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    DRUG:

    vidutolimod (CMP-001)

    i
    Other names: CYT-003, CYT003 PolQb, CYT003 PolQbeta, virus-like particle-based cancer vaccine, CMP-001, CYT003-QbG10, QbG10, CYT 003 QbG10, Immunodrug CYT003-QbG10, ARB 1598, CMP 001, CYT003, QbG10, allergy vaccine, ARB-1598
    Company:
    Kuros, Regeneron, Xoma
    Drug class:
    Immunomodulator, TLR9 agonist
    Related drugs:
    9d
    CMP-001 for Relapsed and Refractory Lymphoma (clinicaltrials.gov)
    P1/2, N=39, Active, not recruiting, Umar Farooq | Suspended --> Active, not recruiting
    Enrollment closed
    |
    Keytruda (pembrolizumab) • vidutolimod (CMP-001)
    14d
    A Trial To Find Out If Vidutolimod Together With Cemiplimab Is Safe And If It Works In Adult Participants With Advanced Cancer Or Metastatic Cancer (clinicaltrials.gov)
    P2, N=77, Terminated, Regeneron Pharmaceuticals | Active, not recruiting --> Terminated; Sponsor Decision related to study drug supply
    Trial termination • Combination therapy • Metastases
    |
    Libtayo (cemiplimab-rwlc) • vidutolimod (CMP-001)
    18d
    A Study Evaluating Whether Pembrolizumab Alone or in Combination With CMP-001 Improves Efficacy in Patients With Operable Melanoma (clinicaltrials.gov)
    P2, N=60, Suspended, National Cancer Institute (NCI) | Trial completion date: Dec 2024 --> Jun 2025 | Trial primary completion date: Dec 2024 --> Jun 2025
    Trial completion date • Trial primary completion date • Combination therapy
    |
    BRAF (B-raf proto-oncogene)
    |
    Keytruda (pembrolizumab) • vidutolimod (CMP-001)
    19d
    Neoadjuvant vidutolimod and nivolumab in high-risk resectable melanoma: A prospective phase II trial. (PubMed, Cancer Cell)
    Our findings support that combined vidutolimod and nivolumab stimulates a broad anti-tumor immune response and is associated with distinct baseline myeloid gene signature and gut microbiota. ClinicalTrials.gov identifier: NCT03618641.
    P2 data • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8)
    |
    Opdivo (nivolumab) • vidutolimod (CMP-001)
    30d
    CMP-001 in Combination With Nivolumab in Subjects With Advanced Melanoma (clinicaltrials.gov)
    P2, N=44, Terminated, Regeneron Pharmaceuticals | Completed --> Terminated; Business Decision
    Trial termination • Combination therapy • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF V600
    |
    Opdivo (nivolumab) • vidutolimod (CMP-001)
    30d
    CMP-001-011: CMP-001 in Combination With Nivolumab Compared to Nivolumab Monotherapy in Subjects With Advanced Melanoma (clinicaltrials.gov)
    P2/3, N=20, Terminated, Regeneron Pharmaceuticals | Completed --> Terminated; Business Decision
    Trial termination • Combination therapy • Metastases
    |
    Opdivo (nivolumab) • vidutolimod (CMP-001)
    30d
    CMP-001-007: CMP-001 in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=24, Terminated, Regeneron Pharmaceuticals | Completed --> Terminated; Business Decision
    Trial termination • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • vidutolimod (CMP-001)
    1m
    Study of TLR9 Agonist Vidutolimod (CMP-001) in Combination with Nivolumab Vs. Nivolumab (clinicaltrials.gov)
    P2, N=9, Completed, Diwakar Davar | Active, not recruiting --> Completed | Trial completion date: Jul 2028 --> Aug 2024 | Trial primary completion date: Jul 2028 --> Aug 2024
