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Soluble LAG-3 Fusion Protein
Eftilagimod Alpha + Pembrolizumab for Head and Neck Cancer (TACTI-003 Trial)
Phase 2
Waitlist Available
Research Sponsored by Immutep S.A.S.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Availability of PD-L1 biomarker result by using the FDA approved Dako standardized diagnostic test (PD-L1 IHC 22C3 pharmDx).
Histologically- or cytologically-confirmed recurrent disease not amenable to curative treatment with local or systemic therapy, or metastatic (disseminated) HNSCC of the oral cavity, oropharynx, hypopharynx, or larynx that is considered incurable by local therapies and to be treated in the first line palliative setting and who are PD-X naïve.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
TACTI-003 Trial Summary
This trial is testing a new drug combination to see if it is more effective than just one of the drugs alone, for people with a certain type of cancer.
Who is the study for?
This trial is for adults with recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) that can't be cured by surgery or other local treatments. They must have a certain level of PD-L1 protein in their tumors, good physical health (ECOG 0-1), and no prior systemic cancer treatment for the recurrent/metastatic disease. People with brain metastases stable after treatment may join.Check my eligibility
What is being tested?
The study tests Eftilagimod alpha combined with Pembrolizumab versus Pembrolizumab alone in treating HNSCC. It aims to see if adding Eftilagimod improves outcomes for patients whose tumors express different levels of the PD-L1 protein.See study design
What are the potential side effects?
Possible side effects include immune-related reactions such as inflammation in various organs, skin rash, fatigue, flu-like symptoms, hormonal gland problems, and infusion-related reactions from either drug.
TACTI-003 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has been tested for PD-L1 using an FDA-approved method.
Select...
My head or neck cancer has returned or spread and cannot be cured with treatment.
Select...
I can carry out all my daily activities without help.
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I can provide a tissue sample for PD-L1 testing.
TACTI-003 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
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) according to RECIST1.1
Secondary outcome measures
Disease control rate according to iRECIST and RECIST 1.1
Duration of (serious) adverse events
Frequency of (serious) adverse events
+7 moreOther outcome measures
Circulating level of TH1 biomarker
Correlation of biomarkers or other characteristics with any efficacy or safety endpoint
PD-L1 expression
TACTI-003 Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: (CPS ≥1): Pembro + EftiExperimental Treatment2 Interventions
Eftilagimod 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).
Group II: (CPS <1): Pembro + EftiExperimental Treatment2 Interventions
Eftilagimod 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).
Group III: (CPS ≥1): PembroActive Control1 Intervention
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
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Immutep S.A.S.Lead Sponsor
11 Previous Clinical Trials
1,520 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,400 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has been tested for PD-L1 using an FDA-approved method.My head or neck cancer has returned or spread and cannot be cured with treatment.I have previously been treated with specific immune system targeting drugs.I can carry out all my daily activities without help.I have stable brain metastases and haven't needed steroids for 14 days.I have had at least one treatment for my cancer after it came back or spread, but not within the last 6 months if it was part of a combined treatment approach for advanced but not spread cancer.I can provide a tissue sample for HPV testing for my throat cancer.My condition can be treated with the goal of curing it.My cancer is in the head or neck but not in areas the study specifies.I am not on high doses of steroids or other immune-weakening medicines.I can provide a tissue sample for PD-L1 testing.I haven't had cancer treatment or been in a trial for new treatments in the last 4 weeks.My head or neck cancer worsened within 6 months after treatment meant to cure it.
Research Study Groups:
This trial has the following groups:- Group 1: (CPS ≥1): Pembro + Efti
- Group 2: (CPS <1): Pembro + Efti
- Group 3: (CPS ≥1): Pembro
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any patients who can still participate in this research?
"Yes, according to the latest information from clinicaltrials.gov, this trial is still looking for patients. The original posting was on 8/27/2021, and it has been updated as recently as 9/15/2022. They are hoping to enroll 154 participants at 3 locations."
Answered by AI
Pembrolizumab has caused serious side effects in some people, correct?
"Pembrolizumab's efficacy has not been clinically proven, but it did receive a score of 2 due to data supporting its safety profile."
Answered by AI
What other scientific papers involving Pembrolizumab have been published?
"City of Hope first studied pembrolizumab in 2010 and, since then, 253 similar trials have completed. As of now, there are 1002 ongoing clinical trials--a majority of which are based in Birmingham, Alabama."
Answered by AI
How many people fit the criteria to participate in this clinical trial?
"The listing on clinicaltrials.gov does show that this research is looking for participants. According to the site, the trial was first posted on 8/27/2021 and updated on 9/15/2022. They need 154 individuals from 3 different locations."
Answered by AI
For what sorts of medical conditions is Pembrolizumab generally prescribed?
"Pembrolizumab is most often administered to patients with malignant neoplasms. It can also help those suffering from unresectable melanoma, microsatellite instability high, and disease progression after chemotherapy."
Answered by AI
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