GY026

Submitted by rfreitag on

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

Article Title

A Phase II/III Study of Paclitaxel/Carboplatin Alone or Combined with Either Trastuzumab and Hyaluronidase-Oysk (Herceptin Hylecta) or Pertuzumab, Trastuzumab, and Hyaluronidase-Zzxf (Phesgo) in Her2 Positive, Stage I-IV Endometrial Serous Carcinoma or Carcinosarcoma

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SURVENT

Submitted by rfreitag on

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

Article Title

A Multicenter Randomized Controlled Trial of Surveillance vs. Endoscopic Therapy for Barrett’s Esophagus with Low-grade Dysplasia

Index Extra:

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

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SOROCk

Submitted by rfreitag on

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

Article Title

A Non-Randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-oophorectomy to Reduce the Risk of Ovarian Cancer Among BRCA1 Carriers [SOROCk]

Index Extra:

Ovarian, gyn, Gynecologic

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SAMURAI

Submitted by rfreitag on

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

Article Title

Randomized Phase II Stereotactic Ablative Radiation Therapy (SABR) For Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy

Index Extra:

GU, Renal

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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,
  • Unresectable 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

Index Extra:

melanoma, skin

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DRAMMATIC

Submitted by rfreitag on

Short Title: DRAMMATIC/S1803

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.

Please note that this study is approaching the protocol specific accrual goal for Registration Step 1 and will permanently close on January 15th at 12:00 PM PST.

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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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/GU010

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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