A Study of INCMGA00012 in Participants With Selected Solid Tumors (POD1UM-203)

Completed · Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT03679767

Run by

Incyte Corporation

People needed

121

Starts

2019-01-09

Expected to finish

2022-06-28

Last updated by the study team

2023-07-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• California Cancer Associates for Research and Excellence — Fresno, California, United States
• California Cancer Associates for Research and Excellence, Inc. — San Marcos, California, United States
• St Joseph Heritage Healthcare — Santa Rosa, California, United States
• St. Joseph Health Medical Group - Annadel Medical Group — Santa Rosa, California, United States
• Rocky Mountain Cancer Centers - Denver - Midtown — Denver, Colorado, United States
• Christiana Care Helen F. Graham Cancer Center — Newark, Delaware, United States
• Rcca Md, Llc — Bethesda, Maryland, United States
• VA New Jersey Health Care System — East Orange, New Jersey, United States
• New York Oncology Hematology - Albany — Albany, New York, United States
• Kaiser Permanente — Portland, Oregon, United States
• Texas Oncology Surgical Specialists - Austin Central — Austin, Texas, United States
• Coastal Bend Cancer Center — Corpus Christi, Texas, United States
• AIM Trials, LLC — Plano, Texas, United States
• Texas Oncology - San Antonio Northeast — San Antonio, Texas, United States
• Oncology and Hematology Associates of Southwest Virginia, Inc. — The Woodlands, Texas, United States
• Texas Oncology - Waco — Waco, Texas, United States
• Oncology & Hematology Associates of Southwest Virginia, Inc. — Wytheville, Virginia, United States
• LKH Graz — Graz, Austria
• Medizinische Universitat Innsbruck — Innsbruck, Austria
• Ordensklinikum — Linz, Austria
• Universitatsklinikum St. Polten — Sankt Pölten, Austria
• Institut Bergonié — Bordeaux, France
• Institut Paoli Calmettes — Marseille, France
• CEPCM / CHU Timone — Marseille, France
• California Cancer Associates for Research and Excellence, Inc. — Fresno, California, United States

Full record on ClinicalTrials.gov

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