Ficerafusp Alfa + Pembrolizumab + SBRT for Head and Neck Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial seeks to determine the optimal dose and effectiveness of a new treatment combination for high-risk, advanced head and neck cancer not caused by HPV. The treatment combines a new drug, ficerafusp alfa, with pembrolizumab (an immunotherapy) and precise radiation therapy (SBRT, or Hypofractionated Stereotactic Body Radiotherapy) before surgery. This study suits those recently diagnosed with advanced head and neck cancer, particularly if it is not HPV-related and can be surgically removed. As a Phase 1/Phase 2 trial, the research focuses on understanding the treatment's effects in people and assessing its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking cancer treatment advancements.
Do I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on systemic treatments like corticosteroids or immunosuppressive drugs, you may need to stop them before starting the trial. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study found the combination of ficerafusp alfa and pembrolizumab to be safe, with no new safety concerns. Most patients tolerated the treatment well, handling it without serious issues. Safety data for pembrolizumab alone show it is generally safe for head and neck cancer, with no new safety issues reported when used before surgery.
Regarding hypofractionated stereotactic body radiotherapy (SBRT), studies have indicated it is generally safe, although some patients may experience side effects later. Overall, research shows that the treatments in this study are safe and tolerable.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they combine innovative approaches to tackle head and neck cancer. Unlike standard treatments, which often rely solely on surgery and chemotherapy, this trial introduces a combination of ficerafusp alfa, pembrolizumab, and hypofractionated stereotactic body radiotherapy (SBRT). Ficerafusp alfa is a novel agent that enhances the immune system's ability to target cancer cells, while pembrolizumab is a well-known checkpoint inhibitor that blocks a protein used by cancer cells to evade the immune system. The use of SBRT, a precise form of radiation therapy, targets the tumor with high doses of radiation in fewer sessions. This multifaceted approach aims to improve effectiveness and reduce treatment time compared to traditional therapies.
What evidence suggests that this trial's treatments could be effective for head and neck cancer?
Research has shown that combining ficerafusp alfa with pembrolizumab yields promising results for treating head and neck cancers. Studies reported a 54% overall response rate, indicating significant tumor shrinkage in many patients. In this trial, participants will receive varying doses of this combination alongside hypofractionated stereotactic body radiotherapy (SBRT), which has effectively controlled tumors, with many patients experiencing complete tumor disappearance. Pembrolizumab alone has extended survival for individuals with advanced head and neck squamous cell carcinoma (HNSCC). Together, these treatments might offer a robust approach against high-risk, HPV-negative head and neck cancer.12346
Who Is on the Research Team?
Sana Karam, MD, PhD
Principal Investigator
Washington University School of Medicine
Sidharth Puram, MD, PhD
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
This trial is for adults (18+) with newly diagnosed, locally advanced, HPV-negative head and neck squamous cell cancer that can be surgically removed. Participants must have good organ function, a certain tumor marker (PD-L1 CPS ≥ 1), and be in generally good health. People with serious infections, immune disorders, recent heart problems, or other cancers can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Treatment
Participants receive neoadjuvant SBRT, pembrolizumab, and ficerafusp alfa prior to surgical resection
Surgical Resection
Standard of care surgical resection or biopsy is performed approximately 6 weeks after the end of SBRT
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ficerafusp alfa
- Hypofractionated Stereotactic Body Radiotherapy (SBRT)
- Pembrolizumab
Trial Overview
The study tests a combination of pembrolizumab (an immunotherapy drug), ficerafusp alfa (a new experimental drug), and focused radiation therapy (SBRT) before surgery for high-risk head and neck cancer. All patients receive these treatments before standard surgery; later care follows usual guidelines.
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
Treatment consists of SBRT beginning on D1 at the dose and number of fractions established in phase I, neoadjuvant pembrolizumab 200 mg at the number of doses established in phase I, and 4 weekly doses of ficerafusp alfa 750 mg (given on D1, D8, D15, and D22). Six weeks after end of SBRT, patients will undergo standard of care (SOC) surgical resection, or biopsy for patients who do not undergo resection, followed by standard of care (SOC) adjuvant chemoradiation per National Comprehensive Cancer Network (NCCN) guidelines.
