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

  • STATUS
    Recruiting
Updated on 14 December 2020
solid tumors
solid tumor

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.

 

Description

For more information, please contact Incyte Corporation at 1.855.463.3463 or visit www.incyteclinicaltrials.com

Details
Condition Solid Tumors
Clinical Study IdentifierTX218064
Last Modified on14 December 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Confirmed diagnosis of one of the following: treatment-naive 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 PDL1 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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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