Status:
COMPLETED
Study of ONT-10 and Varlilumab to Treat Advanced Ovarian or Breast Cancer
Lead Sponsor:
Cascadian Therapeutics Inc.
Collaborating Sponsors:
Celldex Therapeutics
Conditions:
Advanced Breast Carcinoma
Advanced Ovarian Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a two-part Phase 1b, open-label study of ONT 10 administered in combination with varlilumab. Two different doses of varlilumab will be studied in combination with the single agent recommended ...
Detailed Description
This is a two-part Phase 1b, open-label study of ONT 10 administered in combination with varlilumab. Two different doses of varlilumab will be studied in combination with the single agent recommended ...
Eligibility Criteria
Inclusion
- Be at least 18 years of age at the time of consent
- Life expectancy of at least 6 months, in the opinion of the investigator
- Have histologically confirmed breast or ovarian carcinoma
- Have evidence of persistent, recurrent, or progressive disease for which there is no known or established treatment available with curative intent, after at least one course of systemic therapy for locally advanced or metastatic disease , including chemotherapy, targeted therapy (small molecule or antibody based), or hormonal therapy
- Measurable or evaluable disease by RECIST 1.1
- ECOG performed status of 0 or 1
- Adequate hematologic function defined by:
- WBC count ≥ 3.0 x 103 cells/µL
- Lymphocyte count ≥ 0.8 x 103 cells/µL
- Platelet count ≥ 75 x 103 /µL, and
- Hemoglobin ≥ 9 g/dL
- Have renal and hepatic function as defined by:
- AST and ALT ≤ 2.5 X ULN
- Total bilirubin ≤ 1.5 X ULN. Patients with elevated bilirubin known to be due to Gilbert's disease may be enrolled after approval from the medical monitor, and
- Creatinine clearance ≥ 50 mL/min
- If female of child bearing potential, have a negative pregnancy test at screening
- If fertile male or female of child-bearing potential, agree to consistently use a highly effective method of birth control (including birth control pills, barrier device, or intrauterine device, abstinence or other methods prescribed by a licensed healthcare provider) from the time of consent through 70 days following the last dose of study drug
- Patient or a legally authorized representative of a patient must be able and willing to sign informed consent document that has been approved by an IRB
Exclusion
- Has medical, social, or psychological factors that, in the opinion of the Investigator, could impact safety or compliance with study procedures
- Is pregnant, breastfeeding, or planning a pregnancy
- Has received treatment with any systemic anticancer therapy, wide-field radiation, or experimental agent within 4 weeks of receiving cyclophosphamide on Day -3, with the exception of anticancer hormonal therapy, which may not be given within 2 weeks of receiving cyclophosphamide on Day -3. All residual toxicity related to prior anticancer therapies (excluding vitiligo, endocrinopathies on stable replacement therapy, alopecia and Grade 2 fatigue) must resolve to Grade 1 severity or less or return to baseline prior to receipt of study treatment.
- Has received treatment with focal radiotherapy within 2 weeks, or radiopharmaceuticals (e.g., strontium, samarium) within 8 weeks of receiving cyclophosphamide on Day -3
- Has untreated or uncontrolled CNS metastases, including patients who require glucocorticoid therapy for CNS metastases
- Has received prior treatment with ONT-10 or varlilumab, or prior treatment with other MUC1 vaccines or CD27-targeted agents
- Has active autoimmune disease or a documented history of autoimmune disease, or history of potential autoimmune syndrome that required systemic steroids or immunosuppressive medications, except for patients with vitiligo, endocrinopathies, type 1 diabetes, or patients with resolved childhood asthma/atopy or other syndromes which would not be expected to recur in the absence of an external trigger (e.g., drug-related serum sickness or post-streptococcal glomerulonephritis). Patients with mild asthma who require intermittent use of bronchodilators (such as albuterol) who have not been hospitalized for asthma in the preceding 3 years will not be excluded from this study.
- Has recognized immunodeficiency disease, including cellular immunodeficiencies, hypogammaglobulinemia, or dysgammaglobulinemia, and/or other hereditary congenital immunodeficiencies
- Has any pre-existing medical condition requiring systemic chronic steroid or immunosuppressive therapy
- a) Inhaled corticosteroids for COPD or topical steroids are allowed
- Known to be positive for HIV, or to have active hepatitis B, or hepatitis C, or have active infection of any kind requiring systemic therapy
- Administration of any other vaccine ≤ 4 weeks of receiving cyclophosphamide on Day -3
- Underlying medical condition that, in the Investigator's opinion, will make the administration of study treatment hazardous or obscure the interpretation of toxicity determination of adverse events. This includes other prior malignancy, except for adequately treated basal or squamous cell skin cancer or in situ cancer; or any other cancer from which the patient has been disease-free for at least 3 years.
- Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension (persistent systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 100 mmHg on antihypertensive medications) or arrhythmia, congestive heart failure (NYHA Class III or IV) related to primary cardiac disease, ischemic or severe valvular heart disease, or myocardial infarction within 6 months prior to the first dose of study treatment
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT02270372
Start Date
November 1 2014
End Date
June 1 2016
Last Update
May 17 2018
Active Locations (4)
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1
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
2
University of Colorado
Aurora, Colorado, United States, 80045
3
NYU Perlmutter Cancer Center
New York, New York, United States, 10016
4
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203