Clinical trial NCT05359692: INCAGN01876 in Combination With Immunotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Metastatic Head and Neck Squamous Cell Carcinoma
Advanced Malignancies
Recurrent Head and Neck Squamous Cell Carcinoma
Keywords: carcinoma
carcinoma, squamous cell
squamous cell carcinoma of head and neck
anti-PD-(L)1 therapy
HNSCC
SCCHN
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2022-05-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Detailed description: 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)

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Part 1: Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Screening through 90 days after end of treatment, up to 24 months
measure: Objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
timeFrame: Assessed every 8 weeks for 12 months, thereafter every 12 weeks up to the end of treatment, up to 24 months.
Secondary outcomes:
measure: Duration of response (DOR) based on RECIST v1.1 and mRECIST
timeFrame: Assessed every 8 weeks for 12 months, then every 12 weeks, up to 24 months.
measure: Disease control rate (DCR) based on RECIST v1.1 and mRECIST
timeFrame: Assessed every 8 weeks for 12 months, then every 12 weeks, up to 24 months.
measure: Progression-free survival (PFS) based on RECIST v1.1 and mRECIST
timeFrame: Assessed every 8 weeks for 12 months, then every 12 weeks, up to 24 months.
measure: Part 2: Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Screening through 90 days after end of treatment, up to 24 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Uab Medicine-the Kirklin Clinic
state: Alabama
city: La Jolla
country: United States
facility: University of California San Diego Medical Center, Moores Cancer Center
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Whittier
country: United States
facility: Toi Clinical Research
state: California
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Westwood
country: United States
facility: University of Kansas Cancer Center
state: Kansas
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland-Greenebaum Cancer Center
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Hackensack
country: United States
facility: John Theurer Cancer Center, Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Mount Sinai Prime
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati Cancer Institute
state: Ohio
city: Portland
country: United States
facility: Providence Portland Med. Ctr
state: Oregon
city: Houston
country: United States
facility: Md Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Richmond
country: United States
facility: The Adult Outpatient Pavilion At Vcu
state: Virginia
Study officials:
affiliation: Incyte Corporation
name: Nawel Bourayou, MD
role: STUDY_DIRECTOR
References: