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 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...
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 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 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 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 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 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 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 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 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

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
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
NCT03312114 Phase II Avelumab Anti—PD-L1 and SAbR for Ovarian Cancer Terminated USA 0
NCT03179410 Phase II Avelumab PD-L1 Inhibition as ChecKpoint Immunotherapy for NeuroEndocrine Phenotype Prostate Cancer (PICK-NEPC) Active, not recruiting USA 0
NCT02968940 Phase II Avelumab Avelumab With Hypofractionated Radiation Therapy in Adults With Isocitrate Dehydrogenase (IDH) Mutant Glioblastoma Completed USA 0
NCT03158883 Phase I Avelumab UCDCC#270: Avelumab and Stereotactic Ablative Radiotherapy in Non-responding and Progressing NSCLC Patients 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
NCT02395172 Phase III Avelumab Docetaxel Avelumab in Non-Small Cell Lung Cancer (JAVELIN Lung 200) Completed USA 28
NCT03341806 Phase I Avelumab Avelumab With Laser Interstitial Therapy for Recurrent Glioblastoma 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
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) Active, not recruiting USA 0
NCT03815643 Phase III Avelumab Avelumab Program Rollover Study Recruiting USA 6
NCT03278405 Phase Ib/II Avelumab Avelumab in G3 NEC (NET-001) Completed CAN 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
NCT02625623 Phase III Avelumab Paclitaxel Irinotecan Avelumab in Third-Line Gastric Cancer (JAVELIN Gastric 300) Completed USA 9
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
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
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
NCT03910439 Phase II Avelumab Avelumab in Combination With Hypofractionated Radiotherapy in Patients With Relapsed Refractory Multiple Myeloma 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
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
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
NCT04637594 Phase III Durvalumab Nivolumab Atezolizumab Avelumab Pembrolizumab Trying to Find the Correct Length of Treatment With Immune Checkpoint Therapy Recruiting USA 0
NCT03747419 Phase II Avelumab Avelumab and Radiation in Muscle-Invasive Bladder Cancer Recruiting USA 0
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
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
NCT01772004 Phase I Avelumab Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor) Completed USA 8
NCT02875613 Phase II Avelumab Avelumab for Recurrent/Metastatic Nasopharyngeal Cancer Terminated 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
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
NCT02718417 Phase III Avelumab Carboplatin + Paclitaxel Avelumab in Previously Untreated Patients With Epithelial Ovarian Cancer (JAVELIN OVARIAN 100) Terminated USA | CAN 23
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
NCT03035630 Phase II Avelumab Sunitinib Sunitinib Followed by Avelumab or the Reverse for Metastatic Renal Cell Carcinoma Withdrawn USA 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 4
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
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
NCT02603419 Phase I Avelumab Avelumab In Patients With Previously Treated Advanced Stage Classical Hodgkin's Lymphoma (JAVELIN HODGKINS) Terminated USA 2
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 Not yet 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
NCT04322643 Phase II Durvalumab Pembrolizumab Avelumab Nivolumab Atezolizumab Intermittent Checkpoint Inhibitor Therapy In Patients With Advanced Urothelial Carcinoma 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
NCT03278379 Phase II Avelumab Avelumab in G2-3 NET (NET-002) Active, not recruiting CAN 0
NCT03719768 Phase I Avelumab Avelumab With Radiotherapy in Patients With Leptomeningeal Disease 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
NCT03000179 Phase II Avelumab Safety and Efficacy of Avelumab in Small Intestinal Adenocarcinoma Active, not recruiting USA 0
NCT03288350 Phase II Cisplatin + Docetaxel + Fluorouracil Avelumab mDCF + Avelumab in Resectable Esophago-gastric Adenocarcinoma (EGA) Recruiting CAN 0
NCT02859454 Phase II Avelumab Avelumab for People With Recurrent Respiratory Papillomatosis Active, not 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
NCT02915523 Phase Ib/II Avelumab Avelumab + Entinostat Phase 1b/2 Study of Avelumab With or Without Entinostat in Patients With Advanced Epithelial Ovarian Cancer Active, not recruiting USA 0
NCT03047473 Phase II Avelumab Avelumab in Patients With Newly Diagnosed Glioblastoma Multiforme (SEJ) Active, not recruiting CAN 0
NCT03271372 Phase III Avelumab Adjuvant Avelumab in Merkel Cell Cancer (ADAM) Recruiting USA 0
NCT03451825 Phase Ib/II Avelumab Phase I/II Study of Avelumab in Pediatric Cancer Subjects Active, not recruiting USA | CAN 3


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