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AzTrials

Breast CancerPhase 2NCT05967884

PD-1 +/- IL-4 Inhibition in ER+ Breast Cancer

A Phase 2 study testing Arm A: Cemiplimab, Arm B: Cemiplimab + Dupilumab in people with Breast Cancer, run by Ottawa Hospital Research Institute at 2 sites in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This proposal is for a Window of Opportunity (WOO) clinical trial using a novel combination of two Health Canada approved agents, cemiplimab (Libtayo) and dupilumab (Dupixent), for off label use in early-stage estrogen receptor positive (ER+) breast cancer. Read more about this study

Who is it for?
Ages 18 to 90 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Arm A: Cemiplimab, Arm B: Cemiplimab + Dupilumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesCanada
Study dates
4 Aug 2023to 1 Aug 2024
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 to 90 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients with newly diagnosed histologically confirmed primary invasive breast cancer currently not undergoing any treatment while awaiting surgery.
  • Invasive ductal or lobular carcinoma, invasive carcinoma Not Otherwise Specified (NOS)
  • ER+ breast cancer (1-10%*) of any size. ER positive tumor defined ≥1% positively staining cells by immunohistochemistry, according to the current American Society of Clinical Oncology (ASCO) / College of American Pathologists (CAP) guidelines.
  • The participant is eligible for surgery within the next 4-6 weeks.
  • HER2/neu must be negative by immunohistochemistry (IHC) defined as IHC 0 or 1+ or fluorescence in situ hybridization (FISH) or other ISH methods with a ratio of < 2 according to current ASCO (American Society of Clinical Oncology)/CAP guidelines.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
  • Age ≥18 years.
  • The participant (or legally acceptable representative if applicable) is able to provide written informed consent for the study.

Who cannot join

  • Known or suspected breast cancer metastasized to distant organ (lung, liver, bone, brain, abdomen)
  • Prior therapy with any chemotherapy or endocrine for breast cancer or other cancers within last 3 months
  • Pre-dominant histology other than invasive ductal or lobular carcinoma or invasive carcinoma NOS.
  • Patients with an active infection or an absolute neutrophil count < 1.5 x 10^9/L.
  • 6. Patients with pre-existing renal impairment, Creatinine clearance calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation of less than 50 mL/min/1.73m2.
  • 7. Known or current history of pneumonitis or interstitial lung disease (e.g., idiopathic pulmonary fibrosis) or pneumonia in past month 8. Has known HIV or active Hepatitis B (e.g., HBV detected by PCR, presence of HBsAg surface antigen and/or Anti-HBc core antigen) or active Hepatitis C (e.g., HCV RNA [qualitative] is detected). Presence of Anti-HBs alone suggesting immunity to Hepatis B is eligible.
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  • 9. Any serious known immediate or delayed hypersensitivity reaction(s) to dupilumab and or cemiplimab.
  • 10. Concurrent medical condition requiring the use of systemic immunosuppressive medications, or systemic corticosteroids at doses of greater than 10 mg Prednisone-equivalent. Topical steroids and other localized corticosteroids are permitted. Patients who have received acute, low-dose, systemic immunosuppressant medications equivalent to ≤ 10mg of prednisone within the 7 days prior to study entry (small dose of dexamethasone for nausea, short course for upper respiratory tract infection etc.) may be enrolled in the study. Use of steroids as prophylactic treatment for subjects with contrast allergies to diagnostic imaging contrast dyes will be permitted.
  • 11. Concurrent use or planned use of any forbidden medications within 4 weeks prior to study drug administration, which include chemotherapy, immunotherapy (tumor vaccine, cytokine, or growth factor given to control cancers), other biologic therapy, investigational therapy, or hormonal therapy.
  • 12. Confirmed pregnancy (by pregnancy test) if patient is of childbearing age or breast feeding.
  • 13. Subjects with signs/symptoms suggestive of COVID-19 and confirmed positive COVID-19 test.
  • 14. Eastern Cooperative Oncology Group (ECOG) performance status ≥3 (see Appendix) 15. Any underlying medical condition that, in the Principal Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity determination or adverse events, or renders the patient ineligible to be on study.

Trial locations and contacts

2 sites in 1 country.

Angel Arnaout, MD contact

613-798-5555

anarnaout@toh.ca

Canada2 sites

  • The Ottawa Hospital Research Institute and Cancer Center

    Ottawa, Ontario, K1Y 4E9

    Angel Arnaout, MD, 613-798-5555 ext. 79622, aarnaout@toh.on.ca

  • Ontario Institute for Cancer Research

    Toronto, Ontario, M5G 0A3

    Melanie Spears, PhD, melanie.spears@oicr.on.ca

    Angel Arnaout, MD

Other trials in Canada

About this study

Official title: A Randomized Phase II Window of Opportunity Clinical Trial of IL-4 +/- PD-1 Inhibition in Early-stage ER+ HER2- Breast Cancer

This proposal is for a Window of Opportunity (WOO) clinical trial using a novel combination of two Health Canada approved agents, cemiplimab (Libtayo) and dupilumab (Dupixent), for off label use in early-stage estrogen receptor positive (ER+) breast cancer.

Read the detailed description

This is a phase II, open-label, randomized window of opportunity trial evaluating the immunologic effects within the tumour, microenvironment, and host blood of patients treated with either

  • Arm A: Cemiplimab (n=10)
  • Arm B: Cemiplimab + Dupilumab (n=10) administered prior to surgery. Randomization will be at 1:1 ratio in patients newly diagnosed with primary operable ER+* HER2- invasive breast cancer awaiting surgery in the next 4-6 weeks who are not planned for neoadjuvant therapy.

Primary Hypothesis: In ER+ breast cancer, blockade of IL-4 signalling using dupilumab enhances anti-tumor immunity (through reduced Th2 skewing) when used in combination with PD-1 inhibitors (Cemiplimab) compared to PD-1 inhibition alone in ER+ breast cancer

Primary Objective:

  • To determine whether addition of dupilumab to cemiplimab reduces TH2 skewing of the tumor, tumor microenvironment (TME) and blood in patients with ER+ breast cancer

Secondary Objectives:

  • To evaluate dynamic changes in immune cell populations as measured by in situ proteomics
  • To characterize the safety of a short-term duration of the combination of dupilumab with cemiplimab in patients with ER+ breast cancer awaiting surgery

Exploratory Objective:

  • To test the effect of tumor PD-1 gene expression and its effect on the immune response in treated and untreated patients

This is a window of opportunity trial which will require administration of cemiplimab or combination of cemiplimab + dupilumab prior to surgery. Surgery will be a minimum of 96 hours to 2 weeks after the cemiplimab. Patient follow-up after surgery will be for a period of 30 days post-surgery.

Target: 20 patients (10 in Arm A and 10 in Arm B). Accounting for screen failures and withdrawals (20%), 24 patients will be accrued.

Conditions
Breast Cancer
Being tested
Arm A: Cemiplimab, Arm B: Cemiplimab + Dupilumab
Keywords
Window of Opportunity Clinical Trials, cemiplimab, dupilumab
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Arm A: Cemiplimab, Arm B: Cemiplimab + DupilumabDrug

    Arm A: Cemiplimab: 350mg IV x 1 dose administered prior to surgery Arm B: Cemiplimab + Dupilumab: Cemiplimab 350mg IV x 1 dose + Dupilumab 600 mg SC x 1 dose administered prior to surgery

Study groups in NCT05967884
Study groupRoleWhat they receive
Arm A: CemiplimabActive comparatorArm A: Cemiplimab (n=10), 350mg IV x 1 dose administered prior to surgery.
Receives: Drug: Arm A: Cemiplimab, Arm B: Cemiplimab + Dupilumab
Arm B: Cemiplimab + DupilumabExperimentalArm B: Cemiplimab + Dupilumab (n=10), Cemiplimab 350mg IV x 1 dose + Dupilumab 600 mg SC x 1 dose administered prior to surgery.
Receives: Drug: Arm A: Cemiplimab, Arm B: Cemiplimab + Dupilumab

What is being measured

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

  1. Immune Cell Population Analysis

    The % change in various immune cell populations (CD3, CD8, macrophages and DC cells) in the tumor and microenvironment, Defined as the post-treatment value / pre-treatment value * 100%

    Measured: up to 6 months

Secondary outcomes (1)

  1. Study Participant Assessment of Adverse Effects

    Number of participants with treatment-related adverse effects of patients treated with short term cemiplimab + dupilumab, using NCI-CTCAE

    Measured: up to 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 posted1 Aug 2023
  2. Study start4 Aug 2023 (estimated)
  3. Primary completion1 Aug 2024 (estimated)
  4. Study completion1 Aug 2024 (estimated)

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05967884
Sponsor's protocol ID
OMS 05-2023
Status last verified
Jul 2023
First submitted
12 Jul 2023
Last updated
1 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Arm A: Cemiplimab, Arm B: Cemiplimab + Dupilumab in people with Breast Cancer, run by Ottawa Hospital Research Institute at 2 sites in Canada.

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 8 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Results are not available in the source record.

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

Contact Angel Arnaout, MD (613-798-5555, anarnaout@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immune Cell Population Analysis (time frame: up to 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 NCT05967884.

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 1 Aug 2023.

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