Gastrointestinal Cancer Clinical Trials

17 trials identified.

Negative Pressure Wound Therapy
Principal Investigator: Blazer, Dan
Protocol Number: PRO00045975

Age Group: Adult
Scope: National

Phase: II
Disease Site: Anus; Colon; Kidney; Liver; Other Digestive Organ; Pancreas; Rectum; Unknown Sites

Contact: DCI Clinical Research Team, Gastrointestinal Oncology
Email:

What is the Condition Being Studied?
Wound care for abdominal (colorectal, liver, or pancreas) surgery
What is the Purpose of this Study?
We are doing this study to learn whether negative pressure wound therapy (NPWT) helps to lower the rate of surgical site infections (SSI) in patients having abdominal surgery compared to routine post-operative wound care. 
Who Can Participate in the Study?
Adult men and women who:
- Are scheduled for an elective open colorectal or hepatopancreatobiliary (liver or pancreas) surgery. 

You may not join the study if you are having emergency or laparoscopic surgery
What is Involved?
If you choose to join this study, you will:
- Be randomized (like a flip of a coin) to one of two groups. 

--- Group One will get a standard wound dressing over their surgical incision. 
--- Group Two will have a negative pressure wound therapy (either Prevena Incision Management System or ActiVAC) that will be put on their surgical incision. 

- We will monitor you for post-operative infection the day of your surgery, 4-5 days after surgery and again between 15 and 45 days after your surgery. 

You will not need to have any additional clinic visits outside of your standard postoperative care. 

Your records will also be monitored for any side effects of your dressing or device.
Participating Institutions:
  • Duke University Health System : Gastrointestinal Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

DKK1 for Gastric Cancer
Principal Investigator: Strickler, John
Protocol Number: PRO00049984

Age Group: Adult
Scope: National

Phase: I (Cancer Control)
Disease Site: Esophagus; Other Digestive Organ

Contact: DCI Clinical Research Team, Gastrointestinal Oncology
Email:

What is the Condition Being Studied?
Gastric cancer
What is the Purpose of this Study?
We are doing this study to see if the study drug (DKN-01) is safe by itself and if the study drug may be taken with paclitaxel or pembrolizumab. 
Who Can Participate in the Study?
Adults who:
- Have histologically confirmed recurrent or metastatic esophageal or GEJ squamous cell or adenocarcinoma 
What is Involved?
If you choose to join this study you will:
- Be put into Parts A-F or monotherapy of this study
-- For parts A-E, you will be given DKN-01 through your vein on Day 1 and Day 15, and paclitaxel on Day 1, 8, 15 and 22 of each 28 day cycle 
-- If you are put in Arm F, you will be given DKN-01 through your vein on Day 1, and 15, and pembrolizumab on Day 1 of each 21 day cycle
-- If you are put in the monotherapy sub-study, you will only get DKN-01 on Day 1 and 15 of each 28 Day cycle
Participating Institutions:
  • Duke University Health System : Gastrointestinal Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

S1316 - Malignant Bowel Obstruction
Principal Investigator: Secord, Angeles
Protocol Number: PRO00058895

Age Group: Adult
Scope: National

Phase: III
Disease Site: Cervix; Other Female Genital; Ovary; Pancreas

Contact: DCI Clinical Research Team, GYN Oncology
Email:

What is the Condition Being Studied?
Malignant bowel obstruction
What is the Purpose of this Study?
We are doing this study to compare the quality of life for participants with malignant bowel obstruction who are treated with surgery to that of similar participants who are treated with the best medical management (non-surgical treatment).
Who Can Participate in the Study?
Adults with malignant bowel obstruction.
What is Involved?
If you agree to be in the study you will:
Be randomized (like a flip of a coin) to one of two standard malignant bowel treatments.
-- Group 1 participants will receive the usual abdominal surgery for malignant bowel obstruction.
-- Group 2 participants will receive the usual non-surgical treatment for malignant bowel obstruction.

Weekly telephone call (or hospital visits if you are in the hospital) for 13 weeks from the start of the study and then monthly telephone calls for up to 1 year. Each telephone call or hospital visit will last for about 15 minutes.

