PDX

Submitted by rfreitag on

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

Article Title

Human-to-mouse cancer tumor grafts for personalized cancer medicine.

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IOV-MEL-301

Submitted by rfreitag on

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

Study Phase:

III

ResearchCancer@CooperHealth.edu

Article Title

A Phase III, Multicenter, Randomized, Open-Label, Parallel group, Treatment Study to Assess the Efficacy and Safety of the Lifileucel (LN-144, Autologous Tumor-Infiltrating Lymphocytes [TIL]) Regimen in Combination with Pembrolizumab compared with Pembrolizumab Monotherapy in Participants with Untreated, Unresectable or Metastatic Melanoma

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melanoma, skin

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IOV-LUN-202

Submitted by rfreitag on

Short Title: IOV-LUN-202

This study is to evaluate the efficacy of LN-145 in patients with metastatic NSCLC without an actionable driver mutation who have disease progression on or following a single line of approved systemic therapy consisting of combined immune checkpoint inhibitor(s) (CPI[s]) + chemotherapy ± bevacizumab.

Study Number:

IOV-LUN-202

Study Status:

Enrolling

Treatment Agent:

Lifileucel, LN-145, Pembrolizumab, LN-145-S1, Ipilimumab, Nivolumab

Resources and Links

National Clinical Trial Identified Number: NCT03645928

Disease:

  • Non-Small Cell Lung Cancer

Study Phase:

II

ResearchCancer@CooperHealth.edu

Article Title

A Phase II, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-144 or LN-145) in Patients with Solid Tumors (Lung)

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lung, thoracic

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DRAMMATIC

Submitted by rfreitag on

Short Title: DRAMMATIC

This clinical trial offers treatment to patients with multiple myeloma who have undergone ASCT, a type of transplant that uses a patient's own stem cells (cells in the bone marrow that produce new blood cells) to replace those normal cells that are damaged by the high dose chemotherapy treatment that is given to kill cancer cells. Because there is a possibility of cancer returning even after ASCT, patients typically receive maintenance treatment, with the goal of preventing or delaying the return of cancer. In this clinical trial, one group of patients will be randomly assigned to receiving the standard maintenance treatment for multiple myeloma — an immunomodulatory drug called lenalidomide - which works by stimulating cells in the immune system, decreasing the blood supply to tumors, and inhibiting the growth of cancer cells.

Study Number:

S1803

Study Status:

Enrolling

Treatment Agent:

Lenalidomide, Daratumumab/rHuPH20

Resources and Links

National Clinical Trial Identified Number: NCT04071457

Disease:

  • Multiple Myeloma

Study Phase:

III

ResearchCancer@CooperHealth.edu

Article Title

Phase III Study of Daratumumab + Lenalidomide (LD) or Lenalidomide (L) as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration

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Myeloma, HEM

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Oral 3D Stent

Submitted by rfreitag on

Short Title: Oral 3D Stent

The primary objective of this randomized trial is to evaluate the acute mucositis rates in non-target mucosa of patients who receive head and neck radiation with or without a customized 3D printed oral stent.

Study Number:

2020-1153

Study Status:

Enrolling

Treatment Agent:

Not Applicable

Resources and Links

National Clinical Trial Identified Number: NCT04870762

Disease:

  • Head and Neck Carcinoma

Study Phase:

Not Applicable

ResearchCancer@CooperHealth.edu

Article Title

A Randomized Study of Head and Neck Radiotherapy With or Without Customized 3D Printed Oral Stents

Index Extra:

Head and Neck

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LEVER

Submitted by rfreitag on

Short Title:  LEVER

This randomized phase II trial studies how well levonorgestrel-releasing intrauterine system works when given alone or with Everolimus in treating patients with atypical hyperplasia (a pre-cancerous growth of the lining of the uterus) or stage IA grade 1 endometrial cancer.

