Clinical Trial 23691

• Overview

  Study Title:

  A Multicenter, Randomized, Double-blind, Phase 2/3 Study of Ficerafusp Alfa (BCA101) or Placebo in Combination with Pembrolizumab for First-Line Treatment of PD-L1-positive, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

  Summary:

  This study intends to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab versus placebo with pembrolizumab in 1L PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC).

  Objective:

  Phase 2 Primary (Dose Selection): * To identify optimal biological dose (OBD) by: - Assessing safety and tolerability of ficerafusp alfa in subjects randomized to ficerafusp alfa 1500 mg once weekly (QW) with pembrolizumab (Treatment Arm A) and ficerafusp alfa 750 mg QW with pembrolizumab (Treatment Arm B). - Assessing antitumor activity of ficerafusp alfa in subjects randomized to ficerafusp alfa 1500 mg QW with pembrolizumab (Treatment Arm A) and ficerafusp alfa 750 mg QW and pembrolizumab (Treatment Arm B). Phase 2 Secondary (Dose Selection): * To further compare antitumor activity of ficerafusp alfa in subjects randomized to ficerafusp alfa 1500 mg QW with pembrolizumab (Treatment Arm A) and ficerafusp alfa 750 mg QW and pembrolizumab (Treatment Arm B). Phase 3 Primary: * To compare efficacy in subjects treated with ficerafusp alfa at the selected OBD in combination with pembrolizumab versus placebo plus pembrolizumab. Phase 3 Secondary: * To compare safety and tolerability of subjects treated with ficerafusp alfa at the selected OBD in combination with pembrolizumab versus placebo plus pembrolizumab. * To further compare efficacy in subjects treated with ficerafusp alfa in combination with pembrolizumab versus placebo plus pembrolizumab. * To evaluate time to deterioration (TTD) in global health status/quality of life and pain in subjects treated with ficerafusp alfa in combination with pembrolizumab versus placebo plus pembrolizumab.

• Treatments

  Therapies:

  Bifunctional recombinant fusion protein targeting EGFR and TGF-Beta; Immunotherapy; PD-L1 Inhibitor

  Medications:

  Pembrolizumab (Keytruda); ficerafusp alfa/Placebo ()

• Inclusion Criteria

  Inclusion Criteria:
  • Age ≥18 years on the day the Informed Consent Form is signed.
  • Histologically or cytologically confirmed R or M HNSCC. Eligible primary tumor locations are oral cavity, hypopharynx, larynx or oropharynx (with documented HPV-negative disease if presenting with OPSCC). Note: primary tumor location of paranasal sinuses and nasopharynx, any histology are excluded.
  • No prior systemic therapy administered in the R or M setting; and completed systemic therapy >6 months prior if given as part of multimodal treatment for locoregionally advanced disease in the adjuvant or definitive setting.
  • Archival tumor tissue or willing to undergo pretreatment biopsy at Screening if archival tissue is insufficient or unavailable.
  • PD-L1 CPS ≥1 (by PD-L1 IHC 22C3 pharmDx assay).
  • Measurable disease based on RECIST 1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate organ function, as defined in the protocol.
  • Other criteria apply

• Exclusion Criteria

  Exclusion Criteria:
  • Disease suitable for local therapy administered with curative intent.
  • Prior treatment with anti-TGFβ therapy.
  • Prior therapy with an anti-EGFR antibody (exception: radio sensitizing agents and multimodal treatment for locoregionally advanced disease).
  • Prior history of Grade ≥2 intolerance or hypersensitivity reaction to anti-EGFR therapy or other murine proteins.
  • Prior therapy with an immune checkpoint inhibitor completed within 6 months prior to study treatment initiation.
  • Progressive disease > Life expectancy less than 3 months.
  • Known active central nervous system metastases, history of spinal cord compression from tumor involvement, a history of carcinomatous meningitis, or leptomeningeal disease are excluded.
  • Current active major bleeding, or a recent major bleeding episode within 4 weeks prior to enrollment.
  • Subject participated in another clinical study or received treatment with another investigational drug must wait at least 5 half-lives of the treatment received or 4 weeks (whichever is shorter) following prior therapy.
  • Active autoimmune disease requiring systemic treatment in the past 2 years.
  • Subjects with chronic hepatitis B virus (HBV) infection with active disease who meet the criteria for anti-HBV therapy and are not on a suppressive antiviral therapy prior to initiation of study treatment.
  • Subjects with a known history of hepatitis C virus (HCV) who have not completed curative antiviral treatment or have an HCV viral load above the limit of quantification at Screening.
  • Known history of human immunodeficiency virus (HIV).
  • Receipt of any organ transplantation, including autologous and allogeneic stem cell transplantation, with the exception of transplants that do not require immunosuppression.
  • Known to be diagnosed and/or treated for any other additional malignancy within 2 years prior to randomization with the exception of the following: curatively treated basal cell carcinoma or squamous cell carcinoma of the skin, and curatively resected in situ cervical cancer, and curatively resected in situ breast cancer, and low-risk early stage prostate cancer.
  • Any condition requiring systemic treatment with either corticosteroids (>10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 7 days prior to the first dose of study treatment, except for topical, intranasal, intrabronchial, or ocular steroids.
  • Use of a live or live attenuated vaccine within 4 weeks prior to Screening.
  • Other criteria may apply

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