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Trial record 2 of 22 for:    bellini

Pre-operative Trial for Breast Cancer With Nivolumab in Combination With Novel IO (BELLINI)

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ClinicalTrials.gov Identifier: NCT03815890
Recruitment Status : Recruiting
First Posted : January 24, 2019
Last Update Posted : January 22, 2021
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
The Netherlands Cancer Institute

Brief Summary:
To determine whether short-term pre-operative nivolumab either as monotherapy or in combination with low dose doxorubicin or novel IO combinations can induce immune activation in early BC.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Nivolumab Drug: Ipilimumab Phase 2

Detailed Description:
The investigators aim to test the activity of nivolumab monotherapy in primary breast tumors in a pre-operative window of opportunity trial. As the data of the investigators generated in the TONIC trial (metastatic TNBC) indicate that low dose doxorubicin may 'prime' the tumor microenvironment (TME) resulting in higher response rates on nivolumab, in addition, cohorts for treatment with nivolumab plus low dose doxorubicin will be opened. Given the emerging data on other immunomodulatory strategies, this platform study allows opening additional cohorts for promising novel immune-oncology (IO) drugs for which a strong efficacy signal has been seen without drug safety issues. The investigators will study the TME and systemic host factors with specific emphasis on immunosuppressive processes that can potentially be targeted by novel IO agents to further optimize BC immunotherapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Separate cohorts will be opened in this trial. LumB and TNBC tumors will be divided in separate cohorts.More cohorts, e.g. combining nivolumab and novel IO, can open after the start of this trial.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pre-operative Phase II Trial for Breast Cancer With Nivolumab in Combination With Novel IO (BELLINI Trial)
Actual Study Start Date : October 4, 2019
Estimated Primary Completion Date : January 7, 2023
Estimated Study Completion Date : January 7, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: 1A; LumB
Nivolumab
Drug: Nivolumab
2 courses 3mg/kg

Experimental: 1B; TNBC
Nivolumab
Drug: Nivolumab
2 courses 3mg/kg

Experimental: 2A; LUMB
Nivolumab and ipilimumab
Drug: Nivolumab
2 courses 3mg/kg

Drug: Ipilimumab
single dose ipilimumab (1mg/kg) at day 1

Experimental: 2B; TNBC
Nivolumab and ipilimumab
Drug: Nivolumab
2 courses 3mg/kg

Drug: Ipilimumab
single dose ipilimumab (1mg/kg) at day 1




Primary Outcome Measures :
  1. Immune activation after pre-operative nivolumab [ Time Frame: through study completion, an average of 1 year ]
    measuring the tumor-associated CD8 and expression of genes induced by IFNy after pre-operative immunotherapy


Secondary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events according to NCI Common Toxicity Criteria version 5.0 [ Time Frame: up to 3 weeks after surgery, an average of 6 months ]
    Adverse events in all regimens will be graded according to NCI Common Toxicity Criteria version 5.0.

  2. Radiological response rate [ Time Frame: At 4 weeks ]
    The percentage of patients having a complete response, partial response or stable disease per cohort assessed by MRI

  3. Pathological response rate [ Time Frame: up to 3 weeks after surgery, an average of 6 months ]
    The percentage of patients having a complete response or residual cancer burden per cohort



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Signed written informed consent
  • 18 years or older at moment of inclusion;
  • Female gender;
  • WHO performance status 0 or 1;
  • Resectable primary breast cancer stage I-III. Nodal status must be examined by ultrasound, fine needle aspiration, sentinel node biopsy, or FDG-PET scan.
  • The tumors must be:

    • at least 10 mm (minimum cT1c) as determined by MRI
    • TNBC defined as ER<10%, HER2-negative OR luminal B defined as ER≥10%, HER2-negative with either grade 3 or Ki67≥20%. HER2 negative is defined as an IHC score of <2 or 2+ with a negative ISH.

Exclusion Criteria:

  • evidence or suspicion of metastatic disease. Evaluation of the presence of distant metastases may include chest X-ray, liver ultrasound, isotope bone-scan, CT-scan of chest and abdomen and/or FDG-PET scan, according to local procedures;
  • evidence of a concurrent contralateral or ipsilateral second primary infiltrating breast cancer. Evaluation of the presence of a concurrent second primary breast cancer may include mammography, breast ultrasound and/or MRI breast;
  • other malignancy except carcinoma in situ and basal-cell and squamous carcinoma of the skin, unless the other malignancy was treated ≥5 years ago with curative intent without the use of chemotherapy or radiotherapy
  • previous radiation therapy or chemotherapy;
  • prior treatment with checkpoint inhibitors (including anti- PD1, -PD-L1, -CTLA-4);
  • concurrent anti-cancer treatment, neoadjuvant therapy or another investigational drug;

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): NCT03815890


Contacts
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Contact: M Kok, MD 3120512 ext 9111 m.kok@nki.nl
Contact: I Nederlof 3120512 ext 9111 i.nederlof@nki.nl

Locations
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Netherlands
NKI-AVL Recruiting
Amsterdam, Netherlands, 1066CX
Contact: M Kok, MD       m.kok@nki.nl   
Contact: I Nederlof       i.nederlof@nki.nl   
Principal Investigator: M Kok, MD         
Sponsors and Collaborators
The Netherlands Cancer Institute
Bristol-Myers Squibb
Investigators
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Principal Investigator: M Kok, MD NKI-AvL
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Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT03815890    
Other Study ID Numbers: M18BEL
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: to be determined

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Netherlands Cancer Institute:
pre-operative
triple negative and Luminal B
resectable, stage I-III
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents