• Read more about DIRECT

Short Title: DIRECT

This phase II trial tests how well an imaging procedure called fludeoxyglucose F-18 (FDG) positron emission tomography/computed tomography (PET/CT) works in predicting response to standard of care chemotherapy prior to surgery in patients with HER2-positive stage IIa-IIIc breast cancer. FDG is a radioactive tracer that is given in a vein before PET/CT imaging and helps to identify areas of active cancer. PET and CT are imaging techniques that make detailed, computerized pictures of areas inside the body. The use of FDG-PET/CT may help doctors better decide if a patient needs more or less treatment before surgery in order to get the best response. This study evaluates whether FDG-PET/CT is useful in predicting a patient's response to standard of care chemotherapy.

Study Number:

EA1211

Study Status:

Enrolling

Treatment Agent:

Chemotherapy

Resources and Links

National Clinical Trial Identified Number: NCT05710328

Disease:

• HER2-Positive Breast Carcinoma,
• Invasive Breast Carcinoma

Study Phase:

II

researchcancer@cooperhealth.edu

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Physician Name:

• Kamel Abou Hussein, MD

Department:

• Breast Cancer

• Read more about BR009

Short Title: BR009/OFSET

To determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).

Study Number:

BR009

Study Status:

Enrolling

Treatment Agent:

Ovarian Function Suppression, Aromatase Inhibitor, Adjuvant Chemotherapy, Ovarian Function Suppression

Resources and Links

National Clinical Trial Identified Number: NCT05879926

Disease:

• Breast Cancer

Study Phase:

III

ResearchCancer@CooperHealth.edu

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Physician Name:

• Danny Markabawi, MD

Department:

• Hematology and Medical Oncology

• Read more about LU008

Short Title: LU008

This phase III trial compares the effect of adding stereotactic body radiation therapy (SBRT) to standard treatment (image guided radiation therapy [IGRT] and chemotherapy followed by immunotherapy with durvalumab) versus standard treatment alone in treating patients with non-small cell lung cancer that cannot be treated by surgery (inoperable). SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. IGRT is a type of radiation that uses a computer to create picture of the tumor, to help guide the radiation beam during therapy, making it more accurate and causing less damage to healthy tissue.

Study Number:

LU008

Study Status:

Enrolling

Treatment Agent:

Cisplatin, Carboplatin, Paclitaxel, Pemetrexed, and Etoposide

Resources and Links

National Clinical Trial Identified Number: NCT05624996

Disease:

• Locally Advanced Lung Non-Small Cell Carcinoma,
• Stage IIB Lung Cancer AJCC v8,
• Stage III Lung Cancer AJCC v8

Study Phase:

III

ResearchCancer@CooperHealth.edu

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Physician Name:

• Joseph F. Lombardo, DO, PharmD

Department:

• Radiation Therapy,
• Lung Cancer

• Read more about GY026

Short Title: GY026

This phase II/III trial tests whether adding trastuzumab and hyaluronidase-oysk (Herceptin HylectaTM) or pertuzumab, trastuzumab and hyaluronidase-zzxf (PhesgoTM) to the usual chemotherapy (paclitaxel and carboplatin) works to shrink tumors in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma. 

Study Number:

GY026

Study Status:

Enrolling

Treatment Agent:

Carboplatin, Hyaluronidase-zzxf/Pertuzumab/Trastuzumab, Paclitaxel, Trastuzumab/Hyaluronidase-oysk

Resources and Links

National Clinical Trial Identified Number: NCT05256225

Disease:

• Endometrial Serous Adenocarcinoma,
• Uterine Corpus Carcinosarcoma

Study Phase:

II/III

Researchcancer@cooperhealth.edu

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Physician Name:

• David P. Warshal, MD, FACOG

Department:

• Gynecologic Cancer Center

• Read more about A022104

Short Title: JANUS

This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan), and CAPOX (capecitabin and oxaliplatin) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Study Number:

A022104

Study Status:

Enrolling

Treatment Agent:

Capecitabine, 5-fluorouracil, Leucovorin calcium, Irinotecan, Oxaliplatin

Resources and Links

National Clinical Trial Identified Number: NCT05610163

Disease:

• Locally Advanced Rectal Carcinoma

Study Phase:

II

researchcancer@cooperhealth.edu

Index Extra:

GI, gastro, rectal

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Physician Name:

• Jamin C. Morrison, MD, MBA

Department:

• Hematology and Medical Oncology

• Read more about SURVENT

Short Title: SURVENT 

The trial’s primary aim is to determine if patients undergoing endoscopic eradication therapy will demonstrate less neoplastic progression and a lower incidence of esophageal adenocarcinoma compared to patients undergoing surveillance. 

Study Number:

SURVENT

Study Status:

Enrolled

Treatment Agent:

Not Applicable

Resources and Links

National Clinical Trial Identified Number: NCT05753748

Disease:

• Barrett’s Esophagus with Low-grade Dysplasia,
• Esophageal Adenocarcinoma

Study Phase:

Not Applicable

researchcancer@cooperhealth.edu

Index Extra:

Esophageal, head and neck, Dysplasia, Barrett’s, Esophagus, gastro

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Physician Name:

• Anthony Infantolino, MD, FACP, FACG, AGAF, MASGE

Department:

• Gastroenterology

• Read more about SOROCk

Short Title: SOROCk/CC008

This clinical trial studies how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for individuals with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal of fallopian tubes, and bilateral salpingo-oophorectomy involves the surgical removal of both the fallopian tubes and ovaries. This study may help doctors determine if the two surgical procedures are nearly the same for ovarian cancer risk reduction for women with BRCA1 mutations.

Study Number:

CC008

Study Status:

Enrolling

Treatment Agent:

Not Applicable

Resources and Links

National Clinical Trial Identified Number: NCT04251052

Disease:

• Ovarian Carcinoma

Study Phase:

Not Applicable

ResearchCancer@CooperHealth.edu

Index Extra:

Ovarian, gyn, Gynecologic

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Physician Name:

• David P. Warshal, MD, FACOG

Department:

• Gynecologic Cancer Center

• Read more about SAMURAI

Short Title: SAMURAI

This phase II trial tests whether the addition of radiation to the primary tumor, typically given with stereotactic ablative radiation therapy (SABR), in combination with standard of care immunotherapy improves outcomes in patients with renal cell cancer that is not recommended for surgery and has spread to other places in the body (metastatic).

Study Number:

GU012

Study Status:

Enrolling

Treatment Agent:

Avelumab, Axitinib, Cabozantinib, Ipilimumab, Lenvatinib, Nivolumab, Pembrolizumab

Resources and Links

National Clinical Trial Identified Number: NCT05327686

Disease:

• Metastatic Renal Cell Carcinoma,
• Unresectable Renal Cell Carcinoma

Study Phase:

II

researchcancer@cooperhealth.edu

Index Extra:

GU, Renal

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Physician Name:

• Gary A. Eastwick, MD

Department:

• Radiation Oncology

• Read more about PDX

Short Title: PDX

To establish a continuously expanded library of human-to-mouse tumor grafts and cell lines from recalcitrant carcinomas, sarcomas or other malignancies.

Study Number:

PDX

Study Status:

Enrolling

Treatment Agent:

Not Applicable

Resources and Links

National Clinical Trial Identified Number: N/A

Disease:

• Acute Myeloid Leukemia,
• Bile Duct Cancer,
• Bladder,
• Breast,
• Colorectal,
• Esophageal,
• Gallbladder,
• Gastric,
• Kidney,
• Liver,
• Lung,
• Lymphoma,
• Melanoma,
• Multiple Myeloma,
• Pancreatic,
• Prostate,
• Thyroid

Study Phase:

Not Applicable

ResearchCancer@CooperHealth.edu

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Physician Name:

• Young Ki Hong, MD, MPH, FACS, FSSO

Department:

• Surgical Oncology,
• Hematology and Medical Oncology

• Read more about IOV-MEL-301

Short Title: IOV-MEL-301

We are the first site to open this study in the world!  This study is a Phase III study of lifileucel plus pembrolizumab compared with pembrolizumab alone in participants with untreated, unresectable or metastatic melanoma. The combination has the potential for enhanced antitumor activity through the combination of programmed cell death protein-1 (PD-1) blockade allowing for optimal engraftment, increased cytotoxicity, and intratumoral expansion of the infused lifileucel product. Continued pembrolizumab therapy after lifileucel infusion is expected to perpetuate the antitumor effect.

Study Number:

IOV-MEL-301

Study Status:

Enrolling

Treatment Agent:

Lifileucel plus Pembrolizumab, Pembrolizumab with Optional Crossover Period

Resources and Links

National Clinical Trial Identified Number: NCT05727904

Disease:

• Metastatic Melanoma,
• Unresectable Melanoma

Study Phase:

III

ResearchCancer@CooperHealth.edu

Index Extra:

melanoma, skin

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Physician Name:

• Young Ki Hong, MD, MPH, FACS, FSSO

Department:

• Skin Cancer,
• Surgical Oncology