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
National Clinical Trial Identified Number: NCT05361174
Disease:
Study Phase:
I/II
researchcancer@cooperhealth.edu
A Phase I/II, Open-Label Study of PD-1 Knockout Tumor Infiltrating Lymphocytes (IOV-4001) in Participants with Unresectable or Metastatic Melanoma or Stage III/IV Non-Small Cell Lung Cancer
Hide from Search:
Off
Physician Name:
Department:
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
National Clinical Trial Identified Number: NCT05675410
Disease:
Study Phase:
III
researchcancer@cooperhealth.edu
A Randomized Phase III Interim Response-Adapted Trial Comparing Standard Therapy with Immuno-oncology Therapy for Adults with Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma
Hide from Search:
Off
Physician Name:
Department:
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.
Short Title: MajesTEC-9
This is a 2-part, multicenter, open-label study in participants with multiple myeloma who have previously received 1 to 3 prior line(s) of therapy.
Part 1 is a Phase III randomized study comparing teclistamab monotherapy versus investigator’s choice of PVd or Kd in participants with relapsed or refractory multiple myeloma. Part 2 is a single-arm cohort (teclistamab monotherapy) to evaluate the safety, efficacy, and PK of an alternative step-up dosing schedule for teclistamab.
Study Number:
MajesTEC-9
Study Status:
Enrolling
Treatment Agent:
Teclistamab, Pomalidomide, Bortezomib, Dexamethasone, Carfilzomib
National Clinical Trial Identified Number: NCT05572515
Disease:
Study Phase:
III
ResearchCancer@cooperhealth.edu
A Phase III Randomized Study Comparing Teclistamab Monotherapy versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants with Relapsed or Refractory Multiple Myeloma who have Received 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Monoclonal Antibody and Lenalidomide
Hide from Search:
Off
Physician Name:
Department:
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
National Clinical Trial Identified Number: NCT05232916
Disease:
Study Phase:
III
researchcancer@cooperhealth.edu
A Randomized, Multicenter, Placebo-controlled, Phase 3 study to Evaluate the Efficacy and Safety of HER2/neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/neu Positive Subjects with Residual Disease or High-Risk PCR after both Neoadjuvant and Postoperative Adjuvant Trastuzumab-based Therapy
Hide from Search:
Off
Physician Name:
Department:
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
National Clinical Trial Identified Number: NCT04804644
Disease:
Study Phase:
III
researchcancer@cooperhealth.edu
Phase III clinical trial evaluating radiation therapy approaches for patients with small cell lung cancer (SCLC) that has metastasized to the brain
Hide from Search:
Off
Physician Name:
Department:
Short Title: ACE-Breast-03
Phase 2 study of ARX788 in HER2-positive Metastatic Breast Cancer Patients who were previously treated with T-DXd. The ARX788 will be administered every 3 weeks via intravenous (IV) infusion.
Study Number:
ACE-Breast-03
Study Status:
Enrolling
Treatment Agent:
ARX788
National Clinical Trial Identified Number: NCT04829604
Disease:
Study Phase:
II
researchcancer@cooperhealth.edu
A Global, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients who were Previously Treated with T-DXd
Hide from Search:
Off
Physician Name:
Department:
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
Hide from Search:
Off
Physician Name:
Department:
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
Hide from Search:
Off
Physician Name:
Department:
