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 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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Drug Name Trade Name Synonyms Drug Classes Drug Description
Avelumab Bavencio MSB0010718C Immune Checkpoint Inhibitor 146 PD-L1/PD-1 antibody 112 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
MLH1 negative endometrial carcinoma sensitive Avelumab Guideline Actionable Bavencio (avelumab) is included in guidelines as a second-line or subsequent-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 endometrial carcinoma (NCCN.org). detail...
MSH6 negative endometrial cancer sensitive Avelumab Phase II Actionable In a Phase II trial, Bavencio (avelumab) treatment resulted in an objective response rate of 26.7% (4/15, 1 complete response, 3 partial responses) and 6-month progression-free survival rate of 40% (6/15) in patients with mismatch repair deficient (dMMR, defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) recurrent or persistent endometrial cancer (PMID: 31461377; NCT02912572). 31461377
MSH6 negative endometrial cancer sensitive Avelumab Guideline Actionable Bavencio (avelumab) is included in guidelines for patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) endometrial cancer who have failed platinum-based therapy (PMID: 35690222; ESMO.org). 35690222 detail...
MLH1 negative endometrial cancer sensitive Avelumab Phase II Actionable In a Phase II trial, Bavencio (avelumab) treatment resulted in an objective response rate of 26.7% (4/15, 1 complete response, 3 partial responses) and 6-month progression-free survival rate of 40% (6/15) in patients with mismatch repair deficient (dMMR, defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) recurrent or persistent endometrial cancer (PMID: 31461377; NCT02912572). 31461377
MLH1 negative endometrial cancer sensitive Avelumab Guideline Actionable Bavencio (avelumab) is included in guidelines for patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) endometrial cancer who have failed platinum-based therapy (PMID: 35690222; ESMO.org). 35690222 detail...
MSH6 negative endometrial carcinoma sensitive Avelumab Guideline Actionable Bavencio (avelumab) is included in guidelines as a second-line or subsequent-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 endometrial carcinoma (NCCN.org). detail...

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT02155647 Phase II Avelumab Avelumab in Subjects With Merkel Cell Carcinoma (JAVELIN Merkel 200) Completed USA | ITA | FRA | ESP | DEU | AUS 1
NCT03617666 Phase II Avelumab Avelumab in the Frontline Treatment of Advanced Classical Hodgkin Lymphoma - a Window Study (AVENuE) Active, not recruiting GBR | AUS 0
NCT03267836 Phase I Avelumab Neoadjuvant Avelumab and Hypofractionated Proton Radiation Therapy Followed by Surgery for Recurrent Radiation-refractory Meningioma Terminated 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 | GBR | FRA | ESP | DEU | CAN | AUS 9
NCT03271372 Phase III Avelumab Adjuvant Avelumab in Merkel Cell Cancer (ADAM) Recruiting USA 0
NCT03719768 Phase I Avelumab Avelumab With Radiotherapy in Patients With Leptomeningeal Disease Active, not recruiting USA 0
NCT02603432 Phase III Avelumab A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100) Completed USA | ITA | GBR | FRA | ESP | CAN | BEL | AUS 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
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 Active, not recruiting USA 0
NCT03158883 Phase I Avelumab UCDCC#270: Avelumab and Stereotactic Ablative Radiotherapy in Non-responding and Progressing NSCLC Patients Completed USA 0
NCT02625623 Phase III Avelumab Paclitaxel Irinotecan Avelumab in Third-Line Gastric Cancer (JAVELIN Gastric 300) Completed USA | ITA | FRA | ESP | DEU | BEL | AUS 3
NCT03135769 Phase II Avelumab Avelumab in Chemo-resistant Gestational Trophoblastic Neoplasias (TROPHIMMUN) Completed FRA 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) (ACTIW) Unknown status FRA 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 | CAN 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
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 Completed USA | ITA | GBR | FRA | ESP | CAN | BEL | AUT | AUS 16
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
NCT03498196 Phase Ib/II Avelumab A Window of Opportunity Trial: Avelumab in Non-metastatic Muscle Invasive Bladder Cancer Terminated USA 0
NCT03000179 Phase II Avelumab Safety and Efficacy of Avelumab in Small Intestinal Adenocarcinoma Terminated USA 0
NCT03910439 Phase II Avelumab Avelumab in Combination With Hypofractionated Radiotherapy in Patients With Relapsed Refractory Multiple Myeloma Terminated USA 0
NCT03179410 Phase II Avelumab PD-L1 Inhibition as ChecKpoint Immunotherapy for NeuroEndocrine Phenotype Prostate Cancer (PICK-NEPC) Completed 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
NCT03006848 Phase II Avelumab A Phase II Trial of Avelumab in Patients With Recurrent or Progressive Osteosarcoma Completed USA 0
NCT04322643 Phase II Durvalumab Pembrolizumab Avelumab Nivolumab Atezolizumab Intermittent Checkpoint Inhibitor Therapy In Patients With Advanced Urothelial Carcinoma Active, not recruiting USA 0
NCT02576574 Phase III Gemcitabine Paclitaxel Cisplatin Avelumab Pemetrexed Disodium Carboplatin Avelumab in First-line NSCLC (JAVELIN Lung 100) Active, not recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 33
NCT03278379 Phase II Avelumab Avelumab in G2-3 NET (NET-002) Unknown status CAN 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 Unknown status USA 0
NCT02875613 Phase II Avelumab Avelumab for Recurrent/Metastatic Nasopharyngeal Cancer Terminated 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
NCT02859454 Phase II Avelumab Avelumab for People With Recurrent Respiratory Papillomatosis Completed USA 0
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 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
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) Active, not recruiting AUS 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 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
NCT03399552 Phase Ib/II Avelumab Stereotactic Body Radiation Therapy and Avelumab Immunotherapy for Treatment of Malignant Mesothelioma Completed 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) Terminated USA | ESP | AUS 2
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
NCT03288350 Phase II Cisplatin + Docetaxel + Fluorouracil Avelumab mDCF + Avelumab in Resectable Esophago-gastric Adenocarcinoma (EGA) Recruiting CAN 0
NCT03944941 Phase II Avelumab Avelumab + Cetuximab Avelumab With or Without Cetuximab in Treating Patients With Advanced Skin Squamous Cell Cancer Recruiting USA 0
NCT03341806 Phase I Avelumab Avelumab With Laser Interstitial Therapy for Recurrent Glioblastoma Completed USA 0
NCT02603419 Phase I Avelumab Avelumab In Patients With Previously Treated Advanced Stage Classical Hodgkin's Lymphoma (JAVELIN HODGKINS) Terminated USA | ITA | GBR 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 Unknown status USA 0
NCT01772004 Phase I Avelumab Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor) Completed USA | GBR | FRA | DEU | BEL 4
NCT03815643 Phase III Avelumab Avelumab Program Rollover Study Active, not recruiting USA | ITA | GBR | FRA | DEU | BEL | AUS 9
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) Recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 4
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
NCT02395172 Phase III Avelumab Docetaxel Avelumab in Non-Small Cell Lung Cancer (JAVELIN Lung 200) Completed USA | ITA | GBR | FRA | ESP | BEL | AUS 22
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
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
NCT04291885 Phase II Avelumab Immunotherapy Adjuvant Trial in Patients With Stage I-III Merkel Cell Carcinoma (I-MAT) Recruiting AUS 1
NCT03312114 Phase II Avelumab Anti—PD-L1 and SAbR for Ovarian Cancer Terminated USA 0
NCT02718417 Phase III Avelumab Carboplatin + Paclitaxel Avelumab in Previously Untreated Patients With Epithelial Ovarian Cancer (JAVELIN OVARIAN 100) Terminated USA | ITA | GBR | DEU | CAN 20
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
NCT03278405 Phase Ib/II Avelumab Avelumab in G3 NEC (NET-001) Completed CAN 0
NCT02968940 Phase II Avelumab Avelumab With Hypofractionated Radiation Therapy in Adults With Isocitrate Dehydrogenase (IDH) Mutant Glioblastoma Completed USA 0
NCT03774901 Phase II Avelumab Maintenance Avelumab Immunotherapy in Patients With Locally Advanced or Metastatic Squamous Cell Penile Carcinoma (PULSE) Recruiting FRA 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
NCT04261855 Phase Ib/II Avelumab Avelumab + lutetium Lu 177 dotatate Targeted Therapy and Avelumab in Merkel Cell Carcinoma (GoTHAM) Recruiting AUS 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
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
NCT04065555 Phase I Avelumab + Subasumstat Cetuximab Cetuximab + Subasumstat Subasumstat Avelumab Intratumoral Microdosing of TAK-981 in Head and Neck Cancer Completed 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
NCT04792073 Phase II Avelumab Study of Avelumab and/or Radiation Therapy in People With Advanced Merkel Cell Carcinoma Recruiting USA 0
NCT03451825 Phase Ib/II Avelumab Phase I/II Study of Avelumab in Pediatric Cancer Subjects Completed USA | CAN | BEL 2
NCT03047473 Phase II Avelumab Avelumab in Patients With Newly Diagnosed Glioblastoma Multiforme (SEJ) Completed CAN 0


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