NCT05359692

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).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

17 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 4, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2025

Completed
Last Updated

September 15, 2023

Status Verified

September 1, 2023

Enrollment Period

1.1 years

First QC Date

April 29, 2022

Last Update Submit

September 14, 2023

Conditions

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

Keywords

carcinomacarcinoma, squamous cellsquamous cell carcinoma of head and neckanti-PD-(L)1 therapyHNSCCSCCHN

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Duration of response (DOR) based on RECIST v1.1 and mRECIST

    Assessed every 8 weeks for 12 months, then every 12 weeks, up to 24 months.

  • Disease control rate (DCR) based on RECIST v1.1 and mRECIST

    Assessed every 8 weeks for 12 months, then every 12 weeks, up to 24 months.

  • Progression-free survival (PFS) based on RECIST v1.1 and mRECIST

    Assessed every 8 weeks for 12 months, then every 12 weeks, up to 24 months.

  • Part 2: Participants With Treatment-Emergent Adverse Events (TEAEs)

    Screening through 90 days after end of treatment, up to 24 months

Study Arms (4)

Part 1: Cohort 1

EXPERIMENTAL

INCAGN01876 every 2 weeks (Q2W) with retifanlimab every 4 weeks (Q4W).

Biological: INCAGN01876Biological: retifanlimab

Part 1: Cohort 2

EXPERIMENTAL

INCAGN01876 Q2W with retifanlimab Q4W.

Biological: INCAGN01876Biological: retifanlimab

Part 2 (Expansion): Treatment Group A

EXPERIMENTAL

INCAGN01876 and retifanlimab combination in participants who have been previously treated with anti-PD-(L)1 therapy.

Biological: INCAGN01876Biological: retifanlimab

Part 2 (Expansion): Treatment Group B

EXPERIMENTAL

INCAGN01876 and retifanlimab combination in participants who are naive to anti-PD-(L)1 therapy.

Biological: INCAGN01876Biological: retifanlimab

Interventions

INCAGN01876BIOLOGICAL

INCAGN1876 will be adminstered via IV at at the protocol-defined dose and schedule according to cohort and treatment group enrollment.

Part 1: Cohort 1Part 1: Cohort 2Part 2 (Expansion): Treatment Group APart 2 (Expansion): Treatment Group B
retifanlimabBIOLOGICAL

retifanlimab will be administered via IV Q4W

Part 1: Cohort 1Part 1: Cohort 2Part 2 (Expansion): Treatment Group APart 2 (Expansion): Treatment Group B

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 may not qualify 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Uab Medicine-the Kirklin Clinic

Birmingham, Alabama, 35233, United States

Location

University of California San Diego Medical Center, Moores Cancer Center

La Jolla, California, 92093, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

Toi Clinical Research

Whittier, California, 90603, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

University of Kansas Cancer Center

Westwood, Kansas, 66205, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40202, United States

Location

University of Maryland-Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

John Theurer Cancer Center, Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Mount Sinai Prime

New York, New York, 10029, United States

Location

University of Cincinnati Cancer Institute

Cincinnati, Ohio, 45219, United States

Location

Providence Portland Med. Ctr

Portland, Oregon, 97213, United States

Location

Md Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

The Adult Outpatient Pavilion At Vcu

Richmond, Virginia, 23219, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and NeckCarcinomaCarcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasms, Squamous Cell

Study Officials

  • Nawel Bourayou, MD

    Incyte Corporation

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
open-label study
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2022

First Posted

May 4, 2022

Study Start

March 1, 2023

Primary Completion

April 20, 2024

Study Completion

January 11, 2025

Last Updated

September 15, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Access Criteria
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
More information

Locations

US(17)