Cabozantinib Plus Durvalumab With or Without Tremelimumab in Patients With Gastroesophageal Cancer and Other Gastrointestinal Malignancies
A Phase I/II Trial of Cabozantinib in Combination With Durvalumab (MEDI4736) With or Without Tremelimumab in Patients With Advanced Gastroesophageal Cancer and Other Gastrointestinal (GI) Malignancies (CAMILLA)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests cabozantinib and durvalumab, with or without tremelimumab, for advanced cancers of the stomach, esophagus, colon, rectum, or liver. It looks at how safe these drug combinations are, how well people tolerate them, and how well they work.
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. The investigators believe that modulating the tumor microenvironment with biologic agents like cabozantinib will have synergistic effect when combined with checkpoint-based immunotherapeutics like durvalumab in this patient population. This is a phase I/II, open label, multi-cohort trial looking at safety, tolerability and efficacy endpoints.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older, weigh more than 66 pounds, and be able to do most daily activities.
- Have a tissue test showing one of the listed cancer types. The cancer must have spread or be stage 3 and unable to be removed by surgery.
- Have cancer that can be measured on scans. Agree to a tumor biopsy (taking a tissue sample) before treatment and possibly more biopsies later.
- For stomach or esophagus cancer: at least one standard drug treatment must have stopped working or caused side effects you could not tolerate.
- For colon or rectal cancer: at least two standard drug treatments must have stopped working or caused side effects you could not tolerate. People with tumors called RAS wild type must also have tried an EGFR-blocking drug without success.
- For liver cancer: prior treatment rules depend on the study group. One group requires one or two prior drug treatments; another allows no prior treatment or up to two prior treatments.
- Have good enough organ and bone marrow function, and have recovered from most past treatment side effects. Tumor results for MSI or MMR, which relate to DNA repair, must be available or tested.
- If able to become pregnant, have a negative pregnancy test. Follow the study's birth control rules during treatment and for 180 days afterward. Men must also avoid donating sperm during that time.
Who can't join
- Past use of cabozantinib or certain drugs that block MET or HGF signals. Past use of certain immune drugs is also excluded, except for people with liver, stomach, or esophagus cancer.
- Certain serious stomach or bowel problems, such as recent holes, abnormal openings, blockages, or pockets of infection; active ulcers or inflammation; cancer growing into the digestive tract; or swollen veins at high risk of bleeding.
- Trouble swallowing pills, fluid buildup in the belly or around the lungs that cannot be controlled, or certain lung or airway problems.
- Recent serious bleeding or cancer growing into major blood vessels. Liver cancer growing into the liver's portal blood vessels is allowed.
- Unhealed treatment side effects, major surgery within 8 weeks, certain radiation within 4 weeks, certain immune-suppressing drugs within 14 days, or a live vaccine within 30 days before treatment.
- A past organ transplant from a donor, certain immune system diseases, or an active infection such as tuberculosis, HIV, or hepatitis B or C. Some people with liver cancer and hepatitis B or C may qualify.
- Blood pressure above 140/90 despite treatment; a stroke, heart attack, or blood clot within 6 months; or untreated cancer spread to the brain, spinal cord, or their lining. Some stable, treated leg clots are allowed.
