Immunotherapy + Pembrolizumab for Head and Neck Cancer
(BelieveIT-201 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores new treatments for individuals with advanced head and neck cancer that can be surgically removed. Researchers aim to determine if combining experimental drugs (TransCon TLR7/8 Agonist and TransCon IL-2 β/γ) with pembrolizumab, a known cancer drug, is more effective than using pembrolizumab alone. Participants will receive one of these treatments before surgery and will undergo follow-up care after surgery to assess safety and effectiveness. The trial seeks individuals newly diagnosed with Stage III or IVA head and neck cancer that has not spread and who are prepared for surgery. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to the development of potentially more effective therapies.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on systemic steroid therapy or other immunosuppressive treatments, you may need to stop them at least 7 days before joining the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Earlier studies found that the TransCon TLR7/8 Agonist, used alone or with pembrolizumab, was generally well-tolerated, with most patients experiencing no serious side effects. It was also well-tolerated when combined with TransCon IL-2 β/γ in patients who had undergone many previous treatments. These results suggest that the treatment might be safe for participants.
The FDA has approved pembrolizumab for other uses, indicating its safety is well-understood. Based on past research and approvals, the combination of these treatments in the trial is expected to be generally safe. However, participants should stay informed about any new information as the trial continues.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for head and neck cancer because they introduce innovative ways to boost the immune system's ability to fight cancer. Unlike traditional treatments like surgery, radiation, or chemotherapy, TransCon IL-2 β/γ and TransCon TLR7/8 Agonist work by enhancing the body’s own immune response. TransCon IL-2 β/γ is designed to activate specific immune cells known as T-cells, while TransCon TLR7/8 Agonist stimulates immune activity directly within the tumor. By combining these agents with pembrolizumab, an established immunotherapy, there’s potential for a more powerful and targeted attack on cancer cells, which could lead to better outcomes for patients.
What evidence suggests that this trial's treatments could be effective for head and neck cancer?
In this trial, participants will receive different treatment combinations. Research has shown that using the TransCon TLR7/8 Agonist with pembrolizumab, one of the combinations being tested, may hold promise for treating cancer. Early results suggest this combination helps the immune system attack cancer cells, and some patients have responded well, which is encouraging.
Another combination in this trial is the TransCon TLR7/8 Agonist combined with TransCon IL-2 β/γ. Studies indicate this combination is generally well-tolerated and can lead to significant improvements. It is designed to enhance the immune system's ability to fight cancer. Both treatments are exciting because they aim to make the immune system work harder against cancer, which could be very effective.12356Who Is on the Research Team?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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)
Treatment
Participants receive study drug(s) every 21 days for 2 cycles followed by curative-intent surgery
Follow-up
Participants are monitored for safety, efficacy, and survival after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Pembrolizumab
- TransCon IL-2 β/γ
- TransCon TLR7/8 Agonist
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ascendis Pharma A/S
Lead Sponsor
Ascendis Pharma Oncology Division A/S
Lead Sponsor