PACIFIC-4

Submitted by rfreitag on

Short Title: PACIFIC-4

This is a Phase III, randomized, placebo-controlled, double-blind, multi-center study assessing the efficacy and safety of durvalumab with standard of care SBRT versus placebo with standard of care SBRT in patients with unresected clinical Stage I/II lymph node-negative (T1 to T3N0M0) NSCLC. An additional cohort will assess Osimertinib following SBRT in patients with early stage unresected T1 to T3N0M0 NSCLC harbouring an EGFR mutation.

Study Number:

D9103C00001

Study Status:

Enrolling

Treatment Agent:

Durvalumab, Osimertinib (single-arm, open-label)

Resources and Links

National Clinical Trial Identified Number: NCT03833154

Disease:

  • Non-Small Cell Lung Cancer

Study Phase:

III

ResearchCancer@CooperHealth.edu

Article Title

A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab with Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients with Unresected Stage I/II, lymph-node negative Non-small Cell Lung Cancer

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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

Index Extra:

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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2020-0517

Submitted by rfreitag on

Short Title: 2020-0517

This phase II trial studies if a single session of palliative radiation therapy can help improve symptoms of gynecologic cancers that have spread to other places in the body (metastatic) and that affect quality of life as well or more so than multiple sessions (which is the standard of care). Palliative radiation therapy may help patients with metastatic gynecologic cancers live more comfortably. Researchers also want to learn how radiation affects the immune system and to compare the effects of giving one radiation treatment to giving multiple radiation treatments.

Study Number:

2020-0517

Study Status:

Enrolling

Treatment Agent:

Not Applicable

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National Clinical Trial Identified Number: NCT04516135

Disease:

  • Metastatic Gynecologic Cancers

Study Phase:

II

ResearchCancer@CooperHealth.edu

Article Title

A Randomized Phase II Trial of Palliative Pelvic Radiation Therapy to Improve Health Related Quality of Life in Gynecologic Malignancies

Index Extra:

Gyn, Gynecologic

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MelPORT

Submitted by rfreitag on

Short Title: MelPORT

This phase II trial seeks to determine the role of nodal radiation therapy after sentinel lymph node biopsy (SLNB) for patients with high risk sentinel lymph node positive melanoma who are planned for immunotherapy without completion lymph node dissection. Prior studies of patients with more advanced melanoma have shown nodal radiation therapy can decrease the risk of nodal recurrence but it is not known if this same benefit will be seen in patients with high risk sentinel lymph node positive disease who are planned for immunotherapy.

Study Number:

2020-0148

Study Status:

Enrolling

Treatment Agent:

Not Applicable

Resources and Links

National Clinical Trial Identified Number: NCT04594187

Disease:

  • Melanoma

Study Phase:

II

ResearchCancer@CooperHealth.edu

Article Title

The Role of Nodal Radiation Therapy in Sentinel Lymph Node Positive Melanoma

Index Extra:

Melanoma, skin

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IOV-COM-202

Submitted by rfreitag on

Short Title: IOV-COM-202

This study is to evaluate the efficacy of autologous TIL in combination with CPIs in patients with metastatic melanoma.

Please note that the cohorts for lung are closed, but the study is still open for patients with Melanoma - Cohort 1A TIL and Pembro.

Study Number:

IOV-COM-202

Study Status:

Enrolling

Treatment Agent:

Pembrolizumab, Ipilimumab, Nivolumab

Resources and Links

National Clinical Trial Identified Number: NCT03645928

Disease:

  • Melanoma

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 Melanoma

Index Extra:

Melanoma, skin

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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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