^
    7d
    MORPHEUS-PDAC: A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer) (clinicaltrials.gov)
    P1/2, N=340, Active, not recruiting, Hoffmann-La Roche | Trial completion date: Oct 2026 --> Jan 2025 | Trial primary completion date: Oct 2025 --> Jan 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • gemcitabine • 5-fluorouracil • Cotellic (cobimetinib) • albumin-bound paclitaxel • oxaliplatin • leucovorin calcium • Actemra IV (tocilizumab) • tiragolumab (RG6058) • etrumadenant (AB928) • pegvorhyaluronidase alfa (PEGPH20) • Aphexda (motixafortide) • selicrelumab (RG7876) • simlukafusp alfa (RG7461)
    3ms
    Morpheus-TNBC: A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer (clinicaltrials.gov)
    P1/2 | N=580 | Recruiting | Sponsor: Hoffmann-La Roche | N=242 ➔ 580 | Trial completion date: May 2026 ➔ May 2028 | Trial primary completion date: May 2026 ➔ May 2028
    Trial completion date • Trial primary completion date • Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    VENTANA PD-L1 (SP142) Assay
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • carboplatin • gemcitabine • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • Verzenio (abemaciclib) • albumin-bound paclitaxel • Kisqali (ribociclib) • fulvestrant • Halaven (eribulin mesylate) • letrozole • ipatasertib (RG7440) • Trodelvy (sacituzumab govitecan-hziy) • Itovebi (inavolisib) • Actemra IV (tocilizumab) • ladiratuzumab vedotin (SGN-LIV1A) • selicrelumab (RG7876)
    9ms
    Systemic Immune Response to a CD40-Agonist Antibody in Nonhuman Primates. (PubMed, J Leukoc Biol)
    Two independent studies in cynomolgus macaque (Macaca fascicularis) studies were performed to further evaluate, potentially immunotoxicological effects associated with drug-induced adverse events seen in human subjects. Studies conducted in monkeys showed that when selicrelumab is administered at doses currently used in clinical trial patients, via subcutaneous injection, it is safe and effective at stimulating a systemic immune response.
    Journal
    |
    TNFA (Tumor Necrosis Factor-Alpha) • CD40 (CD40 Molecule) • ACACA (Acetyl-CoA Carboxylase Alpha)
    |
    selicrelumab (RG7876)
    11ms
    Harnessing the potential of CD40 agonism in cancer therapy. (PubMed, Cytokine Growth Factor Rev)
    In this review, we present the current understanding of the mechanism of action for CD40, along with results from the clinical development of agonistic human CD40 antibodies in cancer treatment (selicrelumab, CDX-1140, APX005M, mitazalimab, 2141-V11, SEA-CD40, LVGN7409, and bispecific antibodies). This review also examines the safety profile of CD40 agonists in both preclinical and clinical settings, highlighting optimized dosage levels, potential adverse effects, and strategies to mitigate them.
    Review • Journal • IO biomarker
    |
    CD8 (cluster of differentiation 8) • TNFA (Tumor Necrosis Factor-Alpha) • CD40 (CD40 Molecule) • CD40LG (CD40 ligand)
    |
    CDX-1140 • cifurtilimab (SEA-CD40) • dalnicastobart (LVGN7409) • mitazalimab (ADC-1013) • selicrelumab (RG7876) • sotigalimab (PYX-107)
    12ms
    MORPHEUS-PDAC: A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer) (clinicaltrials.gov)
    P1/2, N=340, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    PD-L1 (Programmed death ligand 1)
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • gemcitabine • 5-fluorouracil • Cotellic (cobimetinib) • albumin-bound paclitaxel • oxaliplatin • leucovorin calcium • Actemra IV (tocilizumab) • tiragolumab (RG6058) • etrumadenant (AB928) • pegvorhyaluronidase alfa (PEGPH20) • Aphexda (motixafortide) • selicrelumab (RG7876) • simlukafusp alfa (RG7461)
    1year
