Short Title: GY028
This phase Ib/II trial tests the safety, side effects, best dose, and effectiveness of the combination of ipatasertib with megestrol acetate to megestrol acetate alone in patients with endometrial cancer that has come back (recurrent) or has spread to other places in the body (metastatic). Ipatasertib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for cell growth. Megestrol acetate lowers the amount of estrogen and also blocks the use of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. The combination of ipatasertib and megestrol acetate may be more effective in treating endometrial cancer than megestrol acetate alone.
Study Number:
GY028
Study Status:
Enrolling
Treatment Agent:
Ipatasertib, Megestrol Acetate
National Clinical Trial Identified Number: NCT05538897
Disease:
Study Phase:
I/II
researchcancer@cooperhealth.edu
A Phase IB and Randomized Phase II Trial of Megestrol Acetate with or without Ipatasertib In Recurrent or Metastatic Endometrioid Endometrial Cancer
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Short Title: IGNYTE-3
P1 is a genetically modified herpes simplex type 1 virus that is designed to directly destroy tumors and to generate an anti-tumor immune response. This is a Phase 1/2, open label, multicenter, dose escalation and expansion, first-in-human (FIH) clinical study to evaluate the safety and tolerability, biodistribution, shedding, and preliminary efficacy of RP1 alone and in combination with nivolumab in adult subjects with advanced and/or refractory solid tumors. The study will include a dose escalation phase for single agent RP1, an expansion phase with a combination of RP1 and nivolumab and a Phase 2 portion in specified tumor types for the combination therapy.
Study Number:
RP1-104 (IGNYTE-3)
Study Status:
Enrolling
Treatment Agent:
RP1, Nivolumab
National Clinical Trial Identified Number: NCT03767348
Disease:
Study Phase:
I/II
researchcancer@cooperhealth.edu
A Randomized, Controlled, Multicenter, Phase 3 Clinical Study Comparing Vusolimogene Oderparepvec in Combination with Nivolumab Versus
Treatment of Physician’s Choice in Patients with Advanced Melanoma That Has Progressed on an Anti-PD-1 and an Anti-CTLA-4 Containing Treatment
Regimen
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This Phase Ib/III study (CAPItello-292) aims to evaluate the efficacy, safety and the degree of added benefit of capivasertib combined with CDK4/6i and fulvestrant in participants with locally advanced (inoperable) or metastatic HR+/HER2- breast cancer. Although the dosing regimens of capivasertib + fulvestrant and of CDK4/6i + fulvestrant are established separately, the dose and schedule for the triplet combinations (capivasertib + CDK4/6i + fulvestrant) need to be confirmed. Therefore, the initial dose finding Phase Ib part of the study will determine the recommended Phase III doses (RP3D) of the triplet combinations. The Phase III part of the study will evaluate the efficacy, safety and the degree of added benefit of the triplet combinations of capivasertib and fulvestrant with investigator's choice of CDK4/6i (either palbociclib or ribociclib at safe and tolerable doses, once identified) in comparison with a control arm (fulvestrant + investigator's choice of CDK4/6i [palbociclib or ribociclib]) in a ER+ HER2- maC high risk population that did not receive prior endocrine therapy in the advanced setting.
Study Number:
CAPitello-292
Study Status:
Enrolling
Treatment Agent:
Capivasertib, Fulvestrant, Palbociclib, Ribociclib,Abemaciclib
National Clinical Trial Identified Number: NCT04862663
Disease:
Study Phase:
IB/III
researchcancer@cooperhealth.edu
A Phase Ib/III, Open-label, Randomized Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer
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Short Title: XL092-035/Stellar 305
This is a multicenter, randomized, double-blind, controlled Phase 2/3 trial of zanzalintinib in combination with pembrolizumab versus zanzalintinib-matched placebo in combination with pembrolizumab in subjects with PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) incurable by local therapies who have not received prior systemic therapy for recurrent or metastatic disease.
Study Number:
XL092-035_ STELLAR-305
Study Status:
Enrolling
Treatment Agent:
Zanzalintinib, Pembrolizumab
National Clinical Trial Identified Number: NCT06082167
Disease:
Study Phase:
Phase II/III
researchcancer@cooperhealth.edu
A Phase II/III, Randomized, Double-Blind, Controlled Study of Zanzalintinib (Xl092) in Combination with Pembrolizumab Vs Pembrolizumab in The First-Line Treatment of subjects with PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
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Dr. Valenti joined Cooper University Health Care in 1998. During her tenure, she has served in a variety of roles including staff nurse in the cardiac catheterization and electrophysiology laboratories before transitioning into nurse leadership roles in the heart institute, patient care services, ambulatory operations, and currently, oncology services.
Ms. St. John joined Cooper University Healthcare in April 2024. She provides operational and clinical oversight for Pre-admission Testing, Operating Room Suites, PACU, Pre-op Holding Area, Surgical Care Unit, Short Procedure Unit, and Central Sterile Processing.
Ms. Farnum joined Cooper University Health Care 2024. She is the lead agent of change to improve operating room (OR) processes and OR utilization while simultaneously enhancing the patients’ overall ambulatory experiences at the Voorhees and Moorestown Surgical Centers.
Dr. Autum Shingler-Nace joined Cooper University Health Care in October 2023. She has executive oversight of inpatient and ambulatory surgical and procedural services, including Perioperative Services; Cardiac Catheterization, Electrophysiology, and Gastrointestinal Labs; and Interventional Radiology.
Short Title: INSPIRE-CRT
The INSPIRE-LUNG-CRT trial is a prospective, pilot study investigating the efficacy of incentive spirometry on the incidence and severity of pneumonitis in lung cancer patients undergoing concurrent chemotherapy and radiation therapy with immunotherapy maintenance. Despite advancements in treatment modalities, pulmonary complications remain a significant challenge, often leading to diminished functional capacity and quality of life. This trial aims to establish incentive spirometry as a non-pharmacological intervention to reduce these complications, thereby improving clinical outcomes and patient well-being. Lung cancer treatments are frequently associated with pulmonary toxicities, such as radiation-induced pneumonitis and fibrosis, immunotherapy induced pneumonitis, significantly impacting patient outcomes. Incentive spirometry, a device that encourages deep breathing and lung expansion, has shown promise in postoperative settings but is underutilized in oncology.
Study Number:
INSPIRE-CRT
Study Status:
Enrolling
Treatment Agent:
Not Applicable
National Clinical Trial Identified Number: NCT06688422
Disease:
Study Phase:
III
ResearchCancer@CooperHealth.edu
Incentive Spirometry for Respiratory Enhancement (INSPIRE-CRT) pilot Clinical Trial in Lung Cancer Patients Undergoing Concurrent Chemotherapy and Radiation Therapy
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