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

INTRODUCTION

Org Study ID: INCMGA 0012-203
Secondary ID: N/A
NTC ID: NCT03679767
Sponsor: Incyte Corporation

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.

Overall Status
Recruiting
Start Date
December 19, 2018
Phase
Phase 2
Study Type
Interventional

Primary Outcome 1 - Measure: Overall response rate

Primary Outcome 1 - Timeframe: Up to at least 6 months from the start of treatment

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

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.

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

Name: Mark Cornfeld, MD

Role: Study Director

Affiliation: Incyte Corporation

Name: Mark Cornfeld, MD

Phone: 1.855.463.3463

Email: medinfo@incyte.com

Facility	Status	Contact
Facility: St. Joseph Health Medical Group - Annadel Medical Group Santa Rosa, California 95403 United States	Status: Recruiting	Contact: N/A
Facility: Rocky Mountain Cancer Centers - Denver - Midtown Denver, Colorado 80218 United States	Status: Recruiting	Contact: N/A
Facility: Christiana Care Helen F. Graham Cancer Center Newark, Delaware 19718 United States	Status: Recruiting	Contact: N/A
Facility: Rcca Md, Llc Bethesda, Maryland 20817 United States	Status: Recruiting	Contact: N/A
Facility: VA New Jersey Health Care System East Orange, New Jersey 07018 United States	Status: Recruiting	Contact: N/A
Facility: New York Oncology Hematology - Albany Albany, New York 12208 United States	Status: Recruiting	Contact: N/A
Facility: Kaiser Permanente Portland, Oregon 97227 United States	Status: Recruiting	Contact: N/A
Facility: Texas Oncology Surgical Specialists - Austin Central Austin, Texas 78731 United States	Status: Recruiting	Contact: N/A
Facility: Coastal Bend Cancer Center Corpus Christi, Texas 78404 United States	Status: Recruiting	Contact: N/A
Facility: Texas Oncology - San Antonio Northeast San Antonio, Texas 78217 United States	Status: Recruiting	Contact: N/A
Facility: Oncology and Hematology Associates of Southwest Virginia, Inc. The Woodlands, Texas 77380 United States	Status: Recruiting	Contact: N/A
Facility: Texas Oncology - Waco Waco, Texas 76712 United States	Status: Recruiting	Contact: N/A
Facility: Oncology & Hematology Associates of Southwest Virginia, Inc. Wytheville, Virginia 24382 United States	Status: Recruiting	Contact: N/A
Facility: LKH Graz Graz, Austria	Status: Recruiting	Contact: N/A
Facility: Medizinische Universitat Innsbruck Innsbruck, A-6020 Austria	Status: Recruiting	Contact: N/A
Facility: Ordensklinikum Linz, 4010 Austria	Status: Recruiting	Contact: N/A
Facility: Universitatsklinikum St. Polten St. Polten, 3100 Austria	Status: Recruiting	Contact: N/A
Facility: Institut Bergonié Bordeaux, 33076 France	Status: Recruiting	Contact: N/A
Facility: Institut Paoli Calmettes Marseille, 13009 France	Status: Recruiting	Contact: N/A
Facility: CEPCM / CHU Timone Marseille, 13885 France	Status: Recruiting	Contact: N/A
Facility: Georges Pompidou European Hospital Paris, 75015 France	Status: Recruiting	Contact: N/A
Facility: Hopitaux Universitaires De Strasbourg Strasbourg, 67091 France	Status: Recruiting	Contact: N/A
Facility: BAZ County Hospital Miskolc, 3526 Hungary	Status: Recruiting	Contact: N/A
Facility: Hetenyi G Korhaz, Onkologiai Kozpont Szolnok, 5004 Hungary	Status: Recruiting	Contact: N/A
Facility: Azienda Ospedaliera Universitaria Ospedali Riuniti di Ancona Ancona, 60126 Italy	Status: Recruiting	Contact: N/A
Facility: ASST Istituti Ospitalieri Cremona, 26100 Italy	Status: Recruiting	Contact: N/A
Facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori Meldola, 47014 Italy	Status: Recruiting	Contact: N/A
Facility: Istituto Nazionale Tumori Regina Elena Rome, 00144 Italy	Status: Recruiting	Contact: N/A
Facility: Azienda Ospedaliera Universitaria Senese Siena, 53100 Italy	Status: Recruiting	Contact: N/A
Facility: Centrum Onkologii- Instytut im Marii Skłodowskiej Curie Warszawa, Mazowieckie Poland	Status: Recruiting	Contact: N/A
Facility: Med-Polonia Sp. z o. o. Poznan, Wielkopolskie Poland	Status: Recruiting	Contact: N/A
Facility: Specjalistyczna Praktyka Lekarska Lublin, 20-093 Poland	Status: Recruiting	Contact: N/A
Facility: BioVirtus Research Site Otwock, 05-400 Poland	Status: Recruiting	Contact: N/A
Facility: Centrul de Oncologie Sfantul Nectarie Craiova, Dolj 200347 Romania	Status: Recruiting	Contact: N/A
Facility: Oncolab SRL Craiova, Dolj 200385 Romania	Status: Recruiting	Contact: N/A
Facility: Medisprof SRL Cluj-Napoca, 400461 Romania	Status: Recruiting	Contact: N/A
Facility: Clinical Emergency Hospital of Constanta Constanta, 900591 Romania	Status: Recruiting	Contact: N/A
Facility: Center of Oncology Euroclinic Iasi, 700106 Romania	Status: Recruiting	Contact: N/A
Facility: Spitalul Clinic Judetean de Urgenta Sibiu Sibiu, 550245 Romania	Status: Recruiting	Contact: N/A
Facility: Oncocenter - Oncologie Clinica SRL Timisoara, 300166 Romania	Status: Recruiting	Contact: N/A
Facility: Hospital Universitari Parc Tauli Sabadell, Barcelona 08208 Spain	Status: Recruiting	Contact: N/A
Facility: Centro Oncologico De Galicia A Coruna, 08041 Spain	Status: Recruiting	Contact: N/A
Facility: Hospital de la Santa Creu i Sant Pau Barcelona, 08025 Spain	Status: Recruiting	Contact: N/A
Facility: Hospital Universitario Vall d'Hebron Barcelona, 08025 Spain	Status: Recruiting	Contact: N/A
Facility: MD Anderson Cancer Center Madrid Madrid, 28033 Spain	Status: Recruiting	Contact: N/A
Facility: Hospital Puerta De Hierro Majadahonda, 28220 Spain	Status: Recruiting	Contact: N/A
Facility: Hospital Universitari La Fe Valencia, 46026 Spain	Status: Recruiting	Contact: N/A

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

A Phase 2 Study of INCMGA00012 (PD-1 Inhibitor) in Participants With Selected Solid Tumors (POD1UM-203)

INTRODUCTION

BRIEF SUMMARY

PRIMARY OUTCOMES

CONDITION

ELIGIBILITY

OFFICIAL INFORMATION

Overall Contact

LOCATION

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