• Read more about EvoPAR-Breast01

Short Title: EvoPAR-Breast01

The primary objective of the study is to measure efficacy of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as IHC 0, 1+, 2+/ ISH non-amplified) advanced breast cancer. 

Participants will be randomised in a 2:2:1 ratio to one of the following intervention groups:

• Arm 1: saruparib (AZD5305) plus camizestrant
• Arm 2: Physician's choice CDK4/6i plus physician's choice ET
• Arm 3: Physician's choice CDK4/6i plus camizestrant Treatment continues until BICR-confirmed disease progression, unacceptable toxicity occurs, or the participant withdraws consent.

Study Number:

EvoPAR-Breast01

Study Status:

Enrolling

Treatment Agent:

Saruparib (AZD5305), Camizestrant, Abemaciclib, Ribociclib, Palbociclib, Fulvestrant, Letrozole, Anastrozole, Exemestane

Resources and Links

National Clinical Trial Identified Number: NCT06380751

Disease:

• Advanced Breast Cancer

Study Phase:

III

researchcancer@cooperhealth.edu

Hide from Search:

Off

Physician Name:

• Rebecca J. Jaslow, MD

Department:

• Hematology and Medical Oncology

• Read more about GY036

Short Title: GY036

This phase III trial compares the effect of olaparib for one year versus two years, with or without bevacizumab, for the treatment of BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer. Olaparib is a polyadenosine 5'-diphosphoribose polymerase (PARP) enzyme inhibitor and may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving olaparib for one year with or without bevacizumab may be effective in treating patients with BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer, when compared to two years of olaparib.

Study Number:

GY036

Study Status:

Enrolling

Treatment Agent:

Bevacizumab, Olaparib

Resources and Links

National Clinical Trial Identified Number: NCT06580314

Disease:

• Fallopian Tube Endometrioid Adenocarcinoma,
• Fallopian Tube High Grade Serous Adenocarcinoma,
• Ovarian Carcinoma,
• Ovarian High Grade Endometrioid Adenocarcinoma,
• Ovarian High Grade Serous Adenocarcinoma,
• Primary Peritoneal Endometrioid Adenocarcinoma,
• Primary Peritoneal High Grade Serous Adenocarcinoma

Study Phase:

III

researchcancer@cooperhealth.edu

Hide from Search:

Off

Physician Name:

• David P. Warshal, MD, FACOG

Department:

• Gynecologic Cancer Center

• Read more about IOV-GM1-201

Short Title: IOV-GM1-201

This study is the first-in-human study of IOV-4001, a genetically modified autologous tumor- infiltrating lymphocytes (TIL) product. IOV-4001 is expected to have antitumor activity through its capacity to directly target and kill tumor cells in a manner that is similar to non-genome-edited TIL, but with the potential for enhanced antitumor activity due to disruption of PDCD1, the gene for programmed cell death protein-1 (PD-1).

Study Number:

IOV-GM1-201

Study Status:

Enrolling

Treatment Agent:

IOV-4001

Resources and Links

National Clinical Trial Identified Number: NCT05361174

Disease:

• Unresectable Melanoma,
• Metastatic Melanoma,
• Stage III Non-small Cell Lung Cancer,
• Stage IV Non-small Cell Lung Cancer

Study Phase:

I/II

researchcancer@cooperhealth.edu

Hide from Search:

Off

Physician Name:

• Young Ki Hong, MD, MPH, FACS, FSSO

Department:

• Hematology and Medical Oncology,
• Lung Cancer

• Read more about AHOD2131

Short Title: AHOD2131

This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard treatment alone in improving survival in patients with stage I and II classical Hodgkin lymphoma. Brentuximab vedotin is in a class of medications called antibody-drug conjugates. It is made of a monoclonal antibody called brentuximab that is linked to a cytotoxic agent called vedotin. Brentuximab attaches to CD30 positive lymphoma cells in a targeted way and delivers vedotin to kill them. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs such as doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, dacarbazine, and procarbazine hydrochloride work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Adding immunotherapy to the standard treatment of chemotherapy with or without radiation may increase survival and/or fewer short-term or long-term side effects in patients with classical Hodgkin lymphoma compared to the standard treatment alone.

Please note that this trial is available at Cooper MD Anderson for ages 18-60 only at this time.

