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A Study to Test Whether Different Combinations of BI 765063, Ezabenlimab, Chemotherapy, Cetuximab, and BI 836880 Help People With Head and Neck Cancer or Liver Cancer

Primary Purpose

Head and Neck Squamous Cell Carcinoma (HNSCC)

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BI 765063
Ezabenlimab
BI 836880
Cetuximab
Investigator´s Choice Chemotherapy
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Squamous Cell Carcinoma (HNSCC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed informed consent form (ICF) prior to any trial-specific procedures.
  • Male or female aged ≥ 18 years at the time of ICF signature.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at the screening visit.
  • Expected life expectancy of at least 3 months.
  • Patients homozygous for V1 allele (including V1-like alleles) of Singal Regulatory Protein-alpha (SIRPα) (V1/V1 SIRPα genotype). SIRPα polymorphism will be assessed in blood sampling (using patient Deoxyribonucleic Acid [DNA]) during Screening 1 Visit.
  • Patients with at least one measurable lesion as per Response Evaluation Critiera In Solid Tumours (RECIST) version 1.1 (v1.1).
  • Patients must agree to provide a mandatory pre treatment (baseline) biopsy and an ontreatment fresh tumour biopsy (unless medically contraindicated). Details on biopsy sample collection are provided in the Lab Manual.

    -- Pre-treatment (baseline) biopsy: A fresh tumour biopsy before receiving the trial medication is preferred. In case a fresh tumour biopsy cannot be obtained, the Sponsor must be notified and archival formalin-fixed paraffin embedded (FFPE) tumour from the most recent time point before entering the trial must be provided (maximum 6 months prior to study entry).

  • Female patients. Women of childbearing potential (WOCBP) must agree to use highly effective methods of contraception per ICH M3 (R2), that results in a less than 1% per year failure rate when used consistently and correctly, starting at the screening visit, during the trial and for 6 months after the end of trial treatment. The requirement of contraception does not apply to women of no childbearing potential, but they must have evidence of such at screening. Women of childbearing potential must have a serum negative pregnancy test within 7 days prior to first drug administration. Women who are postmenopausal for at least 1 year (defined as more than 12 months since last menses) or are surgically sterilized do not require this test. The following methods of contraception are considered highly effective:

    • Combined (oestrogen and progestogen containing) hormonal birth control that prevents ovulation (oral, intravaginal, transdermal)
    • Progestogen-only hormonal birth control that prevents ovulation (oral, injectable, implantable)
    • Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)
    • Bilateral tubal occlusion
    • Vasectomised partner (provided that this is the sole sexual partner and has received medical assessment of the surgical success)
    • Sexual abstinence (if accepted by local ethics boards and regulatory agencies as highly effective) Although use of a contraceptive pill and Intrauterine device (IUD) together are considered a highly-effective method of birth control, women of childbearing potential taking a contraceptive pill must use an additional barrier method for the entire duration of the trial treatment intake and for 6 months after the end of the trial treatment intake.

Further inclusion criteria apply.

Exclusion criteria:

  • Patients with at least one SIRPα V2 allele, i.e. SIRPα V1/V2 or V2/V2 individuals.
  • Patients with symptomatic/active central nervous system (CNS) metastases. Patients with previously treated brain metastases are eligible, if there is no evidence of progression for at least 28 days before the first trial drug administration without requirement for treatment with corticosteroids, as ascertained by clinical examination and brain imaging (MRI (magnetic resonance imaging) or CT (computed tomography)) during the screening period.
  • Prior allogeneic stem cell or solid organ transplantation.
  • Any tumour location necessitating an urgent therapeutic intervention (e.g., palliative care, surgery or radiation therapy, such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture).
  • Presence of active invasive cancers other than the one treated in this trial within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin, or in situ carcinoma of uterine cervix, or other local tumours considered cured by local treatment.
  • Patients with active autoimmune disease or a documented history of autoimmune disease, that requires systemic treatment, i.e. corticosteroids or immunosuppressive drugs, except patients with vitiligo, resolved childhood asthma/atopy, alopecia, or any chronic skin condition that does not require systemic therapy; patients with autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and/or controlled Type 1 diabetes mellitus on a stable insulin regimen are eligible.
  • History of severe hemorrhagic or thromboembolic event in the past 12 months (excluding central venous catheter thrombosis and peripheral deep vein thrombosis).
  • Known prior history of severe infusion related reactions to monoclonal antibodies (Grade ≥ 3 National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events (CTCAE) v5.0).