    Trial completion • Trial completion date • Trial primary completion date • Combination therapy
    |
    CD8 (cluster of differentiation 8)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • vidutolimod (CMP-001)
    3ms
    CMP-001-011: CMP-001 in Combination With Nivolumab Compared to Nivolumab Monotherapy in Subjects With Advanced Melanoma (clinicaltrials.gov)
    P2/3, N=20, Completed, Regeneron Pharmaceuticals | Active, not recruiting --> Completed
    Trial completion • Combination therapy • Metastases
    |
    Opdivo (nivolumab) • vidutolimod (CMP-001)
    3ms
    A Trial To Find Out If Vidutolimod Together With Cemiplimab Is Safe And If It Works In Adult Participants With Advanced Cancer Or Metastatic Cancer (clinicaltrials.gov)
    P2, N=77, Active, not recruiting, Regeneron Pharmaceuticals | Suspended --> Active, not recruiting | N=225 --> 77 | Trial completion date: Jul 2027 --> Oct 2024 | Trial primary completion date: Jul 2027 --> Oct 2024
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Libtayo (cemiplimab-rwlc) • vidutolimod (CMP-001)
    3ms
    Vidutolimod (CMP-001) in Combination With Nivolumab for the Treatment of Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov)
    P2, N=10, Suspended, Emory University | Recruiting --> Suspended
    Trial suspension • Combination therapy • Metastases
    |
    Opdivo (nivolumab) • vidutolimod (CMP-001)
    4ms
    A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley) (clinicaltrials.gov)
    P1/2, N=409, Terminated, Pfizer | Phase classification: P1b/2 --> P1/2
    Phase classification • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    Bavencio (avelumab) • vidutolimod (CMP-001) • utomilumab (PF-05082566) • PD 360324 • ivuxolimab (PF-04518600)
    7ms
    Study of TLR9 Agonist Vidutolimod (CMP-001) in Combination With Nivolumab vs. Nivolumab (clinicaltrials.gov)
    P2, N=9, Active, not recruiting, Diwakar Davar | Suspended --> Active, not recruiting | N=36 --> 9 | Trial completion date: Jul 2030 --> Jul 2028
    Enrollment closed • Enrollment change • Trial completion date • Combination therapy
    |
    CD8 (cluster of differentiation 8)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • vidutolimod (CMP-001)
    8ms
    A Trial To Find Out If Vidutolimod Together With Cemiplimab Is Safe And If It Works In Adult Participants With Advanced Cancer Or Metastatic Cancer (clinicaltrials.gov)
    P2, N=225, Suspended, Regeneron Pharmaceuticals | Recruiting --> Suspended
    Trial suspension • Combination therapy • Metastases
    |
    Libtayo (cemiplimab-rwlc) • vidutolimod (CMP-001)
    8ms
    Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing (clinicaltrials.gov)
    P3, N=61, Active, not recruiting, Pfizer | Recruiting --> Active, not recruiting | N=262 --> 61 | Trial completion date: May 2025 --> Sep 2026 | Trial primary completion date: May 2025 --> Sep 2026
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    Bavencio (avelumab) • Talzenna (talazoparib) • pemetrexed • Inlyta (axitinib) • vidutolimod (CMP-001) • utomilumab (PF-05082566) • ivuxolimab (PF-04518600)
    8ms
    CMP-001 for Relapsed and Refractory Lymphoma (clinicaltrials.gov)
    P1/2, N=39, Suspended, Umar Farooq | Recruiting --> Suspended
    Trial suspension
    |
    Keytruda (pembrolizumab) • vidutolimod (CMP-001)
    8ms
