Summary

Eligibility
for people ages 18-99 (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

Summary

The purpose of this study is to determine the safety, tolerability, efficacy, PK and pharmacodynamics of INCAGN01876 when given in combination with retifanlimab. The study will consist of 2 parts: a safety lead-in part (Part 1) followed by a dose expansion part (Part 2).

Official Title

Phase 2, Open-Label, Multicenter Study of INCAGN01876 in Combination With Immunotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Details

The purpose of this study is to determine the safety, tolerability, efficacy, PK and pharmacodynamics of INCAGN01876 when given in combination with retifanlimab in participants with GITR expression in recurrent or metastatic HNSCC who have progressed on or after prior systemic therapy including anti-PD-(L)1 therapy. The study will consist of 2 parts: a safety lead-in part (Part 1) followed by a dose expansion part (Part 2)

Keywords

Recurrent Cancer Metastatic Cancer Advanced Malignancies Head and Neck Squamous Cell Carcinoma carcinoma carcinoma, squamous cell squamous cell carcinoma of head and neck anti-PD-(L)1 therapy HNSCC SCCHN Recurrence INCAGN01876 retifanlimab

Eligibility

You can join if…

Open to people ages 18-99

  • Histologically or cytologically confirmed recurrent or metastatic HNSCC (oral cavity, oropharynx, hypopharynx, or larynx), that is not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy). Participants with squamous cell carcinomas of the nasopharynx, salivary gland, or nonsquamous cell histology are excluded.
  • Documented progression on or after PD-(L)1 inhibitor alone or in combination with platinum-based chemotherapy for recurrent or metastatic HNSCC. Exception: Treatment

Group B (Part 2, expansion): PD-(L)1-naïve.

  • ECOG performance status of 0 to 1.
  • Measurable disease based on RECIST v1.1.
  • Mandatory pre-treatment and on-treatment tumor biopsies.
  • GITR-positive tumor confirmed by central laboratory before study treatment start.
  • Willingness to avoid pregnancy or fathering children.

You CAN'T join if...

  • Have received chemotherapy, targeted small molecule therapy or curative radiation within 21 days of first dose of study drug; prior mAB for anticancer therapy other within 28 days of first dose of study drug; or investigational study drugs or devices within 28 days or five half-lives prior to enrollment unless approved by medical monitor.
  • Prior treatment with any TNF Super Family agonist therapy.
  • Have not recovered to ≤ Grade 1 from toxic effects of prior therapy.
  • Laboratory and medical history parameters not within the Protocol-defined range before the first administration of study treatment.

Known active HBV or HCV, or Known to be seropositive for HIV.

  • Have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
  • Have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
  • Known active infections requiring systemic treatment.

Locations

  • University of California San Diego Medical Center, Moores Cancer Center not yet accepting patients
    La Jolla California 92093 United States
  • University of Utah not yet accepting patients
    Salt Lake City Utah 84112 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Incyte Biosciences International Sàrl
ID
NCT05359692
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 47 study participants
Last Updated