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Therapy Name | Avelumab |
Synonyms | |
Therapy Description |
Bavencio (avelumab) is a monoclonal antibody binds to human immunosuppressive ligand programmed death-ligand 1 (PD-L1, CD274) and blocks protein signaling, resulting in immune regulation and antitumor immunity (PMID: 26014098). Bavencio (avelumab) is FDA-approved for use in patients with metastatic Merkel cell carcinoma and urothelial carcinoma, and in combination with axitinib in advanced renal cell carcinoma (FDA.gov). |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Avelumab | Bavencio | MSB0010718C | Immune Checkpoint Inhibitor 141 PD-L1/PD-1 antibody 83 | Bavencio (avelumab) is a monoclonal antibody binds to human immunosuppressive ligand programmed death-ligand 1 (PD-L1, CD274) and blocks protein signaling, resulting in immune regulation and antitumor immunity (PMID: 26014098). Bavencio (avelumab) is FDA-approved for use in adult and pediatric patients of 12 years or older with metastatic Merkel cell carcinoma, as maintenance therapy in locally advanced or metastatic urothelial carcinoma (UC), in locally advanced or metastatic UC that progressed following chemotherapy, and in combination with axitinib as first-line therapy in advanced renal cell carcinoma (FDA.gov). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
MLH1 negative | endometrial carcinoma | sensitive | Avelumab | Guideline | Actionable | Bavencio (avelumab) is included in guidelines as a second-line therapy for patients with high microsatellite instability (MSI-H) or mismatch repair deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) recurrent, metastatic, or high-risk endometrial carcinoma (NCCN.org). | detail... |
MSH6 negative | endometrial carcinoma | sensitive | Avelumab | Guideline | Actionable | Bavencio (avelumab) is included in guidelines as a second-line therapy for patients with high microsatellite instability (MSI-H) or mismatch repair deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) recurrent, metastatic, or high-risk endometrial carcinoma (NCCN.org). | detail... |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT03260023 | Phase Ib/II | Avelumab Avelumab + Tipapkinogene sovacivec | Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers | Recruiting | USA | FRA | ESP | 0 |
NCT02576574 | Phase III | Gemcitabine Paclitaxel Cisplatin Avelumab Pemetrexed Disodium Carboplatin | Avelumab in First-line Non-Small Cell Lung Cancer (JAVELIN Lung 100) | Active, not recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | 35 |
NCT02968940 | Phase II | Avelumab | Avelumab With Hypofractionated Radiation Therapy in Adults With Isocitrate Dehydrogenase (IDH) Mutant Glioblastoma | Completed | USA | 0 |
NCT02875613 | Phase II | Avelumab | Avelumab for Recurrent/Metastatic Nasopharyngeal Cancer | Terminated | USA | 0 |
NCT03047473 | Phase II | Avelumab | Avelumab in Patients With Newly Diagnosed Glioblastoma Multiforme (SEJ) | Active, not recruiting | CAN | 0 |
NCT03815643 | Phase III | Avelumab | Avelumab Program Rollover Study | Active, not recruiting | USA | BEL | 6 |
NCT03312114 | Phase II | Avelumab | Anti—PD-L1 and SAbR for Ovarian Cancer | Terminated | USA | 0 |
NCT04068194 | Phase Ib/II | Avelumab Avelumab + Peposertib | Testing the Combination of New Anti-cancer Drug Nedisertib With Avelumab and Radiation Therapy for Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies | Recruiting | USA | 0 |
NCT02767063 | Phase Ib/II | Avelumab Pioglitazone | Therapies in Combination or Sequentially With Tyrosine Kinase Inhibitors (TKIs) in Chronic Phase Chronic Myelogenous Leukemia Patients in CCR (ACTIW) | Recruiting | FRA | 0 |
NCT04065555 | Phase I | Avelumab + TAK-981 Cetuximab Cetuximab + TAK-981 TAK-981 Avelumab | Intratumoral Microdosing of TAK-981 in Head and Neck Cancer | Recruiting | USA | 0 |