    Morpheus-TNBC: A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer (clinicaltrials.gov)
    P1/2; Active, not recruiting --> Recruiting
    Enrollment open • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    PD-L1 expression • PIK3CA mutation
    |
    VENTANA PD-L1 (SP142) Assay
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • carboplatin • gemcitabine • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • Verzenio (abemaciclib) • albumin-bound paclitaxel • Kisqali (ribociclib) • fulvestrant • Halaven (eribulin mesylate) • ipatasertib (RG7440) • Trodelvy (sacituzumab govitecan-hziy) • Itovebi (inavolisib) • Actemra IV (tocilizumab) • ladiratuzumab vedotin (SGN-LIV1A) • selicrelumab (RG7876)
    1year
    MORPHEUS-PDAC: A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer) (clinicaltrials.gov)
    P1/2, N=340, Recruiting, Hoffmann-La Roche | Trial completion date: Jun 2024 --> Oct 2026 | Trial primary completion date: Jun 2024 --> Oct 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • gemcitabine • 5-fluorouracil • Cotellic (cobimetinib) • albumin-bound paclitaxel • oxaliplatin • leucovorin calcium • Actemra IV (tocilizumab) • tiragolumab (RG6058) • etrumadenant (AB928) • pegvorhyaluronidase alfa (PEGPH20) • Aphexda (motixafortide) • selicrelumab (RG7876) • simlukafusp alfa (RG7461)
    over1year
    Morpheus-TNBC: A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer (clinicaltrials.gov)
    P1/2; N=133 --> 242 | Trial completion date: May 2024 --> May 2026 | Trial primary completion date: May 2024 --> May 2026
    Trial completion date • Trial primary completion date • Enrollment change • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    PD-L1 expression • PIK3CA mutation
    |
    VENTANA PD-L1 (SP142) Assay
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • carboplatin • gemcitabine • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • Verzenio (abemaciclib) • albumin-bound paclitaxel • Kisqali (ribociclib) • fulvestrant • Halaven (eribulin mesylate) • ipatasertib (RG7440) • Trodelvy (sacituzumab govitecan-hziy) • Itovebi (inavolisib) • Actemra IV (tocilizumab) • ladiratuzumab vedotin (SGN-LIV1A) • selicrelumab (RG7876)
    almost2years
    Morpheus-TNBC: A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic or Inoperable Locally Advanced Triple-Negative Breast Cancer (clinicaltrials.gov)
    P1/2; N=280 --> 133
    Enrollment change • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    PD-L1 expression • PIK3CA mutation
    |
    VENTANA PD-L1 (SP142) Assay
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • carboplatin • gemcitabine • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • Verzenio (abemaciclib) • albumin-bound paclitaxel • Kisqali (ribociclib) • fulvestrant • Halaven (eribulin mesylate) • ipatasertib (RG7440) • Trodelvy (sacituzumab govitecan-hziy) • Itovebi (inavolisib) • Actemra IV (tocilizumab) • ladiratuzumab vedotin (SGN-LIV1A) • selicrelumab (RG7876)
    2years
    Morpheus-TNBC: A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic or Inoperable Locally Advanced Triple-Negative Breast Cancer (clinicaltrials.gov)
    P1/2; Recruiting --> Active, not recruiting | Trial completion date: Sep 2023 --> May 2024 | Trial primary completion date: Sep 2023 --> May 2024
    Trial completion date • Trial primary completion date • Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • HER-2 expression • PGR expression
    |
    VENTANA PD-L1 (SP142) Assay
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • carboplatin • gemcitabine • capecitabine • albumin-bound paclitaxel • Halaven (eribulin mesylate) • ipatasertib (RG7440) • Trodelvy (sacituzumab govitecan-hziy) • Actemra IV (tocilizumab) • ladiratuzumab vedotin (SGN-LIV1A) • selicrelumab (RG7876)
