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Monoclonal Antibodies

INCAGN01876 for Head and Neck Squamous Cell Carcinoma

Phase 2
Waitlist Available
Research Sponsored by Incyte Biosciences International Sàrl
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening through 90 days after end of treatment, up to 24 months
Awards & highlights

Study Summary

This trial is testing a new drug, INCAGN01876, to see if it is safe and effective when given with retifanlimab. The trial will have two parts, with the first part testing safety and the second part expanding on the doses given.

Eligible Conditions
  • Head and Neck Squamous Cell Carcinoma
  • Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening through 90 days after end of treatment, up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening through 90 days after end of treatment, up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Part 1: Participants With Treatment-Emergent Adverse Events (TEAEs)
Secondary outcome measures
Disease control rate (DCR) based on RECIST v1.1 and mRECIST
Duration of response (DOR) based on RECIST v1.1 and mRECIST
Part 2: Participants With Treatment-Emergent Adverse Events (TEAEs)
+1 more

Side effects data

From 2021 Phase 1 & 2 trial • 145 Patients • NCT03126110
100%
Nausea
50%
Dizziness
50%
Oropharyngeal pain
50%
Oedema peripheral
50%
Hypercalcaemia
50%
Confusional state
50%
Fungal infection
50%
Hyperuricaemia
50%
Iridocyclitis
50%
Mucosal infection
50%
Musculoskeletal chest pain
50%
Pericardial effusion
50%
Vomiting
50%
Atelectasis
50%
Oesophageal candidiasis
50%
Tachycardia
50%
Decreased appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab
Phase 2 Group C2 PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg
Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg
Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg
Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg
Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg
Total

Trial Design

4Treatment groups
Experimental Treatment
Group I: Part 2 (Expansion): Treatment Group BExperimental Treatment2 Interventions
INCAGN01876 and retifanlimab combination in participants who are naive to anti-PD-(L)1 therapy.
Group II: Part 2 (Expansion): Treatment Group AExperimental Treatment2 Interventions
INCAGN01876 and retifanlimab combination in participants who have been previously treated with anti-PD-(L)1 therapy.
Group III: Part 1: Cohort 2Experimental Treatment2 Interventions
INCAGN01876 Q2W with retifanlimab Q4W.
Group IV: Part 1: Cohort 1Experimental Treatment2 Interventions
INCAGN01876 every 2 weeks (Q2W) with retifanlimab every 4 weeks (Q4W).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
INCAGN01876
2016
Completed Phase 2
~250
Retifanlimab
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Incyte Biosciences International SàrlLead Sponsor
14 Previous Clinical Trials
762 Total Patients Enrolled
Nawel Bourayou, MDStudy DirectorIncyte Corporation
1 Previous Clinical Trials
40 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the desired outcome of this trial?

"This clinical trial aims to observe the Objective response rate (ORR) of patients based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 over 90 days post-intervention, up to 24 months. Secondary endpoints include a Part 2: Participants With Treatment-Emergent Adverse Events (TEAEs), Progression-free survival (PFS) and Duration of response (DOR). TEAE is defined as any adverse event reported for the first time or worsening of an existing condition after initial treatment, PFS is measured from start of combination therapy until disease progression or death due to any cause"

Answered by AI

To whom does the eligibility criteria of this trial apply?

"The current recruitment process is seeking 47 individuals aged between 18 – 99 years old with recurrent cancer. To be eligible, patients must have histopathologically or cytologically confirmed advanced head and neck squamous cell carcinoma (HNSCC), that doesn't meet the criteria for curative intent local therapy (surgery or radiation in combination with chemotherapy). Furthermore, those who are PD-(L)1 inhibitor naive and have a performance status of 0-1 according to Eastern Cooperative Oncology Group scale should qualify. Additionally, applicants will need proof of measurable disease via RECIST v1.1., pre-treatment/on-treatment tumor bi"

Answered by AI

Has the FDA granted clearance for INCAGN01876?

"While no clinical data exists that assesses INCAGN01876's efficacy, there is evidence to suggest its safety and as such it was assigned a score of 2."

Answered by AI

Is this research endeavor currently recruiting participants?

"Indeed, the clinical trial is currently searching for 47 participants who will be drawn from 18 different healthcare facilities. The initial post date of this study was November 15th 2022 and it has been modified since then."

Answered by AI

How many participants are currently eligible for this clinical research study?

"Correct. The clinical trial is still recruiting, with information posted on clinicaltrials.gov to confirm this fact. It was first published on November 15th 2022 and the same date marks its last update - 47 participants are needed across 18 sites."

Answered by AI

Does the research encompass persons of advanced age?

"This clinical trial is restricted to patients between the ages of 18-99. There are 238 trials available for individuals under 18 and 3491 studies accessible to those above 65 years old."

Answered by AI

Are there a large number of healthcare facilities conducting this research trial in North America?

"This medical trial is being conducted in multiple sites across the United States, including Md Anderson Cancer Center located in Houston Texas, The Adult Outpatient Pavilion At Vcu situated in Richmond Virginia and Innovative Clinical Research Institute established in Lakewood California. In addition to these three locations there are 18 other clinical research centres participating."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
INCAGN01876 in Combination With Immunotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
2023. "INCAGN01876 in Combination With Immunotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05359692.
~0 spots leftby Apr 2025
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