NCT03387098 | Phase Ib/II | GI-4000 Leucovorin Nab-paclitaxel Bevacizumab Avelumab ALT-803 Fluorouracil ETBX-011 Oxaliplatin Aldoxorubicin Capecitabine Cyclophosphamide | QUILT-3.070: Molecularly Informed Integrated Immunotherapy Combining Innate High-affinity Natural Killer (haNK) Cell Therapy With Adenoviral and Yeast-based Vaccines to Induce T-cell Responses in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy | Unknown status | USA | 0 |
NCT03135769 | Phase II | Avelumab | Avelumab in Chemo-resistant Gestational Trophoblastic Neoplasias (TROPHIMMUN) | Completed | FRA | 0 |
NCT02912572 | Phase II | Avelumab + Talazoparib Avelumab Avelumab + Axitinib | Avelumab in Patients With MSS, MSI-H and POLE-mutated Recurrent or Persistent Endometrial Cancer and of Avelumab/Talazoparib and Avelumab/Axitinib in Patients With MSS Recurrent or Persistent Endometrial Cancer | Recruiting | USA | 0 |
NCT03387111 | Phase Ib/II | Capecitabine Nab-paclitaxel Leucovorin GI-6301 GI-6207 Avelumab ETBX-021 ETBX-051 ETBX-061 Aldoxorubicin Cisplatin Cyclophosphamide Bevacizumab Necitumumab GI-4000 Cetuximab ALT-803 Fluorouracil ETBX-011 | Molecularly Informed Integrated Immunotherapy Combining Innate haNK Cell Therapy With Adenoviral and Yeast-based Vaccines to Induce T-cell Responses in Subjects With SCC Who Have Progressed on or After Platinum-based Chemotherapy and Anti- PD-1/ PD-L1 Therapy | Active, not recruiting | USA | 0 |
NCT02580058 | Phase III | Doxorubicin Avelumab | A Study Of Avelumab Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer | Active, not recruiting | USA | ITA | FRA | ESP | CAN | BEL | AUT | 18 |
NCT02603432 | Phase III | Avelumab | A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100) | Active, not recruiting | USA | ITA | FRA | ESP | CAN | BEL | 23 |
NCT02603419 | Phase I | Avelumab | Avelumab In Patients With Previously Treated Advanced Stage Classical Hodgkin's Lymphoma (JAVELIN HODGKINS) | Terminated | USA | ITA | 1 |
NCT03617666 | Phase II | Avelumab | Avelumab in the Frontline Treatment of Advanced Classical Hodgkin Lymphoma - a Window Study (AVENuE) | Active, not recruiting | 2 | |
NCT03747419 | Phase II | Avelumab | Avelumab and Radiation in Muscle-Invasive Bladder Cancer | Recruiting | USA | 0 |
NCT04637594 | Phase III | Durvalumab Nivolumab Atezolizumab Avelumab Pembrolizumab | Trying to Find the Correct Length of Treatment With Immune Checkpoint Therapy | Recruiting | USA | 0 |
NCT02395172 | Phase III | Avelumab Docetaxel | Avelumab in Non-Small Cell Lung Cancer (JAVELIN Lung 200) | Completed | USA | ITA | FRA | ESP | BEL | 24 |
NCT03050554 | Phase Ib/II | Avelumab | Stereotactic Body Radiation Therapy (SBRT) Combined With Avelumab (Anti-PD-L1) for Management of Early Stage Non-Small Cell Lung Cancer (NSCLC) | Terminated | USA | 0 |
NCT04261855 | Phase Ib/II | Avelumab Avelumab + lutetium Lu 177 dotatate | Targeted Therapy and Avelumab in Merkel Cell Carcinoma (GoTHAM) | Recruiting | 1 | |
NCT04387084 | Phase I | Durvalumab Pembrolizumab Avelumab Cemiplimab Atezolizumab Nivolumab | Short-term Fasting Prior to PD-1/PD-L1 Inhibitor Therapy for of Advanced or Metastatic Skin Malignancy | Recruiting | USA | 0 |
NCT02943317 | Phase I | Defactinib Avelumab | Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of Defactinib in Combination With Avelumab in Epithelial Ovarian Cancer | Terminated | USA | 0 |
NCT03391479 | Phase II | Avelumab | A Study of Avelumab in Penile Cancer Who Are Unfit for or Have Progressed After Platinum-Based Chemotherapy | Recruiting | CAN | 0 |
NCT04322643 | Phase II | Durvalumab Pembrolizumab Avelumab Nivolumab Atezolizumab | Intermittent Checkpoint Inhibitor Therapy In Patients With Advanced Urothelial Carcinoma | Recruiting | USA | 0 |
NCT03498196 | Phase Ib/II | Avelumab | A Window of Opportunity Trial: Avelumab in Non-metastatic Muscle Invasive Bladder Cancer | Terminated | USA | 0 |
