Therapy Detail

Therapy Name Avelumab
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Avelumab Bavencio MSB0010718C Immune Checkpoint Inhibitor 99 PD-L1/PD-1 antibody 48 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 (FDA.gov).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown transitional cell carcinoma not applicable Avelumab Phase I Actionable In a Phase I trial that supported FDA approval (JAVELIN), Bavencio (avelumab) demonstrated safety and resulted in a response rate of 17% (27/161; 9 complete responses and 18 partial responses), median progression-free survival of 6.3 weeks, and median overall survival of 6.5 months in patients with platinum-refractory metastatic urothelial carcinoma (PMID: 29217288; NCT01772004). 29217288
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 Merkel cell carcinoma not applicable Avelumab FDA approved Actionable In a Phase II trial 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 Merkel cell carcinoma (PMID: 27592805). 27592805
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 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
Clinical Trial Phase Therapies Title Recruitment Status
NCT03387085 Phase Ib/II ETBX-051 Aldoxorubicin ETBX-061 Cisplatin Cyclophosphamide GI-4000 Bevacizumab ALT-803 Fluorouracil ETBX-011 Oxaliplatin Capecitabine Leucovorin GI-6301 nab-paclitaxel Avelumab GI-6207 QUILT-3.067: 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 TNBC Who Have Progressed on or After Standard-of-care Therapy. Recruiting
NCT02603432 Phase III Avelumab A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100) Recruiting
NCT02875613 Phase II Avelumab Avelumab for Recurrent/Metastatic Nasopharyngeal Cancer Active, not recruiting
NCT02718417 Phase III Avelumab Paclitaxel + Carboplatin Avelumab in Previously Untreated Patients With Epithelial Ovarian Cancer (JAVELIN OVARIAN 100) Active, not recruiting
NCT01772004 Phase I Avelumab Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor) Active, not recruiting
NCT03278379 Phase II Avelumab Avelumab in G2-3 NET (NET-002) Recruiting
NCT03006848 Phase II Avelumab A Phase II Trial of Avelumab in Patients With Recurrent or Progressive Osteosarcoma Recruiting
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
NCT03312114 Phase II Avelumab Anti—PD-L1 and SAbR for Ovarian Cancer Recruiting
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
NCT02625623 Phase III Avelumab Paclitaxel Irinotecan Avelumab in Third-Line Gastric Cancer (JAVELIN Gastric 300) Active, not recruiting
NCT02395172 Phase III Avelumab Docetaxel Avelumab in Non-Small Cell Lung Cancer (JAVELIN Lung 200) Active, not recruiting
NCT03498196 Phase Ib/II Avelumab A Window of Opportunity Trial: Avelumab in Non-metastatic Muscle Invasive Bladder Cancer Recruiting
NCT03341806 Phase I Avelumab Avelumab With Laser Interstitial Therapy for Recurrent Glioblastoma Recruiting
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 Active, not recruiting
NCT02603419 Phase I Avelumab Avelumab In Patients With Previously Treated Advanced Stage Classical Hodgkin's Lymphoma (JAVELIN HODGKINS) Active, not recruiting
NCT02625610 Phase III Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Avelumab Capecitabine + Oxaliplatin Avelumab in First-Line Gastric Cancer (JAVELIN Gastric 100) Active, not recruiting
NCT03271372 Phase III Avelumab Adjuvant Avelumab in Merkel Cell Cancer (ADAM) Recruiting
NCT03747419 Phase II Avelumab Avelumab and Radiation in Muscle-Invasive Bladder Cancer Recruiting
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
NCT03815643 Phase III Avelumab Avelumab Program Rollover Study Not yet recruiting
NCT03278405 Phase Ib/II Avelumab Avelumab in G3 NEC (NET-001) Recruiting
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
NCT03267836 Phase I Avelumab Neoadjuvant Avelumab and Hypofractionated Proton Radiation Therapy Followed by Surgery for Recurrent Radiation-refractory Meningioma Recruiting
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
NCT03770455 Phase II Avelumab ODM-201 Abiraterone Enzalutamide Apalutamide Phase II Trial of Avelumab Plus 2nd-generation ADT in African American Subjects With mCRPC Recruiting
NCT02155647 Phase II Avelumab Avelumab in Subjects With Merkel Cell Carcinoma (JAVELIN Merkel 200) Active, not recruiting
NCT03035630 Phase II Avelumab Sunitinib Sunitinib Followed by Avelumab or the Reverse for Metastatic Renal Cell Carcinoma Withdrawn
NCT03047473 Phase II Avelumab Avelumab in Patients With Newly Diagnosed Glioblastoma Multiforme (SEJ) Recruiting
NCT03451825 Phase Ib/II Avelumab Phase I/II Study of Avelumab in Pediatric Cancer Subjects Recruiting
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
NCT03399552 Phase Ib/II Avelumab Stereotactic Body Radiation Therapy and Avelumab Immunotherapy for Treatment of Malignant Mesothelioma Recruiting
NCT03719768 Phase I Avelumab Avelumab With Radiotherapy in Patients With Leptomeningeal Disease Recruiting
NCT03288350 Phase II Cisplatin + Docetaxel + Fluorouracil Avelumab mDCF + Avelumab in Resectable Esophago-gastric Adenocarcinoma (EGA) Recruiting
NCT02912572 Phase II Avelumab Study of Avelumab in Patients With MSS, MSI-H and POLE-mutated Recurrent or Persistent Endometrial Cancer Recruiting
NCT02859454 Phase II Avelumab Avelumab for People With Recurrent Respiratory Papillomatosis Active, not recruiting
NCT03158883 Phase I Avelumab Avelumab and Stereotactic Ablative Radiotherapy in Non-responding and Progressing NSCLC Patients Recruiting
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 Recruiting
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
NCT02968940 Phase III Avelumab Avelumab With Hypofractionated Radiation Therapy in Adults With Isocitrate Dehydrogenase (IDH) Mutant Glioblastoma Active, not recruiting
NCT03179410 Phase II Avelumab PD-L1 Inhibition as ChecKpoint Immunotherapy for NeuroEndocrine Phenotype Prostate Cancer (PICK-NEPC) Recruiting
NCT03391479 Phase II Avelumab A Study of Avelumab in Penile Cancer Who Are Unfit for or Have Progressed After Platinum-Based Chemotherapy Recruiting
NCT02576574 Phase III Gemcitabine Paclitaxel Cisplatin Avelumab Pemetrexed Carboplatin Avelumab in First-line Non-Small Cell Lung Cancer (JAVELIN Lung 100) Active, not recruiting
NCT03000179 Phase II Avelumab Safety and Efficacy of Avelumab in Small Intestinal Adenocarcinoma Recruiting
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