Eftilagimod alpha for Oral Squamous Cell Carcinoma

Phase-Based Estimates
1
Effectiveness
2
Safety
AZ Nikolaas, Sint-Niklaas, Belgium
Oral Squamous Cell Carcinoma+1 More
Eftilagimod alpha - Drug
Eligibility
18+
All Sexes
Eligible conditions
Oral Squamous Cell Carcinoma

Study Summary

This study is evaluating whether a drug called eftilagimod alpha can be used to treat head and neck cancer.

See full description

Eligible Conditions

  • Oral Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of Head and Neck
  • HNSCC

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Eftilagimod alpha will improve 1 primary outcome, 10 secondary outcomes, and 3 other outcomes in patients with Oral Squamous Cell Carcinoma. Measurement will happen over the course of At Screening: three weeks prior to cycle 1 day 1.

Day 1
PD-L1 expression
Up to 24 months
Circulating level of TH1 biomarker
Correlation of biomarkers or other characteristics with any efficacy or safety endpoint
Disease control rate according to iRECIST and RECIST 1.1
Duration of (serious) adverse events
Frequency of (serious) adverse events
Objective response rate (ORR) according to RECIST1.1
Objective response rate (ORR) according to iRECIST
Occurrence of anti-efti-specific antibodies
Overall survival (OS)
Progression free survival (PFS) according to iRECIST and RECIST 1.1
Quality of Life using EORTC QLQ-H&N35
Severity of (serious) adverse events
Time to and duration of responses according to iRECIST and RECIST 1.1

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

3 Treatment Groups

(CPS ≥1): Pembro
(CPS <1): Pembro + Efti

This trial requires 154 total participants across 3 different treatment groups

This trial involves 3 different treatments. Eftilagimod Alpha is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

(CPS <1): Pembro + EftiEftilagimod alpha: 30 mg every 2 weeks for the first 4 cycles;thereafter every 3 weeks for up to 18 cycles(1 cycle = 6 weeks). Pembrolizumab: 400 mg every 6 weeks for up to 18 cycles (1 cycle = 6 weeks).
(CPS ≥1): Pembro + EftiEftilagimod alpha: 30 mg every 2 weeks for the first 4 cycles;thereafter every 3 weeks for up to 18 cycles(1 cycle = 6 weeks). Pembrolizumab: 400 mg every 6 weeks for up to 18 cycles (1 cycle = 6 weeks).
(CPS ≥1): Pembro
Drug
Pembrolizumab: 400 mg every 6 weeks for up to 18 cycles (1 cycle = 6 weeks).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 24 months for reporting.

Closest Location

University of Alabama at Birmingham (UAB) - O'Neal Cancer Center - Birmingham, AL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Oral Squamous Cell Carcinoma or the other condition listed above. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The text states that tissue for PD-L1 biomarker analysis can be obtained from a core or excisional biopsy. show original
HNSCC that is recurrent and has not been cured with local or systemic treatment, or that has metastasized and is considered incurable, may be treated with palliative care show original
The study found that HPV DNA was present in 73% of oropharyngeal cancer tumors, with a higher prevalence in tumors associated with HPV16 (88%) than those associated with any other HPV type show original
Main
The Dako PD-L1 IHC 22C3 pharmDx test is a FDA approved test that can determine the level of PD-L1 expression in a tumor. show original
ECOG performance status 0-1.

Patient Q&A Section

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

Is eftilagimod alpha safe for people?

Add answer

When given in a subcutaneous formulation, eftilagimod alpha is safe and well-tolerated when given across a broad spectrum of conditions. Given the favorable PK/PD profile, the risk of a SAE in people is low.

Unverified Answer

Have there been other clinical trials involving eftilagimod alpha?

Add answer

Although all patients with oral squamous cell carcinoma need to be evaluated and treated on a case-by-case basis, there may be opportunities for routine assessment, monitoring and treatment with eftilagimod alpha in cases of oral squamous cell carcinoma.

Unverified Answer

What are the signs of oral squamous cell carcinoma?

Add answer

Oral and oropharyngeal squamous cell carcinomas are often accompanied by erythema nodosum-like conditions, and this is thought to be associated with increased recurrence rates and a higher incidence of lymph node invasion.

Unverified Answer

Can oral squamous cell carcinoma be cured?

Add answer

The vast majority of patients undergoing treatment for advanced OSCC have complete (95%) responses to the treatment regimen. The authors conclude that OSCC can be cured if treatment is provided early and intensively.

Unverified Answer

What are common treatments for oral squamous cell carcinoma?

Add answer

There is only limited evidence available regarding the use of these various modes of treatment for OSCC and future clinical research is needed to identify the best treatment for this prevalent disease.

Unverified Answer

What is oral squamous cell carcinoma?

Add answer

The disease is one that causes abnormal bleeding in the mouth of an individual or a group of people and is often asymptomatic. The tumour in the mouth was first described in the 17th Century and has a poorer prognosis than other forms of oral cancer. However, the tumour is not the only form of cancer that occurs in this region of the body and is often metastasized and often lethal from disease present in the skin and lungs.

Unverified Answer

How many people get oral squamous cell carcinoma a year in the United States?

Add answer

About 30,000 new cases are diagnosed annually in the United States. The incidence of oral cancer is higher in blacks than in whites. The lifetime risk of getting oral cancer is similar for whites and blacks.

Unverified Answer

What causes oral squamous cell carcinoma?

Add answer

This is the largest pooled analysis to date comparing oral SCC and oral AKA OEDC with respect to risk factors, histologic subtype, and clinical behaviors. Significant factors include smoking and HPV, but age and gender are the strongest risk factors. The combination of HPV and smoking increase the risk of developing high-grade OEDC.

Unverified Answer

What is the latest research for oral squamous cell carcinoma?

Add answer

Oral SCC remains a serious and growing health and economic burden in the United States. It is necessary for oral surgeons to keep up with the latest research information on oral SCC to remain current in their field. This article describes the latest research findings in oral cancers.

Unverified Answer

What are the common side effects of eftilagimod alpha?

Add answer

The most common safety finding was a change in the pattern of reported dermatologic conditions during the course of treatment. Other reported side effects included headache, fatigue, nausea, vomiting, diarrhea, and constipation. The incidence of adverse dermatologic effects was similar to previous studies of eftilagimod alpha treatment. There were no clinically meaningful changes in circulating immunoglobulin M, eosinophil cationic protein plasma levels, or C-reactive protein at the end of treatment. Results from a recent clinical trial suggest that eftilagimod alpha does not interact with circulating immunoglobulin M, eosinophil cationic protein, or C-reactive protein, or interfere with these circulating analytes.

Unverified Answer

Have there been any new discoveries for treating oral squamous cell carcinoma?

Add answer

There have been no newly discovered therapies for treating oral squamous cell carcinoma, and new drugs for treating the disease might be discovered only in the future. It is worthwhile to consider the possibility of treatments developed for other types of cancer in the future.

Unverified Answer

Has eftilagimod alpha proven to be more effective than a placebo?

Add answer

EFT is not more effective than a placebo in the treatment of ASCC. Additional studies are required to evaluate its effectiveness before it can be recommended as a viable alternative to platinum-based regimens.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Oral Squamous Cell Carcinoma by sharing your contact details with the study coordinator.