Study Number:

AHOD2131

Study Status:

Enrolling

Treatment Agent:

Bleomycin Sulfate, Brentuximab Vedotin, Cyclophosphamide, Dacarbazine, Doxorubicin Hydrochloride, Etoposide, Etoposide Phosphate, Nivolumab, Prednisolone, Prednisone, Procarbazine Hydrochloride, Vinblastine Sulfate, Vincristine Sulfate

Resources and Links

National Clinical Trial Identified Number: NCT05675410

Disease:

• Lugano Classification Limited Stage Hodgkin Lymphoma

Study Phase:

III

researchcancer@cooperhealth.edu

Hide from Search:

Off

Physician Name:

• Sushil Ghimire, MD

Department:

• Hematology and Medical Oncology

• Read more about Miriam Ziegler, MSN, RN

Ms. Ziegler serves as the Assistant Vice President of Nursing Operations, providing oversight of adult Critical Care, Trauma Admitting, Trauma Stepdown, Trauma Med-Surg, Inpatient Oncology, and the Vascular Access team. In this role, she is dedicated to driving operational excellence and advancing quality outcomes across the continuum of care.

• Read more about FLAMINGO-01

Short Title: FLAMINGO-01

This is a prospective, randomized, double-blinded, placebo-controlled, multi-center, phase 3 study of GLSI-100 immunotherapy in HLA-A*02 positive and HER2/neu positive subjects who are at high risk for disease recurrence and have completed both neoadjuvant and postoperative adjuvant standard of care therapy. Treatment consists of 6 intradermal injections, Primary Immunization Series (PIS), over the first 6 months of treatment and 5 booster intradermal injections spaced 6 months apart. A third open-label arm will explore GLSI-100 immunotherapy in non-HLA-A*02 positive and HER2/neu positive subjects.

Study Number:

GLSI-21-01_FLAMINGO-01

Study Status:

Enrolling

Treatment Agent:

GLSI-100

Resources and Links

National Clinical Trial Identified Number: NCT05232916

Disease:

• Breast Cancer

Study Phase:

III

researchcancer@cooperhealth.edu

Hide from Search:

Off

Physician Name:

• Kamel Abou Hussein, MD

Department:

• Hematology and Medical Oncology,
• Breast Cancer

• Read more about CC009

Short Title: CC009

This phase III trial compares the effect of stereotactic radiosurgery to standard of care memantine and whole brain radiation therapy that avoids the hippocampus (the memory zone of the brain) for the treatment of small cell lung cancer that has spread to the brain. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Whole brain radiation therapy delivers a low dose of radiation to the entire brain including the normal brain tissue. Hippocampal avoidance during whole-brain radiation therapy (HA-WBRT) decreases the amount of radiation that is delivered to the hippocampus which is a brain structure that is important for memory. The drug, memantine, is also often given with whole brain radiotherapy because it may decrease the risk of side effects related to thinking and memory. Stereotactic radiosurgery may decrease side effects related to memory and thinking compared to standard of care HA-WBRT plus memantine.

Study Number:

CC009

Study Status:

Enrolling

Treatment Agent:

Memantine Hydrochloride, Radiation

Resources and Links

National Clinical Trial Identified Number: NCT04804644

Disease:

• Metastatic Lung Small Cell Carcinoma,
• Metastatic Malignant Neoplasm in the Brain,
• Recurrent Lung Small Cell Carcinoma

Study Phase:

III

researchcancer@cooperhealth.edu

Hide from Search:

Off

Physician Name:

• Justin M. Mann, MD

Department:

• Radiation Oncology,
• Brain Tumors

• Read more about RP1-104 (IGNYTE-3)

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

Resources and Links

National Clinical Trial Identified Number: NCT03767348

Disease:

• Melanoma,
• Mismatch Repair Deficiency,
• Microsatellite Instability,
• Non-melanoma Skin Cancer,
• Cutaneous Melanoma

Study Phase:

I/II

researchcancer@cooperhealth.edu

Hide from Search:

Off

Physician Name:

• Jamin C. Morrison, MD, MBA

Department:

• Hematology and Medical Oncology

• Read more about XL092-035/Stellar 305

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

Resources and Links

National Clinical Trial Identified Number: NCT06082167

Disease:

• Head and Neck Squamous Cell Carcinoma

Study Phase:

Phase II/III

researchcancer@cooperhealth.edu

Hide from Search:

Off

Physician Name:

• Christian Squillante, MD

Department:

• Hematology and Medical Oncology

• Read more about Assistant Vice President, Oncology Services

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.