Surgery

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Clinical Trials

The Department of Surgery doesn’t just excel in the operating room. Through our extensive and innovative research programs, we are also focused on the development of new techniques and therapies that promote better outcomes and improve the quality of life for patients following surgery. 

As part of that goal, the department’s surgeons are involved in groundbreaking clinical trials. In addition to their research value, clinical trials may also give patients access to new treatments that are not available anywhere else.

Learn more about our current clinical trials below or visit the Joint Clinical Trials Office at Weill Cornell Medicine and NewYork-Presbyterian.

This clinical trial is for men and women with unresectable glioblastoma or gliosarcoma at first or second recurrence.

Key Inclusion / Exclusion Criteria:
  • Open to men and women age 18 and older
  • Diagnoses with glioblastoma or gliosarcoma at first or second recurrence
  • Participants must have unresectable disease
  • Detailed eligibility will be reviewed when you contact the study team

This is an international, phase 2, open-label, 2-arm, response rate study of talazoparib (also known as MDV3800, BMN 673), a poly(ADP-ribose) polymerase (PARP) inhibitor in development for treatment of men with metastatic castration-resistant prostate cancer (CRPC) who previously received t

Key Inclusion / Exclusion Criteria:

Age 18 and older. 
Have metastatic castration-resistant prostate cancer
ECOG performance status of 0 to 2 
Detailed eligibility reviewed when you contact the study team. 

    

The purpose of this study is to learn about the effects of the study drug, PF-06480605, when treating subjects with moderate to severe ulcerative colitis (UC). PF-06480605 is an investigational drug. An investigational drug is one that is not approved for sale in this country. 

Key Inclusion / Exclusion Criteria:
  • Male or female subjects between ≥ 18 and ≤ 75 years of age at the time of informed consent 
  • Male subjects able to father children and female subjects of childbearing potential must agree to use two highly effective methods of contraception throughout the study and until the Week 26 visit 
  • Diagnosis of ulcerative colitis for ≥ 4 months 
  • Subjects with moderate to severe active ulcerative colitis as defined by screening colonoscopy with total Mayo score of ≥ 6, with rectal bleeding subscore of ≥ 1, and an endoscopic subscore of ≥ 2 on the Mayo 
  • Active disease beyond the rectum (> 15 cm of active disease at the screening colonoscopy) 
  • Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for ulcerative colitis such as: Steroids; Immunosuppressants (AZA, 6-MP, or MTX); Anti -TNF inhibitors (eg, infliximab, adalimumab, or golimumab); Anti-integrin inhibitors (eg, vedolizumab). 
  • Subjects currently receiving the following treatment are eligible provided they have been on stable doses of Oral 5-ASA or sulfasalazine for at least 4 weeks prior to baseline; oral corticosteroids stable dose for at least 2 weeks prior to baseline; 6-MP or AZA stable dose for 8 weeks prior to baseline 

Exclusion: 

  • Diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, microscopic colitis or Crohn's Disease. Subjects with clinical findings suggestive of Crohn's disease (eg, fistulae, granulomas on biopsy) are also excluded. 
  • Subjects with colonic dysplasia or neoplasia, toxic megacolon, primary sclerosing cholangitis, known colonic stricture, history of colonic or small bowel stoma, history of colonic or small bowel obstruction or resection 
  • Presence of active enteric infections (positive stool culture and sensitivity) 
  • Known history of HIV based on documented history with positive serological test, or positive HIV serologic test at screening 
  • Presence of a transplanted organ 
  • Cancer or history of cancer or lymphoproliferative disease within the previous 5 years (other than resected cutaneous basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence); 
  • Acute coronary syndrome (eg., myocardial infarction, unstable angina pectoris); 
  • Any history of cerebrovascular disease within 24 weeks before screening; 
  • Subject with current or a history of QT prolongation 
  • Class III or Class IV heart failure 
  • Prior evidence of liver injury or toxicity due to methotrexate 
  • Abnormality in hematology and/or chemistry profiles during screening (as detailed in the protocol) 
  • Subjects receiving the following therapies within the designated time period: 
    • 9 mg/day of oral budesonide or 20 mg/day prednisone or equivalent within 2 weeks prior to baseline 
    • IV, IM (parenteral), or topical (rectal) treatment of 5-ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline 
    • Biologics including anti-TNF inhibitors as described: Infliximab, Adalimumab, or Golimumab within 8 weeks prior to baseline 
    • Anti-integrin inhibitors (eg, vedolizumab) within 12 weeks prior to baseline 
    • Other investigational procedures or products, or live attenuated vaccine within 30 days prior to baseline. 
  • Current or history (within 2 years) of serious psychiatric disease or alcohol or drug abuse 

The purpose of this study is to find out about the safety and efficacy of PTG‐100 for the treatment of moderately to severe active ulcerative colitis, which is an inflammatory bowel disease (IBD) in which patients have bloody diarrhea, abdominal cramps and fatigue. 

Key Inclusion / Exclusion Criteria:

   - Male and female subjects age 18 to 80 years, inclusive 
   - Diagnosis of UC for at least 2 months prior to screening 
   - Detailed eligibility will be reviewed when you contact the study team 

The purpose of this research study is to compare the effects of the investigational study drugs, PF-06651600 and PF-06700841, with placebo to find out which is better for treating UC. 

Key Inclusion / Exclusion Criteria:

- Men and women 18 Years to 70 Years (Adult, Senior).
- Diagnosis of ulcerative colitis for greater than/equal to 4 months.
- Moderate to severe active ulcerative colitis.
- Inadequate response to, loss of response to, or intolerance to at least one conventional therapy for UC. 

Exclusion Criteria: 
- Pregnant or breastfeeding
- Clinical findings suggestive of Crohn's Disease 
- History of bowel surgery within 6 months 

    

Cardiac amyloid is a condition in which abnormal protein deposits within the heart. Patients with cardiac amyloid are at increased risk for clinical symptoms such as shortness of breath, fatigue, heart pain, or even death, possibly due to damaging effects of amyloid protein on the heart.

Key Inclusion / Exclusion Criteria:
  • Cardiac amyloid
  • Detailed criteria will be reviewed with study team

Currently, patients receiving a transplanted kidney are required to take life-long immunosuppressive medications to prevent rejection of the transplanted kidney. These medications carry substantial side effects.

Key Inclusion / Exclusion Criteria:

Inclusion

  • Planned recipient of a first kidney allograft from an HLA-matched, living related donor.
  • Age greater than or equal to 18 and less than or equal to 65 years at the time of providing informed consent.
  • Single solid organ recipient (kidney only).
  • ABO compatibility with donor
  • Able and willing to fully comply with all study procedures and restrictions.

Exclusion 

  • Underlying kidney disease with a high risk of disease recurrence in the transplanted kidney
  • History of HUS, atypical HUS, or TTP.
  • Is taking immunosuppressive therapy [eg, glucocorticoids, cyclosporine, mycophenolate, tumor necrosis factor (TNF) inhibitors] for multiple sclerosis, systemic lupus erythematosus, rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, or other acute or chronic condition.
  • Tests confirmed positive for HIV-1/2, human T-cell lymphotropic virus (HTLV)-I/II, West Nile Virus, HBV, HCV ,T. cruzi, or syphilis. Epstein-Barr Virus (EBV)- positive donors will be excluded if the prospective transplant recipient is EBV naïve. 
  • History of infection with Zika virus (ZIKV) in the past 6 months

This clinical trial is for men and women with advanced urothelial cancer. The purpose of this study is to compare the effects of an investigational drug called erdafitinib to those of docetaxel or vinflunine (chemotherapy) and of pembrolizumab (immunotherapy).

Key Inclusion / Exclusion Criteria:
  • Men and women age 18 and older 
  • Urothelial cancer with specific gene mutations 
  • One previous treatment for metastatic disease (disease which has spread to other parts of the body) 
  • Detailed eligibility reviewed when you contact the study team 

This clinical trial is for men and women who have been diagnosed with NonAlcoholic Steatohepatitis (NASH) and liver fibrosis (damaged/scarred liver tissue). Due to NASH, the liver is swollen and damaged because of a buildup of fat in the liver.

Key Inclusion / Exclusion Criteria:
  • Men and women who are 18 years of age and older
  • Must be diagnosed with NASH and liver scarring
  • Detailed eligibility reviewed when you contact the study team

This clinical trial is for males and females with veno-occlusive disease who are scheduled to undergo allogeneic or autologous hematopoietic stem cell transplant (HSCT) and are at high risk or very high risk of developing veno-occlusive disease (VOD). The medicines that are rec

Key Inclusion / Exclusion Criteria:

   - Males and females age 18 through 65
   - Patient must be scheduled to undergo allogeneic or autologous hematopoietic stem cell transplant (HSCT) 
   - Detailed eligibility will be reviewed when you contact the study team.

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