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

Currently Enrolling

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/  

To enroll in this study at USF Health, please contact Kaitlyn Tibbetts at (813) 259-0655.

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 Hillary Henry at (813) 259-8685.

Protocol Title: A Randomized, Placebo-Controlled, Dose Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Subcutaneous Dose of CBP-4888 or Placebo in Hospitalized Participants with Preterm Preeclampsia Receiving Standard of Care, Expectant Management

Start-up/pending

This study is to investigate the safety, pharmacodynamic, pharmacokinetic characteristics of CBP-4888 in hospitalized participants with preterm preeclampsia and their children up to 24 months. 

To enroll in this study at USF Health, please contact Kaitlyn Tibbetts at (813) 259-0655. 

Protocol Title: A Phase 1B/2 Multicohort Umbrella Study to Evaluate the Safety and Efficacy of Novel Treatments And/Or Combinations of Treatments in Participants With Ovarian Cancer (OPAL) 

Ongoing but not currently enrolling

This study will evaluate the efficacy and safety of niraparib and novel treatment combinations of niraparib as described within each cohort-specific supplement in participants with ovarian, fallopian tube, or primary peritoneal cancer. Cohort A (single arm) includes participants with recurrent ovarian cancer. Cohort B will not be initiated. Cohort C (randomized-2 arms) includes participants with newly diagnosed ovarian cancer.

For more information please visit t https://clinicaltrials.gov/study/NCT03574779?term=NCT03574779&rank=1.

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

Protocol Title: A Phase 1 Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of STRO-002, an Anti-Folate Receptor alpha (FolRα) Antibody-Drug Conjugate (ADC), in Combination with Bevacizumab in Patients with Advanced Epithelial Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers)

Ongoing but not currently enrolling

This study is a Phase 1, open-label, multicenter, dose escalation study to assess preliminary efficacy for STRO-002 combined with bevacizumab in patients with advanced ovarian cancer that is refractory or has relapsed after standard available therapy. Fallopian tube and primary peritoneal cancers are treated in the same manner as epithelial ovarian cancers and are thus included in this study.

For more information visit https://clinicaltrials.gov/study/NCT05200364. 

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

Protocol Title: REFRaME-O1: A Phase 2/3 Open-label Study Evaluating the Efficacy and Safety of Luveltamab Tazevibulin (STRO-002) versus Investigator’s Choice (IC) Chemotherapy in Women with Relapsed Platinum-resistant Epithelial Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing Folate Receptor Alpha (FOLR1)

Currently Enrolling 

The goal of this study is to investigate the efficacy outcomes measures of luveltamab tazevibulin like overall survival and duration of response in subjects with relapsed platinum-resistant epithelial ovarian cancer expressing FOLR1.

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

Protocol Title: A Phase 1 Study of ZN-c3 as a Single Agent in Subjects With Solid Tumors

Ongoing But Not Currently Enrolling

This is a Phase 1 open-label, multicenter study of ZN-c3 monotherapy which consists of Dose Escalation, a Food Effect Cohort, and Dose Expansion. This study will evaluate the safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics of ZN-c3.

For more information please visit https://clinicaltrials.gov/study/NCT04158336. 

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

Protocol Title: A phase 2 open-label, Multicenter Study To Evaluate Efficacy And Safety Of ZN-c3 In Adult Women With Recurrent Or Persistent Uterine Serous Carcinoma.

Currently Enrolling

This is a Phase 2 open-label, multicenter study that aims to determine the safety and tolerability of ZN-c3 in subjects with recurrent or persistent uterine serous carcinoma (USC). Additionally, this study investigates the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC. For more information visit https://www.clinicaltrials.gov/study/NCT04814108?id=NCT04814108&rank=1

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

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

Enrolling Soon

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. 

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

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

Enrolling Soon

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: 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.

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: 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.