Back to resultsINCAGN01876 in Combination With Immunotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Primary Purpose
Metastatic Head and Neck Squamous Cell Carcinoma, Advanced Malignancies, Recurrent Head and Neck Squamous Cell Carcinoma
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
INCAGN01876
retifanlimab
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Head and Neck Squamous Cell Carcinoma focused on measuring carcinoma, carcinoma, squamous cell, squamous cell carcinoma of head and neck, anti-PD-(L)1 therapy, HNSCC, SCCHN
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.
Sites / Locations
- Uab Medicine-the Kirklin Clinic
- University of California San Diego Medical Center, Moores Cancer Center
- Stanford University
- Toi Clinical Research
- University of Chicago
- University of Kansas Cancer Center
- Norton Cancer Institute
- University of Maryland-Greenebaum Cancer Center
- Dana Farber Cancer Institute
- Karmanos Cancer Institute
- John Theurer Cancer Center, Hackensack University Medical Center
- Mount Sinai Prime
- University of Cincinnati Cancer Institute
- Providence Portland Med. Ctr
- Md Anderson Cancer Center
- University of Utah
- The Adult Outpatient Pavilion At Vcu
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Part 1: Cohort 1
Part 1: Cohort 2
Part 2 (Expansion): Treatment Group A
Part 2 (Expansion): Treatment Group B
Arm Description
INCAGN01876 every 2 weeks (Q2W) with retifanlimab every 4 weeks (Q4W).
INCAGN01876 Q2W with retifanlimab Q4W.
INCAGN01876 and retifanlimab combination in participants who have been previously treated with anti-PD-(L)1 therapy.
INCAGN01876 and retifanlimab combination in participants who are naive to anti-PD-(L)1 therapy.
Outcomes
Primary Outcome Measures
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.
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).
Secondary Outcome Measures
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.
Disease control rate (DCR) based on RECIST v1.1 and mRECIST
Defined as the percentage of participants having CR, PR, or stable disease (SD).
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.
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.
Full Information
NCT ID
NCT05359692
First Posted
April 29, 2022
Last Updated
September 14, 2023
Sponsor
Incyte Biosciences International Sàrl
1. Study Identification
Unique Protocol Identification Number
NCT05359692
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Business decision; no safety concerns
Study Start Date
March 1, 2023 (Anticipated)
Primary Completion Date
April 20, 2024 (Anticipated)
Study Completion Date
January 11, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Biosciences International Sàrl
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
open-label study
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part 1: Cohort 1
Arm Type
Experimental
Arm Description
INCAGN01876 every 2 weeks (Q2W) with retifanlimab every 4 weeks (Q4W).
Arm Title
Part 1: Cohort 2
Arm Type
Experimental
Arm Description
INCAGN01876 Q2W with retifanlimab Q4W.
Arm Title
Part 2 (Expansion): Treatment Group A
Arm Type
Experimental
Arm Description
INCAGN01876 and retifanlimab combination in participants who have been previously treated with anti-PD-(L)1 therapy.
Arm Title
Part 2 (Expansion): Treatment Group B
Arm Type
Experimental
Arm Description
INCAGN01876 and retifanlimab combination in participants who are naive to anti-PD-(L)1 therapy.
Intervention Type
Biological
Intervention Name(s)
INCAGN01876
Intervention Description
INCAGN1876 will be adminstered via IV at at the protocol-defined dose and schedule according to cohort and treatment group enrollment.
Intervention Type
Biological
Intervention Name(s)
retifanlimab
Intervention Description
retifanlimab will be administered via IV Q4W
Primary Outcome Measure Information:
Title
Part 1: Participants With Treatment-Emergent Adverse Events (TEAEs)
Description
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.
Time Frame
Screening through 90 days after end of treatment, up to 24 months
Title
Objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Description
Defined as the percentage of participants having complete response (CR) or partial response (PR).
Time Frame
Assessed every 8 weeks for 12 months, thereafter every 12 weeks up to the end of treatment, up to 24 months.
Secondary Outcome Measure Information:
Title
Duration of response (DOR) based on RECIST v1.1 and mRECIST
Description
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.
Time Frame
Assessed every 8 weeks for 12 months, then every 12 weeks, up to 24 months.
Title
Disease control rate (DCR) based on RECIST v1.1 and mRECIST
Description
Defined as the percentage of participants having CR, PR, or stable disease (SD).
Time Frame
Assessed every 8 weeks for 12 months, then every 12 weeks, up to 24 months.
Title
Progression-free survival (PFS) based on RECIST v1.1 and mRECIST
Description
Defined as the time from the start of combination therapy until the earliest date of disease progression or death due to any cause.
Time Frame
Assessed every 8 weeks for 12 months, then every 12 weeks, up to 24 months.
Title
Part 2: Participants With Treatment-Emergent Adverse Events (TEAEs)
Description
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.
Time Frame
Screening through 90 days after end of treatment, up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nawel Bourayou, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Uab Medicine-the Kirklin Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of California San Diego Medical Center, Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Toi Clinical Research
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Kansas Cancer Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Maryland-Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
John Theurer Cancer Center, Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Mount Sinai Prime
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of Cincinnati Cancer Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Providence Portland Med. Ctr
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Md Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
The Adult Outpatient Pavilion At Vcu
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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
IPD Sharing Time Frame
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD Sharing 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.
IPD Sharing URL
https://www.incyte.com/our-company/compliance-and-transparency
Learn more about this trial
INCAGN01876 in Combination With Immunotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
We'll reach out to this number within 24 hrs