Study Number:

2014-0944

Study Status:

Enrolling

Treatment Agent:

Everolimus

Resources and Links

National Clinical Trial Identified Number: NCT02397083

Disease:

  • Atypical hyperplasia ,
  • Stage IA grade 1 Endometrial Cancer

Study Phase:

II

ResearchCancer@CooperHealth.edu

Article Title

Phase II Study of the Levonorgestrel Intrauterine Device Alone or in Combination with the mTORC1 Inhibitor, Everolimus, for the Treatment of Complex Atypical Hyperplasia and Stage Ia Grade 1 Endometrial Cancer

Index Extra:

Endometrial, Gyn, Gynecologic

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GY019

Submitted by rfreitag on

Short Title: GY019

This phase III trial studies how well letrozole with or without paclitaxel and carboplatin works in treating patients with stage II-IV low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum. Letrozole is an enzyme inhibitor that lowers the amount of estrogen made by the body which in turn may stop the growth of tumor cells that need estrogen to grow. Drugs used in chemotherapy, such as paclitaxel and carboplatin, 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. It is not yet known whether giving letrozole alone or in combination with paclitaxel and carboplatin works better in treating patients with low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum compared to paclitaxel and carboplatin without letrozole.

Study Number:

GY019

Study Status:

Enrolling

Treatment Agent:

Carboplatin, Letrozole, Paclitaxel

Resources and Links

National Clinical Trial Identified Number: NCT04095364

Disease:

  • Low-Grade Serous Carcinoma of the Ovary, Fallopian tube, or Peritoneum

Study Phase:

III

ResearchCancer@CooperHealth.edu

Article Title

A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum

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Bone Sarcoma

Submitted by rfreitag on

Short Title: PA14-1067

The objectives of the study are to better understand the role of genomic alterations in bone sarcoma patients whose cancers have either progressed on therapy, after a period of response, or were refractory to initial "first-line" treatment.

Study Number:

PA14-1067

Study Status:

Enrolling

Treatment Agent:

Not Applicable

Resources and Links

National Clinical Trial Identified Number: N/A

Disease:

  • Bone Sarcoma

Study Phase:

Not Applicable

ResearchCancer@CooperHealth.edu

Article Title

Genomic Analysis of Bone Sarcomas

Index Extra:

Bone, Orthopedic

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Guidance

Submitted by rfreitag on

Short Title: Guidance

This phase III trial uses the Decipher risk score to guide intensification (for higher Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment to better match therapies to an individual patient's cancer aggressiveness. The Decipher risk score evaluates a prostate cancer tumor for its potential for spreading. In patients with low risk scores, this trial compares radiation therapy alone to the usual treatment of radiation therapy and hormone therapy (androgen deprivation therapy).

Study Number:

GU010

Study Status:

Enrolling

Treatment Agent:

Bicalutamide, Buserelin, Darolutamide, Degarelix, Flutamide, Goserelin, Histrelin, Leuprolide

Resources and Links

National Clinical Trial Identified Number: NCT05050084

Disease:

  • Prostate Cancer

Study Phase:

III

ResearchCancer@CooperHealth.edu

Article Title

Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification and Intensification Clinical Trial Evaluation (Guidance)

Index Extra:

Prostate, GU

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PREDICT-RT

Submitted by rfreitag on

Short Title: PREDICT-RT

This phase III trial compares less intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in treating patients with high risk prostate cancer and low gene risk score. This trial also compares more intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in patients with high risk prostate cancer and high gene risk score.

Study Number:

GU009

Study Status:

Enrolling

Treatment Agent:

Apalutamide, Bicalutamide, Buserelin, Degarelix, Flutamide, Goserelin, Histrelin, Leuprolide

Resources and Links

National Clinical Trial Identified Number: NCT04513717

Disease:

  • Prostate Cancer

Study Phase:

III

ResearchCancer@CooperHealth.edu

Article Title

Parallel Phase III Randomized Trials for High Risk Prostate Cancer Evaluating De-Intensification for Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic Risk with Radiation (PREDICT-RT*) *Prostate RNA Expression/Decipher to Individualize Concurrent Therapy with Radiation

Index Extra:

GU, Prostate

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