A Trial to Learn How the Cancer Vaccine BNT116 in Combination With Cemiplimab Works and How Safe the Combination is in Adults With Advanced Non-small Cell Lung Cancer (EMPOWERVAX Lung 1)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT05557591
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Advanced Non-Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BNT116 — DRUG
    BNT116 is administered by IV injection.
  • Cemiplimab — DRUG
    Cemiplimab is administered Q3W by IV infusion

Study Details

This study is researching an investigational drug, called BNT116, in combination with cemiplimab. BNT116 and cemiplimab will each be called a "study drug", and together be called "study drugs". The study is focused on patients who have advanced non-small cell lung cancer (NSCLC). The aims of this study are to see how safe and tolerable BNT116 is in combination with cemiplimab and to see how effective BNT116 in combination with cemiplimab is compared to cemiplimab by itself at treating cancer. The study is looking at several other research questions, including: * What side effects may happen from receiving the study drugs * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug(s) (which could make the drug less effective or could lead to side effects)

Key Dates

Start date
Apr 21, 2023
Status verified
May 2026
Primary completion
Jan 26, 2028
Completion
May 16, 2028

Study Design

Enrollment
51 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 2: Cemiplimab
    Arm A: Cemiplimab is administered by IV infusion Q3W
  • Experimental: Phase 2: BNT116 + Cemiplimab
    Arm B: BNT116 is administered by IV injection. Cemiplimab is administered by IV infusion Q3W.

Primary Outcome Measure

Objective response rate (ORR) as assessed by blinded independent review committee (BIRC) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) [ Time Frame: Up to 136 weeks from randomization ]

Locations (9)

FacilityCityStateZIPSite coordinators
The Oncology Institute of Hope and InnovationLos AngelesCalifornia90033-
UCLA Medical CenterSanta MonicaCalifornia90095-
Norton Cancer Institute, DowntownLouisvilleKentucky40202-
San Juan Oncology AssociatesFarmingtonNew Mexico87401-
Weill Cornell MedicineNew YorkNew York10065-
FirstHealth of the Carolinas Outpatient Cancer CenterPinehurstNorth Carolina28374-
Millenium Research & Clinical DevelopmentHoustonTexas77090-
Virginia Cancer SpecialistsFairfaxVirginia22031-
Northwest Medical Specialties, PLLCTacomaWashington98405-

Find similar trials in Los Angeles, CA

By research site
The Oncology Institute of Hope and Innovation· Los Angeles, CAUCLA Medical Center· Santa Monica, CANorton Cancer Institute, Downtown· Louisville, KYSan Juan Oncology Associates· Farmington, NMWeill Cornell Medicine· New York, NYFirstHealth of the Carolinas Outpatient Cancer Center· Pinehurst, NC

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