    over2years
    Morpheus-TNBC: A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic or Inoperable Locally Advanced Triple-Negative Breast Cancer (clinicaltrials.gov)
    P1/2; Trial completion date: Mar 2023 --> Sep 2023 | Trial primary completion date: Mar 2023 --> Sep 2023
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • HER-2 expression • PGR expression
    |
    VENTANA PD-L1 (SP142) Assay
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • carboplatin • gemcitabine • capecitabine • albumin-bound paclitaxel • Halaven (eribulin mesylate) • ipatasertib (RG7440) • Trodelvy (sacituzumab govitecan-hziy) • Actemra IV (tocilizumab) • ladiratuzumab vedotin (SGN-LIV1A) • selicrelumab (RG7876)
    over2years
    MORPHEUS-PDAC: A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer) (clinicaltrials.gov)
    P1/2, N=290, Recruiting, Hoffmann-La Roche | Active, not recruiting --> Recruiting
    Enrollment open
    |
    PD-L1 (Programmed death ligand 1)
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • gemcitabine • 5-fluorouracil • Cotellic (cobimetinib) • albumin-bound paclitaxel • oxaliplatin • leucovorin calcium • Actemra IV (tocilizumab) • tiragolumab (RG6058) • etrumadenant (AB928) • pegvorhyaluronidase alfa (PEGPH20) • Aphexda (motixafortide) • selicrelumab (RG7876) • simlukafusp alfa (RG7461)
    over2years
    MORPHEUS-PDAC: A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer) (clinicaltrials.gov)
    P1/2, N=290, Active, not recruiting, Hoffmann-La Roche | Trial completion date: Nov 2022 --> Jun 2024 | Trial primary completion date: Nov 2022 --> Jun 2024
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • gemcitabine • 5-fluorouracil • Cotellic (cobimetinib) • albumin-bound paclitaxel • oxaliplatin • leucovorin calcium • Actemra IV (tocilizumab) • tiragolumab (RG6058) • etrumadenant (AB928) • pegvorhyaluronidase alfa (PEGPH20) • Aphexda (motixafortide) • selicrelumab (RG7876) • simlukafusp alfa (RG7461)
    over3years
    MORPHEUS-PDAC: A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer) (clinicaltrials.gov)
    P1/2, N=290, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting
    Clinical • Enrollment closed
    |
    PD-L1 (Programmed death ligand 1)
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • gemcitabine • 5-fluorouracil • Cotellic (cobimetinib) • albumin-bound paclitaxel • oxaliplatin • leucovorin calcium • Actemra IV (tocilizumab) • tiragolumab (RG6058) • etrumadenant (AB928) • pegvorhyaluronidase alfa (PEGPH20) • Aphexda (motixafortide) • selicrelumab (RG7876) • simlukafusp alfa (RG7461)
    over3years
    Co-Stimulatory versus Cell Death Aspects of Agonistic CD40 Monoclonal Antibody Selicrelumab in Chronic Lymphocytic Leukemia. (PubMed, Cancers (Basel))
    Taken together, these novel insights into selicrelumab-stimulatory effects in CLL may be considered for developing new therapeutic strategies, particularly in combination with obinutuzumab.
    Journal • IO biomarker
    |
    BCL2 (B-cell CLL/lymphoma 2) • CD20 (Membrane Spanning 4-Domains A1) • TNFA (Tumor Necrosis Factor-Alpha) • FAS (Fas cell surface death receptor) • CD40 (CD40 Molecule) • CD40LG (CD40 ligand) • CD86 (CD86 Molecule)
    |
    CD20 positive • BCL2 expression
    |
    Venclexta (venetoclax) • Rituxan (rituximab) • Gazyva (obinutuzumab) • selicrelumab (RG7876)
    over3years
    Neoadjuvant selicrelumab, an agonist CD40 antibody, induces changes in the tumor microenvironment in patients with resectable pancreatic cancer. (PubMed, Clin Cancer Res)
    This unparalleled examination of CD40 therapeutic mechanisms in patients provides insights for design of subsequent clinical trials targeting this pathway.