Monthly telephone calls from the Arizona Diet, Behavior, and Quality of Life Assessment Lab to find out what you are eating. Each telephone call will last for about 15-20 minutes.
Participating Institutions:
  • Duke University Health System : GYN Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

ETCTN 9673: Nivo and Ipi in Anal cancer
Principal Investigator: Abbruzzese, James
Protocol Number: PRO00064189

Age Group: Adult
Scope: National

Phase: II (Cancer Control)
Disease Site: Anus

Contact: DCI Clinical Research Team, Gastrointestinal Oncology
Email:

What is the Condition Being Studied?
Advanced anal canal cancer 
What is the Purpose of this Study?
We are doing this study to learn about any good and bad effects of nivolumab in combination with ipilimumab and to learn if biomarker tests are helpful to decide if people will benefit from these treatments. Biomarkers are found in the blood/tissue and may be related to your reaction to the study drugs.
Who Can Participate in the Study?
-- Adult patients with confirmed previously treated metastatic squamous cell carcinoma of the anal canal
-- Willing to undergo testing for HIV testing if not tested within the past 6 months.
What is Involved?
If you join the study you will be enrolled in Part B
-- You will be put into a group by chance (like flipping a coin).  Your doctor will not choose and you cannot choose which study group you are in. You will have an equal chance of being in either group. 
-- You will receive either Nivolumab OR Nivolumab plus Ipilimumab. 
-- Nivolumab will be given intravenously through your vein over 30 minutes once every 4 weeks.
--- If you are assigned to Ipilimumab group, it will be given intravenously through your vein over 30 minutes once every 8 weeks. 

You will receive nivolumab alone or nivolumab with ipilimumab for as long as you receive clinical benefit. 

After you finish treatment, the study team will continue to watch you for side effects for at least 100 days. 
Participating Institutions:
  • Duke University Health System : Gastrointestinal Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

ECOG-ACRIN EAY131 (Solid Tumors, Lymphoma, Multiple Myeloma)
Principal Investigator: Salama, April
Protocol Number: PRO00065775

Age Group: Adult
Scope: National

Phase: II (Cancer Control)
Disease Site: Ovary; Rectum

Contact: DCI Clinical Research Team, Gastrointestinal Oncology
Email:

What is the Condition Being Studied?
Solid Tumors, Lymphoma, Multiple Myeloma
What is the Purpose of this Study?
We are doing this study to see if different study drugs or drug combinations that target specific genetic changes found in some cancers will shrink the tumor and/or prolong the time to progression.
Who Can Participate in the Study?
Adults with solid tumors, lymphoma, or multiple myeloma who:
- Have progressed following at least one line of standard systemic therapy and for whose disease no standard treatment exists that has been shown to prolong survival
- Are not pregnant or nursing
What is Involved?
If you choose to join this study, you will:
- Have a sample of your tumor tissue tested to see if it contains a genetic change that is targeted by one or more of the drugs being tested as part of this study
Participating Institutions:
  • Duke University Health System : Gastrointestinal Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

MEDI4736 and Tremelimumab for Patients with Hepatocellular Carcinoma
Principal Investigator: Morse, Michael
Protocol Number: PRO00066636

Age Group: Adult
Scope: National

Phase: II (Cancer Control)
Disease Site: Liver; Other Digestive Organ

Contact: DCI Clinical Research Team, Gastrointestinal Oncology
Email:

What is the Condition Being Studied?
Hepatocellular carcinoma
What is the Purpose of this Study?
We are doing this study to learn whether the study drugs Durvalumab, Tremelimumab, and bevacizumab are safe for patients, and whether the study drug regimen can reduce or slow the growth of your cancer. 

Additionally, we want to learn what effects, good or bad, the study drugs may have on your body. 
Who Can Participate in the Study?
Adults who:
- Have never had treatment with drugs similar to durvalumab, tremelimumab, or bevacizumab 
- Have a body weight of at least 66 pounds
- Have hepatocellular carcinoma
What is Involved?
If you choose to join this study, you will receive a combination of the study drugs durvalumab and bevacizumab until your cancer gets worse or the study doctor decides to take you off the study.
Participating Institutions:
  • Duke University Health System : Gastrointestinal Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

Niclosamide for Colon Cancer
Principal Investigator: Morse, Michael
Protocol Number: PRO00066964

Age Group: Adult
Scope: Local

Phase: I (Cancer Control)
Disease Site: Colon

Contact: DCI Clinical Research Team, Gastrointestinal Oncology
Email:

What is the Condition Being Studied?
Colon Cancer
What is the Purpose of this Study?
We are doing this study to find out what effects (good and bad) that the study drug, niclosamide, has on you and your cancer.  

We are trying to learn if giving niclosamide to people with cancer is safe and if it affects your cancer.  
Who Can Participate in the Study?
Adults who:
- Have color cancer
- Have brain metastases
- Not have an active infection including HIV or hepatitis 
What is Involved?
If you choose to join this study, you will: 
- Be taking the study drug,niclosamide, by mouth every day for 7 days before your surgery. 
- The dose of study drug and how often (either once per day or twice per day) you take it will depend on when you start the study.  
Participating Institutions:
  • Duke University Health System : Gastrointestinal Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

PLANET
Principal Investigator: Morse, Michael
Protocol Number: PRO00074917

Age Group: Adult
Scope: Local

Phase: I/II (Cancer Control)
Disease Site: Other Digestive Organ

Contact: DCI Clinical Research Team, Gastrointestinal Oncology
Email:

What is the Condition Being Studied?
Neuroendocrine tumor of the gastrointestinal (GI) tract or pancreas (GEP-NET)
What is the Purpose of this Study?
We are doing this study to learn if the study drug combination of pembrolizumab and lanreotide is safe for patients and also if these drugs can slow, stop, or make your tumor smaller. 
Who Can Participate in the Study?
Adults who:
- Have gastroenteropancreatic neuroendocrine tumor (GEP-NETs)
- Do not have an active infection requiring systemic therapy
What is Involved?
If you choose to join this study, you will:
- Get Pembrolizumab by injection into your vein every 3 weeks and Lanreotide by injection under your skin every 3 weeks
-- These 21-day cycles will be repeated until your cancer gets worse or you are no longer able to tolerate the study drugs
Participating Institutions:
  • Duke University Health System : Gastrointestinal Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

KeyLARGO for Gastro-esophageal Cancer
Principal Investigator: Uronis, Hope
Protocol Number: PRO00080566

Age Group: Adult
Scope: National

Phase: II (Cancer Control)
Disease Site: Esophagus; Stomach

Contact: DCI Clinical Research Team, Gastrointestinal Oncology
Email:

What is the Condition Being Studied?
Esophageal/ Stomach Cancer
What is the Purpose of this Study?
We are doing this study learn about the good and bad side effects pembrolizumab, oxaliplatin, and capecitabine has on you and your cancer. 
Who Can Participate in the Study?
Adults who:
- Are diagnosed with recurrent (metastatic) cancer (adenocarcinoma) of the esophagus or stomach 
- Are HER2 Negative unless you cannot take Herceptin
- Have not had any prior treatment for their cancer, with a few exceptions
What is Involved?
The study will be done in two stages: 

Stage 1 is a safety study to make sure the study drug is safe and doesn't cause too many bad side effects.

Stage 2 is a dose expansion study where the study drug will be given to a higher number of subjects to make sure the study drug is safe and doesn't cause too many bad side effects.

If you choose to join this study, you will:
- Get pembrolizumab and oxaliplatin into a vein on day 1 of each 21 days and Capecitabine by mouth on days 1-14 of each 21 day cycle. 
- Have routine clinic visits to check you and your cancer
Participating Institutions:
  • Duke University Health System : Gastrointestinal Oncology DCI Clinical Research Team
  • Johnston Health (Smithfield) : Gastrointestinal Oncology DCI Clinical Research Team
  • Lexington Medical Center
  • Maria Parham Health (Henderson) : Gastrointestinal Oncology DCI Clinical Research Team
  • Scotland Health Care System (Laurinburg) : Gastrointestinal Oncology DCI Clinical Research Team
  • Southeastern Regional Medical Center (Lumberton) : Gastrointestinal Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

Cancer Imaging using HS-196
Principal Investigator: Morse, Michael
Protocol Number: PRO00082272

Age Group: Adult
Scope: Local

Phase: I
Disease Site: Breast; Pancreas; Prostate; Unknown Sites

Contact: Hollister, Beth
Phone:

What is the Condition Being Studied?
Breast, Prostate, and Pancreatic Cancer Imaging
What is the Purpose of this Study?
We are doing this study to see if the study drug, HS-196, is safe and to see if there are any side effects that people may experience while taking it.

HS-196 is a drug which marks cancer cells and it may help doctors see the cancer during and after surgery.
Who Can Participate in the Study?
Adults who are having surgery for:
- Prostate cancer
- pancreatic cancer
- breast cancer 
What is Involved?
If you choose to join this study, you will:
- Be given the study drug, HS-196 by injection up to 36 hours before surgery
- Allow us to use your tissue that is removed for research
- Give blood on the day of the injection, day after injection, 1 week following injection, and 1 month following injection
Participating Institutions:
  • Duke Cancer Center Cary : Beth Hollister
  • Duke Center for Living/Sarah Stedman Nutrition : Beth Hollister
  • Duke Primary Care : Beth Hollister
  • Duke Private Diagnostic Clinic (PDC) : Beth Hollister
  • Duke Raleigh Hospital : Beth Hollister
  • Duke Regional Hospital : Beth Hollister
  • Duke University Health System : Beth Hollister
  • Duke Women's Cancer Care Raleigh (Macon Pond) : Beth Hollister
  • Johnston Health (Smithfield) : Beth Hollister
  • Maria Parham Health (Henderson) : Beth Hollister
  • Scotland Health Care System (Laurinburg) : Beth Hollister
  • Southeastern Regional Medical Center (Lumberton) : Beth Hollister
View this trial at ClinicalTrials.gov

MOUNTAINEER for Metastatic Colorectal Cancer
Principal Investigator: Strickler, John
Protocol Number: PRO00082879

Age Group: Adult
Scope: National

Phase: II (Cancer Control)
Disease Site: Colon

Contact: DCI Clinical Research Team, Gastrointestinal Oncology
Email:

What is the Condition Being Studied?
Metastatic Colorectal Cancer
What is the Purpose of this Study?
We are doing this study to look at the effects (good and/or bad) of taking study drugs Tucatinib and Trastuzumab has on you and your metastatic colorectal cancer. 
Who Can Participate in the Study?
Adults who:
- Are diagnosed with metastatic colorectal cancer
- Have a positive test for HER2 overexpression or amplification
- Have not been treated with anti-HER2 therapy
What is Involved?
If you choose to join this study, you will: 
- Get the study drugs tucatinib and trastuzumab 
-- Tucatinib is given by mouth twice a day and trastuzumab is given into your arm the first day of every 21 days in the clinic at Duke
-- This cycle will be repeated until your cancer gets worse or you have bad side effects or you choose to stop the study for any reason. 
- Have tests, exams and procedures that are part of your standard of care and for study purposes. Clinic visits will usually last 4-5 hours
Participating Institutions:
  • Duke University Health System : Gastrointestinal Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

UM1 9947 Cisplatin/Gemcitabine +/- VX-970 in Metastatic Urothelial Carcinoma
Principal Investigator: Abbruzzese, James
Protocol Number: PRO00083963

Age Group: Adult
Scope: National

Phase: II (Cancer Control)
Disease Site: Urinary Bladder

Contact: DCI Clinical Research Team, Genitourinary Oncology
Email:

