- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03804944
Converting HR+ Breast Cancer Into an Individualized Vaccine (CBCV)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Sharanya Chandrasekhar, M.S.
- Phone Number: 646 962-2196
- Email: shc2043@med.cornell.edu
Study Contact Backup
- Name: Pragya Yadav, Ph.D.
- Phone Number: 646-962-2199
- Email: pry2003@med.cornell.edu
Study Locations
-
-
California
-
Los Angeles, California, United States, 90048
- Withdrawn
- Cedars-Sinai Medical Center
-
-
New York
-
New York, New York, United States, 11215
- Recruiting
- Brooklyn Methodist Hospital - NewYork Presbyterian
-
Contact:
- Sharanya Chandrasekhar, M.S.
- Phone Number: 646-962-2196
- Email: shc2043@med.cornell.edu
-
Contact:
- Pragya Yadav, Ph.D.
- Phone Number: 6469622199
- Email: pry2003@med.cornell.edu
-
Principal Investigator:
- Hani Ashamalla, M.D.
-
New York, New York, United States, 10065
- Recruiting
- New York Presbyterian Hospital - Queens
-
Contact:
- Sarah Stankiewich
- Phone Number: 718-661-7246
- Email: sas9306@nyp.org
-
Contact:
- Sharanya Chandrasekhar
- Phone Number: 6469623110
- Email: shc2043@med.cornell.edu
-
Principal Investigator:
- Akkamma Ravi, M.D.
-
New York, New York, United States, 10065
- Recruiting
- Weill Cornell Medicine New York Presbyterian Hospital
-
Principal Investigator:
- Silvia Formenti, M.D.
-
Contact:
- Weill Cornell Medicine New York Presbyterian Hospital
- Phone Number: 646-962-2196
- Email: shc2043@med.cornell.edu
-
New York, New York, United States, 10027
- Withdrawn
- icahn School of Medicine at Mt Sinai
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15232
- Withdrawn
- UPMC Hillman Cancer Center
-
-
Texas
-
Dallas, Texas, United States, 75390-9179
- Recruiting
- UT Southwestern Medical Center
-
Contact:
- Shahbano Shakeel
- Phone Number: 214-645-9682
- Email: shahbano.shakeel@utsouthwestern.edu
-
Principal Investigator:
- Heather McArthur, M.D.
-
Houston, Texas, United States, 77030
- Recruiting
- Houston Methodist Cancer Center
-
Contact:
- Genevieve Santibanez, CCRP
- Phone Number: 713-441-0685
- Email: gsantibanez@houstonmethodist.org
-
Principal Investigator:
- Jenny Chang, M.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Post-menopausal female ≥ 18 years of age (Post-menopausal status defined as either 1) at least 2 years without menstrual period or 2) or patients older than 50 with serological evidence of post-menopausal status or 3) hysterectomized patients of any age with FSH confirmation of post-menopausal status.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Biopsy proven diagnosis of ER+ PR+ or PR- HER2- breast cancer.
- Clinical stage I(>1.5cm, if N0) - III breast cancer, as per AJCC staging 8th edition.
- Patient needs to be able to understand and demonstrate willingness to sign a written informed consent document.
Adequate bone marrow reserve and liver function:
WBC ≥ 2000/uL Absolute neutrophil count (ANC) ≥1500/μL Platelets ≥100 000/μL Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/La Creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases) 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
Exclusion Criteria:
- Active connective tissue disorders, such as lupus or scleroderma requiring flare therapy
- Current use of systemic chemotherapy, endoctine therap or HER2-neu targeted therapy
- Post surgical excision of breast cancer.
- Previous radiotherapy of the same breast.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
- Inability to obtain histologic proof of breast cancer
- Has received a live vaccine within 30 days prior to the first dose of study drug.
Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
- 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 the first dose of study treatment. Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- Has a known additional malignancy (second primary) that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
- 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.