    Clinical • Journal
    |
    CXCL10 (Chemokine (C-X-C motif) ligand 10) • CCL2 (Chemokine (C-C motif) ligand 2) • CCL22 (C-C Motif Chemokine Ligand 22) • CD40 (CD40 Molecule)
    |
    selicrelumab (RG7876)
    over3years
    MORPHEUS-PDAC: A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer) (clinicaltrials.gov)
    P1/2, N=290, Recruiting, Hoffmann-La Roche | Trial completion date: Nov 2021 --> Nov 2022 | Trial primary completion date: Nov 2021 --> Nov 2022
    Clinical • Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • gemcitabine • 5-fluorouracil • Cotellic (cobimetinib) • albumin-bound paclitaxel • oxaliplatin • leucovorin calcium • Actemra IV (tocilizumab) • tiragolumab (RG6058) • etrumadenant (AB928) • pegvorhyaluronidase alfa (PEGPH20) • Aphexda (motixafortide) • selicrelumab (RG7876) • simlukafusp alfa (RG7461)
    over3years
    Agonistic CD40 Antibodies in Cancer Treatment. (PubMed, Cancers (Basel))
    The reduction in tumor growth and ability to reprogram the tumor microenvironment in preclinical models lays the foundation for clinical development of agonistic CD40 antibodies (APX005M, ChiLob7/4, ADC-1013, SEA-CD40, selicrelumab, and CDX-1140) that are currently being evaluated in early phase clinical trials. In this article, we focus on CD40 expression and immunity in cancer, agonistic human CD40 antibodies, and their pre-clinical and clinical development. With the broad pro-inflammatory effects of CD40 and its ligand on dendritic cells and macrophages, and downstream B and T cell activation, agonists of this pathway may enhance the anti-tumor activity of other systemic therapies.
    Review • Journal • IO biomarker
    |
    CD8 (cluster of differentiation 8) • CD40 (CD40 Molecule)
    |
    CD40 expression
    |
    CDX-1140 • Chi Lob 7/4 • cifurtilimab (SEA-CD40) • mitazalimab (ADC-1013) • selicrelumab (RG7876) • sotigalimab (PYX-107)
    over3years
    [VIRTUAL] T cell inflammation in the tumor microenvironment after agonist CD40 antibody: Clinical and translational results of a neoadjuvant clinical trial (AACR 2021)
    Here, we performed a neoadjuvant clinical trial of agonistic CD40 mAb (selicrelumab) administered intravenously with or without chemotherapy (gemcitabine and nab-paclitaxel) to 16 resectable patients with pancreatic ductal adenocarcinoma (PDAC) prior to surgery followed by adjuvant chemotherapy and CD40 mAb. This study provides proof-of-concept in patients that agonistic CD40 mAb alters the TME, enhances T-cell infiltration, and modulates systemic inflammatory responses. These findings inform design of next-generation CD40 clinical trials.
    Clinical
    |
    CD8 (cluster of differentiation 8) • CXCL10 (Chemokine (C-X-C motif) ligand 10) • CCL2 (Chemokine (C-C motif) ligand 2) • CCL22 (C-C Motif Chemokine Ligand 22) • CD40 (CD40 Molecule)
    |
    gemcitabine • albumin-bound paclitaxel • selicrelumab (RG7876)
    4years
    Phase Ib study of anti-CSF-1R antibody emactuzumab in combination with CD40 agonist selicrelumab in advanced solid tumor patients. (PubMed, J Immunother Cancer)
    Emactuzumab in combination with selicrelumab demonstrated a manageable safety profile and evidence of PD activity but did not translate into objective clinical responses.
    Clinical • P1 data • Journal • Combination therapy
    |
    CD14 (CD14 Molecule) • CSF1R (Colony stimulating factor 1 receptor)
    |
    emactuzumab (RG7155) • selicrelumab (RG7876)
    4years
    [VIRTUAL] Phase Ib/II open-label, randomized evaluation of atezolizumab (atezo) + selicrelumab (seli) + gemcitabine+nab-paclitaxel (gem+nabP) or bevacizumab (bev) vs control in MORPHEUS-PDAC, -TNBC and -CRC (SITC 2020)
    Control treatments were gem+nabP in PDAC, capecitabine in TNBC, and regorafenib in CRC. Preliminary efficacy was observed for atezo+seli+gem+nabP in PDAC. Together with preliminary evidence of on-treatment pharmacodynamic effects in CRC and TNBC tumor samples, CD40 agonist strategies warrant further investigation.
