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Metastatic Head and Neck Squamous Cell CarcinomaPhase 2NCT05359692

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

A Phase 2 study testing INCAGN01876 and retifanlimab in people with Metastatic Head and Neck Squamous Cell Carcinoma and Advanced Malignancies, run by Incyte Biosciences International Sàrl at 17 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
INCAGN01876 and retifanlimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
17 sitesUnited States
Study dates
1 Mar 2023to 11 Jan 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • University of Maryland-Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Uab Medicine-the Kirklin Clinic

    Birmingham, Alabama, 35233

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • University of Chicago

    Chicago, Illinois, 60637

  • University of Cincinnati Cancer Institute

    Cincinnati, Ohio, 45219

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • John Theurer Cancer Center, Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Md Anderson Cancer Center

    Houston, Texas, 77030

  • University of California San Diego Medical Center, Moores Cancer Center

    La Jolla, California, 92093

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

  • Mount Sinai Prime

    New York, New York, 10029

  • Stanford University

    Palo Alto, California, 94304

  • Providence Portland Med. Ctr

    Portland, Oregon, 97213

  • The Adult Outpatient Pavilion At Vcu

    Richmond, Virginia, 23219

  • University of Utah

    Salt Lake City, Utah, 84112

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205

  • Toi Clinical Research

    Whittier, California, 90603

Other trials in United States

About this study

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

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).

Read the 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)

Being tested
INCAGN01876, retifanlimab
Keywords
carcinoma, carcinoma, squamous cell, squamous cell carcinoma of head and neck, anti-PD-(L)1 therapy, HNSCC, SCCHN
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Carcinoma, Carcinoma, Squamous Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INCAGN01876Biological

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

  • retifanlimabBiological

    retifanlimab will be administered via IV Q4W

Study groups in NCT05359692
Study groupRoleWhat they receive
Part 1: Cohort 1ExperimentalINCAGN01876 every 2 weeks (Q2W) with retifanlimab every 4 weeks (Q4W).
Receives: Biological: INCAGN01876; Biological: retifanlimab
Part 1: Cohort 2ExperimentalINCAGN01876 Q2W with retifanlimab Q4W.
Receives: Biological: INCAGN01876; Biological: retifanlimab
Part 2 (Expansion): Treatment Group AExperimentalINCAGN01876 and retifanlimab combination in participants who have been previously treated with anti-PD-(L)1 therapy.
Receives: Biological: INCAGN01876; Biological: retifanlimab
Part 2 (Expansion): Treatment Group BExperimentalINCAGN01876 and retifanlimab combination in participants who are naive to anti-PD-(L)1 therapy.
Receives: Biological: INCAGN01876; Biological: retifanlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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).

    Measured: Assessed every 8 weeks for 12 months, thereafter every 12 weeks up to the end of treatment, up to 24 months.

Secondary outcomes (4)

  1. 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.

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

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

    Defined as the percentage of participants having CR, PR, or stable disease (SD).

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

  3. 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.

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

  4. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2022
  2. Study start1 Mar 2023 (estimated)
  3. Primary completion20 Apr 2024 (estimated)
  4. Study completion11 Jan 2025 (estimated)

Why it stopped: Business decision; no safety concerns

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05359692
Sponsor's protocol ID
INCAGN 1876-204
Status last verified
Sep 2023
First submitted
29 Apr 2022
Last updated
15 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing INCAGN01876 and retifanlimab in people with Metastatic Head and Neck Squamous Cell Carcinoma and Advanced Malignancies, run by Incyte Biosciences International Sàrl at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: Screening through 90 days after end of treatment, up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05359692.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.

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