Trial purpose
Cancer treatment
Tumor type
Lower gastrointestinal tract
Age
18+
Clinical summary
Summary
This study consists of two stages. Stage 1 is a phase 1b trial and will assess the safety of the new treatment regime. Stage 2 is a phase 2 trial which will be assessing the treatment safety and effectiveness. Patients eligible to participate in this study will receive either FOLFOX and bevacuzimab or FOLFOX, bevacuzimab, durvalumab and oleclumab. All treaments will be intravenously administered on Day 1 and 2 of a 14-week cycle.
Conditions
This trial is treating people with Metastatic Microsatellite-stable Colorectal Cancer
Eligibility
Inclusion
- Written informed consent and any locally required authorization obtained from the participant/legal representative prior to performing any protocol-related procedures, including screening evaluations.
- Age ≥ 18 years at the time of screening.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Participants must have histologic documentation of advanced or metastatic CRC and: (a) A documented mutation test during screening and confirmed tumor locations from disease assessment for enrollment. (b) Participants must NOT have defective deoxyribonucleic acid (DNA) mismatch repair (MSI) as documented by testing. (c) Participants must not have received any prior systemic therapy for recurrent/metastatic disease (prior adjuvant chemotherapy or radio-chemotherapy is acceptable so long as progression was not within 6 months of completing the adjuvant regimen).
- Participants must have at least one lesion that is measurable by RECIST v1.1 (Eisenhauer et al, 2009).
- Participants must have adequate organ function.
- Participants with medical conditions requiring systemic anticoagulation (eg, atrial fibrillation) are eligible provided that both of the following criteria are met: - The participant has an in-range International Normalized Ratio (INR) on a stable dose of oral anticoagulant or be on a stable dose of low molecular weight heparin. - The participant has no active bleeding or pathological condition that carries a high risk of bleeding.
- Body weight >35 kg.
- Adequate method of contraception per protocol.
Exclusion
- History of allogeneic organ transplantation.
- Active or prior documented autoimmune disorders within the past 5 years.
- History of venous thrombosis within the past 3 months.
- Cardiovascular criteria: (a) Presence of acute coronary syndrome including myocardial infarction or unstable angina pectoris, other arterial thrombotic event including cerebrovascular accident or transient ischemic attack or stroke within the past 6 months. (b) New York Heart Association (NYHA) class II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, or uncontrolled hypertension. (c) History of hypertensive crisis/hypertensive encephalopathy within the past 6 months.
- Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 ms.
- No significant history of bleeding events or gastrointestinal perforation.
- Uncontrolled intercurrent illness.
- History of another primary malignancy except for: (a) Malignancy treated with curative intent and with no known active disease ≥ 5 years of low potential risk for recurrence. (b) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. (c) Adequately treated carcinoma in situ without evidence of disease.
- History of active primary immunodeficiency.
- Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade > 1 from previous anticancer therapy.
- History of leptomeningeal disease or cord compression.
- Untreated central nervous system (CNS) metastases.
- Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication.
- Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- Prior immunotherapy or anti-angiogenics.
- Receipt of live attenuated vaccine within the past 30 days.
- Major surgical procedure, open biopsy, or significant traumatic injury within the past 28 days.
- Current or prior use of immunosuppressive medication within the past 14 days, with exceptions per protocol.
Inclusion
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
MedImmune, LLC
Scientific Title
A Phase 1b/2, Open-label, Multicenter Study of Novel Oncology Therapies in Combination With Chemotherapy and Bevacizumab as First-line Therapy in Metastatic Microsatellite-stable Colorectal Cancer
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