Adult Clinical Trials

Gastrointestinal Cancers - Colorectal cancers and cancers of the stomach, esophagus and other digestive organs

If you need additional information about any of the trials listed or would like to inquire about other open trials, please contact the Gastrointestinal (GI) Clinical Trials Office at 919-668-1861.

17 trials identified.

A Phase I Trial of the IGF-1R Antibody AMG 479 in Combination with Everolimus (RAD001) and Panitumumab in Patients with Advanced Cancer (The RAP Trial)
Phase: Phase I
Sponsor: PI initiated
Principal Investigator: Herbert Hurwitz
Contact: Anthony Amara
Phone: 919.668.1861
Purpose: This open-label, non-randomized, dose escalation phase I biomarker trial of the triplet regimen of AMG 479, everolimus, and panitumumab for subjects with refractory advanced solid tumors is designed to assess the safety and tolerability of this combination as well as preliminary efficacy.
Reference Number: 00021317
View this trial at ClinicalTrials.gov

A Multicenter Randomized Phase II Study of NPC-1C in Combination with Gemcitabine and nab-Paclitaxel versus Gemcitabine and nab-Paclitaxel alone in Patients with Metastatic or Locally Advanced Pancreatic Cancer Previously Treated with FOLFIRINOX
Phase: Phase I
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Michael Morse
Contact: GI Oncology Clinical Trials Office
Phone: 919.668.1861
Purpose: This is a randomized phase II multi-institution prospective open label study in which up to 90 subjects with metastatic, locally advanced unresectable or recurrent pancreatic cancer who previously received treatment with chemotherapy with FOLFIRINOX or FOLFIRINOX-like regimen will be enrolled into one of two arms: A: NPC-1C with gemcitabine and nab-paclitaxel or B: gemcitabine and nab-paclitaxel
Reference Number: 00043261
View this trial at ClinicalTrials.gov

A Pilot Study of Active Immunotherapy with CEA(6D) VRP Vaccine (AVX701) in Patients with Stage III Colorectal Cancer
Phase: Phase II
Sponsor: Internal Investigator Initiated Therapeutic &/or Interventional
Principal Investigator: Michael Morse
Contact: Ireka Burrus
Phone: 919.668.1861
Purpose: This is a pilot study to evaluate the safety of a vaccine that consists of an alphavirus replicon (VRP) encoding the protein (CEA) that has been found to be associated with cancers such as colon cancer in patients that have stage III colon cancer. We will also evaluate the patient immune response to the vaccine.
Reference Number: 00045976
View this trial at ClinicalTrials.gov

Cabozantinib (XL184) with Panitumumab in Subjects with KRAS Wild-Type Metastatic Colorectal Cancer and Cabozantinib Monotherapy in Subjects with MET Amplified Treatment-Refractory Colorectal Cancer
Phase: Phase I
Sponsor: Internal Investigator Initiated Therapeutic &/or Interventional
Principal Investigator: John Strickler
Contact: GI Oncology Clinical Trials Office
Phone: 919.668.1861
Purpose: There will be three parts to this phase I study: 1) the Combination Dose Finding cohort; 2) the Combination Expansion cohort; and 3) the Monotherapy MET Amplified cohort. In the Combination Dose Finding cohort and the Combination Expansion cohort, we will combine cabozantinib and panitumumab in patients with KRAS wild-type metastatic colorectal cancer (CRC). In the Monotherapy MET Amplified cohort, we will screen at least 50 patients for MET gene amplification (MET amplification). Patients with MET amplification will receive cabozantinib only (monotherapy). The primary objective of this open-label phase Ib trial are: 1. To determine the maximum tolerated dose and the recommended phase II dose for the combination of cabozantinib and panitumumab in patients with KRAS wild-type metastatic colorectal cancer and 2. To identify the objective response rate (ORR) of cabozantinib monotherapy in patients with prospectively identified MET amplified metastatic colorectal cancer. The secondary objectives are: 1. To describe the non-dose limiting toxicities of cabozantinib and panitumumab. 2. To describe the clinical activity (ORR, PFS, OS) of cabozantinib and panitumumab. 3. To describe the safety and tolerability of cabozantinib monotherapy in patients with MET amplified colorectal cancer. 4. To describe the clinical activity (PFS, OS) of cabozantinib monotherapy in patients with MET amplified colorectal cancer.
Reference Number: 00049983
View this trial at ClinicalTrials.gov

DEK-DKK1-P102: A Four Part, Phase 1, Multi-center, Open- label Study of DKN-01 in Combination with Weekly Paclitaxel; Part A: A Dose-Escalation Study in Patients with Relapsed or Refractory Esophageal Cancer or Gastro-esophageal Junction Tumors; Part B: An Expansion Cohort in Patients with Relapsed or Refractory Esophageal Cancer or Gastro- esophageal Junction Tumors; Part C: An Expansion Cohort in Patients with Relapsed or Refractory Esophageal or Gastro-esophageal Junction Adenocarcinoma; Part D: An Expansion Cohort in Patients with Relapsed or Refractory Esophageal Squamous Cell Cancer; Part E: An Expansion Cohort in Patients with Relapsed or Refractory Gastric Adenocarcinoma with Wnt Signaling Alterations
Phase: Phase I
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: John Strickler
Contact: GI Oncology Clinical Trials Office
Phone: 919.668.1861
Purpose: A study to evaluate the safety and tolerability of DKN-01 in combination with weekly paclitaxel in participants with refractory/recurrent esophageal, gastro-esophageal junction and gastric cancer.
Reference Number: 00049984
View this trial at ClinicalTrials.gov

A Phase 2 Clinical Trial of Nivolumab and Nivolumab plus Ipilimumab in Recurrent and Metastatic Microsatellite Instability High (MSI-H) and non-MSI-H Colon Cancer
Phase: Phase II
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Michael Morse
Contact: GI Oncology Clinical Trials Office
Phone: 919.668.1861
Purpose: The purpose of this study is to examine if Nivolumab by itself, or Nivolumab in combination with other anti-cancer drugs, will result in meaningful tumor size reduction, in patients with colon cancer that has come back or has spread, and who have a specific biomarker in their tumors.
Reference Number: 00052582
View this trial at ClinicalTrials.gov

A Phase 1, First-in-Human, Open Label, Dose Escalation Study of MGD007, A Humanized gpA33 x CD3 Dual-Affinity Re-Targeting (DART) Protein in Patients with Relapsed/Refractory Metastatic Colorectal Carcinoma
Phase: Phase I
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Herbert Hurwitz
Contact: GI Oncology Clinical Trials Office
Phone: 919.668.1861
Reference Number: 00056149

Phase 2 Study of ADXS11-001 in Subjects With Persistent/Recurrent, Loco-Regional or Metastatic Squamous Cell Carcinoma of the Anorectal Canal
Phase: Phase II
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Hope Uronis
Contact: GI Oncology Clinical Trials Office
Phone: 919.668.1861
Purpose: This is a single arm Phase 2 study. Stage 1 and 2 of the study are monotherapy evaluations of ADXS11-001 in 31 and 24 subjects, respectively with persistent/recurrent, loco-regional or metastatic SCCA of the anorectal canal that have received at least 1 regimen for the treatment of advanced disease
Reference Number: 00064449
View this trial at ClinicalTrials.gov

Duke Gastrointestinal Biomarkers and Epidemiology Study
Phase: N/A
Sponsor: Internal Investigator Initiated Non-therapeutic/Non-interventional
Principal Investigator: Qingyi Wei
Contact: Epidemiology Oncology Research Team
Phone: 919.668.7383
Reference Number: 00065084

A Study of Safety, Tolerability, and Clinical Activity of MEDI4736 and Tremelimumab Administered as Monotherapy and in Combination to Subjects with Unresectable Hepatocellular Carcinoma
Phase: Phase II
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Michael Morse
Contact: GI Oncology Clinical Research Trials Office
Phone: 919.668.1861
Purpose: This is a multicenter, open-label, stratified, randomized study to evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of MEDI4736 (Durvalumab) in combination with tremelimumab, MEDI4736 monotherapy or tremelimumab monotherapy in subjects with unresectable hepatocellular carcinoma
Reference Number: 00066636
View this trial at ClinicalTrials.gov

A Phase 1b/2, Open Label, Dose Escalation Study of Margetuximab in Combination with Pembrolizumab in Patients with Relapsed/Refractory Advanced HER2+ Gastroesophageal Junction or Gastric Cancer
Phase: Phase II
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Hope Uronis
Contact: GI Oncology Clinical Trials Office
Phone: 919.668.1861
Purpose: This main purpose of this clinical study is to learn about the safety and activity of margetuximab and pembrolizumab combination treatment in patients with HER2+ gastric and gastroesophageal junction cancer.
Reference Number: 00068590
View this trial at ClinicalTrials.gov

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS 5745 Combined with mFOLFOX6 as First Line Treatment in Patients with Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Phase: Phase III
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: John Strickler
Contact: GI Oncology Clinical Trials Office
Phone: 919.668.1861
Purpose: The primary objective of this study is to compare the efficacy of andecaliximab (formerly GS-5745) versus placebo in combination with modified fluorouracil (5-FU), leucovorin (LV), and oxaliplatin (OXA) (mFOLFOX6) as measured by overall survival.
Reference Number: 00069751
View this trial at ClinicalTrials.gov

ECOG-ACRIN EA2142: Randomized Phase II Study of Cisplatin and Etoposide versus Temozolomide and Capecitabine in Patients with Advanced G3 Non-Small Cell Gastroenteropancreatic Neuroendocrine Carcinomas
Phase: Phase II
Sponsor: Cooperative Group Initiated
Principal Investigator: Jeffrey Crawford
Contact: GI Oncology Clinical Research Trials Office
Phone: 919.668.1861
Purpose: This randomized phase II trial studies how well temozolomide and capecitabine work compared to standard treatment with cisplatin and etoposide in treating patients with neuroendocrine carcinoma of the gastrointestinal tract or pancreas that has spread to other parts of the body (metastatic) or cannot be removed by surgery. Drugs used in chemotherapy, such as temozolomide, capecitabine, cisplatin, and etoposide, 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. Certain types of neuroendocrine carcinomas may respond better to treatments other than the current standard treatment of cisplatin and etoposide. It is not yet known whether temozolomide and capecitabine may work better than cisplatin and etoposide in treating patients with this type of neuroendocrine carcinoma, called non-small cell neuroendocrine carcinoma.
Reference Number: 00069873
View this trial at ClinicalTrials.gov

A Phase III Study of Pembrolizumab vs. Chemotherapy in Microsatellite Instability- High or Mismatch Repair Deficient Stage IV Colorectal Cancer
Phase: Phase III
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Michael Morse
Contact: GI Oncology Clinical Research Trials Office
Phone: 919.668.1861
Purpose: In this study, participants with MSI-H or dMMR advanced colorectal carcinoma will be randomly assigned to receive either pembrolizumab or the Investigator's choice of 1 of 6 standard of care (SOC) chemotherapy regimens for the treatment of advanced colorectal carcinoma. The primary study hypothesis is that pembrolizumab will prolong progression-free survival (PFS) compared to current SOC chemotherapy.
Reference Number: 00070459
View this trial at ClinicalTrials.gov

A Multicenter, Randomized, Open-label Study in Patients with Esophageal Cancer Refractory or Intolerant to Combination Therapy with Fluoropyrimidine and Platinum-based Drugs
Phase: Phase III
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Hope Uronis
Contact: GI Oncology Clinical Research Trials Office
Phone: 919.668.1861
Purpose: The purpose of study is to evaluate the efficacy and safety of Nivolumab in unresectable advanced or recurrent esophageal cancer patients who have failed in standard chemotherapies.
Reference Number: 00070461
View this trial at ClinicalTrials.gov

Phase 1a/b Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of OMP-131R10 in Advanced Solid Tumors and in Combination with FOLFIRI for Patients with Previously Treated Metastatic Colorectal or Gastric Cancer
Phase: Phase I
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: John Strickler
Contact: GI Oncology Clinical Research Trials Office
Phone: 919.668.1861
Purpose: This is an open-label Phase 1a/b dose-escalation study to assess the safety, tolerability, and PK of OMP-131R10 as a single agent for advanced solid tumors and in subjects with metastatic colorectal cancer.
Reference Number: 00072844
View this trial at ClinicalTrials.gov

A Randomized, Multicenter, Double Blind, Phase III Study of Adjuvant Nivolumab or Placebo in Subjects with Resected Esophageal, or Gastroesophageal Junction Cancer
Phase: Phase III
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Hope Uronis
Contact: GI Oncology Clinical Research Trials Office
Phone: 919.668.1861
Purpose: The purpose of this study is to determine whether nivolumab will improve overall survival, disease-free survival, or both compared with placebo.
Reference Number: 00072847
View this trial at ClinicalTrials.gov