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A022104

Submitted by rfreitag on

Short Title: JANUS

This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan), and CAPOX (capecitabin and oxaliplatin) 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.

Study Number:

A022104

Study Status:

Enrolling

Treatment Agent:

Capecitabine, 5-fluorouracil, Leucovorin calcium, Irinotecan, Oxaliplatin

Resources and Links

National Clinical Trial Identified Number: NCT05610163

Disease:

  • Locally Advanced Rectal Carcinoma

Study Phase:

II

researchcancer@cooperhealth.edu

Article Title

A Randomized Phase II Trial Testing the Efficacy of Triplet Versus Doublet Chemotherapy to Achieve Clinical Complete Response in Patients with Locally Advanced Rectal Cancer

Index Extra:

GI, gastro, rectal

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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

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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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.

Cohort 1, Cohort 2, and Cohort 4 are open:

Cohort 1: Patients whose tumors did not express programmed cell death-ligand 1 (PD-L1), ie, tumor proportion score (TPS) <1%, prior to ICI treatment and patients with no available historical TPS 

Cohort 2: Patients whose tumors expressed PD-L1 (TPS ≥1%) prior to ICI treatment 

Cohort 4: Patients, regardless of tumor PD-L1 expression status prior to ICI treatment, who had pre-progression tumor harvest 

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 2 Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients with Metastatic Non-Small-Cell Lung Cancer

Index Extra:

lung, thoracic

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