What is the Condition Being Studied?
Bladder cancer that has spread beyond the bladder
What is the Purpose of this Study?
We are doing this study to compare any good and bad effects of using VX-970 along with the usual chemotherapy compared to usual chemotherapy alone. 
Who Can Participate in the Study?
Adult patients with bladder cancer that has spread beyond the bladder who are planning to receive standard chemotherapy (cisplatin with gemcitabine).  
What is Involved?
If you join this study, after a screening period, you will be randomized (like the flip of a coin) to one of 2 groups: 
-- standard chemotherapy (cisplatin with gemcitabine) alone
OR
-- standard chemo therapy plus VX-970.  
-- You will receive treatment in 3 week cycles for up to 6 cycles.  
-- You will have regular clinic visits and labs to see how you are tolerating the treatment.  
-- You will also have imaging every 9 weeks to see whether your cancer is responding to the treatment.  
Participating Institutions:
  • Duke University Health System : Genitourinary Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

Alliance A021502 for Colon Cancer
Principal Investigator: Crawford, Jeffrey
Protocol Number: PRO00087658

Age Group: Adult
Scope: National

Phase: III (Cancer Control)
Disease Site: Colon

Contact: DCI Clinical Research Team, Gastrointestinal Oncology
Email:

What is the Condition Being Studied?
Stage III Colon Cancer
What is the Purpose of this Study?
We are doing this study to find out if the study drug atezolizumab given with the usual chemotherapy is better, the same, or worse than the usual chemotherapy by itself.  
Who Can Participate in the Study?
Adults with Stage III colon cancer who:
- Have a completely resected tumor
- Have no active autoimmune disease
- Are not pregnant or nursing
What is Involved?
If you choose to join this study, you will:
- Be randomized (put into one of two groups by chance like the flip of a coin) and get either:
-- Group 1: Chemotherapy plus atezolizumab for 6 months, then atezolizumab alone for 6 months
-- Group 2: Chemotherapy for 6 months
- Get a thyroid test before you begin the study drug regimen
- Get a colonoscopy within 6 weeks of completing chemotherapy 
- Be asked to complete an optional quality of life questionnaires about your physical and emotional well-being
Participating Institutions:
  • Duke University Health System : Gastrointestinal Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

BLU-285-1303 for Metastatic Gastrointestinal Stromal Tumor
Principal Investigator: Riedel, Richard
Protocol Number: PRO00091857

Age Group: Adult
Scope: National

Phase: III (Cancer Control)
Disease Site: Soft Tissue

Contact: DCI Clinical Research Team, Sarcoma
Email:

What is the Condition Being Studied?
Locally advanced or advanced GIST (Gastrointestinal stromal tumor)
What is the Purpose of this Study?
We are doing this study to find out if a drug called avapritinib (BLU-285) will work against GIST. 
Who Can Participate in the Study?
Adults with GIST tumor who:

- Are locally advanced, but cannot be removed by surgery 

OR
 
- Advanced (spread throughout the body)

Disease has gotten worse on prior therapies with drugs called tyorisine kinase inhibitors (no more than 3 kinds)
What is Involved?
If you choose to join this study, you will:
-Be randomized (like the flip of a coin) to take either avapritinib or regoarafenib by the mouth every day.
- Have study visits once a month at Duke
Participating Institutions:
  • Duke Cancer Center Cary : Sarcoma DCI Clinical Research Team
  • Duke Center for Living/Sarah Stedman Nutrition : Sarcoma DCI Clinical Research Team
  • Duke Primary Care : Sarcoma DCI Clinical Research Team
  • Duke Private Diagnostic Clinic (PDC) : Sarcoma DCI Clinical Research Team
  • Duke Raleigh Hospital : Sarcoma DCI Clinical Research Team
  • Duke Regional Hospital : Sarcoma DCI Clinical Research Team
  • Duke University Health System : Sarcoma DCI Clinical Research Team
  • Duke Women's Cancer Care Raleigh (Macon Pond) : Sarcoma DCI Clinical Research Team
  • Johnston Health (Smithfield) : Sarcoma DCI Clinical Research Team
  • Maria Parham Health (Henderson) : Sarcoma DCI Clinical Research Team
  • Scotland Health Care System (Laurinburg) : Sarcoma DCI Clinical Research Team
  • Southeastern Regional Medical Center (Lumberton) : Sarcoma DCI Clinical Research Team
View this trial at ClinicalTrials.gov

