Protocol Summary

Protocol No.: OCR15873

Sponsor Protocol No.: INCAGN 1876-201, INCAGN

Protocol Title: Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies

Principal Investigator: George, Thomas

Objective: 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

Age: 18 Years - N/A

Gender: All

Scope: National

Treatment:
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:
INCLUSION CRITERIA:
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.
EXCLUSION CRITERIA:
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 Conditions:

  • Bladder Cancer
  • Gastrointestinal Cancer
  • Gynecologic Cancer
  • Kidney Cancer (Renal Cell)
  • Liver Cancer
  • Lung Cancer
  • Ovarian Cancer
  • Urologic Cancer
  • Participation Institution:

  • UF Gainesville : Marlene Sarmiento
  • Contact:
    Marlene Sarmiento, RN
    Phone: +1 352-265-0680 ext. 50704
    Email: msarmien@ufl.edu

    More Information: View study listing on ClinicialTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT03126110