Testing MDNA11 with Pembrolizumab (KEYTRUDA®) for advanced solid tumor

Exclusion

• −Known severe hypersensitivity to any component of study drug(s).
• −Has known active CNS metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screeningScreeningThe checks done before joining, to see whether a study fits.Read more →), clinically stable and without requirement of steroid treatment for at least 14 days prior to start of treatment, subject to discussion with MM.
• −Known hepatitis B or C virus infection.
• −Last administration of prior antitumor therapy:
• −Prior systemic anti-cancer therapy including investigational agents within 4 weeks (could consider shorter interval for kinase inhibitors or other short half-life drugs) prior to start of treatment.
• −Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to start of treatment. Concomitant participation in an observational studyObservational studyA study that watches what happens without assigning any treatment.Read more → must be discussed on a case-by-case basis with the MM for approval.
• −Active malignancy (other than the disease under treatment in the study) within the previous 3 years except for curable cancers.
• −Condition requiring long-term systemic treatment with either corticosteroids \> 10 mg daily prednisone equivalent or any other form of immunosuppressive therapy within 7 days prior to start of treatment.
• −Severe pulmonary, cardiac or other systemic disease.
• −Has had an allogeneic tissue/solid organ transplant.
• −Active infection requiring systemic therapy.
• −Any medical, emotional or psychiatric condition that interfere with the patient's ability to adhere to the protocolProtocolThe detailed plan a study must follow.Read more →
• −Any other underlying medical conditions that, in the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s opinion, will make the administration of study drug(s) unsafe or obscure the interpretation of toxicity determination or adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more →.
• −Inability to comply with study and follow upFollow-upContinued check-ins after the treatment part is finished.Read more → procedures as judged by the Investigator.
• −Females who are pregnant or lactating or planning to become pregnant during the study.
• −Prior radiotherapy within 2 weeks prior to start of treatment or has had a history of radiation pneumonitis. A 1-week washoutWashout periodA gap with no treatment, so the previous one clears your system.Read more → is required for palliative radiation (\<2 weeks of radiotherapy) to non-CNS disease.
• −Radiation therapy to the lung that is \> 30Gy within 6 months prior to start of treatment.
• −Clinically significant active, known or suspected autoimmune disease, or diseases that can be exacerbated with immunotherapy.