Nektar-262 for Colorectal Cancer
Principal Investigator: Strickler, John
Protocol Number: PRO00094387

Age Group: Adult
Scope:

Phase: I/II
Disease Site: Colon

Contact: DCI Clinical Research Team, Gastrointestinal Oncology
Email:

What is the Condition Being Studied?
Colorectal Cancer
What is the Purpose of this Study?
We are doing this study to test if the doublet and triplet study drugs are safe for patients, and also to test if they can work to slow down the growth of your tumor or make it smaller. 
Who Can Participate in the Study?
Adults who:
- Have diagnosed colorectal cancer
- Have had 2 anti-cancer therapies which did not work
- Have tumors large enough to be injected
What is Involved?
If you choose to join this study you will:
- Be assigned to get either the doublet, or the triplet study drugs (like the flip of a coin)
-- In both the doublet and the triplet study drug procedures you will be given NKTR-262 by injection straight into your tumor in the clinic at Duke on Day 1 of the first 3 cycles
-- Each study cycle lasts 21 days
- You will then be given NKTR-214 in the vein over 30 minutes, after you get NKTR-262 and Opdivo in the vein (for triplet study drug participants only) over 30 minutes following NKTR-214, beginning at Cycle 1.
Participating Institutions:
  • Duke Cancer Center Cary : Gastrointestinal Oncology DCI Clinical Research Team
  • Duke Center for Living/Sarah Stedman Nutrition : Gastrointestinal Oncology DCI Clinical Research Team
  • Duke Primary Care : Gastrointestinal Oncology DCI Clinical Research Team
  • Duke Private Diagnostic Clinic (PDC) : Gastrointestinal Oncology DCI Clinical Research Team
  • Duke Raleigh Hospital : Gastrointestinal Oncology DCI Clinical Research Team
  • Duke Regional Hospital : Gastrointestinal Oncology DCI Clinical Research Team
  • Duke University Health System : Gastrointestinal Oncology DCI Clinical Research Team
  • Duke Women's Cancer Care Raleigh (Macon Pond) : Gastrointestinal Oncology DCI Clinical Research Team
  • Johnston Health (Smithfield) : Gastrointestinal Oncology DCI Clinical Research Team
  • Maria Parham Health (Henderson) : Gastrointestinal Oncology DCI Clinical Research Team
  • Scotland Health Care System (Laurinburg) : Gastrointestinal Oncology DCI Clinical Research Team
  • Southeastern Regional Medical Center (Lumberton) : Gastrointestinal Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

AMG 510 for People with NSCLC
Principal Investigator: Strickler, John
Protocol Number: PRO00100212

Age Group: Adult
Scope:

Phase: I
Disease Site: Colon; Lung; Rectum

Contact: DCI Clinical Research Team, Gastrointestinal Oncology
Email:

What is the Condition Being Studied?
Colorectal Cancer and Non-Small cell Lung Cancer
What is the Purpose of this Study?
We are doing this study to find out if a new study drug, AMG 510, for colorectal cancer patients with a specific genetic mutation is safe and if your body can handle the potential side effects. 