NCT03288350 | Phase II | Cisplatin + Docetaxel + Fluorouracil Avelumab | mDCF + Avelumab in Resectable Esophago-gastric Adenocarcinoma (EGA) | Recruiting | CAN | 0 |
NCT03244176 | Phase I | Avelumab | Feasibility Study of Induction and Maintenance Avelumab Plus R-CHOP in Patients With Diffuse DLBCL: The AvR-CHOP Study (AvR-CHOP) | Recruiting | 1 | |
NCT03893903 | Phase I | Avelumab IDH1 R132H peptide vaccine Avelumab + IDH1 R132H peptide vaccine | AMPLIFYing NEOepitope-specific VACcine Responses in Progressive Diffuse Glioma (AMPLIFY-NEOVAC) | Recruiting | DEU | 0 |
NCT03271372 | Phase III | Avelumab | Adjuvant Avelumab in Merkel Cell Cancer (ADAM) | Recruiting | USA | 0 |
NCT03179410 | Phase II | Avelumab | PD-L1 Inhibition as ChecKpoint Immunotherapy for NeuroEndocrine Phenotype Prostate Cancer (PICK-NEPC) | Completed | USA | 0 |
NCT02859454 | Phase II | Avelumab | Avelumab for People With Recurrent Respiratory Papillomatosis | Completed | USA | 0 |
NCT03674424 | Phase II | Avelumab + Gemcitabine + Paclitaxel Avelumab + Cisplatin + Doxorubicin + Methotrexate + Vinblastine Avelumab Avelumab + Cisplatin + Gemcitabine | Avelumab as Neoadjuvant Therapy in Subjects With Urothelial Muscle Invasive Bladder Cancers (AURA Trial) (AURA) | Active, not recruiting | FRA | BEL | 0 |
NCT03035630 | Phase II | Avelumab Sunitinib | Sunitinib Followed by Avelumab or the Reverse for Metastatic Renal Cell Carcinoma | Withdrawn | USA | 0 |
NCT02625610 | Phase III | Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Avelumab Capecitabine + Oxaliplatin | Avelumab in First-Line Gastric Cancer (JAVELIN Gastric 100) | Completed | USA | ITA | FRA | ESP | DEU | CAN | 11 |
NCT03158883 | Phase I | Avelumab | UCDCC#270: Avelumab and Stereotactic Ablative Radiotherapy in Non-responding and Progressing NSCLC Patients | Completed | USA | 0 |
NCT03278379 | Phase II | Avelumab | Avelumab in G2-3 NET (NET-002) | Unknown status | CAN | 0 |
NCT02584634 | Phase I | Crizotinib Avelumab Lorlatinib | Study to Evaluate Safety, Efficacy, Pharmacokinetics And Pharmacodynamics Of Avelumab In Combination With Either Crizotinib Or PF-06463922 In Patients With NSCLC. (Javelin Lung 101) | Active, not recruiting | USA | ESP | 3 |
NCT03387085 | Phase Ib/II | ETBX-051 Aldoxorubicin ETBX-061 Cisplatin Cyclophosphamide haNK cells GI-4000 Bevacizumab ALT-803 Fluorouracil ETBX-011 Oxaliplatin Capecitabine Leucovorin GI-6301 Nab-paclitaxel Avelumab GI-6207 | QUILT-3.067: NANT Triple Negative Breast Cancer (TNBC) Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With TNBC Who Have Progressed on or After Standard-of-care Therapy. | Active, not recruiting | USA | 0 |
NCT03136406 | Phase Ib/II | GI-4000 Leucovorin Avelumab Nab-paclitaxel Bevacizumab Cyclophosphamide Capecitabine Oxaliplatin Fluorouracil ETBX-011 ALT-803 | QUILT-3.039: NANT Pancreatic Cancer Vaccine: Combination Immunotherapy in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy | Active, not recruiting | USA | 0 |
NCT03278405 | Phase Ib/II | Avelumab | Avelumab in G3 NEC (NET-001) | Completed | CAN | 0 |
NCT03910439 | Phase II | Avelumab | Avelumab in Combination With Hypofractionated Radiotherapy in Patients With Relapsed Refractory Multiple Myeloma | Terminated | USA | 0 |
NCT03000179 | Phase II | Avelumab | Safety and Efficacy of Avelumab in Small Intestinal Adenocarcinoma | Terminated | USA | 0 |
NCT03451825 | Phase Ib/II | Avelumab | Phase I/II Study of Avelumab in Pediatric Cancer Subjects | Completed | USA | CAN | BEL | 2 |
NCT02625623 | Phase III | Avelumab Paclitaxel Irinotecan | Avelumab in Third-Line Gastric Cancer (JAVELIN Gastric 300) | Completed | USA | ITA | FRA | ESP | DEU | BEL | 4 |
NCT02915523 | Phase Ib/II | Avelumab Avelumab + Entinostat | Phase 1b/2 Study of Avelumab With or Without Entinostat in Patients With Advanced Epithelial Ovarian Cancer | Unknown status | USA | 0 |
NCT02584829 | Phase Ib/II | IFN-B Avelumab | Localized Radiation Therapy or Recombinant Interferon Beta and MSB0010718C With or Without Cellular Adoptive Immunotherapy in Treating Patients With Metastatic Merkel Cell Carcinoma | Terminated | USA | 0 |
