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

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ClinicalTrials.gov Identifier: NCT03679767
Recruitment Status : Recruiting
First Posted : September 20, 2018
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
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 Drug: INCMGA00012 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of INCMGA00012 (PD-1 Inhibitor) in Participants With Selected Solid Tumors (POD1UM-203)
Actual Study Start Date : December 19, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : April 2021


Arm Intervention/treatment
Experimental: INCMGA00012
INCMGA00012 administered to cohorts of specific tumor types.
Drug: INCMGA00012
INCMGA00012 administered intravenously at the recommended Phase 2 dose every 4 weeks.




Primary Outcome Measures :
  1. Overall response rate [ Time Frame: Up to at least 6 months from the start of treatment ]
    Defined as the percentage of participants having a complete response (CR) or partial response (PR), according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by the investigator.


Secondary Outcome Measures :
  1. Duration of response [ Time Frame: Up to approximately 3 years ]
    Defined as the time from an initial objective response (CR or PR) according to RECIST v1.1 until first observation of documented disease progression as determined by investigator or death due to any cause.

  2. Disease control rate [ Time Frame: Up to approximately 3 years ]
    Defined as the proportion of participants with either an objective response (CR and PR) or stable disease, according to RECIST v1.1.

  3. Progression-free survival [ Time Frame: Up to approximately 3 years ]
    Defined as the time from the start of therapy until disease progression, as determined by investigator or death due to any cause.

  4. Overall survival [ Time Frame: Up to approximately 3 years ]
    Defined as the time from the start of therapy until death due to any cause.

  5. Number of treatment-emergent adverse events [ Time Frame: Up to approximately 3 years ]
    Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.

  6. Cmax of INCMGA00012 [ Time Frame: Up to approximately 2 years ]
    Maximum observed plasma or serum concentration.

  7. Tmax of INCMGA00012 [ Time Frame: Up to approximately 2 years ]
    Time to maximum concentration.

  8. Cmin of INCMGA00012 [ Time Frame: Up to approximately 2 years ]
    Minimum observed plasma or serum concentration over the dose interval.

  9. AUC0-t of INCMGA00012 [ Time Frame: Up to approximately 2 years ]
    Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • Active malignancy requiring treatment of a type not included in the study population.
  • 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 highly active 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03679767


Contacts
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Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 globalmedinfo@incyte.com

Locations
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United States, Texas
Coastal Bend Oncology Recruiting
Corpus Christi, Texas, United States, 78404
AIM Trials, LLC Recruiting
Plano, Texas, United States, 75093
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Mark Cornfeld, MD Incyte Corporation

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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03679767     History of Changes
Other Study ID Numbers: INCMGA 0012-203
First Posted: September 20, 2018    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Incyte Corporation:
PD-1inhibitor
non-small cell lung cancer
urothelial cancer
melanoma
renal cell carcinoma

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Non-Small-Cell Lung
Melanoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases