incmga00012 plus chemotherapy in participants with advanced solid tumors (pod1um-105)

Conditions: Advanced and/or Metastatic Solid Tumors; Stage IIIB Not Amenable to Curative Therapy to Stage IV Non-small Cell Lung Cancer; Advanced/Metastatic Unresectable Malignant Pleural Mesothelioma

Summary: the purpose of this study is to assess the safety and tolerability and to determine the recommended phase 2 dose of incmga00012 in combination with common standard-of-care chemotherapy regimens in participants with advanced solid tumors.


Eligibility criteria:
inclusion criteria: * advanced and/or metastatic solid tumors including the following: histologically or cytologically confirmed diagnosis of stage iiib not amenable to curative treatment or stage iv non-small cell lung cancer (pemetrexed-platinum treatment groups must have nonsquamous histology type); and histologically or cytologically confirmed diagnosis of advanced/metastatic unresectable malignant pleural mesothelioma. * no prior systemic treatment with the following exceptions: participants with a known sensitizing mutation (eg, braf, egfr, alk, or ros1) should have had disease progression on or following an approved targeted tyrosine kinase inhibitor; and participants who received adjuvant or neoadjuvant chemotherapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 6 months before the date of enrollment. * measurable or nonmeasurable tumor lesions per recist v1.1. * eastern cooperative oncology group performance status 0 to 1. exclusion criteria: * received prior treatment with checkpoint inhibitor agents (such as anti-pd-1, anti-pd-l1, anti-pd-l2, or anti-ctla-4). * had major surgery within 3 weeks before the first dose of study treatment. * received radiation therapy to the lung(s) that is \> 30 gy within 6 months of the first dose of study treatment. * received palliative radiotherapy within 7 days before the first dose of study treatment. * has ≥ grade 2 residual toxicities from the most recent prior therapy (except alopecia). * organ function (renal, hepatic), bone marrow reserve, and coagulation panel outside the protocol-defined laboratory values. * is currently participating and receiving investigational therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks before the first dose of study treatment. * has active autoimmune disease requiring systemic immunosuppression with corticosteroids (\> 10 mg once daily of prednisone or equivalent) or immunosuppressive drugs within 2 years before the first dose of study treatment. * is on chronic systemic steroids (\> 10 mg once daily of prednisone or equivalent). * known active central nervous system metastases and/or carcinomatous meningitis (patients with previously-treated and clinically stable brain metastases are eligible and a washout period of ≥ 4 weeks since radiation therapy is required). * known additional malignancy that is progressing or requires active treatment. * evidence of interstitial lung disease or active, noninfectious pneumonitis. * history of organ transplant, including allogeneic stem cell transplantation. * active infections requiring systemic antibiotics. * known active hepatitis b or c. * has a diagnosis of immunodeficiency, including participants known to be hiv positive (positive for hiv 1/2 antibodies). * significant cardiac event within 6 months before cycle 1 day 1. * has received a live vaccine within 28 days of the planned start of study treatment. * known hypersensitivity to any component of the study drugs, excipients, or another monoclonal antibody which cannot be controlled with standard measures (eg, antihistamines and corticosteroids).

Keywords: solid tumors non-small cell lung cancer malignant pleural mesothelioma chemotherapy programmed cell death protein 1 (pd-1) inhibitor