A Study of INCMGA00012 in Participants With Selected Solid Tumors (POD1UM-203)
Condition: 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
MeSH terms: Carcinoma; Carcinoma, Non-Small-Cell Lung; Melanoma; Carcinoma, Renal Cell
Intervention: Retifanlimab
Intervention description: Retifanlimab administered intravenously at 500 mg every 4 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PD-1inhibitor; non-small cell lung cancer; urothelial cancer; melanoma; 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.