^
    1d
    Ficerafusp Alfa (BCA101) With Pembrolizumab for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Two-Year Results of an Expansion Cohort of a Phase I/Ib Trial. (PubMed, J Clin Oncol)
    Ficerafusp alfa plus pembrolizumab demonstrated favorable safety and tolerability with promising antitumor activity in the first-line treatment of R/M HNSCC, particularly in those with HPV-negative tumors.
    P1 data • Journal • First-in-human
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • ficerafusp alfa (BCA101)
    1d
    PIONEER: Pirfenidone to Prevent Fibrosis in Ards. (clinicaltrials.gov)
    P3, N=130, Recruiting, Università Vita-Salute San Raffaele | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Jun 2026
    Trial completion date • Trial primary completion date
    4d
    A Study to Evaluate the Efficacy, Drug Levels and Safety of Luspatercept (ACE-536) for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in Chinese and Japanese Participants With Ring Sideroblasts Who Require Red Blood Cell Transfusions (clinicaltrials.gov)
    P2, N=30, Completed, Celgene | Active, not recruiting --> Completed
    Trial completion
    |
    Reblozyl (luspatercept-aamt)
    4d
    Luspatercept for Anemia in Lower Risk MDS or Non-proliferative MDS/MPN Neoplasms (clinicaltrials.gov)
    P2, N=6, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Recruiting --> Active, not recruiting | N=70 --> 6
    Enrollment closed • Enrollment change
    |
    SF3B1 (Splicing Factor 3b Subunit 1) • SRSF2 (Serine and arginine rich splicing factor 2) • U2AF1 (U2 Small Nuclear RNA Auxiliary Factor 1) • ZRSR2 (Zinc Finger CCCH-Type, RNA Binding Motif And Serine/Arginine Rich 2)
    |
    SF3B1 mutation • SRSF2 mutation
    |
    Reblozyl (luspatercept-aamt)
    9d
    A Study in Adults With Desmoid Tumors (clinicaltrials.gov)
    P2, N=50, Recruiting, Elpiscience (Suzhou) Biopharma, Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    10d
    ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions (clinicaltrials.gov)
    P3, N=360, Recruiting, Bristol-Myers Squibb | Active, not recruiting --> Recruiting
    Enrollment open
    |
    Reblozyl (luspatercept-aamt)
    10d
    SOTERIA: A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038) (clinicaltrials.gov)
    P3, N=815, Recruiting, Merck Sharp & Dohme LLC | Active, not recruiting --> Recruiting
    Enrollment open • Trial initiation date
    |
    Winrevair (sotatercept-csrk)
    10d
    A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions (clinicaltrials.gov)
    P3, N=225, Recruiting, Takeda | N=82 --> 225
    Enrollment change
    |
    elritercept (KER-050)
    10d
    FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC (clinicaltrials.gov)
    P2/3, N=650, Recruiting, Bicara Therapeutics | N=216 --> 650
    Enrollment change
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • ficerafusp alfa (BCA101)
    10d
    ELRiSE MDS: A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions (clinicaltrials.gov)
    P3, N=300, Recruiting, Takeda | N=84 --> 300
    Enrollment change • Trial initiation date
    |
    elritercept (KER-050)
    13d
    HYPERION: Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13) (clinicaltrials.gov)
    P3, N=321, Terminated, Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA | Completed --> Terminated; Study was stopped early due to loss of clinical equipoise based on robust evidence of clinical benefit of sotatercept demonstrated in previous studies.
    Trial termination
    |
    Winrevair (sotatercept-csrk)
    13d
    Ficerafusp Alfa, Pembrolizumab, and Stereotactic Body Radiotherapy (SBRT) for Head and Neck Squamous Cell Carcinoma (HNSCC) (clinicaltrials.gov)
    P1/2, N=45, Not yet recruiting, Washington University School of Medicine
    New P1/2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • ficerafusp alfa (BCA101)