GEN-001 (Live Biotherapeutic Product) and Avelumab Combination Study for Patients With Solid Tumors Who Have Progressed on Anti-PD-(L)1 Therapy

PHASE1CompletedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

October 26, 2020

Primary Completion Date

January 11, 2023

Study Completion Date

January 11, 2023

Conditions
Solid TumorNon Small Cell Lung CancerSquamous Cell Carcinoma of Head and NeckUrothelial Carcinoma
Interventions
DRUG

GEN-001

The capsules taken by mouth once a daily. Each capsule will contain ≥ 1x10\^11 colony-forming units (CFU)

DRUG

Avelumab

800 mg given by intravenous (IV) infusion once every 2 weeks

Trial Locations (3)

30322

Emory University Winship Cancer Institute, Atlanta

97239

Oregon Health & Science University, Portland

06510

Yale Cancer Center, New Haven

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

collaborator

Pfizer

INDUSTRY

lead

Genome & Company

INDUSTRY