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Monoclonal Antibodies

Immunotherapy + Pembrolizumab for Head and Neck Cancer (BelieveIT-201 Trial)

Phase 2

Recruiting

Research Sponsored by Ascendis Pharma Oncology Division A/S

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 5 years

Awards & highlights

BelieveIT-201 Trial Summary

This trial will evaluate if two treatments and pembrolizumab can help people with head and neck cancer before surgery to reduce risk of recurrence and improve survival.

Who is the study for?

This trial is for adults with newly diagnosed, resectable Stage III/IVA head and neck squamous cell carcinoma. Participants must have a tumor suitable for surgery, adequate organ function, an ECOG performance status of 0 or 1, and no immunodeficiency or significant cardiac disease. They should not be on high-dose steroids or other immune-suppressing drugs.Check my eligibility

What is being tested?

The trial tests the safety and effectiveness of two experimental treatments (TransCon TLR7/8 Agonist with pembrolizumab in Arm A; TransCon TLR7/8 Agonist with TransCon IL-2 β/γ in Arm B) against pembrolizumab alone (Arm C). It includes a safety run-in phase followed by randomized comparison over up to two years post-surgery.See study design

What are the potential side effects?

Potential side effects may include reactions at the injection site, immune-related issues due to activation of the body's defense system by the drugs being tested, fatigue, flu-like symptoms from IL-2 stimulation, and complications related to pembrolizumab.

BelieveIT-201 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Major Pathological Response

Secondary outcome measures

Event Free Survival

Overall Survival

Pathological Complete Response

+1 more

BelieveIT-201 Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: TransCon TLR7/8 Agonist in combination with pembrolizumabExperimental Treatment2 Interventions

Participants receive 2 cycles, once every 3 weeks of TransCon TLR7/8 Agonist intratumoral (IT) injection in combination with pembrolizumab as a 30-minute intravenous (IV) infusion

Group II: TransCon TLR7/8 Agonist in combination with TransCon IL-2 β/γExperimental Treatment2 Interventions

Participants receive 2 cycles, once every 3 weeks of TransCon TLR7/8 Agonist (IT injection) in combination with TransCon IL-2 β/γ as a 30-minute IV infusion

Group III: PembrolizumabActive Control1 Intervention

Participants receive 2 cycles, once every 3 weeks of pembrolizumab alone as a 30-minute IV infusion

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ascendis Pharma Oncology Division A/SLead Sponsor

2 Previous Clinical Trials

613 Total Patients Enrolled

Joan MorrisStudy DirectorAscendis Pharma Oncology Division A/S

2 Previous Clinical Trials

280 Total Patients Enrolled

Frequently Asked Questions

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

What adverse effects may result from the combined use of TransCon TLR7/8 Agonist and pembrolizumab?

"Taking into account the Phase 2 status of this intervention, our team at Power considers TransCon TLR7/8 Agonist in combination with pembrolizumab to be relatively secure and gave it a score of two."

Answered by AI

Are new participants actively being sought for this scientific research?

"Affirmative, clinicaltrials.gov displays that this trial is actively enrolling participants. First posted on September 29th 2023 and last updated on October 12th 2023, the study requires 92 people to be recruited from a single medical centre."

Answered by AI

How many test subjects are involved in the ongoing clinical research?

"Affirmative. According to clinicaltrials.gov, this examination is recruiting participants since its post date of September 29th 2023 and last updated on October 12th 2023. An approximate 92 persons need to be recruited from 1 site for the trial's completion."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

TransCon (TC) TLR7/8 Agonist, TC IL-2 β/γ, Pembrolizumab Prior to Surgery for Advanced Head and Neck Squamous Cell Carcinoma

2023. "TransCon (TC) TLR7/8 Agonist, TC IL-2 β/γ, Pembrolizumab Prior to Surgery for Advanced Head and Neck Squamous Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05980598.

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