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CVA21/pembrolizumab

Phase 1

Non-small Cell Lung Cancer | Monoclonal antibody | Oncology |Merck & Company, Inc.|Trials Updated: May 6, 2023

CVA21/pembrolizumab development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jan 2014

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment85

FDA Designations

No designations recorded

CVA21/pembrolizumab clinical trials

CVA21/pembrolizumab · 1 trial · 2 indications

Phase 1 1
NCT02043665CVA21 and Pembrolizumab in NSCLC & Bladder Cancer (VLA-009 STORM/ KEYNOTE-200)Non-small Cell Lung Cancer
COMPLETED85 Analytics
PHASE1COMPLETED
CVA21 and Pembrolizumab in NSCLC & Bladder Cancer (VLA-009 STORM/ KEYNOTE-200)
Non-small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Response rate assessed according to immune-related RECIST 1.1 criteria
Up to 6 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CVA21/pembrolizumabEXPERIMENTALCVA21/pembrolizumab

Interventions

NameTypeDescription
CVA21/pembrolizumabBIOLOGICAL -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * Histologically-confirmed (1) NSCLC, (2) bladder cancer, (3) castrate-resistant prostate cancer which are metastatic, or (4) stage 3C or stage 4 melanoma. * VLA009A: Locally advanced and/or metastatic disease for which curative surgery and/or radiation therapy is not possible a...

Countries:United StatesAustraliaUnited Kingdom
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Competitive Landscape -Non-Small Cell Lung Cancer 541 trials

Top 20 of 90 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK37PHASE3Pembrolizumab, Olaparib, Sacituzumab tirumotecan, Intismeran autogene, Pembrolizumab Berahyaluronidase alfa
Revolution Medicines, Inc.RVMD9PHASE3Daraxonrasib, Zoldonrasib, Elironrasib, RMC-5127
Eli Lilly and CompanyLLY18PHASE3Selpercatinib, Pemetrexed, Abemaciclib, Olomorasib, LY3537982
AbbVie, Inc.ABBV12PHASE3ABBV-1480, Telisotuzumab vedotin, Telisotuzumab Adizutecan, Livmoniplimab, Budigalimab
AstraZeneca PLCAZN68PHASE3Datopotamab deruxtecan, Durvalumab, Oleclumab, Monalizumab, Tremelimumab
Gilead Sciences, Inc.GILD7PHASE3Sacituzumab govitecan, Zimberelimab, Domvanalimab, Etrumadenant, TUB-040- Dose escalation
Bristol-Myers Squibb CompanyBMY24PHASE3Repotrectinib, Nivolumab, Pumitamig, Relatlimab, Adagrasib
Johnson & JohnsonJNJ19PHASE3Lazertinib, Amivantamab, JNJ-90301900, JNJ-86974680, Cetrelimab
BioNTech SE Sponsored ADRBNTX7PHASE3Gotistobart, Pumitamig, BNT326, BNT116, BNT324
Pfizer Inc.PFE20PHASE3Lorlatinib, Crizotinib, Avelumab, Talazoparib, Axitinib
Amgen Inc.AMGN4PHASE3ABP 234, Sotorasib, Anvumetostat
Novartis AG Sponsored ADRNVS12PHASE3Opnurasib, TNO155, DKY709, Spartalizumab, trametinib
GSK plc Sponsored ADRGSK3PHASE3Dostarlimab, Belrestotug, Nelistotug, Cobolimab
ArriVent BioPharma, Inc.AVBP9PHASE3Firmonertinib
Summit Therapeutics IncSMMT2PHASE3Ivonescimab
Nuvation Bio, Inc. Class ANUVB4PHASE3Taletrectinib
Genmab A/S Sponsored ADRGMAB4PHASE3Acasunlimab, Rina-S, GEN1042
Regeneron Pharmaceuticals, Inc.REGN7PHASE2Cemiplimab, Marlotamig, Fianlimab, REGN5093
Nuvalent, Inc. Class ANUVL1PHASE3Neladalkib
BeOne Medicines Ltd. Sponsored ADRONC7PHASE3Tislelizumab, BGB-A445, LBL-007, BGB-15025, BGB-43395
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Frequently asked questions about CVA21/pembrolizumab

What is CVA21/pembrolizumab?

CVA21/pembrolizumab is an investigational combination therapy studied in oncology. It pairs CVA21, an oncolytic virus, with pembrolizumab, a monoclonal antibody. The combination was evaluated in a Phase 1 clinical trial in patients with non-small cell lung cancer and bladder cancer. It is not an approved treatment.

What is CVA21/pembrolizumab used for in non-small cell lung cancer?

CVA21/pembrolizumab was studied as a treatment for non-small cell lung cancer in a Phase 1 clinical trial. The trial also enrolled patients with bladder cancer. The combination is investigational and has not been approved for any indication.

Who makes CVA21/pembrolizumab?

Merck & Company, Inc. (ticker: MRK) is the developer associated with CVA21/pembrolizumab. The combination includes pembrolizumab, a Merck monoclonal antibody, and CVA21, an oncolytic virus.

What phase is CVA21/pembrolizumab in?

CVA21/pembrolizumab is in Phase 1 clinical development. The single trial evaluating the combination has been completed. It is investigational and not approved by the FDA for any indication.

What clinical trials is CVA21/pembrolizumab in?

CVA21/pembrolizumab was evaluated in one clinical trial: NCT02043665, titled CVA21 and Pembrolizumab in NSCLC & Bladder Cancer (VLA-009 STORM/ KEYNOTE-200). This Phase 1 trial enrolled 85 patients across the United States, Australia, and the United Kingdom and is completed.