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

NCT ID: NCT03679767

Last Updated: 2023-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-09
• Study Completion Date: 2022-06-28

Brief 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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Melanoma: retifanlimab 500 mg

Participants with melanoma received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle.

Group Type: EXPERIMENTAL

Retifanlimab

Intervention Type: DRUG

Retifanlimab administered intravenously at 500 mg every 4 weeks

NSCLC: retifanlimab 500 mg

Participants with non-small cell lung cancer (NSCLC) received retifanlimab 500 mg Q4W, administered by IV infusion over 30 minutes on Day 1 of each 28-day cycle.

Group Type: EXPERIMENTAL

Retifanlimab

Intervention Type: DRUG

Retifanlimab administered intravenously at 500 mg every 4 weeks

UC: retifanlimab 500 mg

Participants with urethelial carcinoma (UC) received retifanlimab 500 mg Q4W, administered by IV infusion over 30 minutes on Day 1 of each 28-day cycle.

Group Type: EXPERIMENTAL

Retifanlimab

Intervention Type: DRUG

Retifanlimab administered intravenously at 500 mg every 4 weeks

RCC: retifanlimab 500 mg

Participants with renal cell carcinoma (RCC) received retifanlimab 500 mg Q4W, administered by IV infusion over 30 minutes on Day 1 of each 28-day cycle.

Group Type: EXPERIMENTAL

Retifanlimab

Intervention Type: DRUG

Retifanlimab administered intravenously at 500 mg every 4 weeks

Interventions

Retifanlimab

Retifanlimab administered intravenously at 500 mg every 4 weeks

Intervention Type: DRUG

Other Intervention Names

INCMGA00012

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Cornfeld, MD

Role: STUDY_DIRECTOR

Incyte Corporation

Locations

California Cancer Associates for Research and Excellence, Inc.

Fresno, California, United States

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

Georges Pompidou European Hospital

Paris, , France

Hopitaux Universitaires De Strasbourg

Strasbourg, , France

BAZ County Hospital

Miskolc, , Hungary

Hetenyi G Korhaz, Onkologiai Kozpont

Szolnok, , Hungary

Azienda Ospedaliera Universitaria Ospedali Riuniti di Ancona

Ancona, , Italy

ASST Istituti Ospitalieri

Cremona, , Italy

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, , Italy

Istituto Nazionale Tumori Regina Elena

Rome, , Italy

Azienda Ospedaliera Universitaria Senese

Siena, , Italy

Med-Polonia Sp. z o. o.

Poznan, Greater Poland Voivodeship, Poland

Centrum Onkologii- Instytut im Marii Skłodowskiej Curie

Warsaw, Masovian Voivodeship, Poland

Specjalistyczna Praktyka Lekarska

Lublin, , Poland

BioVirtus Research Site

Otwock, , Poland

Centrul de Oncologie Sfantul Nectarie

Craiova, Dolj, Romania

Oncolab SRL

Craiova, Dolj, Romania

Medisprof SRL

Cluj-Napoca, , Romania

Clinical Emergency Hospital of Constanta

Constanța, , Romania

Center of Oncology Euroclinic

Iași, , Romania

Spitalul Clinic Judetean de Urgenta Sibiu

Sibiu, , Romania

Oncocenter - Oncologie Clinica SRL

Timișoara, , Romania

Hospital Universitari Parc Tauli

Sabadell, Barcelona, Spain

Centro Oncologico De Galicia

A Coruña, , Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Hospital Universitario Vall d'Hebron

Barcelona, , Spain

MD Anderson Cancer Center Madrid

Madrid, , Spain

Hospital Puerta De Hierro

Majadahonda, , Spain

Hospital Universitari La Fe

Valencia, , Spain

Countries

United States; Austria; France; Hungary; Italy; Poland; Romania; Spain

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

INCMGA 0012-203

Identifier Type: -

Identifier Source: org_study_id