New Clinical Trials Available at FHCI

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Breast
Alliance A221505: Phase III randomized trial of hypofractionated post-mastectomy radiation with breast reconstruction

CBYL719X2402: A Phase II, multi-center, open-label, two-cohort, non-comparative study to assess the efficacy and safety of alpelisib plus fulvestrant or letrozole in patients with PIK3CA mutant, hormone-receptor (HR) positive, HER2-negative advanced breast cancer (aBC), who have progressed on or after CDK 4/6 inhibitor treatment

Genitourinary
SPI-QAP-306: A randomized, multi-center, two-arm, single-dose, double-blind, placebo-controlled Phase III study of intravesical Qapzola (apaziquone) as a chemotherapy adjuvant to transurethral Resection of bladder tumors in patients with low- to intermediate-risk non-muscle invasive bladder cancer (CONQUER)

7465-CL-0301: An open-label, randomized Phase III study to evaluate enfortumab vedotin vs. chemotherapy in subjects with previously treated locally advanced or metastatic urothelial cancer

GU006: A Phase II, double-blinded, placebo-controlled randomized trial of salvage radiotherapy with or without enhanced anti-androgen therapy with apalutamide in recurrent prostate cancer

Gyn/Onc
Clovis/GOG 3020: A multi-center, randomized, double-blind, placebo-controlled Phase III study of rucaparib in combination with nivolumab versus placebo as switch maintenance following response to front-line platinum-based chemotherapy in patients with high-grade serous or endometrioid epithelial ovarian, primary peritoneal or fallopian tube cancer

MK3475-775: A multi-center, open-label, randomized, Phase III trial to compare the efficacy and safety of lenvatinib in combination with pembrolizumab versus treatment of physicians choice in participants with advanced endometrial cancer 

Hematologic
JZP963-201: A Phase II, prospective, randomized, open-label study on the efficacy of defibrotide added to standard-of-care immunoprophylaxis for the prevention of acute graft-versus-host-disease in adult and pediatric patients after allogeneic hematopoietic stem cell transplant

Lung
MK3475-598: A Phase III, randomized, double-blind study of pembrolizumab plus ipilimumab vs pembrolizumab plus placebo in previously untreated, advanced/recurrent non-small cell lung cancer subjects whose tumors are PD-L1 positive (TPS 50%) 

GRN-1201-002: Phase II study of GRN-1201 added to pembrolizumab in subjects with PD-L1+ non-small cell lung cancer

MM-398-01-03-04: A randomized, open-label, Phase III study of irinotecan liposome injection (ONIVYDE) versus topotecan in patients with small cell lung cancer who have progressed on or after platinum-based first-line therapy (RESILIENT)

For more information or to refer a patient, call the Clinical Research Office at Call407-303-7302. Eligibility criteria may also be viewed at https://www.adventhealthcancerinstitute.com/

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