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Triple Negative Breast CancerPhase 2NCT05255666

Combination Liposomal Irinotecan and Pembrolizumab For Triple-Negative Breast Cancer (TNBC) With Brain Metastases (BM)

A Phase 2 study testing Pembrolizumab and Liposomal Irinotecan in people with Triple Negative Breast Cancer and Brain Metastases, run by Washington University School of Medicine.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The study is a phase II with safety lead in, single arm, study using Nal-IRI in combination with pembrolizumab. Nal-IRI will be given IV every 2 weeks starting at 50mg/m2. Pembrolizumab will be given 400mg IV every 6 weeks. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pembrolizumab and Liposomal Irinotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
31 Jul 2023to 31 Jan 2030
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject must meet all of the following applicable inclusion criteria to participate in this study:
  • Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
  • Age ≥ 18 years at the time of consent.
  • ECOG Performance Status of 0-1 within 28 days prior to registration.
  • Histological or cytological confirmation of triple-negative breast cancer (TNBC) NOTE: TNBC will be defined as expression of ER<10%, PR< 10% and HER2 negative either by IHC (0, 1+ are negative, 2+ equivocal) or in situ hybridization method (ratio <2.0 is negative). AJCC, 8th edition.
  • Subjects must have brain metastasis; new or progressive with at least one lesion ≥ 5 mm in at least one dimension. NOTE: the number of brain lesions is not limited.
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  • Measurable disease according to RECIST 1.1 and/or RANO-BM within 28 days prior to registration.
  • Prior treatment with immunotherapy is allowed. Patients CANNOT have received prior liposomal irinotecan or irinotecan. Patients who received prior sacituzumab govitecan are eligible if without disease progression for at least 16 weeks on therapy and a washout of at least 24 weeks prior to C1D1. NOTE: No more than 4 prior lines of therapy in the metastatic setting is allowed.
  • Prior cancer treatment including investigational agents must be completed at least 14 days prior to registration and the subject must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to Grade ≤ 1 or baseline.
  • Demonstrate adequate organ function as defined in the table below. All screening labs to be obtained within 14 days prior to registration.
  • Hematological
  • Absolute Neutrophil Count (ANC): ≥ 1.5 K/mm3
  • Hemoglobin (Hgb): ≥ 9 g/dL; without erythropoietin dependency and without packed red blood cell (PRBC) transfusion within 2 weeks of registration
  • Platelet Count (PLT): ≥100 000/µL
  • Renal
  • Creatinine OR: ≤1.5 × ULN OR
  • Calculated creatinine clearance: ≥30 mL/min
  • Hepatic
  • Total Bilirubin: ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN
  • Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT): ≤2.5 × ULN (≤5 × ULN for participants with liver metastases)
  • Albumin: > 30 g/L
  • Coagulation ---International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT): ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
  • Life expectancy of ≥ 12 weeks as assessed by the investigator.
  • Females of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Females of childbearing potential and males must be willing to abstain from heterosexual intercourse or to use an effective method(s) of contraception as outlined in the protocol.
  • As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study (or that legally authorized representative will do so on their behalf).

Who cannot join

  • Subjects meeting any of the criteria below may not participate in the study:
  • Has a known history of Human Immunodeficiency Virus (HIV) infection. NOTE: No HIV testing is required unless mandated by local health authority.
  • Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. NOTE: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.
  • Has a known history of active TB (Bacillus Tuberculosis).
  • Has an active infection requiring systemic therapy.
  • Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
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  • Has received colony-stimulating factors (e.g., granulocyte colony stimulating factor [G-CSF], granulocyte macrophage colony stimulating factor [GM-CSF]) within 2 weeks prior to the first dose of study drug.
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to C1D1.
  • Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.
  • Has had an allogenic tissue/solid organ transplant.
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
  • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
  • Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • Is pregnant or breastfeeding.

About this study

Official title: Phase II Study of the Combination of Liposomal Irinotecan (Nal-IRI) and Pembrolizumab for Triple-Negative Breast Cancer (TNBC) With Brain Metastases (BM)

The study is a phase II with safety lead in, single arm, study using Nal-IRI in combination with pembrolizumab. Nal-IRI will be given IV every 2 weeks starting at 50mg/m2. Pembrolizumab will be given 400mg IV every 6 weeks. Treatment will continue until progression, intolerable side effects or patient/doctor decision to discontinue treatment.

Being tested
Pembrolizumab, Liposomal Irinotecan
Medical subject headings
Triple Negative Breast Neoplasms, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabDrug

    Also called Keytruda

    400 mg intravenously

  • Liposomal IrinotecanDrug

    Also called NaI-IRI

    Starting at 50 mg/m^2. The dose may be increased to 70 mg/m^2 if tolerated or dose reduced to 35 mg/m^ if treatment-emergent severe adverse event (TESAE) occurs.

Study groups in NCT05255666
Study groupRoleWhat they receive
Pembrolizumab + Liposomal IrinotecanExperimental* 400 mg of pembrolizumab intravenously on Day 1 of each Cycle (Cycle is 42 days) * 50 mg/m^2 of liposomal irinotecan (Nal-IRI) intravenously every 2 weeks of each Cycle (Cycle is 42 days)
Receives: Drug: Pembrolizumab; Drug: Liposomal Irinotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Central Nervous System Disease Control Rate (DCR)

    -DCR is defined as the rate of complete response (CR) + rate of partial response (PR), and rate of stable disease (SD) at 6 months and will be determined as per modified Neuro-Oncology-Brain Metastases (RANO-BM) criteria

    Measured: 6 months

Secondary outcomes (5)

  1. Safety and tolerability as measured by the number of grade 3 and 4 adverse events

    -Defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v5

    Measured: Through 90 days after completion of treatment (estimated to be 9 months)

  2. Central Nervous System Objective Response Rate (ORR)

    -ORR will include CNS complete response (CR) + partial response (PR) and will be determined as per modified RANO-BM criteria.

    Measured: Through completion of treatment (estimated to be 6 months)

  3. Non-Central Nervous System Objective Response Rate (ORR)

    -ORR will include confirmed complete response (CR) + confirmed partial response (PR) and will be determined as per RECIST 1.1

    Measured: Through completion of treatment (estimated to be 6 months)

  4. Progression Free Survival (PFS)

    -PFS is defined as the time from Day 1 of treatment until the criteria for disease progression is met as defined by RECIST 1.1 and/or RANO-BM or death as a result of any cause.

    Measured: Through completion of follow-up (estimated to be 3 years and 6 months)

  5. Overall Survival (OS)

    -OS is defined as the time from Day 1 of treatment until death as a result of any cause.

    Measured: Through completion of follow-up (estimated to be 3 years and 6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2022
  2. Study start31 Jul 2023 (estimated)
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion31 Jan 2030 (estimated)

Why it stopped: No drug

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05255666
Sponsor's protocol ID
202111198
Status last verified
Jul 2023
First submitted
15 Feb 2022
Last updated
11 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab and Liposomal Irinotecan in people with Triple Negative Breast Cancer and Brain Metastases, run by Washington University School of Medicine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Central Nervous System Disease Control Rate (DCR) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05255666.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023.

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