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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedRetifanlimab

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 21, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?52 U.S. locations

Locations may change over time.

Who runs it?Incyte Corporation

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Incyte Corporation
Interventions being studied: Drug: Retifanlimab

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Early-stage or resectable→Locally advanced→Metastatic or stage IV→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

California Cancer Associates for Research and Excellence, Inc.Fresno, California
California Cancer Associates for Research and ExcellenceFresno, California
California Cancer Associates for Research and Excellence, Inc.San Marcos, California
St Joseph Heritage HealthcareSanta Rosa, California
St. Joseph Health Medical Group - Annadel Medical GroupSanta Rosa, California
Rocky Mountain Cancer Centers - Denver - MidtownDenver, Colorado
Christiana Care Helen F. Graham Cancer CenterNewark, Delaware
Rcca Md, LlcBethesda, Maryland
VA New Jersey Health Care SystemEast Orange, New Jersey
New York Oncology Hematology - AlbanyAlbany, New York
Kaiser PermanentePortland, Oregon
Texas Oncology Surgical Specialists - Austin CentralAustin, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 21, 2023. Always confirm current availability with the study team.

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