    A Study Evaluating Whether Pembrolizumab Alone or in Combination With CMP-001 Improves Efficacy in Patients With Operable Melanoma (clinicaltrials.gov)
    P2, N=60, Suspended, National Cancer Institute (NCI) | Recruiting --> Suspended
    Trial suspension • Combination therapy
    |
    BRAF (B-raf proto-oncogene)
    |
    Keytruda (pembrolizumab) • vidutolimod (CMP-001)
    9ms
    CMP-001 in Combination With Nivolumab in Subjects With Advanced Melanoma (clinicaltrials.gov)
    P2, N=44, Completed, Regeneron Pharmaceuticals | Active, not recruiting --> Completed
    Trial completion • Combination therapy • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF V600
    |
    Opdivo (nivolumab) • vidutolimod (CMP-001)
    9ms
    Study of TLR9 Agonist Vidutolimod (CMP-001) in Combination With Nivolumab vs. Nivolumab (clinicaltrials.gov)
    P2, N=36, Suspended, Diwakar Davar | Recruiting --> Suspended
    Trial suspension • Combination therapy
    |
    CD8 (cluster of differentiation 8)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • vidutolimod (CMP-001)
    9ms
    Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing (clinicaltrials.gov)
    P3, N=262, Recruiting, Pfizer | Trial completion date: Dec 2025 --> May 2025 | Trial primary completion date: Dec 2025 --> May 2025
    Trial completion date • Trial primary completion date
    |
    Bavencio (avelumab) • Talzenna (talazoparib) • pemetrexed • Inlyta (axitinib) • vidutolimod (CMP-001) • utomilumab (PF-05082566) • ivuxolimab (PF-04518600)
    9ms
    A Trial To Find Out If Vidutolimod Together With Cemiplimab Is Safe And If It Works In Adult Participants With Advanced Cancer Or Metastatic Cancer (clinicaltrials.gov)
    P2, N=225, Recruiting, Regeneron Pharmaceuticals | Trial completion date: Mar 2027 --> Jul 2027 | Trial primary completion date: Mar 2027 --> Jul 2027
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Libtayo (cemiplimab-rwlc) • vidutolimod (CMP-001)
    9ms
    CMP-001 in Combination With Nivolumab in Subjects With Advanced Melanoma (clinicaltrials.gov)
    P2, N=44, Active, not recruiting, Regeneron Pharmaceuticals | Trial completion date: Oct 2024 --> Feb 2024 | Trial primary completion date: Oct 2024 --> Feb 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF V600
    |
    Opdivo (nivolumab) • vidutolimod (CMP-001)
    10ms
    CMP-001-007: CMP-001 in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=24, Completed, Regeneron Pharmaceuticals | Active, not recruiting --> Completed
    Trial completion
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • vidutolimod (CMP-001)
    1year
    CMP-001-007: CMP-001 in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=24, Active, not recruiting, Regeneron Pharmaceuticals | Trial completion date: Jul 2024 --> Jan 2024 | Trial primary completion date: Jul 2024 --> Jan 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • vidutolimod (CMP-001)
    1year
    Combination Treatment of Intratumoral Vidutolimod, Radiosurgery, Nivolumab, and Ipilimumab for Microsatellite Stable Colorectal Carcinoma With Liver Metastases. (PubMed, Clin Colorectal Cancer)
    The combination of intratumoral vidutolimod, radiosurgery, nivolumab and ipilimumab was not found to be efficacious in MSS mCRC with liver metastases. The juxtaposition of liver irradiation and intratumoral vidutolimod injection was associated with high hepatic toxicity.
    Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker • Surgery
    |
    TMB (Tumor Mutational Burden) • CXCL10 (Chemokine (C-X-C motif) ligand 10) • IL10 (Interleukin 10)
    |
    TMB-H
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • vidutolimod (CMP-001)
    over1year
    A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley) (clinicaltrials.gov)
    P1b/2, N=405, Terminated, Pfizer | Active, not recruiting --> Terminated; The study was terminated since there was no need for further safety or efficacy data to be collected. The participants having benefit from the Investigational treatments have been moved to a continuation study (NCT05059522)
    Trial termination • Combination therapy • IO biomarker • Metastases
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • CD8 (cluster of differentiation 8)
    |
    PD-L1 expression • EGFR mutation • ALK translocation
    |
    Bavencio (avelumab) • vidutolimod (CMP-001) • utomilumab (PF-05082566) • PD 360324 • ivuxolimab (PF-04518600)
    over1year
    CMP-001 in Combo With Nivolumab in Stage IIIB/C/D Melanoma Patients With Clinically Apparent Lymph Node Disease (clinicaltrials.gov)
    P2, N=34, Active, not recruiting, Diwakar Davar | Trial completion date: Mar 2023 --> Dec 2023
    Trial completion date • Combination therapy
    |
    SOX10 (SRY-Box 10)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • vidutolimod (CMP-001)
    over1year
    A Trial to Find Out if Vidutolimod Together With Cemiplimab is Safe and if it Works in Adult Participants With Advanced Cancer or Metastatic Cancer (clinicaltrials.gov)
    P2, N=200, Recruiting, Regeneron Pharmaceuticals | Trial completion date: Apr 2026 --> Mar 2027 | Trial primary completion date: Apr 2026 --> Mar 2027
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Libtayo (cemiplimab-rwlc) • vidutolimod (CMP-001)
    over1year
    CMP-001 and INCAGN01949 for Patients With Stage IV Pancreatic Cancer and Other Cancers Except Melanoma (clinicaltrials.gov)
    P1/2, N=2, Terminated, University of Southern California | N=42 --> 2 | Trial completion date: Apr 2024 --> Dec 2022 | Recruiting --> Terminated | Trial primary completion date: Apr 2023 --> Dec 2022; Study drug no longer available
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Combination therapy • Metastases
    |
    BRCA (Breast cancer early onset)
    |
    BRCA mutation
    |
    vidutolimod (CMP-001) • INCAGN1949
    over1year
    Vidutolimod in Combination With Atezolizumab With and Without Radiation Therapy in Patients With Programmed Cell Death Protein 1 or Programmed Death-Ligand 1 Blockade-Resistant Advanced NSCLC. (PubMed, JTO Clin Res Rep)
    In the two patients with initial tumor shrinkage in part A, a strong serum induction of C-X-C motif chemokine ligand 10 was observed. Vidutolimod and atezolizumab with and without RT had a manageable safety profile, with minimal clinical activity in heavily pretreated patients with programmed cell death protein 1 or programmed death-ligand 1 blockade-resistant NSCLC.
    Journal • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1) • CXCL10 (Chemokine (C-X-C motif) ligand 10)
    |
    Tecentriq (atezolizumab) • vidutolimod (CMP-001)
    over1year
    The XernaTM TME Panel potentially predicts response to a combination of the TLR9 agonist vidutolimod and PD-1 inhibitor pembrolizumab in metastatic melanomas with prior anti-PD-1 treatment (AACR 2023)
    The Xerna TME Panel shows potential activity as a predictive and pharmacodynamic biomarker for the combination of vidutolimod and pembrolizumab in anti-PD-1 refractory melanoma patients.
    PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    Xerna TME™ Panel
    |
    Keytruda (pembrolizumab) • vidutolimod (CMP-001)
    almost2years
    CMP-001 in Combination With Nivolumab in Subjects With Advanced Melanoma (clinicaltrials.gov)
    P2, N=44, Active, not recruiting, Regeneron Pharmaceuticals | Trial completion date: Feb 2023 --> Oct 2024 | Trial primary completion date: Feb 2023 --> Oct 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF V600
    |
    Opdivo (nivolumab) • vidutolimod (CMP-001)
    almost2years
    Study of TLR9 Agonist Vidutolimod (CMP-001) in Combination With Nivolumab vs. Nivolumab (clinicaltrials.gov)
