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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 is a Phase 1/2 Open-label Rollover Study for Subjects Who Have Participated in an Astellas Sponsored ASP2215 Trial.

Key Inclusion / Exclusion Criteria:
  • Open to men and women 18 years of age and older currently participating in an Astellas-sponsored ASP2215 trial, receiving ASP2215 and able to enroll in this rollover study without interruption of study drug, or with no more than 2 weeks interruption in study drug.
  • Subject must be deriving benefit from continued treatment as determined by the Investigator. 

Detailed eligibility criteria will be reviewed by the study team.

This clinical trial is for patients with locally advanced or metastatic urothelial cancer.

Key Inclusion / Exclusion Criteria:
  • Adults 18 Years and older 
  • Diagnosis of locally advanced or metastatic urothelial cancer 
  • Eligible for CPI therapy and must be either ineligible for first-line cisplatin-based chemotherapy 
  • Detailed eligibility reviewed when you contact the study team. 

This clinical trial is open to men age 18 or older who have metastatic prostate cancer to check safety and tolerability of ZEN003694 in combination with enzalutamide. 

Key Inclusion / Exclusion Criteria:
  • Open to men 18 years or older 
  • With metastatic, castrate resistant, confirmed prostate cancer (surgically castrated or continuous medical castration for ≥ 8 weeks prior to screening). 
  • Detailed eligibility reviewed when you contact the study team 

This clinical trial is for men and women with advanced urothelial cancer. The purpose of this study is to research the effects (both good and bad) of two investigational drugs called erdafitinib and JNJ-63723283.

Key Inclusion / Exclusion Criteria:
  • Men and women age 18 and older 
  • Urothelial cancer with specific gene mutations 
  • 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 is a Phase 1b/2 study for men and women with a myeloid neoplasm: myelodysplastic syndrome (MDS), a myeloproliferative neoplasm (MPN), or chronic myelomonocytic leukemia (CMML), who are positive for a TP53 mutation. 

Key Inclusion / Exclusion Criteria:
  • Open to men and women age 18 years or older with a diagnosis of myelodysplastic syndrome (MDS), MDS/ myeloproliferative neoplasm (MPN) or chronic myelomonocytic leukemia (CMML) 
  • Documentation of a TP53 gene mutation by next-generation sequencing (NGS) 
  • Detailed eligibility reviewed when you contact the study team. 

The primary objective of this trial is to evaluate the effectiveness and safety of IMMU-13 in men and women with bladder cancer

Key Inclusion / Exclusion Criteria:
  • Women and men 18 and older who have been diagnosed with bladder cancer 
  • Prior therapies:
    - Cohort 1: have had progression or recurrence of bladder cancer following receipt of platinum- containing regimen (cisplatin or carboplatin) and anti-PD-1/anti-PD-L1 therapy. 
    - Cohort 2: have had progression or recurrence of bladder cancer after a first-line therapy for metastatic disease. 
  • Detailed eligibility reviewed when you contact the study team. 

This clinical trial is for men and women age 18 and older with B-cell non-follicular indolent non-Hodgkin’s lymphoma. Relapsed and refractory indolent non-Hodgkin’s lymphomas are difficult to treat with poor overall response rate and overall survival. 

Key Inclusion / Exclusion Criteria:
  • Men and women age 18 and older. 
  • Histologically confirmed diagnosis of B-cell non-follicular indolent non-Hodgkin’s lymphoma, including Waldenstrom’s macroglobulinemia. 
  • Relapsed or refractory after at least one prior treatment regimen, with no limit on prior therapies. 
  • Detailed eligibility reviewed when you contact the study team. 

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 

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