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    DRUG:

    Panvac-VF (falimarev/inalimarev)

    i
    Other names: vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine, CV301, CEA-MUC-1/TRICOM, MVA-BNCV301/FPVCV301, CV-301, CVAC-301, CEA-MUC-1-TRICOM
    Associations

    News

    Trials
    Company:
    Bavarian Nordic, National Cancer Institute - Bethesda
    Drug class:
    MUC1 inhibitor, CEA inhibitor
    Related drugs:
    Associations

    News

    Trials
    21d
    Vaccine Therapy and Sargramostim in Treating Patients With Pancreas Cancer That Cannot Be Removed By Surgery (clinicaltrials.gov)
    P1, N=18, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Apr 2024 --> Apr 2025
    Trial completion date • Surgery
    |
    Leukine (sargramostim) • Panvac-VF (falimarev/inalimarev)
    27d
    HCRN GI16-288: A Trial of Perioperative CV301 Vaccination in Combination With Nivolumab and Systemic Chemotherapy for Metastatic CRC (clinicaltrials.gov)
    P2, N=78, Active, not recruiting, Patrick Boland | Trial completion date: Jun 2023 --> Dec 2024 | Trial primary completion date: Jun 2023 --> Mar 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Opdivo (nivolumab) • 5-fluorouracil • oxaliplatin • leucovorin calcium • Panvac-VF (falimarev/inalimarev)
    3ms
    Combination Immunotherapy in Biochemically Recurrent Prostate Cancer (clinicaltrials.gov)
    P2, N=29, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Jan 2024 --> Jan 2025
    Trial completion date • Trial primary completion date
    |
    bintrafusp alfa (M7824) • Panvac-VF (falimarev/inalimarev) • ProstVac (rilimogene galvacirepvec)
    6ms
    Phase II Trial of Combination Immunotherapy in Subjects With Advanced Small Bowel and Colorectal Cancers (clinicaltrials.gov)
    P2, N=32, Active, not recruiting, National Cancer Institute (NCI) | Completed --> Active, not recruiting | N=23 --> 32 | Trial completion date: Feb 2023 --> Jan 2026
    Enrollment closed • Enrollment change • Trial completion date • Metastases
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5) • CD4 (CD4 Molecule)
    |
    bintrafusp alfa (M7824) • Anktiva (nogapendekin alfa inbakicept-pmln) • PDS01ADC • Panvac-VF (falimarev/inalimarev)
    7ms
    Durvalumab Plus CV301 With Maintenance Chemotherapy in Metastatic Colorectal or Pancreatic Adenocarcinoma (clinicaltrials.gov)
    P1/2, N=8, Terminated, Georgetown University | Active, not recruiting --> Terminated; Study closed due to lack of enrollment.
    Trial termination • Combination therapy • Metastases
    |
    Avastin (bevacizumab) • Imfinzi (durvalumab) • capecitabine • Panvac-VF (falimarev/inalimarev)
    10ms
    Combination Immunotherapy in Biochemically Recurrent Prostate Cancer (clinicaltrials.gov)
    P2, N=29, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    bintrafusp alfa (M7824) • Panvac-VF (falimarev/inalimarev) • ProstVac (rilimogene galvacirepvec)
    1year
    Phase I/II Trial Investigating the Safety, Tolerability, Pharmacokinetics, Immune and Clinical Activity of SX-682 in Combination With BinTrafusp Alfa (M7824 or TGF-beta "Trap"/PD-L1) With CV301 TRICOM in Advanced Solid Tumors (STAT) (clinicaltrials.gov)
    P1/2, N=12, Active, not recruiting, National Cancer Institute (NCI) | Trial primary completion date: Oct 2021 --> Feb 2023
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CD4 (CD4 Molecule)
    |
    HER-2 amplification • HER-2 negative • CDKN2A negative
    |
    bintrafusp alfa (M7824) • SX-682 • Panvac-VF (falimarev/inalimarev)
    1year
    Phase II Trial of Combination Immunotherapy in Subjects With Advanced Small Bowel and Colorectal Cancers (clinicaltrials.gov)
    P2, N=23, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed | Trial completion date: Jul 2024 --> Feb 2023 | Trial primary completion date: Jul 2024 --> Oct 2022
    Trial completion • Trial completion date • Trial primary completion date • Metastases
    |
    MUC1 (Mucin 1) • CD4 (CD4 Molecule)
    |
    bintrafusp alfa (M7824) • Anktiva (nogapendekin alfa inbakicept-pmln) • PDS01ADC • Panvac-VF (falimarev/inalimarev)
    over1year
    Phase II Trial of Combination Immunotherapy in Subjects With Advanced Small Bowel and Colorectal Cancers (clinicaltrials.gov)
    P2, N=23, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting | N=80 --> 23
    Enrollment closed • Enrollment change • Metastases
    |
    MUC1 (Mucin 1) • CD4 (CD4 Molecule)
    |
    bintrafusp alfa (M7824) • Anktiva (nogapendekin alfa inbakicept-pmln) • PDS01ADC • Panvac-VF (falimarev/inalimarev)
    over1year
    Phase II trial of CV301 vaccine combined with atezolizumab in advanced urothelial carcinoma. (PubMed, Cancer Immunol Immunother)
    A Phase 2, single-arm trial was designed to evaluate CV301 plus atezolizumab as first-line treatment for cisplatin-ineligible advanced urothelial carcinoma (aUC) (Cohort 1) or progressing after platinum chemotherapy (Cohort 2). Patients exhibiting benefit demonstrated T-cell response to CEA and MUC-1. The trial illustrates the challenges in the development of vaccines, which should be guided by robust preclinical data.
    P2 data • Journal
    |
    MUC1 (Mucin 1) • ICAM1 (Intercellular adhesion molecule 1) • CD58 (CD58 Molecule)
    |
    cisplatin • Tecentriq (atezolizumab) • Panvac-VF (falimarev/inalimarev)
    almost2years
    A Trial of Perioperative CV301 Vaccination in Combination With Nivolumab and Systemic Chemotherapy for Metastatic CRC (clinicaltrials.gov)
    P2; Trial primary completion date: Jun 2022 --> Dec 2022
    Combination therapy • Trial primary completion date
    |
    FoundationOne® CDx
    |
    Opdivo (nivolumab) • 5-fluorouracil • oxaliplatin • leucovorin calcium • Panvac-VF (falimarev/inalimarev)
    almost2years
    Phase I/II Trial Investigating the Safety, Tolerability, Pharmacokinetics, Immune and Clinical Activity of SX-682 in Combination With BinTrafusp Alfa (M7824 or TGF-beta "Trap"/PD-L1) With CV301 TRICOM in Advanced Solid Tumors (STAT) (clinicaltrials.gov)
    P1/2, N=12, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jun 2026 --> May 2024 | Trial primary completion date: Dec 2025 --> Oct 2021
    Trial completion date • Trial primary completion date • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • CD4 (CD4 Molecule)
    |
    PD-L1 expression • HER-2 amplification • HER-2 negative • CDKN2A negative
    |
    bintrafusp alfa (M7824) • SX-682 • Panvac-VF (falimarev/inalimarev)
    almost2years
    Phase II Trial of Combination Immunotherapy in Subjects With Advanced Small Bowel and Colorectal Cancers (clinicaltrials.gov)
    P2, N=80, Recruiting, National Cancer Institute (NCI) | Trial primary completion date: Jul 2023 --> Jul 2024
    Trial primary completion date
    |
    MUC1 (Mucin 1) • CD4 (CD4 Molecule)
    |
    bintrafusp alfa (M7824) • Anktiva (nogapendekin alfa inbakicept-pmln) • PDS01ADC • Panvac-VF (falimarev/inalimarev)
    2years
    Clinical responses in pancreaticobiliary cancer patients who received bintrafusp alfa (BA) or BA plus CXCR1/2 inhibitor (SX- 682) plus CEA/MUC1-targted vaccine (CV301) (ESMO-GI 2022)
    No abstract available
    Clinical
    |
    MUC1 (Mucin 1) • CXCR1 (Chemokine (C-X-C motif) receptor 1)
    |
    bintrafusp alfa (M7824) • Panvac-VF (falimarev/inalimarev)
    over2years
    A Trial of Perioperative CV301 Vaccination in Combination With Nivolumab and Systemic Chemotherapy for Metastatic CRC (clinicaltrials.gov)
    P2; N=78; Active, not recruiting; Sponsor: Kristen Spencer; Trial primary completion date: Dec 2021 --> Jun 2022
    Combination therapy • Trial primary completion date
    |
    FoundationOne® CDx
    |
    Opdivo (nivolumab) • 5-fluorouracil • oxaliplatin • leucovorin calcium • Panvac-VF (falimarev/inalimarev)
    over2years
    Phase II Trial of Combination Immunotherapy in Subjects With Advanced Small Bowel and Colorectal Cancers (clinicaltrials.gov)
    P2, N=80, Recruiting, National Cancer Institute (NCI) | Suspended --> Recruiting | N=14 --> 80
    Enrollment open • Enrollment change
    |
    MUC1 (Mucin 1) • CD4 (CD4 Molecule)
    |
    bintrafusp alfa (M7824) • Anktiva (nogapendekin alfa inbakicept-pmln) • PDS01ADC • Panvac-VF (falimarev/inalimarev)
    over2years
    Phase I/II Trial Investigating the Safety, Tolerability, Pharmacokinetics, Immune and Clinical Activity of SX-682 in Combination With BinTrafusp Alfa (M7824 or TGF-beta "Trap"/PD-L1) With CV301 TRICOM in Advanced Solid Tumors (STAT) (clinicaltrials.gov)
    P1/2, N=8, Active, not recruiting, National Cancer Institute (NCI) | Suspended --> Active, not recruiting
    Clinical • Enrollment closed • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • CD4 (CD4 Molecule)
    |
    PD-L1 expression • HER-2 amplification • HER-2 negative • CDKN2A negative
    |
    bintrafusp alfa (M7824) • SX-682 • Panvac-VF (falimarev/inalimarev)
    over2years
    Phase II Trial of Combination Immunotherapy in Subjects With Advanced Small Bowel and Colorectal Cancers (clinicaltrials.gov)
    P2, N=14, Suspended, National Cancer Institute (NCI) | N=80 --> 14 | Recruiting --> Suspended
    Clinical • Enrollment change • Trial suspension
    |
    MUC1 (Mucin 1) • CD4 (CD4 Molecule)
    |
    bintrafusp alfa (M7824) • Anktiva (nogapendekin alfa inbakicept-pmln) • PDS01ADC • Panvac-VF (falimarev/inalimarev)
    over2years
    Phase I/II Trial Investigating the Safety, Tolerability, Pharmacokinetics, Immune and Clinical Activity of SX-682 in Combination With BinTrafusp Alfa (M7824 or TGF-beta "Trap"/PD-L1) With CV301 TRICOM in Advanced Solid Tumors (STAT) (clinicaltrials.gov)
    P1/2, N=8, Suspended, National Cancer Institute (NCI) | N=105 --> 8 | Recruiting --> Suspended
    Clinical • Enrollment change • Trial suspension • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • CD4 (CD4 Molecule)
    |
    PD-L1 expression • HER-2 amplification • HER-2 negative • CDKN2A negative
    |
    bintrafusp alfa (M7824) • SX-682 • Panvac-VF (falimarev/inalimarev)
    3years
    A Trial of Perioperative CV301 Vaccination in Combination With Nivolumab and Systemic Chemotherapy for Metastatic CRC (clinicaltrials.gov)
    P2; Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2020 --> Dec 2021
    Combination therapy • Trial primary completion date • Enrollment closed
    |
    FoundationOne® CDx
    |
    Opdivo (nivolumab) • 5-fluorouracil • oxaliplatin • leucovorin calcium • Panvac-VF (falimarev/inalimarev)
    over3years
    Phase I/II Trial Investigating the Safety, Tolerability, Pharmacokinetics, Immune and Clinical Activity of SX-682 in Combination With BinTrafusp Alfa (M7824 or TGF-beta "Trap"/PD-L1) With CV301 TRICOM in Advanced Solid Tumors (STAT) (clinicaltrials.gov)
    P1/2, N=105, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting
    Clinical • Enrollment open • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • CD4 (CD4 Molecule)
    |
    PD-L1 expression • HER-2 amplification • HER-2 negative • CDKN2A negative
    |
    bintrafusp alfa (M7824) • SX-682 • Panvac-VF (falimarev/inalimarev)
    over3years
    Phase I/II Trial Investigating the Safety, Tolerability, Pharmacokinetics, Immune and Clinical Activity of SX-682 in Combination With BinTrafusp Alfa (M7824 or TGF-beta "Trap"/PD-L1) With CV301 TRICOM in Advanced Solid Tumors (STAT) (clinicaltrials.gov)
    P1/2, N=105, Not yet recruiting, National Cancer Institute (NCI)
    Clinical • New P1/2 trial • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • CD4 (CD4 Molecule)
    |
    PD-L1 expression • HER-2 amplification • HER-2 negative • CDKN2A negative
    |
    bintrafusp alfa (M7824) • SX-682 • Panvac-VF (falimarev/inalimarev)
    over3years
    Phase II Trial of Combination Immunotherapy in Subjects With Advanced Small Bowel and Colorectal Cancers (clinicaltrials.gov)
    P2, N=80, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting
    Clinical • Enrollment open
    |
    MUC1 (Mucin 1) • CD4 (CD4 Molecule)
    |
    bintrafusp alfa (M7824) • Anktiva (nogapendekin alfa inbakicept-pmln) • PDS01ADC • Panvac-VF (falimarev/inalimarev)
    almost4years
    Phase II Trial of Combination Immunotherapy in Subjects With Advanced Small Bowel and Colorectal Cancers (clinicaltrials.gov)
    P2, N=80, Not yet recruiting, National Cancer Institute (NCI)
    Clinical • New P2 trial
    |
    MUC1 (Mucin 1) • CD4 (CD4 Molecule)
    |
    bintrafusp alfa (M7824) • Anktiva (nogapendekin alfa inbakicept-pmln) • PDS01ADC • Panvac-VF (falimarev/inalimarev)
    4years
    A Trial of CV301 in Combination With Anti-PD-1 Therapy in Subjects With Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=24, Completed, Bavarian Nordic | Active, not recruiting --> Completed
    Clinical • Trial completion • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    PD-L1 expression • EGFR mutation • PD-L1 overexpression • ALK translocation • CEACAM5 expression
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Panvac-VF (falimarev/inalimarev)