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INCAGN01876 in Combination With Immunotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

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

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

NCT05359692•Incyte Biosciences International Sàrl

View on ClinicalTrials.gov

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

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

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.

Locations (17)

Uab Medicine-the Kirklin Clinic

Birmingham, Alabama, United States

University of California San Diego Medical Center, Moores Cancer Center

La Jolla, California, United States

Stanford University

Palo Alto, California, United States

Toi Clinical Research

Whittier, California, United States

University of Chicago

Chicago, Illinois, United States

University of Kansas Cancer Center

Westwood, Kansas, United States

Norton Cancer Institute

Louisville, Kentucky, United States

University of Maryland-Greenebaum Cancer Center

Baltimore, Maryland, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Key Dates

Start Date

March 1, 2023

Primary Completion Date

April 20, 2024

Completion Date

January 11, 2025

Last Updated

September 15, 2023

Conditions

Metastatic Head and Neck Squamous Cell CarcinomaAdvanced MalignanciesRecurrent Head and Neck Squamous Cell Carcinoma

Interventions

INCAGN01876

BIOLOGICAL

retifanlimab

BIOLOGICAL

Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer

NCT06980038

Head and Neck Squamous Cell CarcinomaHypopharyngeal Squamous Cell Carcinoma+20 more

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RECRUITINGPHASE1/PHASE2

BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)

NCT04752826

Advanced MalignanciesOvarian Cancer+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 15, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer

BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)

Lovastatin and Pembrolizumab for the Treatment of Patients With Recurrent or Metastatic Head and Neck Cancer, LAPP Trial

Combining Immunotherapy Salvage Surgery & IORT Tx Persistent/Recurrent Head & Neck Cancer

Study to Assess Safety, Tolerability and Activity of DSB2455 in Participants With Advanced Malignancies

A Study of ASP-1929 Photoimmunotherapy in Combination With Pembrolizumab in First-line Treatment of Locoregional Recurrent Squamous Cell Carcinoma of the Head and Neck With No Distant Metastases