INCMGA00012 in Combination With Other Therapies in Patients With Advanced Solid Tumors



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:8/11/2018
Start Date:July 27, 2018
End Date:February 2022
Contact:Incyte Corporation Call Center (US)
Email:medinfo@incyte.com
Phone:1.855.463.3463

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A Phase 1b Study of INCMGA00012 in Combination With Other Therapies in Patients With Advanced Solid Tumors

The purpose of this study is to determine the safety, preliminary evidence of clinical
activity, and recommended Phase 2 dose (RP2D) of INCMGA00012 in combination with other agents
that may improve the therapeutic efficacy of anti-PD-1 monotherapy.


Inclusion Criteria:

- Histologically proven, locally advanced unresectable or metastatic solid tumors for
whom no approved therapy with demonstrated clinical benefit is available or
participants who are intolerant to or have declined standard therapy

- Measurable or nonmeasurable tumor lesions per RECIST v 1.1.

- Willing to provide fresh or archival tumor tissue for correlative studies.

- Eastern Cooperative Oncology Group performance status 0 to 1.

- Willingness to avoid pregnancy or fathering children based on protocol-defined
criteria.

Exclusion Criteria:

- Receipt of anticancer therapy within 21 days of the first administration of study
treatment, with the exception of localized radiotherapy.

- Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline (with the
exception of alopecia and anemia not requiring transfusional support).

- Laboratory values outside the protocol-defined range at screening.

- Active autoimmune disease requiring systemic immunosuppression in excess of
physiologic maintenance doses of corticosteroids.

- Known hypersensitivity to any of the study drugs, excipients, or another monoclonal
antibody which cannot be controlled with standard measures (eg, antihistamines and
corticosteroids).

- Evidence of interstitial lung disease or active, noninfectious pneumonitis.
We found this trial at
7
sites
Chicago, Illinois 60637
Principal Investigator: Jason Luke
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Juneko Grilley-Olson
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Chapel Hill, NC
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London,
Principal Investigator: Udai Banerji
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London,
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Los Angeles, California 90048
Principal Investigator: Ani Balmanoukian
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Los Angeles, CA
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Greg Beatty
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, PA
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San Antonio, Texas 78229
Principal Investigator: Kyriakos Papadopolous
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San Antonio, TX
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Seattle, Washington 98195
Principal Investigator: Gabi Chiorean
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Seattle, WA
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