- Certain other cancers or health problems that make participation unsafe, an allergy to a study drug or its ingredients, or use of certain blood thinners. Low-dose aspirin and some injected blood thinners are allowed under study rules.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Age ≥ 18 years 2. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 3. Histologically confirmed diagnosis of any of the following: • Gastric or gastroesophageal junction adenocarcinoma * Esophageal adenocarcinoma * Colorectal adenocarcinoma (CRC) * Hepatocellular carcinoma (HCC) 4. Patients should have advanced (stage 4) or locally unresectable (stage III) disease. 5. Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 6. 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. 7. Patients with gastric, gastroesophageal, or esophageal adenocarcinoma must show evidence of progression or intolerance to at least one previous standard of care systemic therapy. 8. 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 (panitumumab or cetuximab) to be eligible. 10\. For cohort 3: Patients with HCC must show evidence of disease progression or intolerance to at least 1 previous systemic regimen (not more than 2 lines of prior therapy). 11\. For cohort 4: Patients with HCC must be treatment naïve or show evidence of disease progression or intolerance to at least 1 previous systemic regimen (not more than 2 lines of prior therapy). 12\. Patients should have known tumor results for microsatellite instability (MSI) or mismatch repair (MMR) proteins. If unknown, analysis will be obtained through local pathology lab using archival tissue if available or the baseline tumor biopsy. 13\. Recovery to baseline or ≤ Grade 1 CTCAE v5.0 from toxicities related to any prior treatments unless AE(s) are clinically nonsignificant and/or stable on supportive therapy. 14\. Body weight \> 66 lbs (30 kg) 15. Adequate organ and marrow function. 16. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. 17\. Women of child-bearing potential and men with partners of child-bearing potential must agree to use the highly effective forms of contraception prior to study entry, for the duration of study participation, and for 180 Days post completion of therapy. Men of child-bearing potential must not donate sperm while on this study and for 180 Days after their last study treatment. Exclusion Criteria: 1. 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). 2. 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 crizotinib, foretinib, tivantinib, rilotumumab, and onartuzumab. 3. 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, gastroesophageal and esophageal adenocarcinoma and CRC). \* Gastric or esophageal varices that are untreated or incompletely treated with bleeding or high risk for bleeding. Subjects treated with adequate endoscopic therapy (according to institutional standards) without any episodes of recurrent GI bleeding requiring transfusion or hospitalization for at least 6 months prior to study entry are eligible. 4. 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 duct or common bile duct, or gastric outlet obstruction. 5. Inability to swallow tablets. 6. Uncontrollable ascites or pleural effusion. 7. Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation. 8. 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. \* Lesions invading any major blood vessels. HCC subjects with lesions invading the hepatic portal vasculature are eligible. 9. Any unresolved toxicity CTCAE Grade ≥2 from previous anticancer therapy 10. 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 11. Major surgery (eg, Gastrointestinal (GI) surgery, removal or biopsy of brain metastasis) within 8 weeks before first dose of study treatment. 12. 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. 13. History of allogenic organ transplantation. 14. Active or prior documented autoimmune or inflammatory disorders 15. History of active primary immunodeficiency 16. 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. 17. Receipt of live attenuated vaccine within 30 days prior to the first dose. 18. Uncontrolled hypertension defined as sustained blood pressure (BP) \> 140 millimeter of mercury (mm Hg) systolic or \> 90 mm Hg diastolic despite optimal antihypertensive treatment. 19. 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. Participants with a diagnosis of deep venous thrombosis (DVT) within 6 months are allowed if stable, asymptomatic, and treated with Low Molecular Weight Heparin (LMWH) for at least 2 weeks before first dose. 20. Has untreated central nervous system (CNS) metastases and/or carcinomatous meningitis 21. Clinically significant disorders that would preclude safe study participation. 22. 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., clopidogrel). Allowed anticoagulants are the following: 1. Low-dose aspirin for cardioprotection (per local applicable guidelines) is permitted. 2. Low-dose (prophylactic) low molecular weight heparins (LMWH) are permitted. 3. Anticoagulation with therapeutic doses of LMWH is allowed in subjects with no known brain metastases, clinically significant hemorrhage, or complications from a thromboembolic event on the anticoagulation regimen (subjects with HCC must also have a screening platelet count \>100,000/μl), and who have been on a stable dose of LMWH for at least 1 week before first dose. 25\. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
Study sites (2)
KS
- University of Kansas Cancer Center · Westwood, KS 66205More trials in Westwood
PA
- UPMC Hillman Cancer Center · Pittsburgh, PA 15232Debra Diecks, RN · Study contact · 4126238364 · diecksda@upmc.eduClare Grzejka, RN · Study contact · 412-623-4891 · grzejkac@upmc.eduMore trials in Pittsburgh