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Monoclonal Antibodies

Enoblituzumab for Head and Neck Cancers

Phase 2
Waitlist Available
Research Sponsored by MacroGenics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically proven, recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) not curable by local therapy
Willing to consent for baseline and on-treatment biopsy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up prior to treatment (baseline) and at the beginning of every 3-week cycle of treatment (post baseline) up to 16.5 months
Awards & highlights

Study Summary

This trial is testing a new cancer treatment consisting of two drugs, enoblituzumab and either retifanlimab or tebotelimab. The treatment will be given to patients with a certain type of head and neck cancer that has returned or spread.

Eligible Conditions
  • Head and Neck Cancers
  • Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~tumor assessment is conducted 6 weeks after first dose, then every 9 weeks until disease progression, up to 16.5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and tumor assessment is conducted 6 weeks after first dose, then every 9 weeks until disease progression, up to 16.5 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
Number of Patients With Adverse Events (AEs) Receiving Enoblituzumab Plus Tebotelimab
ORR of Enoblituzumab Plus Tebotelimab
Overall Response Rate (ORR) of Enoblituzumab Plus Retifanlimab
Secondary outcome measures
Best Overall Response (BOR)
Disease-control Rate (DCR)
Duration of Response
+12 more

Side effects data

From 2022 Phase 1 trial • 3 Patients • NCT04630769
100%
Investigations - Other, specify
100%
Abdominal pain
100%
Infections and infestations - Other,
100%
Nausea
100%
Skin infection
100%
Blood and lymphatic system disorders - Other, specify
100%
Lymphocyte count decreased
100%
White blood cell decreased
100%
Thromboembolic event
100%
Anemia
100%
Blood lactate dehydrogenase increased
100%
Abdominal distension
100%
Small intestinal obstruction
100%
Anorexia
100%
Diarrhea
100%
Vomiting
100%
Sore throat
100%
Dyspepsia
100%
Constipation
100%
General disorders and administration site conditions - Other, specify
100%
Hepatobiliary disorders - Other, specify
100%
Hypocalcemia
100%
Neutrophil count decreased
100%
Hypoalbuminemia
100%
Renal and urinary disorders - Other, specify
100%
Proteinuria
100%
Edema limbs
100%
Fatigue
100%
Urinary tract infection
100%
Hypomagnesemia
100%
Hyponatremia
100%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Monotherapy: IP FT516 at 9 x 10^7 Cells/Dose on Day 1, 8, and 15
Monotherapy: IP FT516 at 9 x 10^8 Cells/Dose on Day 1, 8, and 15
Monotherapy: IP FT516 at 3 x 10^8 Cells/Dose on Day 1, 8, and 15

Trial Design

2Treatment groups
Experimental Treatment
Group I: Tebotelimab CohortExperimental Treatment2 Interventions
Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks for up to 35 cycles
Group II: Retifanlimab CohortExperimental Treatment2 Interventions
Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks for up to 35 cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enoblituzumab
2021
Completed Phase 1
~180
Retifanlimab
2018
Completed Phase 2
~320

Find a Location

Who is running the clinical trial?

MacroGenicsLead Sponsor
48 Previous Clinical Trials
5,032 Total Patients Enrolled
Chet Bohac, MD, PharmD, MScStudy DirectorMacroGenics
Chet Bohac, MD PharmD MScStudy DirectorMacroGenics
2 Previous Clinical Trials
303 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Enoblituzumab Plus Retifanlimab or Tebotelimab in Head and Neck Cancer
2021. "Enoblituzumab Plus Retifanlimab or Tebotelimab in Head and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04634825.
~15 spots leftby Apr 2025
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