pelvic floor muscle strengthening. If you have any questions, please contact Maha Al Jumaily at 813-259-8680 or at mahaaljumaily@usf.edu.

Protocol Title: A Randomized Phase 3 Study Assessing the Efficacy and Safety of Olvi-Vec followed by Platinum-doublet Chemotherapy and Bevacizumab Compared with Physician’s Choice of Chemotherapy and Bevacizumab in Women with Platinum-Resistant/Refractory Ovarian Cancer

Currently Enrolling 

The OnPrime study is a multi-center, randomized open-label phase 3 study evaluating the safety and efficacy of Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab in patients with Platinum-Resistant/Refractory Ovarian Cancer including fallopian tube carcinoma and peritoneal carcinomatosis. This Phase III trial builds on the efficacy and safety data reported in the previous Phase II VIRO-15 trial with promising objective response rate and progression-free survival observed in heavily pre-treated patients with platinum-resistant/refractory ovarian cancer.

For more information please visit  https://clinicaltrials.gov/study/NCT05281471?term=Olvi-Vec-022&rank=1&rank=1.

To enroll in this study at USF/TGH, please contact Kathleen Richman at (813) 844-4151. 

Protocol Title: A Phase 1 Basket Study Evaluating the Safety and Feasibility of T-Plex, Autologous Customized T Cell Receptor-Engineered T Cells Targeting Multiple Peptide/HLA Antigens in Participants with Antigen-positive Locally Advanced (Unresectable) or Metastatic Solid Tumors: PLEXI-T™

Ongoing but not currently enrolling 

This is a multi-center, non-randomized, multi-arm, open-label, basket study evaluating the safety and preliminary efficacy of single and repeat dose regimens of TCR'Ts as monotherapies and as T-Plex combinations after lymphodepleting chemotherapy in participants with locally advanced, metastatic solid tumors disease.

For more information please visit https://clinicaltrials.gov/study/NCT05973487 or https://www.tscan.com/for-patients/solid-tumors/.

To enroll in this study at USF/TGH, please contact Kathleen Murillo at (813) 844-4151.