NCT04792073 | Phase II | Avelumab | Study of Avelumab and/or Radiation Therapy in People With Advanced Merkel Cell Carcinoma | Recruiting | USA | 0 |
NCT04841148 | Phase II | Hydroxychloroquine Avelumab + Palbociclib Hydroxychloroquine + Palbociclib Avelumab | Avelumab or Hydroxychloroquine With or Without Palbociclib to Eliminate Dormant Breast Cancer (PALAVY) | Recruiting | USA | 0 |
NCT02718417 | Phase III | Avelumab Carboplatin + Paclitaxel | Avelumab in Previously Untreated Patients With Epithelial Ovarian Cancer (JAVELIN OVARIAN 100) | Terminated | USA | ITA | DEU | CAN | 21 |
NCT03076554 | Phase II | Avelumab | A Pilot Study to Investigate the Safety and Clinical Activity of Avelumab (MSB0010718C) in Thymoma and Thymic Carcinoma After Progression on Platinum-Based Chemotherapy | Recruiting | USA | 0 |
NCT03267836 | Phase I | Avelumab | Neoadjuvant Avelumab and Hypofractionated Proton Radiation Therapy Followed by Surgery for Recurrent Radiation-refractory Meningioma | Active, not recruiting | USA | 0 |
NCT02155647 | Phase II | Avelumab | Avelumab in Subjects With Merkel Cell Carcinoma (JAVELIN Merkel 200) | Active, not recruiting | USA | ITA | FRA | ESP | DEU | 2 |
NCT01772004 | Phase I | Avelumab | Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor) | Completed | USA | FRA | DEU | BEL | 5 |
NCT03006848 | Phase II | Avelumab | A Phase II Trial of Avelumab in Patients With Recurrent or Progressive Osteosarcoma | Active, not recruiting | USA | 0 |
NCT04291885 | Phase II | Avelumab | Immunotherapy Adjuvant Trial in Patients With Stage I-III Merkel Cell Carcinoma (I-MAT) | Recruiting | 1 | |
NCT03719768 | Phase I | Avelumab | Avelumab With Radiotherapy in Patients With Leptomeningeal Disease | Active, not recruiting | USA | 0 |
NCT05092958 | Phase III | Avelumab + Cabozantinib Avelumab | Testing the Addition of the Anti-cancer Drug, Cabozantinib, to the Usual Immunotherapy Treatment, Avelumab, in Patients With Metastatic Urothelial Cancer, MAIN-CAV Study | Recruiting | USA | 0 |
NCT03341806 | Phase I | Avelumab | Avelumab With Laser Interstitial Therapy for Recurrent Glioblastoma | Completed | USA | 0 |
NCT03056599 | Phase I | Pembrolizumab Avelumab Interferon gamma Olaratumab Trabectedin Nivolumab Gemcitabine Interferon alpha-2b Doxorubicin Atezolizumab Eribulin Ipilimumab Durvalumab Aldesleukin Bortezomib Docetaxel | Precise Local Injection of Anti-cancer Drugs Using Presage's CIVO™ Device in Soft Tissue Sarcoma | Completed | USA | 0 |
NCT03186326 | Phase II | Aflibercept + Fluorouracil + Irinotecan + Leucovorin Aflibercept + Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin + Panitumumab Cetuximab + Fluorouracil + Irinotecan + Leucovorin Bevacizumab + Fluorouracil + Irinotecan + Leucovorin Fluorouracil + Irinotecan + Leucovorin + Panitumumab Cetuximab + Fluorouracil + Leucovorin + Oxaliplatin Avelumab Bevacizumab + Fluorouracil + Leucovorin + Oxaliplatin | Standard Chemotherapy vs Immunotherapie in 2nd Line Treatment of MSI Colorectal Mestastatic Cancer (SAMCO) | Active, not recruiting | FRA | 0 |
NCT03399552 | Phase Ib/II | Avelumab | Stereotactic Body Radiation Therapy and Avelumab Immunotherapy for Treatment of Malignant Mesothelioma | Active, not recruiting | USA | 0 |
NCT05327530 | Phase II | Avelumab Avelumab + NKTR-255 Avelumab + Sacituzumab govitecan-hziy Avelumab + M6223 | A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley) | Not yet recruiting | USA | 0 |
NCT03774901 | Phase II | Avelumab | Maintenance Avelumab Immunotherapy in Patients With Locally Advanced or Metastatic Squamous Cell Penile Carcinoma (PULSE) | Recruiting | FRA | 0 |
NCT03944941 | Phase II | Avelumab Avelumab + Cetuximab | Avelumab With or Without Cetuximab in Treating Patients With Advanced Skin Squamous Cell Cancer | Recruiting | USA | 0 |