Back to Clinical Trials

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

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

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.


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

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Overall response rate

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

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

ELIGIBILITY


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

OFFICIAL INFORMATION

Name: Mark Cornfeld, MD

Role: Study Director

Affiliation: Incyte Corporation

Overall Contact

Name: Mark Cornfeld, MD

Phone: 1.855.463.3463

Email: medinfo@incyte.com

LOCATION

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