Protocol Summary

Protocol No.: OCR15873

Sponsor Protocol No.: INCAGN 1876-201, INCAGN

Study Title
A Phase 1/2 study exploring the safety, tolerability, and efficacy of INCAGN01876 in combination with immune therapies in subjects with advanced or metastatic malignancies

Principal Investigator(s)
George, Thomas

The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01876 when given in combination with immune therapies in subjects with advanced or metastatic malignancies.

Phase: Phase I/II

Age Group: Adult

Scope: National

INCAGN01876 + Nivolumab

INCAGN01876 + Ipilimumab

INCAGN01876 + Nivolumab + Ipilimumab

In Phase 1 subjects will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment.

In Phase 2, subjects will be administered IV study drug at the recommended dose from Phase 1.

Detailed Eligibility
1. Ages 18 years old and older
2. Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
3. Phase 1: Subjects with advanced or metastatic solid tumors.
4. Phase 1: Subjects who have disease progression after treatment with available therapies.
5. Phase 2: Subjects with advanced or metastatic endometrial cancer, gastric cancer (including stomach, esophageal, and GEJ), and SCCHN.
6. Presence of measurable disease based on RECIST v1.1.
7. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.

1. Laboratory and medical history parameters not within the Protocol-defined range
2. Prior treatment with an immune-therapy.
3. Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
4. Has not recovered to ≤ Grade 1 from toxic effects of prior therapy.
5. Active autoimmune disease.
6. Known active central nervous system metastases and/or carcinomatous meningitis.
7. Evidence of active, noninfectious pneumonitis or history of interstitial lung disease.
8. Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
9. Known history of human immunodeficiency virus (HIV; HIV 1/2 antibodies).

Applicable Disease Sites
Bladder Cancer
Gastrointestinal Cancer
Gynecologic Cancer
Kidney Cancer (Renal Cell)
Liver Cancer
Lung Cancer
Ovarian Cancer
Urologic Cancer

Participating Institutions
UF Gainesville : Marlene Sarmiento

Marlene Sarmiento, RN
Phone: +1 352-265-0680 ext. 50704


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