27 Participants Needed

Immunotherapy + Pembrolizumab for Head and Neck Cancer

(BelieveIT-201 Trial)

Recruiting at 54 trial locations
MR
JC
EB
EB
AO
Overseen ByAscendis Oncology Clinical Trials
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this trial is to evaluate the safety and efficacy of TransCon TLR7/8 Agonist, TransCon IL-2 β/γ, and pembrolizumab given prior to curative intent surgery in treatment of participants with newly diagnosed Stage III/IVA resectable locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC). After surgery, participants will receive local standard-of-care treatment and will be followed for safety, efficacy, and survival for up to 2 years.This trial contains a safety run-in to evaluate the safety and tolerability of the two treatment arms: Arm A (TransCon TLR7/8 Agonist plus pembrolizumab) and Arm B (TransCon TLR7/8 Agonist plus TransCon IL-2 β/γ). The safety run-in will be followed by the randomized Phase 2, open-label part of the trial comparing the safety, efficacy and survival of treatment Arm A or Arm B compared to treatment Arm C (pembrolizumab monotherapy).

Who Is on the Research Team?

JM

Joan Morris

Principal Investigator

Ascendis Pharma Oncology Division A/S

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My cancer is a new, operable, non-spreading squamous cell carcinoma.
My organs are working well.
I am scheduled for surgery on my head or neck cancer.
See 4 more

Exclusion Criteria

Active autoimmune conditions
I have a serious heart condition.
Known bleeding disorder that poses unacceptable risk for bleeding complications from IT injections or biopsies
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Run-in

Evaluate the safety and tolerability of the two treatment arms: Arm A (TransCon TLR7/8 Agonist plus pembrolizumab) and Arm B (TransCon TLR7/8 Agonist plus TransCon IL-2 β/γ)

6 weeks
2 visits (in-person)

Treatment

Participants receive study drug(s) every 21 days for 2 cycles followed by curative-intent surgery

6 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety, efficacy, and survival after treatment

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Pembrolizumab
  • TransCon IL-2 β/γ
  • TransCon TLR7/8 Agonist
Trial Overview 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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: TransCon TLR7/8 Agonist in combination with pembrolizumabExperimental Treatment2 Interventions
Group II: TransCon TLR7/8 Agonist in combination with TransCon IL-2 β/γExperimental Treatment2 Interventions
Group III: PembrolizumabActive Control1 Intervention

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸
Approved in United States as KEYTRUDA for:
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Approved in European Union as KEYTRUDA for:
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Approved in United Kingdom as KEYTRUDA for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ascendis Pharma A/S

Lead Sponsor

Trials
15
Recruited
1,600+

Ascendis Pharma Oncology Division A/S

Lead Sponsor

Trials
3
Recruited
560+
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