Treatment during the Phase 1 Level 1 consists of Stereotactic Body Radiotherapy (SBRT) at 8 Gy x 3 fractions over one week (given on Days 1, 3, and 5), 2 doses of neoadjuvant pembrolizumab at 200 mg (given on D1 and D22), and 4 weekly doses of ficerafusp alfa at 750 mg (given on D1, D8, D15, and D22). Six weeks after end of SBRT, patients will undergo standard of care (SOC) surgical resection, or biopsy for patients who do not undergo resection, followed by standard of care (SOC) adjuvant chemoradiation per National Comprehensive Cancer Network (NCCN) guidelines.
Treatment during the Phase 1 Level -3 consists of Stereotactic Body Radiotherapy (SBRT) at 8 Gy x 3 fractions over one week (given on Day 1), 1 dose of neoadjuvant pembrolizumab at 200 mg (given on D1), and 4 weekly doses of ficerafusp alfa at 750 mg (given on D1, D8, D15, and D22). Six weeks after end of SBRT, patients will undergo standard of care (SOC) surgical resection, or biopsy for patients who do not undergo resection, followed by standard of care (SOC) adjuvant chemoradiation per National Comprehensive Cancer Network (NCCN) guidelines.
Treatment during the Phase 1 Level -2 consists of Stereotactic Body Radiotherapy (SBRT) at 8 Gy x 3 fractions over one week (given on Days 1 and 4), 1 dose of neoadjuvant pembrolizumab at 200 mg (given on D1), and 4 weekly doses of ficerafusp alfa at 750 mg (given on D1, D8, D15, and D22). Six weeks after end of SBRT, patients will undergo standard of care (SOC) surgical resection, or biopsy for patients who do not undergo resection, followed by standard of care (SOC) adjuvant chemoradiation per National Comprehensive Cancer Network (NCCN) guidelines.
Treatment during the Phase 1 Level -1 consists of Stereotactic Body Radiotherapy (SBRT) at 8 Gy x 3 fractions over one week (given on Days 1, 3, and 5), 1 dose of neoadjuvant pembrolizumab at 200 mg (given on D1), and 4 weekly doses of ficerafusp alfa at 750 mg (given on D1, D8, D15, and D22). Six weeks after end of SBRT, patients will undergo standard of care (SOC) surgical resection, or biopsy for patients who do not undergo resection, followed by standard of care (SOC) adjuvant chemoradiation per National Comprehensive Cancer Network (NCCN) guidelines.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
Bicara Therapeutics
Industry Sponsor
Citations
Ficerafusp Alfa (BCA101) With Pembrolizumab for ...
Ficerafusp alfa plus pembrolizumab demonstrated favorable safety and tolerability with promising antitumor activity in the first-line treatment ...
2.
ir.bicara.com
ir.bicara.com/news-releases/news-release-details/ficerafusp-alfa-2000mg-q2w-demonstrates-deep-durable-responsesFicerafusp Alfa 2000mg Q2W Demonstrates Deep, Durable ...
2000mg Q2W of ficerafusp alfa demonstrated a 48% confirmed overall response rate (ORR), with 26% of patients achieving a complete response (CR) ...
3.
onclive.com
onclive.com/view/less-frequent-ficerafusp-alfa-dosing-strategy-yields-durable-responses-in-metastatic-hnsccLess-Frequent Ficerafusp Alfa Dosing Strategy Yields ...
First-line ficerafusp alfa at 2000 mg every 2 weeks plus pembrolizumab was deemed safe and effective in recurrent or metastatic HPV-negative ...
Neoadjuvant Ficerafusp Alfa With Pembrolizumab in ...
This trial is to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab prior to surgical resection in ...
Ficerafusp alfa with pembrolizumab in patients ...
Ficerafusp alfa combined with pembrolizumab continues to show promising efficacy relative to historical data on the current standard of care, particularly in ...
Phase I Clinical Trial of the Bifunctional EGFR/TGF-β Fusion ...
With combination therapy, four of 13 evaluable patients (31%) had a confirmed response, including one with head and neck squamous cell carcinoma refractory to ...
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