Therapy Detail
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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). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Avelumab | Bavencio | MSB0010718C | Immune Checkpoint Inhibitor 98 PD-L1/PD-1 antibody 68 | 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). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| Unknown unknown | Merkel cell carcinoma | not applicable | Avelumab | FDA approved | Actionable | In a Phase II trial (JAVELIN Merkel 200) that supported FDA approval, Bavencio (avelumab) treatment resulted in an objective response response rate of 31.8% (28/88), with complete response in 9% (8/88) and partial response in 23% (20/88) of patients with metastatic Merkel cell carcinoma that progressed after chemotherapy (PMID: 27592805; NCT02155647). | 27592805 detail... |
| Unknown unknown | Merkel cell carcinoma | not applicable | Avelumab | Phase Ib/II | Actionable | In a Phase I/II trial, addition of Bavencio (avelumab) to adoptive transfer of Merkel cell polyomavirus (MCPyV)-specific T cells and HLA upregulation resulted in sustained complete response in 75% (3/4) of patients with MCPyV-associated Merkel cell carcinoma (J Clin Oncol 35, 2017 (suppl; abstr 3044)). | detail... |
| Unknown unknown | Merkel cell carcinoma | not applicable | Avelumab | Phase III | Actionable | In a Phase II trial (JAVELIN Merkel 200), Bavencio (avelumab) treatment resulted in a 62.1% (18/29) objective response rate and a median progression-free survival of 9.1 months in patients with treatment-naive metastatic Merkel cell carcinoma, with response duration estimated to be greater than 3 months and 6 months in 93% and 83% of responding patients, respectively (PMID: 29566106; NCT 02155647). | 29566106 |
| Unknown unknown | transitional cell carcinoma | not applicable | Avelumab | FDA approved | Actionable | In a Phase I trial (JAVELIN Solid Tumor) that supported FDA approval, Bavencio (avelumab) demonstrated safety and resulted in a response rate of 17% (27/161; 9 complete responses and 18 partial responses), a median progression-free survival of 6.3 weeks, and a median overall survival of 6.5 months in patients with platinum-refractory metastatic urothelial carcinoma (PMID: 29217288; NCT01772004). | detail... 29217288 |
| Unknown unknown | transitional cell carcinoma | not applicable | Avelumab | FDA approved | Actionable | In a Phase III trial (JAVELIN Bladder 100) that supported FDA approval, addition of maintenance Bavencio (avelumab) to best supportive care (BSC) significantly improved overall survival compared to BSC alone (21.4 vs 14.3 mo, HR=0.69, p=0.0005) in patients with advanced urothelial carcinoma (J Clin Oncol 38, (Jun 2020) no. 18_suppl; NCT02603432). | detail... detail... |
| Unknown unknown | adrenocortical carcinoma | not applicable | Avelumab | Phase Ib/II | Actionable | In a Phase Ib trial (JAVELIN), Bavencio (avelumab) treatment demonstrated safety and some anti-tumor activity in patients with metastatic adrenocortical carcinoma, resulting in an overall response rate of 6% (3/50, all partial responses), stable disease in 42% (21/50), a median progression-free survival (PFS) of 2.6 months, 6 mo. and 12 mo. PFS rates of 20.9% and 8.7% respectively, a median overall survival (OS) of 10.6 mo, and a 1-year OS of 43.4% (PMID: 30348224; NCT01772004). | 30348224 |
| Unknown unknown | malignant mesothelioma | not applicable | Avelumab | Phase I | Actionable | In a Phase I trial (JAVELIN), Bavencio (avelumab) resulted in an objective response rate (ORR) of 9% (5/53, 1 complete response, 4 partial response) and a disease control rate of 58% (31/53) in patients with advanced unresectable mesothelioma, with a median progression-free survival of 4.1 months and a median overall survival of 10.7 months; ORR were 19% (3/16) and 7% (2/27) in patients with CD274 (PD-L1)-positive (5% or greater) or negative tumors (p=0.34) respectively (PMID: 30605211; NCT01772004). | 30605211 |