We will also try to find what dose of the study drug is safe for patients to take. 
Who Can Participate in the Study?
Adults who: 
-Have colorectal or non-small cell lung cancer with a documented KRAS p.G12C mutation
- Are considered non-small cell lung cancer patients (you must have had prior treatment with platinum-based combination therapy and/or targeted therapies)
-Are considered colorectal cancer participants (you must have had prior treatment with 2 prior systemic therapies)
What is Involved?
If you choose to join this study, you will:
- Take the study drug, AMG 510, by mouth, once a day
--The study drug regimen will be given in 3 week cycles
--During each cycle, you will need to visit the clinic 5 times during the first cycle, 2 times during the second cycle, and once per cycle for all the remaining cycles
-The cycles of the study drug regimen that you will receive will depend on the side effects that you get
-During your clinic visits blood samples and other procedures will be performed
Participating Institutions:
  • Duke Cancer Center Cary : Gastrointestinal Oncology DCI Clinical Research Team
  • Duke Center for Living/Sarah Stedman Nutrition : Gastrointestinal Oncology DCI Clinical Research Team
  • Duke Primary Care : Gastrointestinal Oncology DCI Clinical Research Team
  • Duke Private Diagnostic Clinic (PDC) : Gastrointestinal Oncology DCI Clinical Research Team
  • Duke Raleigh Hospital : Gastrointestinal Oncology DCI Clinical Research Team
  • Duke Regional Hospital : Gastrointestinal Oncology DCI Clinical Research Team
  • Duke University Health System : Gastrointestinal Oncology DCI Clinical Research Team
  • Duke Women's Cancer Care Raleigh (Macon Pond) : Gastrointestinal Oncology DCI Clinical Research Team
  • Johnston Health (Smithfield) : Gastrointestinal Oncology DCI Clinical Research Team
  • Maria Parham Health (Henderson) : Gastrointestinal Oncology DCI Clinical Research Team
  • Scotland Health Care System (Laurinburg) : Gastrointestinal Oncology DCI Clinical Research Team
  • Southeastern Regional Medical Center (Lumberton) : Gastrointestinal Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

Merck 3475 for Stomach and Esophagus Cancer
Principal Investigator: Uronis, Hope
Protocol Number: PRO00100448

Age Group: Adult
Scope:

Phase: III
Disease Site: Esophagus

Contact: DCI Clinical Research Team, Gastrointestinal Oncology
Email:

What is the Condition Being Studied?
Stomach and Esophagus Cancer
What is the Purpose of this Study?
We are doing this study to compare the anti- tumor activitivy when the study drug, pembrolizumab, is given with trastuzumab and standard of care chemotherapy versus trastuzumab with placebo (an inactive pill) and chemotherapy.

We also want to test to see if it is safe, how well the drug combination works, and how your body handles the study drug if you do not receive the placebo.
Who Can Participate in the Study?
Adults who:
- Are at least 18 years of age  
- Have confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction adenocarcinoma
What is Involved?
If you choose to join this study, you will: 
- Be randomly assigned (like a flip of a coin) to get either pembrolizumab (study drug) or placebo which is an inactive pill (along with trastuzumab and standard of care chemotherapy)
-- These will be given through an IV on Day 1 of each 3 week cycle
-- Depending on the side effects you may experience will decide how many cycles of the study drug you will get
- Have a study visit once every 3 weeks
-- During your clinic visits, blood samples and other procedures will be performed
- Have tests, exams, and procedures that are part of your standard care and for study purposes
Participating Institutions:
  • Duke Cancer Center Cary : Gastrointestinal Oncology DCI Clinical Research Team
  • Duke Center for Living/Sarah Stedman Nutrition : Gastrointestinal Oncology DCI Clinical Research Team
  • Duke Primary Care : Gastrointestinal Oncology DCI Clinical Research Team
  • Duke Private Diagnostic Clinic (PDC) : Gastrointestinal Oncology DCI Clinical Research Team
  • Duke Raleigh Hospital : Gastrointestinal Oncology DCI Clinical Research Team
  • Duke Regional Hospital : Gastrointestinal Oncology DCI Clinical Research Team
  • Duke University Health System : Gastrointestinal Oncology DCI Clinical Research Team
  • Duke Women's Cancer Care Raleigh (Macon Pond) : Gastrointestinal Oncology DCI Clinical Research Team
  • Johnston Health (Smithfield) : Gastrointestinal Oncology DCI Clinical Research Team
  • Maria Parham Health (Henderson) : Gastrointestinal Oncology DCI Clinical Research Team
  • Scotland Health Care System (Laurinburg) : Gastrointestinal Oncology DCI Clinical Research Team
  • Southeastern Regional Medical Center (Lumberton) : Gastrointestinal Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov