a study of incmga00012 in participants with selected solid tumors (pod1um-203)

Conditions: Metastatic Non-small Cell Lung Cancer; Locally Advanced Urothelial Cancer; Metastatic Urothelial Cancer; Unresectable Melanoma; Metastatic Melanoma; Locally Advanced Renal Cell Carcinoma; Metastatic Clear-Cell Renal Cell Carcinoma

Summary: the purpose of this study is to assess the clinical activity and safety of incmga00012 in participants with advanced solid tumors where the efficacy of pd-1 inhibitors has previously been established.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of one of the following: treatment-naïve metastatic non-small cell lung cancer with high pd-l1 expression (tumor proportion score ≥ 50%) and no epidermal growth factor receptor (egfr), alkaline phosphatase (alk), or ros activating genomic tumor aberrations; locally advanced or metastatic urothelial carcinoma in participants who are not eligible for cisplatin therapy and whose tumors express pd-l1 with a combined positive score ≥ 10; unresectable or metastatic melanoma; locally advanced or metastatic renal cell carcinoma with clear cell component (with or without sarcomatoid features) and having received no prior systemic therapy. * measurable disease per recist v1.1. * eastern cooperative oncology group performance status 0 to 1. * willingness to avoid pregnancy or fathering children. exclusion criteria: * receipt of anticancer therapy or participation in another interventional clinical study within 21 days before the first administration of study drug. * prior treatment with pd-1 or pd-l1 directed therapy (other immunotherapies may be acceptable with prior approval from the medical monitor). * radiotherapy within 14 days of first dose of study treatment with the following caveats: 28 days for pelvic radiotherapy; 6 months for thoracic region radiotherapy that is \> 30 gy. * toxicity of prior therapy that has not recovered to ≤ grade 1 or baseline (with the exception of anemia not requiring transfusion support and any grade of alopecia). endocrinopathy, if well-managed, is not exclusionary and should be discussed with sponsor medical monitor. * has not recovered adequately from toxicities and/or complications from surgical intervention before starting study drug. * laboratory values outside the protocol-defined range at screening. * known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 3 years of study entry. * active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (\> 10 mg of prednisone or equivalent). * evidence of interstitial lung disease or active noninfectious pneumonitis. * known active central nervous system metastases and/or carcinomatous meningitis. * known active hepatitis b antigen, hepatitis b virus, or hepatitis c virus infection. * active infections requiring systemic therapy. * known to be hiv-positive, unless all of the following criteria are met: cd4+ count ≥ 300/μl, undetectable viral load, receiving antiretroviral therapy. * known hypersensitivity to another monoclonal antibody that cannot be controlled with standard measures (eg, antihistamines and corticosteroids). * impaired cardiac function or clinically significant cardiac disease. * is pregnant or breastfeeding. * has received a live vaccine within 28 days of the planned start of study drug.

Keywords: pd-1inhibitor non-small cell lung cancer urothelial cancer melanoma renal cell carcinoma