    P1/2 data • Clinical • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • CD40 (CD40 Molecule)
    |
    PD-L1 expression • PD-L1 negative
    |
    VENTANA PD-L1 (SP142) Assay
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • gemcitabine • capecitabine • albumin-bound paclitaxel • Stivarga (regorafenib) • selicrelumab (RG7876)
    4years
    [VIRTUAL] Phase Ib/II open-label, randomized evaluation of atezolizumab (atezo) + selicrelumab (seli) + gemcitabine+nab-paclitaxel (gem+nabP) or bevacizumab (bev) vs control in MORPHEUS-PDAC, -TNBC and -CRC (SITC 2020)
    Control treatments were gem+nabP in PDAC, capecitabine in TNBC, and regorafenib in CRC. Preliminary efficacy was observed for atezo+seli+gem+nabP in PDAC. Together with preliminary evidence of on-treatment pharmacodynamic effects in CRC and TNBC tumor samples, CD40 agonist strategies warrant further investigation.
    P1/2 data • Clinical • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • CD40 (CD40 Molecule)
    |
    PD-L1 expression • PD-L1 negative
    |
    VENTANA PD-L1 (SP142) Assay
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • gemcitabine • capecitabine • albumin-bound paclitaxel • Stivarga (regorafenib) • selicrelumab (RG7876)
    over4years
    Morpheus-TNBC: A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic or Inoperable Locally Advanced Triple-Negative Breast Cancer (clinicaltrials.gov)
    P1/2, N=280, Recruiting, Hoffmann-La Roche | Trial completion date: May 2023 --> Jan 2023 | Trial primary completion date: May 2023 --> Jan 2023
    Clinical • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • HER-2 expression
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • carboplatin • gemcitabine • capecitabine • albumin-bound paclitaxel • Halaven (eribulin mesylate) • ipatasertib (RG7440) • Trodelvy (sacituzumab govitecan-hziy) • Actemra IV (tocilizumab) • ladiratuzumab vedotin (SGN-LIV1A) • selicrelumab (RG7876)
    over4years
    MORPHEUS-PDAC: A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer) (clinicaltrials.gov)
    P1/2; Trial completion date: Feb 2022 --> Nov 2021 | Trial primary completion date: Feb 2022 --> Nov 2021
    Trial completion date • Trial primary completion date • Clinical
    |
    PD-L1 (Programmed death ligand 1)
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • gemcitabine • 5-fluorouracil • Cotellic (cobimetinib) • albumin-bound paclitaxel • oxaliplatin • leucovorin calcium • Actemra IV (tocilizumab) • tiragolumab (RG6058) • etrumadenant (AB928) • pegvorhyaluronidase alfa (PEGPH20) • Aphexda (motixafortide) • selicrelumab (RG7876) • simlukafusp alfa (RG7461)
    almost5years
    A Study of Selicrelumab (RO7009789) in Combination With Atezolizumab in Participants With Locally Advanced and/or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=140, Completed, Hoffmann-La Roche | Active, not recruiting --> Completed
    Clinical • Trial completion • Combination therapy • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8)
    |
    PD-L1 expression
    |
    Tecentriq (atezolizumab) • selicrelumab (RG7876)
    almost5years
    MORPHEUS-PDAC: A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer) (clinicaltrials.gov)
    P1/2; Trial completion date: Sep 2020 --> Feb 2022 | Trial primary completion date: Nov 2019 --> Feb 2022
    Trial completion date • Trial primary completion date • Clinical
    |
    PD-L1 (Programmed death ligand 1)
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • gemcitabine • 5-fluorouracil • Cotellic (cobimetinib) • albumin-bound paclitaxel • oxaliplatin • leucovorin calcium • Actemra IV (tocilizumab) • tiragolumab (RG6058) • etrumadenant (AB928) • pegvorhyaluronidase alfa (PEGPH20) • Aphexda (motixafortide) • selicrelumab (RG7876) • simlukafusp alfa (RG7461)
    5years
    A Study of Selicrelumab (RO7009789) in Combination With Atezolizumab in Participants With Locally Advanced and/or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=142, Active, not recruiting, Hoffmann-La Roche | N=230 --> 142
    Clinical • Enrollment change • Combination therapy • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8)
    |
    PD-L1 expression
    |
    Tecentriq (atezolizumab) • selicrelumab (RG7876)
    over5years
    A Study of Selicrelumab (RO7009789) in Combination With Atezolizumab in Participants With Locally Advanced and/or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=230, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting | Trial completion date: Jun 2019 --> Oct 2019 | Trial primary completion date: Jun 2019 --> Oct 2019
    Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8)
    |
    PD-L1 expression
    |
    Tecentriq (atezolizumab) • selicrelumab (RG7876)
    over5years
    A Study of Selicrelumab (RO7009789) in Combination With Atezolizumab in Participants With Locally Advanced and/or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=230, Recruiting, Hoffmann-La Roche | Trial completion date: Oct 2019 --> Jun 2019 | Trial primary completion date: Oct 2019 --> Jun 2019
    Clinical • Trial completion date • Trial primary completion date • Combination therapy • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8)
    |
    PD-L1 expression
    |
    Tecentriq (atezolizumab) • selicrelumab (RG7876)
    almost6years
    A Study of Emactuzumab and RO7009789 Administered in Combination in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=38, Completed, Hoffmann-La Roche | Active, not recruiting --> Completed | N=146 --> 38 | Trial completion date: Jul 2018 --> Apr 2018 | Trial primary completion date: Jul 2018 --> Apr 2018
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    emactuzumab (RG7155) • selicrelumab (RG7876)
    6years
    Combination of subcutaneous selicrelumab (CD40 agonist) and vanucizumab (anti-Ang2/VEGF) in patients with solid tumors demonstrates early clinical activity and a favorable safety profile (SITC 2018)
    Trial Registrationl This study is registered on Clinicaltrials.gov: NCT02665416 ; Background Selicrelumab is a fully human agonistic IgG2 monoclonal antibody to CD40, a member of the TNFreceptor superfamily expressed on antigenpresenting cells (APC), endothelial cells and some tumors. The combination demonstrated a favorable safety profile with no evidence for systemic autoimmune toxicity. The results triggered an expansion of the study in selected tumor indications with 16mg SC selicrelumab in combination with bevacizumab (anti- VEGF).
    Clinical • IO biomarker
    |
    ANGPT2 (Angiopoietin 2)
    |
    Avastin (bevacizumab) • selicrelumab (RG7876) • vanucizumab (RG7221)
    6years
    MORPHEUS-PDAC: A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer) (clinicaltrials.gov)
    P1/2; Trial completion date: Apr 2020 --> Sep 2020
    Trial completion date • Clinical
    |
    PD-L1 (Programmed death ligand 1)
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • gemcitabine • 5-fluorouracil • Cotellic (cobimetinib) • albumin-bound paclitaxel • oxaliplatin • leucovorin calcium • Actemra IV (tocilizumab) • tiragolumab (RG6058) • etrumadenant (AB928) • pegvorhyaluronidase alfa (PEGPH20) • Aphexda (motixafortide) • selicrelumab (RG7876) • simlukafusp alfa (RG7461)
    over6years
    Study Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Therapeutic Activity of Selicrelumab (RO7009789) With Vanucizumab or Bevacizumab in Participants With Metastatic Solid Tumors (clinicaltrials.gov)
    P1; N=170; Recruiting; Sponsor: Hoffmann-La Roche; Trial completion date: Nov 2019 --> Jun 2020; Trial primary completion date: Nov 2019 --> Jun 2020
    Trial completion date • Trial primary completion date
    |
    Avastin (bevacizumab) • selicrelumab (RG7876) • vanucizumab (RG7221)
    over6years
    A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer (Morpheus-CRC) (clinicaltrials.gov)
    P1/2; N=120; Not yet recruiting; Sponsor: Hoffmann-La Roche
    New P1/2 trial
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • Stivarga (regorafenib) • Sarclisa (isatuximab-irfc) • idasanutlin (RG7388) • etrumadenant (AB928) • Imprime PGG (odetiglucan) • delolimogene mupadenorepvec (LOAd703) • selicrelumab (RG7876)
    over6years
    A Study of Emactuzumab and RO7009789 Administered in Combination in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1; N=38; Completed; Sponsor: Hoffmann-La Roche; Active, not recruiting --> Completed; N=146 --> 38; Trial completion date: Jul 2018 --> Apr 2018; Trial primary completion date: Jul 2018 --> Apr 2018
    Trial completion date • Trial primary completion date • Enrollment change • Trial completion • Clinical
    |
    emactuzumab (RG7155) • selicrelumab (RG7876)
    over6years
    A Study of Emactuzumab and RO7009789 Administered in Combination in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=146, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    emactuzumab (RG7155) • selicrelumab (RG7876)