Evorpacept for Head and Neck Squamous Cell Carcinoma (HNSCC)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Head and Neck Squamous Cell Carcinoma (HNSCC)+1 MoreEvorpacept - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a new drug, Evorpacept, in combination with pembrolizumab, to see if it is effective in treating patients with advanced head and neck squamous cell carcinoma.

Eligible Conditions
  • Head and Neck Squamous Cell Carcinoma (HNSCC)
  • Head and Neck Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Up to 36 months

Month 12
12-month overall survival rate
Week 24
Objective response rate per RECIST 1.1
Up to 36 months
Adverse events
Duration of response
Overall survival
Progression-free survival

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

Side Effects for

Pembrolizumab+EP
54%Neutropenia
45%Anaemia
38%Nausea
34%Alopecia
31%Decreased appetite
29%Constipation
27%Fatigue
26%Thrombocytopenia
22%Leukopenia
21%Diarrhoea
20%Cough
17%Asthenia
17%Dyspnoea
16%Vomiting
14%Pyrexia
14%Dizziness
13%Arthralgia
13%Rash
13%Headache
12%Hypothyroidism
11%Insomnia
11%Pruritus
11%Back pain
10%Weight decreased
9%Hyponatraemia
9%Aspartate aminotransferase increased
8%Oedema peripheral
8%Upper respiratory tract infection
8%Alanine aminotransferase increased
8%Pneumonia
7%Abdominal pain
7%Blood creatinine increased
7%Hypokalaemia
7%Febrile neutropenia
6%Abdominal pain upper
6%Stomatitis
6%Dysgeusia
6%Erythema
6%Dry skin
5%Hyperthyroidism
5%Dyspepsia
5%Dysphagia
5%Chest pain
5%Blood alkaline phosphatase increased
5%Musculoskeletal pain
5%Hypertension
5%Nasopharyngitis
5%Musculoskeletal chest pain
5%Pain in extremity
4%Urinary tract infection
4%Hypotension
2%Death
2%Acute kidney injury
2%Pneumonitis
2%Pulmonary embolism
2%Atrial fibrillation
1%Neutropenic sepsis
1%Inappropriate antidiuretic hormone secretion
1%Diabetes mellitus
1%Hemiparesis
1%Transient ischaemic attack
1%Superior vena cava syndrome
1%Pneumothorax
1%Gastritis
1%Aortic aneurysm
1%Sepsis
1%Pleural infection
1%Infusion related reaction
1%Clostridium difficile colitis
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab+EP ARM group. Side effects include: Neutropenia with 54%, Anaemia with 45%, Nausea with 38%, Alopecia with 34%, Decreased appetite with 31%.

Trial Design

2 Treatment Groups

Pembrolizumab
1 of 2
Evorpacept (ALX148) + Pembrolizumab
1 of 2

Active Control

Experimental Treatment

183 Total Participants · 2 Treatment Groups

Primary Treatment: Evorpacept · No Placebo Group · Phase 2

Evorpacept (ALX148) + PembrolizumabExperimental Group · 2 Interventions: Pembrolizumab, Evorpacept · Intervention Types: Drug, Drug
Pembrolizumab
Drug
ActiveComparator Group · 1 Intervention: Pembrolizumab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 36 months

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,676 Previous Clinical Trials
4,959,741 Total Patients Enrolled
ALX Oncology Inc.Lead Sponsor
8 Previous Clinical Trials
1,265 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
People with advanced head and neck squamous cell carcinoma (HNSCC) that is positive for the PD-L1 protein (CPS > 1) and who have not received prior systemic therapy for their advanced disease.
Having an ECOG performance status of 2 or less.
Bone marrow that is functioning correctly.
The patient needs to have good kidney and liver function in order to take this drug.