PRAGMATICA

Submitted by rfreitag on

Short Title: PRAGMATICA

This phase III trial compares the effect of the combination of ramucirumab and pembrolizumab versus standard of care chemotherapy for the treatment of non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. 

Study Number:

S2302

Study Status:

Enrolling

Treatment Agent:

Pembrolizumab, Ramucirumab

Resources and Links

National Clinical Trial Identified Number: NCT05633602

Disease:

  • Recurrent Lung Non-Small Cell Carcinoma,
  • Stage IV Lung Cancer

Study Phase:

III

researchcancer@cooperhealth.edu

Article Title

A Prospective Randomized Study of Ramucirumab Plus Pembrolizumab Versus Standard of Care for Participants Previously Treated with Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer

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lung, thoracic

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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

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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]

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Ovarian, gyn, Gynecologic

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DECREASE

Submitted by rfreitag on

Short Title: DECREASE

This phase II trial studies how well lower-dose chemotherapy plus radiation (chemoradiation) therapy works in comparison to standard-dose chemoradiation in treating patients with early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin, fluorouracil, and capecitabine, 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. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells. This study may help doctors find out if lower-dose chemoradiation is as effective and has fewer side effects than standard-dose chemoradiation, which is the usual approach for treatment of this cancer type.

Study Number:

EA2182

Study Status:

Enrolling

Treatment Agent:

Capecitabine, Fluorouracil, Mitomycin

Resources and Links

National Clinical Trial Identified Number: NCT04166318

Disease:

  • Anal Basaloid Carcinoma,
  • Anal Canal Cloacogenic Carcinoma,
  • Anal Canal Squamous Cell Carcinoma,
  • Anal Margin Squamous Cell Carcinoma

Study Phase:

II

researchcancer@cooperhealth.edu

Article Title

A Randomized Phase II Study of De-Intensified ChemoRadiation for Early-Stage Anal Squamous Cell Carcinoma

Index Extra:

GI, Anal

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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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TROPION-BREAST 03

Submitted by rfreitag on

Short Title: TROPION - BREAST 03

The study will investigate the efficacy and safety of Dato-DXd with or without durvalumab when compared with ICT (capecitabine and/or pembrolizumab) in participants with stage I to III TNBC who have residual invasive disease in the breast and/or axillary lymph nodes at surgical resection following neoadjuvant systemic therapy.

Study Number:

D926XC00001

Study Status:

Enrolling

Treatment Agent:

Dato-DXd, Durvalumab, Capecitabine, Pembrolizumab

Resources and Links

National Clinical Trial Identified Number: NCT05629585

Disease:

  • Stage I-III Triple-negative Breast Cancer

Study Phase:

III

ResearchCancer@CooperHealth.edu

Article Title

A Phase III Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) With or Without Durvalumab Versus Investigator’s Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Who Have Residual Invasive Disease in the Breast and/or Axillary Lymph Nodes at Surgical Resection Following Neoadjuvant Systemic Therapy

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breast

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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

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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

Index Extra:

Myeloma, HEM

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