BR009

Submitted by rfreitag on

Short Title: OFSET

To determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).

Study Number:

BR009

Study Status:

Enrolling

Treatment Agent:

Ovarian Function Suppression, Aromatase Inhibitor, Adjuvant Chemotherapy, Ovarian Function Suppression

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National Clinical Trial Identified Number: NCT05879926

Disease:

  • Breast Cancer

Study Phase:

III

ResearchCancer@CooperHealth.edu

Article Title

A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression plus Endocrine Therapy in Premenopausal Patients with pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score ≤ 25

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LU008

Submitted by rfreitag on

Short Title: LU008

This phase III trial compares the effect of adding stereotactic body radiation therapy (SBRT) to standard treatment (image guided radiation therapy [IGRT] and chemotherapy followed by immunotherapy with durvalumab) versus standard treatment alone in treating patients with non-small cell lung cancer that cannot be treated by surgery (inoperable). SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. IGRT is a type of radiation that uses a computer to create picture of the tumor, to help guide the radiation beam during therapy, making it more accurate and causing less damage to healthy tissue.

Study Number:

LU008

Study Status:

Enrolling

Treatment Agent:

Cisplatin, Carboplatin, Paclitaxel, Pemetrexed, and Etoposide

Resources and Links

National Clinical Trial Identified Number: NCT05624996

Disease:

  • Locally Advanced Lung Non-Small Cell Carcinoma,
  • Stage IIB Lung Cancer AJCC v8,
  • Stage III Lung Cancer AJCC v8

Study Phase:

III

ResearchCancer@CooperHealth.edu

Article Title

Phase III Prospective Randomized Trial of Primary Lung Tumor Stereotactic Body Radiation Therapy Followed by Concurrent Mediastinal Chemoradiation for LocallyAdvanced Non-Small Cell Lung Canc

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MajesTEC-9

Submitted by rfreitag on

Short Title: MajesTEC-9

Multiple myeloma is an incurable, malignant, plasma cell disorder. Teclistamab (JNJ-64007957) is a full-size, Immunoglobulin G (IgG) 4 proline, alanine, and alanine (PAA) bispecific antibody that targets the cluster of differentiation (CD3) receptor expressed on the surface of T cells and B cell maturation antigen (BCMA). With its dual binding sites, teclistamab is able to draw CD3 positive T cells in close proximity to BCMA positive cells, resulting in T-cell activation and subsequent lysis of BCMA positive cells. Pomalidomide is a third-generation immunomodulatory imide drug (IMiD) that exerts potent, direct tumoricidal and immune-enhancing effects and Carfilzomib is a second-generation proteasome inhibitor that inhibits proteasome which results in disruption of protein turnover and induces apoptosis.

Study Number:

MajesTEC-9

Study Status:

Enrolling

Treatment Agent:

Teclistamab, Pomalidomide, Bortezomib, Dexamethasone, Carfilzomib

Resources and Links

National Clinical Trial Identified Number: NCT05572515

Disease:

  • Relapsed or Refractory Multiple Myeloma

Study Phase:

III

ResearchCancer@cooperhealth.edu

Article Title

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

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SunRISe-3

Submitted by rfreitag on

Short Title: SunRISe-3

Bladder cancer is the tenth most common malignancy worldwide. About 75 percent (%) of bladder cancers are non-muscle invasive at diagnosis with approximately 25% of NMIBC patients have HR, NMIBC. The TAR-200/gemcitabine (JNJ-17000139) product is an intravesical drug delivery system regulated as an investigational drug. The drug constituent consists of gemcitabine and osmotic minitablets. Cetrelimab (JNJ-63723283) is a fully human immunoglobulin G4 (IgG4) kappa monoclonal antibody (mAb) that binds programmed-cell death protein (PD)-1. The mainstay of treatment for HR-NMIBC is transurethral resection of bladder tumor, followed by intravesical treatment with BCG. In this study metronomic dosing of intravesical gemcitabine, delivered via TAR-200, alone or in combination with cetrelimab will be evaluated and compared against intravesical BCG.

Study Number:

SunRISe-3

Study Status:

Enrolling

Treatment Agent:

TAR-200, Cetrelimab, BCG Vesiculture

Resources and Links

National Clinical Trial Identified Number: NCT05714202

Disease:

  • Bladder Cancer,
  • BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC)

Study Phase:

III

ResearchCancer@CooperHealth.edu

Article Title

A Phase 3, Open-Label, Multi-Center, Randomized Study Evaluating the Efficacy and
Safety of TAR-200 in Combination with Cetrelimab or TAR-200 Alone Versus Intravesical
Bacillus Calmette-Guérin (BCG) in Participants with BCG-naïve High-Risk Non-Muscle
Invasive Bladder Cancer (HR-NMIBC

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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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