Study on Ficerafusp Alfa and Pembrolizumab for First-Line Treatment of PD-L1 Positive Recurrent or Metastatic Head and Neck Cancer
Sponsor: Bicara Therapeutics
ClinicalTrials ID:NCT06788990
This clinical trial is testing a new treatment combination of ficerafusp alfa and pembrolizumab against a placebo and pembrolizumab in patients with recurrent or metastatic head and neck cancer that is PD-L1 positive.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The study aims to evaluate the safety and effectiveness of a new drug, ficerafusp alfa, when used with pembrolizumab, compared to a placebo with pembrolizumab, in treating patients with recurrent or metastatic head and neck cancer that is PD-L1 positive. Ficerafusp alfa targets two proteins, EGFR and TGF-β, which are involved in cancer growth and spread.
Description
This study involves testing a new drug, ficerafusp alfa, which targets two proteins known to help cancer grow and spread. The study is divided into two phases:
-
Phase 2: This phase will determine the best dose of ficerafusp alfa by looking at its safety, how well patients tolerate it, and its effectiveness. Participants will be randomly assigned to one of three groups:
- Group A: Receives 1500 mg of ficerafusp alfa weekly and 200 mg of pembrolizumab every three weeks.
- Group B: Receives 750 mg of ficerafusp alfa weekly and 200 mg of pembrolizumab every three weeks.
- Group C (Control): Receives a placebo weekly and 200 mg of pembrolizumab every three weeks.
-
Phase 3: This phase will compare the effectiveness of the best dose of ficerafusp alfa with pembrolizumab against the placebo with pembrolizumab. Participants will be randomly assigned to either the treatment group or the control group in a 2:1 ratio.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of recurrent or metastatic head and neck cancer, specifically in the oral cavity, hypopharynx, larynx, or oropharynx (must be HPV-negative if in the oropharynx).
- No previous systemic treatment for recurrent or metastatic cancer, and any previous treatment for advanced disease must have been completed more than 6 months ago.
- Must provide a tumor sample or agree to a biopsy if a sample is not available.
- Cancer must be PD-L1 positive with a CPS score of 1 or higher.
- Must have measurable disease according to specific criteria.
- Must be in good general health with an ECOG performance status of 0 or 1.
- Must have adequate organ function as defined by the study protocol.
Exclusion Criteria
- Cancer that can be treated with local therapy aimed at a cure.
- Previous treatment with anti-TGFβ or anti-EGFR therapy, except in specific cases.
- History of severe reactions to anti-EGFR therapy or similar proteins.
- Recent treatment with immune checkpoint inhibitors within 6 months.
- Cancer progression within 6 months of completing curative treatment.
- Life expectancy of less than 3 months.
- Active brain metastases or certain other brain conditions.
- Recent major bleeding or active bleeding issues.
- Participation in another clinical study or recent treatment with investigational drugs.
- Active autoimmune disease requiring treatment in the past 2 years.
- Active hepatitis B or C infection or untreated HIV.
- Recent organ transplant requiring immunosuppression.
- Recent diagnosis or treatment for another cancer, except for certain skin or cervical cancers.
- Use of systemic steroids or immunosuppressive drugs recently.
- Recent use of live vaccines.
Other criteria may apply as defined in the study protocol.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Site#0117 | 45221 | Cincinnati | Ohio |
| Site#0104 | 29425 | Charleston | South Carolina |
| Site#0126 | 37203 | Nashville | Tennessee |
| Site#0134 | 22904 | Charlottesville | Virginia |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.