Further exclusion criteria apply.

Sites / Locations

  • Valkyrie Clinical TrialsRecruiting
  • Washington University School of MedicineRecruiting
  • CTR Georges-François LeclercRecruiting
  • CTR Leon BerardRecruiting
  • HOP TimoneRecruiting
  • INS CurieRecruiting
  • HOP CivilRecruiting
  • INS Claudius Regaud IUCT-OncopoleRecruiting
  • Az. Ospedaliere Umberto I di AnconaRecruiting
  • National Cancer Center Hospital EastRecruiting
  • Kobe University HospitalRecruiting
  • Kanagawa Cancer CenterRecruiting
  • Osaka International Cancer InstituteRecruiting
  • Shizuoka Cancer CenterRecruiting
  • Japanese Foundation for Cancer ResearchRecruiting
  • Hospital Sultan IsmailRecruiting
  • University of Malaya Medical CentreRecruiting
  • Sarawak General HospitalRecruiting
  • National Cancer Institute (IKN)Recruiting
  • ARKE SMO S.A. de C.VRecruiting
  • Hospital Universitario Dr Jose Eleuterio GonzalezRecruiting
  • FAICIC S de RL de C.V.Recruiting
  • Investigacion Biomedica para el Desarrollo de Farmacos, S.A. de C.V.Recruiting
  • ARENSIA Exploratory MedicineRecruiting
  • Medical University GdanskRecruiting
  • Mandziuk Slawomir Specialist Medical PracticeRecruiting
  • 4. Wojskowy Szpital Kliniczny z PoliklinikaRecruiting
  • "Prof. Dr. Alexandru Trestioreanu" Oncology InstitutRecruiting
  • Institutul Oncologic "Prof. Dr. Ion Chiricuta"Recruiting
  • Hospital Vall d'HebronRecruiting
  • Hospital Duran i ReynalsRecruiting
  • Hospital Clínico San CarlosRecruiting
  • King Chulalongkorn Memorial HospitalRecruiting
  • Ramathibodi HospitalRecruiting
  • Songklanagarind HospitalRecruiting
  • King's College HospitalRecruiting
  • The Royal Marsden Hospital, ChelseaRecruiting
  • Hammersmith HospitalRecruiting
  • The Royal Marsden Hospital, SuttonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort A: BI 765063 + ezabenlimab + cetuximab

Cohort B: BI 765063 + ezabenlimab + chemo (invest choice)

Cohort C: BI 765063 + ezabenlimab

Cohort D: BI 765063 + ezabenlimab + BI 836880

Cohort E: BI 765063 + ezabenlimab + BI 836880

Arm Description

30 Signal Regulatory Protein Alpha (SIRPα) V1/V1 homozygous patients with 2nd line recurrent/metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) who had received prior platinum-based therapy within the recurrent/metastatic setting.

30 SIRPα V1/V1 homozygous patients with 2nd line recurrent/metastatic HNSCC who had received prior platinum-based therapy within the recurrent/metastatic setting.

30 SIRPα V1/V1 homozygous patients with advanced or metastatic 1st line Hepatocellular Carcinoma (HCC).

30 SIRPα V1/V1 homozygous patients with advanced or metastatic 1st line HCC.

30 SIRPα V1/V1 homozygous patients with advanced or metastatic 2nd line HCC who progressed on therapy with atezolizumab in combination with bevacizumab.

Outcomes

Primary Outcome Measures

Objective Response (OR)
Objective response (OR) with confirmation, defined as the best overall response of complete response (CR) or partial response (PR), where best overall response is determined according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1) by investigator's assessment from first treatment administration until the earliest of disease progression, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, lost to follow-up or withdrawal of consent.