| Unknown unknown | hepatocellular carcinoma | not applicable | Avelumab | Phase II | Actionable | In a Phase II trial, Bavencio (avelumab) treatment did not meet the primary endpoint in hepatocellular carcinoma patients previously treated with Nexavar (sorafenib), but resulted in an objective response rate of 10% (3/30, 3 partial responses), disease control rate (DCR) of 73.3% (22/30), median time to progression (TTP) of 4.4 months, and median overall survival (OS) of 14.2 months, and led to greater TTP, DCR, and OS in patients with longer Nexavar (sorafenib) treatment (PMID: 33139266; NCT03389126). | 33139266 |
| Unknown unknown | ovarian cancer | not applicable | Avelumab | Phase I | Actionable | In a Phase I trial (JAVELIN), Bavencio (avelumab) treatment resulted in objective response in 9.6% (12/125, 1 complete response, 11 partial response) of patients with recurrent or refractory ovarian cancer, with a 1-year progression-free survival rate of 10.2% and a median overall survival of 11.2 months; response did not correlate with tumor CD274 (PD-L1) status (PMID: 30676622; NCT01772004). | 30676622 |
| Unknown unknown | stomach cancer | not applicable | Avelumab | Phase I | Actionable | In a Phase I trial, Bavencio (avelumab) treatment resulted in partial response in 27% (3/11) of patients with advanced gastric cancer (J Clin Oncol 33, 2015 (suppl; abstr 4047)). | detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| NCT04792073 | Phase II | Avelumab | Study of Avelumab and/or Radiation Therapy in People With Advanced Merkel Cell Carcinoma | Recruiting | USA | 0 |
| NCT02718417 | Phase III | Avelumab Carboplatin + Paclitaxel | Avelumab in Previously Untreated Patients With Epithelial Ovarian Cancer (JAVELIN OVARIAN 100) | Terminated | USA | CAN | 23 |
| 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 |
| 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 |
| NCT04068194 | Phase Ib/II | Avelumab Avelumab + MSC2490484A | 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 |
| NCT04322643 | Phase II | Durvalumab Pembrolizumab Avelumab Nivolumab Atezolizumab | Intermittent Checkpoint Inhibitor Therapy In Patients With Advanced Urothelial Carcinoma | Recruiting | USA | 0 |
| NCT03747419 | Phase II | Avelumab | Avelumab and Radiation in Muscle-Invasive Bladder Cancer | Recruiting | USA | 0 |
| NCT03719768 | Phase I | Avelumab | Avelumab With Radiotherapy in Patients With Leptomeningeal Disease | Recruiting | USA | 0 |
| NCT03006848 | Phase II | Avelumab | A Phase II Trial of Avelumab in Patients With Recurrent or Progressive Osteosarcoma | 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 | CAN | 23 |
| 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. | Unknown status | USA | 0 |
| NCT03047473 | Phase II | Avelumab | Avelumab in Patients With Newly Diagnosed Glioblastoma Multiforme (SEJ) | Active, not recruiting | CAN | 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 |
| 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 |
| NCT03278379 | Phase II | Avelumab | Avelumab in G2-3 NET (NET-002) | Active, not recruiting | CAN | 0 |
| NCT03000179 | Phase II | Avelumab | Safety and Efficacy of Avelumab in Small Intestinal Adenocarcinoma | Active, not recruiting | USA | 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 |
| NCT03910439 | Phase II | Avelumab | Avelumab in Combination With Hypofractionated Radiotherapy in Patients With Relapsed Refractory Multiple Myeloma | Terminated | USA | 0 |
| NCT03158883 | Phase I | Avelumab | UCDCC#270: Avelumab and Stereotactic Ablative Radiotherapy in Non-responding and Progressing NSCLC Patients | 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 |
| 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 |
| NCT02859454 | Phase II | Avelumab | Avelumab for People With Recurrent Respiratory Papillomatosis | Active, not recruiting | USA | 0 |
| 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 |
