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Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer (LuCa-MERIT-1)

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ClinicalTrials.gov Identifier: NCT05142189
Recruitment Status : Recruiting
First Posted : December 2, 2021
Last Update Posted : November 14, 2022
Sponsor:
Information provided by (Responsible Party):
BioNTech SE

Brief Summary:
This First-in-human (FIH) trial for BNT116 aims to establish the safety profile and a safe dose for BNT116 monotherapy as well as for BNT116 in combination with cemiplimab or in combination with docetaxel in patients with advanced or metastasized non-small cell lung cancer (NSCLC). The trial will comprise several cohorts for dose confirmation in monotherapy as well as in combinations.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Biological: BNT116 Biological: Cemiplimab Drug: Docetaxel Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: LuCa-MERIT-1: First-in-human, Open Label, Phase I Dose Confirmation Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer
Actual Study Start Date : June 17, 2022
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : July 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Cohort 1 - BNT116 monotherapy Biological: BNT116
intravenous injection

Experimental: Cohort 2 - BNT116 + cemiplimab Biological: BNT116
intravenous injection

Biological: Cemiplimab
intravenous infusion

Experimental: Cohort 3 - BNT116 + docetaxel Biological: BNT116
intravenous injection

Drug: Docetaxel
intravenous infusion

Experimental: Cohort 4 - BNT116 + cemiplimab Biological: BNT116
intravenous injection

Biological: Cemiplimab
intravenous infusion




Primary Outcome Measures :
  1. Occurrence of dose-limiting toxicities (DLTs) during Cycle 1 [ Time Frame: assessed during the first cycle (21 days) ]
  2. Occurrence of unsolicited treatment-emergent adverse events (TEAEs) reported by relationship, seriousness, and grade according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 [ Time Frame: up to 27 months ]

Secondary Outcome Measures :
  1. Overall response rate (ORR) defined as the number of patients with complete response (CR) or partial response (PR) as best overall response (BOR) [ Time Frame: up to 27 months ]
    according to response evaluation criteria in solid tumors (RECIST) v1.1 divided by the number of patients in the efficacy analysis set

  2. Duration of response (DoR) defined as the time from initial response until first objective tumor progression according to RECIST v1.1 [ Time Frame: up to 27 months ]
  3. Disease control rate (DCR) defined as the number of patients with CR or PR or stable disease (SD) as BOR according to RECIST v1.1 divided by the number of patients in the efficacy analysis set [ Time Frame: up to 27 months ]
  4. Duration of disease control defined as the time from initial detection of stable disease or response until first objective tumor progression according to RECIST v1.1 [ Time Frame: up to 27 months ]
  5. Progression-free survival (PFS) defined as the time of first trial treatment until the first objective tumor progression according to RECIST v1.1 or death from any cause, whichever occurs first [ Time Frame: up to 48 months ]
  6. Overall survival (OS) defined as the time of first trial treatment until death from any cause [ Time Frame: up to 48 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Patients must have histologically confirmed unresectable Stage III or metastatic Stage IV NSCLC and measurable disease by RECIST v1.1. Note: Patients in Cohort 1 do not have to have measurable disease.
  • Patients in Cohorts 2 and 4 must be able to tolerate additional anti-PD-1 therapy (i.e., did not permanently discontinue anti-programmed death protein 1 (PD-1) / programmed death ligand 1 (PD-L1) therapy due to toxicity) and must have recovered to stage 1 or 0 from any previous PD-1/PD-L1-related toxicity or be on a stable hormone substitute therapy.
  • Patients in Cohorts 2 and 3 must have an Eastern Cooperative Oncology Group performance status (ECOG-PS) ≤1. Patients in Cohort 1 and 4 with an ECOG-PS of 0-2 are eligible.

Cohort-specific inclusion criteria:

Cohort 1:

  • Patients' prior therapy must have included at least a PD-1/PD-L1 inhibitor and a platinum-based chemotherapy regimen as well as one other line of systemic therapy (except if a patient is not candidate for a platinum-based chemotherapy and/or PD-1/PD-L1 inhibitor and/or another line of systemic therapy).

Cohort 2:

  • Patients must present with PD-L1 expression of tumor proportion score (TPS) ≥50% in tumor cells (as determined locally prior to inclusion in this trial).
  • Patients must present with progressive disease either

    1. in the advanced or metastasized stage of NSCLC: while on a PD-1/PD-L1 inhibitor therapy or within 6 months of termination of this treatment as first-line treatment. Or
    2. be refractory to ongoing adjuvant therapy with a PD-1/PD-L1 inhibitor that has been given for at least 3 months in monotherapy (i.e., after an initial combination therapy) before being enrolled into this trial.

Cohort 3:

  • Patients' prior therapy must have included at least a PD-1/PD-L1 inhibitor and a platinum-based chemotherapy regimen (except if a patient is not candidate for a platinum-based chemotherapy and/or PD-1/PD-L1 inhibitor).

Cohort 4:

  • Patients' who are not candidates for chemotherapy as first-line treatment for the advanced or metastasized stage of NSCLC may be enrolled if presenting with PD-L1 expression: TPS ≥1% in tumor cells.

Key Exclusion Criteria:

  • Ongoing active systemic treatment against NSCLC.
  • Presence of a driver mutation for which approved target therapies are available.
  • Ongoing or recent evidence (within the last 5 years) of significant autoimmune disease that required treatment with systemic immunosuppressive treatments which may suggest risk for immune-related adverse events. Note: Patients with autoimmune-related hyperthyroidism, autoimmune-related hypothyroidism who are in remission, or on a stable dose of thyroid-replacement hormone, vitiligo, or psoriasis may be included.
  • Current evidence of new or growing brain or spinal metastases during screening. Patients with leptomeningeal disease are excluded. Patients with known brain or spinal metastases may be eligible if they:
  • had radiotherapy or another appropriate therapy for the brain or spinal bone metastases, AND
  • have no neurological symptoms that can be attributed to the current brain lesions, AND
  • have stable brain or spinal disease on the computed tomography (CT) or magnetic resonance imaging (MRI) scan within 4 weeks before signing the informed consent (confirmed by stable lesions on two scans at least 4 weeks apart), AND
  • do not require steroid therapy for the treatment of brain or spinal metastases within 14 d before the first dose of trial treatment. Note: Spinal bone metastases (i.e., of the vertebrae) are allowed, unless imminent fracture or cord compression is anticipated.
  • Systemic immune suppression:
  • Current use of chronic systemic steroid medication (≤5 mg/day prednisolone equivalent is allowed); patients using physiological replacement doses of prednisone for adrenal or pituitary insufficiency are eligible.
  • Other clinically relevant systemic immune suppression within the last 3 months before trial enrollment.
  • Known history of seropositivity for human immunodeficiency virus (HIV) with CD4+ T-cell (CD4+) counts <350 cells/µL and with a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections.
  • Prior splenectomy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05142189


Contacts
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Contact: BioNTech clinical trials patient information +49 6131 9084 ext 0 patients@biontech.de

Locations
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United States, Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Not yet recruiting
Baltimore, Maryland, United States, 21287
United States, Virginia
NEXT Virginia Recruiting
Fairfax, Virginia, United States, 22031
Germany
Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF) Not yet recruiting
Frankfurt, Germany, 60488
Hungary
ICON-PRA Budapest, Fázis 1 Vizsgálóhely Recruiting
Budapest, Hungary, 1077
Semmelweis Egyetem ÁOK Belgyógyászati és Onkológiai Klinika Recruiting
Budapest, Hungary, 1083
National Institute of Oncology Recruiting
Budapest, Hungary, 1122
Clinexpert Ltd Recruiting
Gyongyos, Hungary, 3200
Turkey
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital Recruiting
Ankara, Turkey, 06200
Ankara City Hospital Recruiting
Ankara, Turkey, 06800
Yeditepe University Recruiting
Istanbul, Turkey, 34718
Ege University School of Medicine Tulay Aktas Oncology Hospital Recruiting
Izmir, Turkey, 35100
Dokuz Eylul Medical School Recruiting
İzmir, Turkey, 35340
Sponsors and Collaborators
BioNTech SE
Investigators
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Study Director: BioNTech Responsible Person BioNTech SE
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Responsible Party: BioNTech SE
ClinicalTrials.gov Identifier: NCT05142189    
Other Study ID Numbers: BNT116-01
2021-004739-94 ( EudraCT Number )
First Posted: December 2, 2021    Key Record Dates
Last Update Posted: November 14, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BioNTech SE:
Cancer Vaccine
Non-Small Cell Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Cemiplimab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological