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IDO1 Inhibitor

Epacadostat for Head and Neck Squamous Cell Carcinoma

Phase 2
Waitlist Available
Research Sponsored by Chase Heaton, MD
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 up to 36 months
Awards & highlights

Study Summary

This study is evaluating whether a combination of three different treatments may be more effective than a single treatment for individuals with a specific type of cancer.

Eligible Conditions
  • Head and Neck Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 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
Best Overall Response Rate
Secondary outcome measures
Clinical Benefit Rate (CBR)
Disease Control Rate (DCR)
Median Duration of Response
+4 more

Side effects data

From 2020 Phase 3 trial • 93 Patients • NCT03361865
33%
Anaemia
23%
Diarrhoea
23%
Rash
23%
Pruritus
21%
Asthenia
19%
Malignant neoplasm progression
16%
Back pain
16%
Constipation
14%
Nausea
14%
Fatigue
12%
Dyspnoea
12%
Urinary tract infection
12%
Blood creatinine increased
12%
Decreased appetite
12%
Hypoalbuminaemia
12%
Pyrexia
9%
Lipase increased
9%
Amylase increased
9%
Aspartate aminotransferase increased
9%
Cough
9%
Hypocalcaemia
9%
Pneumonitis
9%
Haematuria
9%
Vomiting
9%
Alanine aminotransferase increased
7%
Arthralgia
7%
Creatinine renal clearance decreased
7%
Hyperuricaemia
7%
Insomnia
7%
Oedema peripheral
7%
Dysuria
7%
Hyperkalaemia
7%
Hypothyroidism
7%
Pneumonia
7%
Weight decreased
5%
Urosepsis
5%
Abdominal pain
5%
Blood alkaline phosphatase increased
5%
Device occlusion
5%
Pain in extremity
2%
Hypophysitis
2%
Renal impairment
2%
Urticaria
2%
Musculoskeletal pain
2%
Death
2%
Encephalitis
2%
Hepatitis
2%
Left ventricular dysfunction
2%
Lymph gland infection
2%
Nephropathy toxic
2%
Pneumocystis jirovecii pneumonia
2%
Renal failure
2%
Small intestinal obstruction
2%
Somnolence
2%
Supraventricular tachycardia
2%
Urinary tract stoma complication
2%
Herpes zoster
2%
Flank pain
2%
Septic shock
2%
Gastroenteritis
2%
Hypercalcaemia
2%
Lung neoplasm malignant
2%
Pneumothorax
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab 200 mg + Epacadostat 100 mg BID
Pembrolizumab 200 mg + Placebo BID
Total

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm C: Tavo-EP, pembrolizumab, CORVaxExperimental Treatment4 Interventions
Tavo-EP will be injected intratumorally on Days 1, 5 and 8 every 6 weeks to up to 7 accessible lesions without exceeding 20 mL per day. Injected lesions will then be electroporated using the ImmunoPulse electroporation device. Pembrolizumab will be administered by a 30-minute IV infusion at a dose of 200 mg every 3 weeks. CORVax will be administered at a total dose of 0.2 mg of (S) protein plasmid in 120 microliter (uL) per lesion intratumorally into a maximum of 4 lesions of at least 0.3 mm in diameter for a total plasmid dose of 0.8 mg on treatment days 1 and 29 of cycle 1 followed by electroporation of the plasmid solution in infiltrated regions. On days when both tavo and CORVax is administered to the same lesions, tavo and CORVax will each be injected into the lesion followed by electroporation.
Group II: Arm B: Tavo-EP, pembrolizumabExperimental Treatment3 Interventions
Tavo-EP will be injected intratumorally on Days 1, 5 and 8 every 6 weeks to up to 7 accessible lesions without exceeding 20 mL per day. Injected lesions will then be electroporated using the ImmunoPulse electroporation device. Pembrolizumab will be administered by a 30 minute IV infusion at a dose of 200 mg every 3 weeks.
Group III: Arm A: Tavo-EP, pembrolizumab, epacadostatExperimental Treatment4 Interventions
Tavo-EP will be injected intratumorally on Days 1, 5 and 8 every 6 weeks to up to 7 accessible lesions without exceeding 20 mL per day. Injected lesions will then be electroporated using the ImmunoPulse electroporation device. Pembrolizumab will be administered by a 30 minute IV infusion at a dose of 200 mg every 3 weeks. Epacadostat will be administered at the dose level determined in the dose escalation safety lead-in.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Epacadostat
2018
Completed Phase 3
~1080
Pembrolizumab
2017
Completed Phase 2
~2010
CORVax
2020
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

Chase Heaton, MDLead Sponsor
Incyte CorporationIndustry Sponsor
364 Previous Clinical Trials
55,151 Total Patients Enrolled
OncoSec Medical IncorporatedIndustry Sponsor
10 Previous Clinical Trials
347 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
Optimizing Antitumor Immunity Using Plasmid Electroporation, Pembrolizumab, and Epacadostat
Chase Heaton, MD 2019. "Optimizing Antitumor Immunity Using Plasmid Electroporation, Pembrolizumab, and Epacadostat". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03823131.
~2 spots leftby Apr 2025
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