| NCT02155647 | Phase II | Avelumab | Avelumab in Subjects With Merkel Cell Carcinoma (JAVELIN Merkel 200) | Active, not recruiting | USA | 6 |
| NCT03498196 | Phase Ib/II | Avelumab | A Window of Opportunity Trial: Avelumab in Non-metastatic Muscle Invasive Bladder Cancer | Terminated | USA | 0 |
| NCT03312114 | Phase II | Avelumab | Anti—PD-L1 and SAbR for Ovarian Cancer | Terminated | USA | 0 |
| NCT03267836 | Phase I | Avelumab | Neoadjuvant Avelumab and Hypofractionated Proton Radiation Therapy Followed by Surgery for Recurrent Radiation-refractory Meningioma | Recruiting | USA | 0 |
| NCT03944941 | Phase II | Avelumab Avelumab + Cetuximab | Avelumab With or Without Cetuximab in Treating Patients With Advanced Skin Squamous Cell Cancer | Recruiting | 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 |
| NCT02625610 | Phase III | Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Avelumab Capecitabine + Oxaliplatin | Avelumab in First-Line Gastric Cancer (JAVELIN Gastric 100) | Active, not recruiting | USA | CAN | 15 |
| 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 | Recruiting | 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) | Recruiting | 1 | |
| NCT03451825 | Phase Ib/II | Avelumab | Phase I/II Study of Avelumab in Pediatric Cancer Subjects | Active, not recruiting | USA | CAN | 3 |
| NCT01772004 | Phase I | Avelumab | Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor) | Completed | USA | 8 |
| 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) (ACTIW) | Recruiting | 1 | |
| 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 | 4 |
| NCT02603432 | Phase III | Avelumab | A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100) | Active, not recruiting | USA | CAN | 27 |
| NCT02968940 | Phase II | Avelumab | Avelumab With Hypofractionated Radiation Therapy in Adults With Isocitrate Dehydrogenase (IDH) Mutant Glioblastoma | Completed | USA | 0 |
| NCT03815643 | Phase III | Avelumab | Avelumab Program Rollover Study | Recruiting | USA | 6 |
| NCT02875613 | Phase II | Avelumab | Avelumab for Recurrent/Metastatic Nasopharyngeal Cancer | Terminated | 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 | Active, not recruiting | USA | 0 |
| NCT03271372 | Phase III | Avelumab | Adjuvant Avelumab in Merkel Cell Cancer (ADAM) | Recruiting | USA | 0 |
| NCT03399552 | Phase Ib/II | Avelumab | Stereotactic Body Radiation Therapy and Avelumab Immunotherapy for Treatment of Malignant Mesothelioma | Active, not recruiting | USA | 0 |
| NCT03179410 | Phase II | Avelumab | PD-L1 Inhibition as ChecKpoint Immunotherapy for NeuroEndocrine Phenotype Prostate Cancer (PICK-NEPC) | Completed | 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 | Active, not recruiting | USA | 0 |
| NCT03035630 | Phase II | Avelumab Sunitinib | Sunitinib Followed by Avelumab or the Reverse for Metastatic Renal Cell Carcinoma | Withdrawn | USA | 0 |
| NCT03135769 | Phase II | Avelumab | Avelumab in Chemo-resistant Gestational Trophoblastic Neoplasias (TROPHIMMUN) | Recruiting | 1 | |
| NCT02603419 | Phase I | Avelumab | Avelumab In Patients With Previously Treated Advanced Stage Classical Hodgkin's Lymphoma (JAVELIN HODGKINS) | Terminated | USA | 2 |
| NCT03288350 | Phase II | Cisplatin + Docetaxel + Fluorouracil Avelumab | mDCF + Avelumab in Resectable Esophago-gastric Adenocarcinoma (EGA) | Recruiting | CAN | 0 |
| NCT02625623 | Phase III | Avelumab Paclitaxel Irinotecan | Avelumab in Third-Line Gastric Cancer (JAVELIN Gastric 300) | Completed | USA | 9 |
| 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 | CAN | 40 |
| NCT02395172 | Phase III | Avelumab Docetaxel | Avelumab in Non-Small Cell Lung Cancer (JAVELIN Lung 200) | Completed | USA | 28 |
| NCT03278405 | Phase Ib/II | Avelumab | Avelumab in G3 NEC (NET-001) | Completed | CAN | 0 |
| NCT03341806 | Phase I | Avelumab | Avelumab With Laser Interstitial Therapy for Recurrent Glioblastoma | Recruiting | USA | 0 |
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