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BRIEF TITLE: Study of INCMGA00012 (PD-1 Inhibitor) 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)


  • Org Study ID: INCMGA 0012-203
  • Secondary ID:
  • NCT ID: NCT03679767
  • NCT Alias:
  • Sponsor: Incyte Corporation - Industry
  • Source: 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.

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

Primary Outcomes:

Primary Outcome 1 - Measure: Overall response rate

Primary Outcome 1 - Time Frame: 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

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.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Mark Cornfeld, MD

Role: Study Director

Affiliation: Incyte Corporation

Overall Contact

Name: Incyte Corporation Call Center (US)

Phone: 1.855.463.3463

Email: medinfo@incyte.com

Locations

Facility Status Contact
California Cancer Associates for Research and Excellence, Inc.
Fresno, California 93720
United States
Not yet recruiting
California Cancer Associates for Research and Excellence, Inc.
San Marcos, California 92069
United States
Not yet recruiting
St. Joseph Health Medical Group - Annadel Medical Group
Santa Rosa, California 95403
United States
Recruiting
Rocky Mountain Cancer Centers - Denver - Midtown
Denver, Colorado 80218
United States
Recruiting
Christiana Care Helen F. Graham Cancer Center
Newark, Delaware 19718
United States
Recruiting
Rcca Md, Llc
Bethesda, Maryland 20817
United States
Recruiting
VA New Jersey Health Care System
East Orange, New Jersey 07018
United States
Recruiting
New York Oncology Hematology - Albany
Albany, New York 12208
United States
Recruiting
Kaiser Permanente
Portland, Oregon 97227
United States
Recruiting
Texas Oncology Surgical Specialists - Austin Central
Austin, Texas 78731
United States
Recruiting
Coastal Bend Cancer Center
Corpus Christi, Texas 78404
United States
Recruiting
AIM Trials, LLC
Plano, Texas 75093
United States
Recruiting
Texas Oncology - San Antonio Northeast
San Antonio, Texas 78217
United States
Recruiting
Oncology and Hematology Associates of Southwest Virginia, Inc.
The Woodlands, Texas 77380
United States
Recruiting
Texas Oncology - Waco
Waco, Texas 76712
United States
Recruiting
Medizinische Universitat Innsbruck
Innsbruck, A-6020
Austria
Recruiting
Institut Paoli Calmettes
Marseille, 13009
France
Recruiting
CEPCM / CHU Timone
Marseille, 13885
France
Recruiting
Hopitaux Universitaires De Strasbourg
Strasbourg, 67091
France
Recruiting
Azienda Ospedaliera Universitaria Ospedali Riuniti di Ancona
Ancona, 60126
Italy
Recruiting
Azienda Ospedaliera Universitaria Senese
Siena, 53100
Italy
Recruiting
Medisprof SRL
Cluj-Napoca, 400461
Romania
Recruiting
Spitalul Clinic Judetean de Urgenta Sibiu
Sibiu, 550245
Romania
Recruiting
Oncocenter - Oncologie Clinica SRL
Timisoara, 300166
Romania
Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Spain
Recruiting
Hospital Universitario Vall d'Hebron
Barcelona, 08025
Spain
Recruiting