INCAGN01876 in Combination With Immunotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Advanced Malignancies Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05359692
• Other study ID #: INCAGN 1876-204
• Status: Withdrawn
• Phase: Phase 2
• Start date: March 1, 2023
• Est. completion date: January 11, 2025

Study information

• Verified date: September 2023
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 11, 2025
• Est. primary completion date: April 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Malignancies
• Carcinoma
• Carcinoma, Squamous Cell
• Metastatic Head and Neck Squamous Cell Carcinoma
• Recurrence
• Recurrent Head and Neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Biological:
• INCAGN01876
INCAGN1876 will be adminstered via IV at at the protocol-defined dose and schedule according to cohort and treatment group enrollment.
• retifanlimab
retifanlimab will be administered via IV Q4W

Locations

Country	Name	City	State
United States	University of Maryland-Greenebaum Cancer Center	Baltimore	Maryland
United States	Uab Medicine-the Kirklin Clinic	Birmingham	Alabama
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	University of Chicago	Chicago	Illinois
United States	University of Cincinnati Cancer Institute	Cincinnati	Ohio
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	John Theurer Cancer Center, Hackensack University Medical Center	Hackensack	New Jersey
United States	Md Anderson Cancer Center	Houston	Texas
United States	University of California San Diego Medical Center, Moores Cancer Center	La Jolla	California
United States	Norton Cancer Institute	Louisville	Kentucky
United States	Mount Sinai Prime	New York	New York
United States	Stanford University	Palo Alto	California
United States	Providence Portland Med. Ctr	Portland	Oregon
United States	The Adult Outpatient Pavilion At Vcu	Richmond	Virginia
United States	University of Utah	Salt Lake City	Utah
United States	University of Kansas Cancer Center	Westwood	Kansas
United States	Toi Clinical Research	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Biosciences International Sàrl

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: Participants With Treatment-Emergent Adverse Events (TEAEs)	A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after the first dose of study treatment.	Screening through 90 days after end of treatment, up to 24 months
Primary	Objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1	Defined as the percentage of participants having complete response (CR) or partial response (PR).	Assessed every 8 weeks for 12 months, thereafter every 12 weeks up to the end of treatment, up to 24 months.
Secondary	Duration of response (DOR) based on RECIST v1.1 and mRECIST	Defined as the time from the earliest date of disease response (CR or PR) until earliest date of disease progression or death due to any cause.	Assessed every 8 weeks for 12 months, then every 12 weeks, up to 24 months.
Secondary	Disease control rate (DCR) based on RECIST v1.1 and mRECIST	Defined as the percentage of participants having CR, PR, or stable disease (SD).	Assessed every 8 weeks for 12 months, then every 12 weeks, up to 24 months.
Secondary	Progression-free survival (PFS) based on RECIST v1.1 and mRECIST	Defined as the time from the start of combination therapy until the earliest date of disease progression or death due to any cause.	Assessed every 8 weeks for 12 months, then every 12 weeks, up to 24 months.
Secondary	Part 2: Participants With Treatment-Emergent Adverse Events (TEAEs)	A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after the first dose of study treatment.	Screening through 90 days after end of treatment, up to 24 months