Comparing 3 approaches for pancreatic cancer

Exclusion

• −Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
• −Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (CTCAE v5.0 Grade ≥ 3).
• −Active brain metastases or leptomeningeal disease.
• −Patients with treated brain metastases that have been treated, are off steroids and anticonvulsants and have imaging documenting stability of brain metastases for 6 weeks post treatment will be eligible for enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more →.
• −Active infection requiring systemic therapy or Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Patients known positive for HIV.
• −Patients who have received prior palliative systemic treatment for their advanced cancer.
• −History of pneumonitis requiring treatment with steroids.
• −History of active interstitial lung disease.
• −For HCC patients they must have a Child Pugh status of A.
• −Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (\< 6 months prior to enrollment), myocardial infarction (\< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
• −Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
• −Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart) \<\<for durvalumab monotherapy and durvalumab + tremelimumab combination studies this criterion can be removed. For durvalumab ±tremelimumab in combination with an agent with pro-arrhythmic potential or where effect of the combination on QT is not known if this criterion should be retained.
• −History of another malignancy or a concurrent malignancy;
• −Prior organ transplantation including allogeneic stem-cell transplantation.
• −Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.
• −Other severe acute or chronic medical conditions including inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, would make the patient inappropriate for entry into this study.
• −Persisting toxicity related to prior therapy (NCI CTCAE v. 5.0 grade \> 1); however, alopecia, sensory neuropathy ≤ grade 2, or other toxicities ≤ grade 2 not constituting a safety risk based on investigator's judgment are acceptable.
• −Enrollment in any other clinical protocolProtocolThe detailed plan a study must follow.Read more → or investigational study with an interventionalInterventional studyA study where participants are given something to see what happens.Read more → agent or assessments that may interfere with study procedures.
• −Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.
• −Prior randomisationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → or treatment in a previous durvalumab and/or tremelimumab clinical study regardless of treatment armArmOne of the groups in a study, each receiving something different.Read more → assignment.
• −Asthma requiring corticosteroid inhalers and having been admitted within the last year for an asthma exacerbation
• −Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth controlControl groupThe group a new treatment is measured against.Read more → from screeningScreeningThe checks done before joining, to see whether a study fits.Read more → to 90 days after the last dose of durvalumab monotherapy or 180 days after the last dose of durvalumab + tremelimumab combination therapy.
• −Exceptions include patients who have been disease-free for 3 years, or patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible, for example cervical cancer in situ. As well patients with a resected malignancy that did not require systemic therapy post-surgery are allowed.
• −Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.