New Clinical Trials Available at AdventHealth Cancer Institute

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Gastrointestinal

MK7902-002: A Phase III multi-center, randomized, double-blind, active-controlled, clinical study to evaluate the safety and efficacy of lenvatinib in combination with pembrolizumab (MK-3475) versus lenvatinib in first-line therapy of participants with unresectable hepatocellular carcinoma (E7080-G000-311)

Genitourinary

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

NRG-GU002: Phase II-III trial of adjuvant radiotherapy and androgen deprivation following radical prostatectomy with or without adjuvant docetaxel

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

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 trans-urethral resection of bladder tumors in patients with low- to intermediate-risk non-muscle invasive bladder cancer (CONQUER)

Gyn/Onc

Clovis CO-338-087/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 physician’s choice in participants with advanced endometrial cancer

YO40482: A Phase IB study of cobimetinib administered in combination with niraparib, with or without atezolizumab, to patients with advanced platinum-sensitive ovarian cancer(Pending Site Activation)

Lung

AP32788-15-101: A Phase I/II study of the safety, pharmacokinetics and anti-tumor activity of the oral EGFR/HER2 inhibitor AP32788 in non-small cell lung cancer (NSCLC)

MK7902-007: A Phase III, randomized, double-blind trial of pembrolizumab (MK 3475) with or without lenvatinib in participants with treatment-naïve, metastatic non-small cell lung cancer (NSCLC) who have a tumor proportion score (TPS) greater than or equal to 1%

Lymphoma

NP40126: A Phase IB study evaluating Ro7082859 in combination with rituximab (R) or obinutuzumab (G) plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in participants with relapsed or refractory non-Hodgkin’s lymphoma (R/RNhl) or in participants with untreated diffuse large B-cell lymphoma (DLBCL)(Pending Activation)

017007: A safety trial of lisocabtagene maraleucel (JCAR017) for relapsed and refractory (R/R) B-cell non-Hodgkin’s lymphoma (NHL) in the outpatient setting (CAR T-cell)(Pending Activation)

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

Radiation Oncology Focused Clinical Trials

AdventHealth Cancer Institute maintains a robust clinical trial menu of studies with an important radiation oncology component.

ALLIANCE CIRB A011202: A randomized Phase III trial comparing axillary lymph node dissection to axillary radiation in breast cancer patients (cT1-3 N1) who have positive sentinel lymph node disease after neoadjuvant chemotherapy

NSABP B-51: A randomized Phase III clinical trial evaluating post-mastectomy chest wall and regional nodal XRT and post-lumpectomy regional nodal XRT in patients with positive axillary nodes before neoadjuvant chemotherapy who convert to pathologically negative axillary nodes after neoadjuvant chemotherapy

ALLIANCE CIRB A221505: A Phase III randomized trial of hypofractionated post-mastectomy radiation with breast reconstruction

ALLIANCE A021501: Preoperative extended chemotherapy vs. chemotherapy plus hypofractionated radiation therapy for borderline resectable adenocarcinoma of the head of the pancreas

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

NRG-GU002: Phase II-III trial of adjuvant radiotherapy and androgen deprivation following radical prostatectomy with or without adjuvant docetaxel

RTOG 0724/GOG-0724: A Phase III randomized study of concurrent chemotherapy and pelvic radiation therapy with or without adjuvant chemotherapy in high-risk patients with early-stage cervical carcinoma following radical hysterectomy

PR-001 PREVLAR: A Phase IIA randomized, parallel group, open-label, multi-center study to assess the safety and efficacy of different schedules of RRx-001 in the attenuation of oral mucositis in patients receiving concomitant chemoradiation for the treatment of locally advanced squamous cell carcinomas of the oral cavity or oropharynx

For more information or to refer a patient to one of these studies, contact Clinical Research Coordinator Melanie Percy, BS, CCRP, at [email protected] or Call407-303-2097.

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