Secondary Outcome Measures

Occurrence of treatment emergent adverse events (AEs)
Occurrence of treatment emergent adverse events (AEs) by investigator's assessment from first treatment administration until the earliest of death, subsequent anti-cancer therapy, lost to follow-up or withdrawal of consent.
Duration of objective response (DOR)
Duration of objective response (DOR), defined as the time from first documented complete response (CR) or partial response (PR) (RECIST v1.1) until the earliest of progressive disease (PD) or death among patients with objective response (OR).
Disease control (DC)
Disease control (DC), defined as best overall response of complete reponse (CR), partial reponse (PR), or stable disease (SD) where best overall response is defined according to RECIST v1.1 as assessed by the Investigator until the earliest of disease progression, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, or permanent treatment discontinuation.
Progression-free survivial (PFS)
Progression-free survival (PFS), defined as the time from first treatment administration until progressive disease (PD) according to RECIST v1.1 or death from any cause, whichever occurs earlier.

Full Information

First Posted
February 10, 2022
Last Updated
August 14, 2023
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT05249426
Brief Title
A Study to Test Whether Different Combinations of BI 765063, Ezabenlimab, Chemotherapy, Cetuximab, and BI 836880 Help People With Head and Neck Cancer or Liver Cancer
Official Title
An Open Label Trial of BI 765063 in Combination With BI 754091 (Ezabenlimab) Alone or With BI 836880, Chemotherapy, or Cetuximab, in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) or Hepatocellular Carcinoma (HCC)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 25, 2022 (Actual)
Primary Completion Date
August 15, 2024 (Anticipated)
Study Completion Date
June 27, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is open to adults with head and neck cancer or liver cancer. This is a study for people for whom previous treatment was not successful or no standard treatment exists. The purpose of this study is to find out whether combining different medicines make tumours shrink in people with head and neck cancer or liver cancer. The tested medicines in this study are antibodies that act in different ways against cancer. BI 765063 and ezabenlimab may help the immune system fight cancer (checkpoint inhibitors). Cetuximab blocks growth signals and may prevent the tumour from growing. BI 836880 blocks the formation of new blood vessels that the tumour needs to grow. All participants get BI 765063 and ezabenlimab. One group gets no additional medicine. The other groups get either BI 836880, cetuximab, or chemotherapy. BI 765063, ezabenlimab, and BI 836880 are given as infusions into veins every 3 weeks. Cetuximab is given as an infusion every 1 or 2 weeks. Participants can stay in the study as long as they benefit from treatment and can tolerate it. The doctors monitor the size of the tumour. The doctors also regularly check participants' health and take note of any unwanted effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Squamous Cell Carcinoma (HNSCC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Partly randomized trial. Patients will be randomized into cohort A, B, C and D. No randomization in cohort E.
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort A: BI 765063 + ezabenlimab + cetuximab
Arm Type
Experimental
Arm Description
30 Signal Regulatory Protein Alpha (SIRPα) V1/V1 homozygous patients with 2nd line recurrent/metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) who had received prior platinum-based therapy within the recurrent/metastatic setting.
Arm Title
Cohort B: BI 765063 + ezabenlimab + chemo (invest choice)
Arm Type
Experimental
Arm Description
30 SIRPα V1/V1 homozygous patients with 2nd line recurrent/metastatic HNSCC who had received prior platinum-based therapy within the recurrent/metastatic setting.
Arm Title
Cohort C: BI 765063 + ezabenlimab
Arm Type
Experimental
Arm Description
30 SIRPα V1/V1 homozygous patients with advanced or metastatic 1st line Hepatocellular Carcinoma (HCC).
Arm Title
Cohort D: BI 765063 + ezabenlimab + BI 836880
Arm Type
Experimental
Arm Description
30 SIRPα V1/V1 homozygous patients with advanced or metastatic 1st line HCC.
Arm Title
Cohort E: BI 765063 + ezabenlimab + BI 836880
Arm Type
Experimental
Arm Description
30 SIRPα V1/V1 homozygous patients with advanced or metastatic 2nd line HCC who progressed on therapy with atezolizumab in combination with bevacizumab.
Intervention Type
Drug
Intervention Name(s)
BI 765063
Intervention Description
BI 765063 (anti-Signal Regulatory Protein Alpha (SIRPα) Monoclonal Antibody (mAb))
Intervention Type
Drug
Intervention Name(s)
Ezabenlimab
Other Intervention Name(s)
BI 754091
Intervention Description
Ezabenlimab (anti-Programmed cell death protein 1 (PD-1) Monoclonal Antibody (mAb))
Intervention Type
Drug
Intervention Name(s)
BI 836880
Intervention Description
BI 836880 (anti-Vascular Endothelial Growth Factor (VEGF) / Angiopoetin 2 (Ang2))
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Intervention Description
Cetuximab
Intervention Type
Other
Intervention Name(s)
Investigator´s Choice Chemotherapy
Intervention Description
Allowable chemotherapies include: paclitaxel, docetaxel, capecitabine, 5-fluorouracil, methotrexate or combinations thereof
Primary Outcome Measure Information:
Title
Objective Response (OR)
Description
Objective response (OR) with confirmation, defined as the best overall response of complete response (CR) or partial response (PR), where best overall response is determined according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1) by investigator's assessment from first treatment administration until the earliest of disease progression, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, lost to follow-up or withdrawal of consent.
Time Frame
Up to 12 months.
Secondary Outcome Measure Information:
Title
Occurrence of treatment emergent adverse events (AEs)
Description
Occurrence of treatment emergent adverse events (AEs) by investigator's assessment from first treatment administration until the earliest of death, subsequent anti-cancer therapy, lost to follow-up or withdrawal of consent.
Time Frame
Up to 12 months.
Title
Duration of objective response (DOR)
Description
Duration of objective response (DOR), defined as the time from first documented complete response (CR) or partial response (PR) (RECIST v1.1) until the earliest of progressive disease (PD) or death among patients with objective response (OR).
Time Frame
Up to 12 months.
Title
Disease control (DC)
Description
Disease control (DC), defined as best overall response of complete reponse (CR), partial reponse (PR), or stable disease (SD) where best overall response is defined according to RECIST v1.1 as assessed by the Investigator until the earliest of disease progression, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, or permanent treatment discontinuation.
Time Frame
Up to 12 months.
Title
Progression-free survivial (PFS)
Description
Progression-free survival (PFS), defined as the time from first treatment administration until progressive disease (PD) according to RECIST v1.1 or death from any cause, whichever occurs earlier.
Time Frame
Up to 12 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent form (ICF) prior to any trial-specific procedures. Male or female aged ≥ 18 years at the time of ICF signature. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at the screening visit. Expected life expectancy of at least 3 months. Patients homozygous for V1 allele (including V1-like alleles) of Singal Regulatory Protein-alpha (SIRPα) (V1/V1 SIRPα genotype). SIRPα polymorphism will be assessed in blood sampling (using patient Deoxyribonucleic Acid [DNA]) during Screening 1 Visit. Patients with at least one measurable lesion as per Response Evaluation Critiera In Solid Tumours (RECIST) version 1.1 (v1.1). Patients must agree to provide a mandatory pre-treatment (baseline) biopsy and an ontreatment fresh tumour biopsy (unless medically contraindicated. or mandatory requirement is lifted by the sponsor). Details on biopsy sample collection are provided in the Lab Manual. -- Pre-treatment (baseline) biopsy: A fresh tumour biopsy before receiving the trial medication is preferred. In case a fresh tumour biopsy cannot be obtained, the Sponsor must be notified and archival formalin-fixed paraffin embedded (FFPE) tumour tissue block from the most recent time point before entering the trial must be provided (maximum 6 months prior to study entry). If these requirements cannot be met, the patient may still be allowed to enter the study at the discretion of the sponsor, after discussion between the Investigator and Sponsor. Female patients. Women of childbearing potential (WOCBP) must agree to use highly effective methods of contraception per ICH M3 (R2), that results in a less than 1% per year failure rate when used consistently and correctly, starting at the screening visit, during the trial and for 6 months after the end of trial treatment. The requirement of contraception does not apply to women of no childbearing potential, but they must have evidence of such at screening. Women of childbearing potential must have a serum negative pregnancy test within 72 hours prior to first drug administration. Women who are postmenopausal for at least 1 year (defined as more than 12 months since last menses) or are surgically sterilized do not require this test. The following methods of contraception are considered highly effective: Combined (oestrogen and progestogen containing) hormonal birth control that prevents ovulation (oral, intravaginal, transdermal) Progestogen-only hormonal birth control that prevents ovulation (oral, injectable, implantable) Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS) Bilateral tubal occlusion Vasectomised partner (provided that this is the sole sexual partner and has received medical assessment of the surgical success) Sexual abstinence (if accepted by local ethics boards and regulatory agencies as highly effective) Sexual abstinence is defined as refraining from heterosexual intercourse during the entire study period from screening through 6 months after last trial treatment. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject. Periodic abstinence (calendar, symptothermal, post-ovulation methods) is not an acceptable method of contraception for use during this trial. Although use of a contraceptive pill and Intrauterine device (IUD) together are considered a highly- effective method of birth control, women of childbearing potential taking a contraceptive pill must use an additional barrier method for the entire duration of the trial treatment intake and for 6 months after the end of the trial treatment intake. WOCBP is defined as: fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tubal ligation is NOT a method of permanent sterilisation. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. Further inclusion criteria apply. Exclusion criteria: Patients with at least one SIRPα V2 allele, i.e. SIRPα V1/V2 or V2/V2 individuals. Patients with symptomatic/active central nervous system (CNS) metastases. Patients with previously treated brain metastases are eligible, if there is no evidence of progression for at least 28 days before the first trial drug administration without requirement for treatment with corticosteroids, as ascertained by clinical examination and brain imaging (MRI (magnetic resonance imaging) or CT (computed tomography)) during the screening period. Prior allogeneic stem cell or solid organ transplantation. Any tumour location necessitating an urgent therapeutic intervention (e.g., palliative care, surgery or radiation therapy, such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture). Presence of active invasive cancers other than the one treated in this trial within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin, or in situ carcinoma of uterine cervix, or other local tumours considered cured by local treatment. Patients with active autoimmune disease or a documented history of autoimmune disease, that requires systemic treatment, i.e. corticosteroids or immunosuppressive drugs, except patients with vitiligo, resolved childhood asthma/atopy, alopecia, or any chronic skin condition that does not require systemic therapy; patients with autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and/or controlled Type 1 diabetes mellitus on a stable insulin regimen are eligible. History of severe hemorrhagic or thromboembolic event in the past 12 months (excluding central venous catheter thrombosis, peripheral deep vein thrombosis and portal vein thrombosis due to HCC tumor invasion). Known prior history of severe infusion related reactions to monoclonal antibodies (Grade ≥ 3 National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events (CTCAE) v5.0). Further exclusion criteria apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Boehringer Ingelheim
Phone
1-800-243-0127
Email
clintriage.rdg@boehringer-ingelheim.com
Facility Information:
Facility Name
Valkyrie Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90067
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
CTR Georges-François Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0805102354
Email
france@bitrialsupport.com
Facility Name
CTR Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0805102354
Email
france@bitrialsupport.com
Facility Name
HOP Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0805102354
Email
france@bitrialsupport.com
Facility Name
INS Curie
City
Paris
ZIP/Postal Code
75248
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0805102354
Email
france@bitrialsupport.com
Facility Name
HOP Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0805102354
Email
france@bitrialsupport.com
Facility Name
INS Claudius Regaud IUCT-Oncopole
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0805102354
Email
france@bitrialsupport.com
Facility Name
Az. Ospedaliere Umberto I di Ancona
City
Ancona
ZIP/Postal Code
60020
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
800977373
Email
italia@bitrialsupport.com
Facility Name
National Cancer Center Hospital East
City
Chiba, Kashiwa
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0120201230
Email
nippon@bitrialsupport.com
Facility Name
Kobe University Hospital
City
Hyogo, Kobe
ZIP/Postal Code
650-0017
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0120201230
Email
nippon@bitrialsupport.com
Facility Name
Kanagawa Cancer Center
City
Kanagawa, Yokohama
ZIP/Postal Code
241-8515
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0120201230
Email
nippon@bitrialsupport.com
Facility Name
Osaka International Cancer Institute
City
Osaka, Osaka
ZIP/Postal Code
541-8567
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0120201230
Email
nippon@bitrialsupport.com
Facility Name
Shizuoka Cancer Center
City
Shizuoka, Sunto-gun
ZIP/Postal Code
411-8777
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0120201230
Email
nippon@bitrialsupport.com
Facility Name
Japanese Foundation for Cancer Research
City
Tokyo, Koto-ku
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0120201230
Email
nippon@bitrialsupport.com
Facility Name
Hospital Sultan Ismail
City
Johor Bahru
ZIP/Postal Code
81100
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
1800814353
Email
malaysia@bitrialsupport.com
Facility Name
University of Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
1800814353
Email
malaysia@bitrialsupport.com
Facility Name
Sarawak General Hospital
City
Kuching, Sarawak
ZIP/Postal Code
93586
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
1800814353
Email
malaysia@bitrialsupport.com
Facility Name
National Cancer Institute (IKN)
City
Putrajaya
ZIP/Postal Code
62250
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
1800814353
Email
malaysia@bitrialsupport.com
Facility Name
ARKE SMO S.A. de C.V
City
Ciudad de Mexico
ZIP/Postal Code
06700
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
018000623749
Email
mexico@bitrialsupport.com
Facility Name
Hospital Universitario Dr Jose Eleuterio Gonzalez
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
018000623749
Email
mexico@bitrialsupport.com
Facility Name
FAICIC S de RL de C.V.
City
Veracruz
ZIP/Postal Code
91900
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
018000623749
Email
mexico@bitrialsupport.com
Facility Name
Investigacion Biomedica para el Desarrollo de Farmacos, S.A. de C.V.
City
Zapopan
ZIP/Postal Code
45070
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
018000623749
Email
mexico@bitrialsupport.com
Facility Name
ARENSIA Exploratory Medicine
City
Chisinau
ZIP/Postal Code
MD-2025
Country
Moldova, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
80060024
Email
moldova@bitrialsupport.com
Facility Name
Medical University Gdansk
City
Gdansk
ZIP/Postal Code
80-214
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
008001218830
Email
polska@bitrialsupport.com
Facility Name
Mandziuk Slawomir Specialist Medical Practice
City
Lublin
ZIP/Postal Code
20-093
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
008001218830
Email
polska@bitrialsupport.com
Facility Name
4. Wojskowy Szpital Kliniczny z Poliklinika
City
Wroclaw
ZIP/Postal Code
50-981
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
008001218830
Email
polska@bitrialsupport.com
Facility Name
"Prof. Dr. Alexandru Trestioreanu" Oncology Institut
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0800895209
Email
romania@bitrialsupport.com
Facility Name
Institutul Oncologic "Prof. Dr. Ion Chiricuta"
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0800895209
Email
romania@bitrialsupport.com
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
900876092
Email
espana@bitrialsupport.com
Facility Name
Hospital Duran i Reynals
City
L'Hospitalet de Llobregat
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
900876092
Email
espana@bitrialsupport.com
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
900876092
Email
espana@bitrialsupport.com
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
1800019059
Email
thai@bitrialsupport.com
Facility Name
Ramathibodi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
1800019059
Email
thai@bitrialsupport.com
Facility Name
Songklanagarind Hospital
City
Songkla
ZIP/Postal Code
90110
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
1800019059
Email
thai@bitrialsupport.com
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08000514022
Email
unitedkingdom@bitrialsupport.com
Facility Name
The Royal Marsden Hospital, Chelsea
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08000514022
Email
unitedkingdom@bitrialsupport.com
Facility Name
Hammersmith Hospital
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08000514022
Email
unitedkingdom@bitrialsupport.com
Facility Name
The Royal Marsden Hospital, Sutton
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08000514022
Email
unitedkingdom@bitrialsupport.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing
Links:
URL
http://www.mystudywindow.com
Description
Related Info

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A Study to Test Whether Different Combinations of BI 765063, Ezabenlimab, Chemotherapy, Cetuximab, and BI 836880 Help People With Head and Neck Cancer or Liver Cancer

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