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New treatment option for Gastric Cancer
Official title Cabozantinib Plus Durvalumab With or Without Tremelimumab in Patients With Gastroesophageal Cancer and Other Gastrointestinal Malignancies
ClinicalTrials.gov ID: NCT03539822
What this study is testing
What is Cabozantinib?
Cabozantinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for gastric cancer.
Also referred to as multi-tyrosine kinase Inhibitor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The investigators propose to evaluate the safety of drug combinations in patients with advanced gastroesophageal cancer and other gastrointestinal (GI) malignancies. Finding effective novel therapies for patients with advanced gastric cancer and other GI malignancies is an area of great unmet need.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Histologically confirmed diagnosis of any of the following:
- Gastric or gastroesophageal junction adenocarcinoma
- Esophageal adenocarcinoma
You likely can't join if
- Prior treatment with a Programmed cell death protein 1 (PD1) or (PD-L1) inhibitor, including durvalumab, or anti PD-L2 (HCC and gastric / esophageal...
- Prior treatment with cabozantinib or other Receptor for hepatocyte growth factor (MET) or Dual MET/ Hepatocyte growth factor (HGF) monoclonal...
- Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose. \ Evidence of tumor invading the...
- Evidence of active peptic ulcer disease, inflammatory bowel disease (eg, Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or...
- Inability to swallow tablets.
- Uncontrollable ascites or pleural effusion.
See the full eligibility criteria
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Histologically confirmed diagnosis of any of the following:
- Gastric or gastroesophageal junction adenocarcinoma
- Esophageal adenocarcinoma
- Colorectal adenocarcinoma (CRC)
- Hepatocellular carcinoma (HCC)
- Patients should have advanced (stage 4) or locally unresectable (stage III) disease.
- Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Patients must consent to undergo a required screening/baseline biopsy procedure (and potentially another tumor biopsy at time of disease response and progression) for correlative testing.
- Patients with gastric, gastroesophageal, or esophageal adenocarcinoma must show evidence of progression or intolerance to at least one previous standard of care systemic therapy.
- Patients with CRC must show evidence of progression or intolerance to at least 2 previous standard of care systemic therapy. Ras wild type patients should fail epidermal growth factor receptor (EGFR) monoclonal antibody...
- Prior treatment with a Programmed cell death protein 1 (PD1) or (PD-L1) inhibitor, including durvalumab, or anti PD-L2 (HCC and gastric / esophageal cancer patients with prior exposure to these agents are eligible).
- Prior treatment with cabozantinib or other Receptor for hepatocyte growth factor (MET) or Dual MET/ Hepatocyte growth factor (HGF) monoclonal antibodies or MET/HGF tyrosine kinase inhibitors (TKIs), including...
- Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose. \ Evidence of tumor invading the GI tract, (Defined as T4 primary tumor in patients with gastric...
- Evidence of active peptic ulcer disease, inflammatory bowel disease (eg, Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, acute obstruction of the pancreatic...
- Inability to swallow tablets.
- Uncontrollable ascites or pleural effusion.
- Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation.
- Clinically significant hematuria, hematemesis, or hemoptysis of \>0.5 tsp (2.5ml) of red blood, or other history of significant bleeding within 12 weeks. \ Any sign indicative of pulmonary hemorrhage within 3 months. \...
- Any unresolved toxicity CTCAE Grade ≥2 from previous anticancer therapy
- Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug
- Major surgery (eg, Gastrointestinal (GI) surgery, removal or biopsy of brain metastasis) within 8 weeks before first dose of study treatment.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses.
- History of allogenic organ transplantation.
- Active or prior documented autoimmune or inflammatory disorders
- History of active primary immunodeficiency
- Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus. HCC patients with hepatitis B or C infection are allowed per protocol specific criteria.
- Receipt of live attenuated vaccine within 30 days prior to the first dose.
- Uncontrolled hypertension defined as sustained blood pressure (BP) \> 140 millimeter of mercury (mm Hg) systolic or \> 90 mm Hg diastolic despite optimal antihypertensive treatment.
- Stroke, including transient ischemic attack (TIA), myocardial infarction (MI), or other ischemic event, or thromboembolic event (eg, deep venous thrombosis, pulmonary embolism) within 6 months before first dose...
- Has untreated central nervous system (CNS) metastases and/or carcinomatous meningitis
- Clinically significant disorders that would preclude safe study participation.
- History of another primary malignancy except for:
- Malignancy treated with curative intent/ resection and with no known active disease before the first dose of investigational product (IP) and of low potential risk for recurrence.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- Adequately treated carcinoma in situ without evidence of disease. 24\. Concomitant anticoagulation with oral anticoagulants (e.g., warfarin, direct thrombin and Factor Xa inhibitors) or platelet inhibitors (e.g...
- Low-dose aspirin for cardioprotection (per local applicable guidelines) is permitted.
- Low-dose (prophylactic) low molecular weight heparins (LMWH) are permitted.
- Anticoagulation with therapeutic doses of LMWH is allowed in people with no known brain metastases, clinically significant hemorrhage, or complications from a thromboembolic event on the anticoagulation regimen (people...
The study team makes the final eligibility decision.
Where it's taking place
- Westwood, Kansas, United States
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Westwood, Kansas, United States; Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.