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Has an active infection requiring systemic therapy.Has a known history of Human Immunodeficiency Virus (HIV). 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). Note: optional based on country.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ARM 1
Focal hypo-fractionated radiation therapy 8 Gy x 3 fractions, starting day 8, every other day (M/W/F or W/F/M or F/M/W).
|
Focal hypo-fractionated radiation therapy 8 Gy x 3 fractions, starting day 8, every other day (M/W/F or W/F/M or F/M/W).
|
Active Comparator: ARM 2
Focal hypo-fractionated radiation therapy - 8 Gy x 3 fractions starting day 8, every other day (M/W/F or W/F/M or F/M/W).
+ Pembrolizumab, on day 12 (last day of radiotherapy), infused over 200mg IV over 30 minutes and then repeated every 3 weeks until disease progression or unacceptable toxicity.
|
Focal hypo-fractionated radiation therapy 8 Gy x 3 fractions, starting day 8, every other day (M/W/F or W/F/M or F/M/W).
Pembrolizumab, on day 12 (last day of radiotherapy), infused over 200mg IV over 30 minutes and then repeated every 3 weeks until disease progression or unacceptable toxicity.
|
Active Comparator: ARM 3
Ftl-3 ligand, self-administered by subcutaneous injections at week 1, daily, for 5 consecutive days + Focal hypo-fractionated radiation therapy - 8 Gy x 3 fractions starting day 8, (every other day (M/W/F or W/F/M or F/M/W).
|
Focal hypo-fractionated radiation therapy 8 Gy x 3 fractions, starting day 8, every other day (M/W/F or W/F/M or F/M/W).
Ftl-3 ligand, self-administered by subcutaneous injections at week 1, daily, for 5 consecutive days.
|
Active Comparator: ARM 4
Ftl-3 ligand, self administered subcutaneous injections at day 1 for 5 consecutive days+ Focal hypo-fractionated Radiation therapy starting day 8, - 8 Gy x 3 fractions, every other day (M/W/F or W/F/M or F/M/W).
+ Pembrolizumab, on day 12 (last day of radiotherapy), 200mg IV infused over 30 minutes then repeated every 3 weeks until disease progression or unacceptable toxicity.
|
Focal hypo-fractionated radiation therapy 8 Gy x 3 fractions, starting day 8, every other day (M/W/F or W/F/M or F/M/W).
Pembrolizumab, on day 12 (last day of radiotherapy), infused over 200mg IV over 30 minutes and then repeated every 3 weeks until disease progression or unacceptable toxicity.
Ftl-3 ligand, self-administered by subcutaneous injections at week 1, daily, for 5 consecutive days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tolerability will be demonstrated if no grade 3 or higher toxicities are observed in the first 8 patients, of each arm.
Time Frame: 3 years
|
Tolerability of adding immunotherapy to a combination of tumor radiotherapy and endocrine therapy in the neoadjuvant setting of newly diagnosed HR+ breast cancer patients will be assessed if no grade 3 or higher toxicities are observed in the first 8 patients of each arm.
CTCAE version 5.0 will be used.
|
3 years
|
Clinical response rate to tumor radiation +/-immunotherapy during standard endocrine therapy for HR+ breast cancer will be measured.
Time Frame: 3 years
|
Clinical response rate to tumor radiation +/-immunotherapy during standard endocrine therapy for HR+ breast cancer will be measured.
|
3 years
|
Pathological response rate to tumor radiation +/-immunotherapy during standard endocrine therapy for HR+ breast cancer will be measured.
Time Frame: 3 years
|
Pathological response rate to tumor radiation +/-immunotherapy during standard endocrine therapy for HR+ breast cancer will be measured.
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Local immune response will be measured by assessing tumor specimens for T-cell infiltration at baseline and and during treatment.
Time Frame: 4 years
|
Local immune response will be measured by assessing tumor specimens for T-cell infiltration at baseline and and during treatment.
|
4 years
|
Systemic immune response will be measured by collecting serial blood samples for serum and peripheral blood mononuclear cells (PBMCs) at multiple time points.
Time Frame: 4 years
|
Systemic immune response will be measured by collecting serial blood samples for serum and peripheral blood mononuclear cells (PBMCs) at multiple time points.
|
4 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Silvia Formenti, M.D., Weill Cornell Medicine - New York Presbyterian Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1808019498
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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