    P2, N=36, Recruiting, Diwakar Davar | Trial completion date: Jul 2028 --> Jul 2030 | Trial primary completion date: Jul 2023 --> Jul 2028
    Trial completion date • Trial primary completion date • Combination therapy
    |
    CD8 (cluster of differentiation 8)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • vidutolimod (CMP-001)
    almost2years
    Study of TLR9 Agonist Vidutolimod (CMP-001) in Combination With Nivolumab vs. Nivolumab (clinicaltrials.gov)
    P2, N=36, Recruiting, Diwakar Davar | N=26 --> 36
    Enrollment change • Combination therapy
    |
    CD8 (cluster of differentiation 8)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • vidutolimod (CMP-001)
    almost2years
    CMP-001 in Combination With IV PD-1-Blocking Antibody in Subjects With Certain Types of Advanced or Metastatic Cancer (clinicaltrials.gov)
    P2, N=279, Recruiting, Regeneron Pharmaceuticals | Trial completion date: Jan 2024 --> Apr 2026 | Trial primary completion date: Sep 2023 --> Apr 2026
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    HER-2 negative • PGR negative
    |
    Libtayo (cemiplimab-rwlc) • vidutolimod (CMP-001)
    2years
    CMP-001-007: CMP-001 in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=24, Active, not recruiting, Regeneron Pharmaceuticals | Trial completion date: Nov 2023 --> Jul 2024 | Trial primary completion date: Jul 2022 --> Jul 2024
    Trial completion date • Trial primary completion date • Combination therapy • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • vidutolimod (CMP-001)
    over2years
    A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley) (clinicaltrials.gov)
    P1b/2, N=398, Active, not recruiting, Pfizer | Trial completion date: Apr 2022 --> Feb 2023 | Trial primary completion date: Apr 2022 --> Feb 2023
    Trial completion date • Trial primary completion date • Combination therapy • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • CD8 (cluster of differentiation 8)
    |
    PD-L1 expression • EGFR mutation • ALK translocation
    |
    Bavencio (avelumab) • vidutolimod (CMP-001) • utomilumab (PF-05082566) • PD 360324 • ivuxolimab (PF-04518600)
    over2years
    CMP-001-007: CMP-001 in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=24, Active, not recruiting, Checkmate Pharmaceuticals | Recruiting --> Active, not recruiting | N=43 --> 24
    Enrollment closed • Enrollment change • Combination therapy • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • vidutolimod (CMP-001)
    over2years
    CMP-001 in Combination With Nivolumab in Subjects With Advanced Melanoma (clinicaltrials.gov)
    P2, N=44, Active, not recruiting, Checkmate Pharmaceuticals | Recruiting --> Active, not recruiting | N=100 --> 44
    Enrollment closed • Enrollment change • Combination therapy
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF V600
    |
    Opdivo (nivolumab) • vidutolimod (CMP-001)
    over2years
    CMP-001 in Combo With Nivolumab in Stage IIIB/C/D Melanoma Patients With Clinically Apparent Lymph Node Disease (clinicaltrials.gov)
    P2, N=34, Active, not recruiting, Diwakar Davar | Completed --> Active, not recruiting | Trial completion date: Mar 2021 --> Mar 2023
    Enrollment closed • Trial completion date • Combination therapy
    |
    SOX10 (SRY-Box 10)
    |
    Opdivo (nivolumab) • vidutolimod (CMP-001)
    3years
    CMP-001 and INCAGN01949 for Patients With Stage IV Pancreatic Cancer and Other Cancers Except Melanoma (clinicaltrials.gov)
    P1/2, N=42, Recruiting, University of Southern California | Not yet recruiting --> Recruiting
    Clinical • Enrollment open • Combination therapy
    |
    BRCA (Breast cancer early onset)
    |
    BRCA mutation
    |
    vidutolimod (CMP-001) • INCAGN1949
    3years
    CMP-001 in Combination With IV PD-1-Blocking Antibody in Subjects With Certain Types of Advanced or Metastatic Cancer (clinicaltrials.gov)
    P2, N=268, Recruiting, Checkmate Pharmaceuticals | Initiation date: Aug 2021 --> Jan 2022 | Trial primary completion date: Jun 2022 --> Sep 2023 | Initiation date: Aug 2021 --> Jan 2022
    Clinical • Trial initiation date • Trial primary completion date • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    HER-2 negative • PGR negative
    |
    Libtayo (cemiplimab-rwlc) • vidutolimod (CMP-001)