Lung Cancer Clinical Trial
A Study of INCMGA00012 in Participants With Selected Solid Tumors (POD1UM-203)
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.
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There are 46 Locations for this study
Fresno California, 93720, United States
Fresno California, 93720, United States
San Marcos California, 92069, United States
Santa Rosa California, 95403, United States
Santa Rosa California, 95403, United States
Denver Colorado, 80218, United States
Newark Delaware, 19718, United States
Bethesda Maryland, 20817, United States
East Orange New Jersey, 07018, United States
Albany New York, 12208, United States
Portland Oregon, 97227, United States
Austin Texas, 78731, United States
Corpus Christi Texas, 78404, United States
Plano Texas, 75093, United States
San Antonio Texas, 78217, United States
The Woodlands Texas, 77380, United States
Waco Texas, 76712, United States
Wytheville Virginia, 24382, United States
Graz , , Austria
Innsbruck , A-602, Austria
Linz , 4010, Austria
St. Polten , 3100, Austria
Bordeaux , 33076, France
Marseille , 13009, France
Marseille , 13885, France
Paris , 75015, France
Strasbourg , 67091, France
Miskolc , 3526, Hungary
Szolnok , 5004, Hungary
Ancona , 60126, Italy
Cremona , 26100, Italy
Meldola , 47014, Italy
Rome , 00144, Italy
Siena , 53100, Italy
Warszawa Mazowieckie, , Poland
Poznan Wielkopolskie, , Poland
Lublin , 20-09, Poland
Otwock , 05-40, Poland
Craiova Dolj, 20034, Romania
Craiova Dolj, 20038, Romania
Cluj-Napoca , 40046, Romania
Constanta , 90059, Romania
Iasi , 70010, Romania
Sibiu , 55024, Romania
Timisoara , 30016, Romania
Sabadell Barcelona, 08208, Spain
A Coruna , 08041, Spain
Barcelona , 08025, Spain
Barcelona , 08025, Spain
Madrid , 28033, Spain
Majadahonda , 28220, Spain
Valencia , 46026, Spain
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