Study of ONT-10 and Varlilumab to Treat Advanced Ovarian or Breast Cancer
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|ClinicalTrials.gov Identifier: NCT02270372|
Recruitment Status : Completed
First Posted : October 21, 2014
Last Update Posted : May 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Advanced Breast Carcinoma Advanced Ovarian Carcinoma||Biological: ONT-10, Varlilumab combination||Phase 1|
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 dose of ONT 10. Intermediate and/or lower doses of varlilumab or ONT-10 may also be studied at the recommendation of the safety monitoring committee (SMC). Treatment will be administered in cycles of 12 weeks each. All patients will receive a single dose of cyclophosphamide on Day -3. During Cycle 1, patients will receive ONT-10 administered SC once per week for 8 weeks followed by ONT-10 once every 6 weeks starting with Cycle 2, in combination with varlilumab administered IV once every 3 weeks x 3 doses, and then once every 6 weeks for cycles 2 through 5.
Each cohort will enroll an initial group of 6 evaluable patients with either breast or ovarian carcinoma. Initial enrollment into a cohort will be staggered, with the first patient treated in any new cohort to be followed for a minimum of two weeks for the occurrence of Unacceptable Toxicity prior to enrollment of the remaining 5 patients. Subsequent enrollment into a cohort may then continue without a staggered schedule until 6 patients treated are considered evaluable. Up to 24 additional evaluable patients may be enrolled and treated in Part 2 at the RD of varlilumab and ONT-10 identified in Part 1, including approximately equal numbers of patients with breast carcinoma (n~12) and ovarian carcinoma (n~12). Treatment in Part 2 will follow the same schedule as in Part 1.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b Study of ONT 10 and Varlilumab in Patients With Advanced Ovarian Cancer or Breast Cancer|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
Experimental: Drug Combination
The drug combination of ONT-10 and varilumab
Biological: ONT-10, Varlilumab combination
ONT-10 a liposomal synthetic glycopolypeptide MUC1 targeted antigen formulated with PET Lipid A adjuvant.
Varlilumab is a recombinant, fully human mAb of the IgG1κ isotype that specifically binds human CD27.
- Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Cycles of 12 weeks ]Assessment of the adverse event profile as an indication of overall safety and tolerability of the combination treatment with ONT-10 and varlilumab
- Immune Response to MUC1 [ Time Frame: 8 weeks on a weekly basis, followed by every 6 weeks ]Determine the immune response of the drug combination of varlilumab and ONT-10 to MUC1 specific humoral and cellular responses.
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): NCT02270372
|United States, Alabama|
|UAB Comprehensive Cancer Center|
|Birmingham, Alabama, United States, 35294|
|United States, Colorado|
|University of Colorado|
|Aurora, Colorado, United States, 80045|
|United States, New York|
|NYU Perlmutter Cancer Center|
|New York, New York, United States, 10016|
|United States, Tennessee|
|Sarah Cannon Research Institute|
|Nashville, Tennessee, United States, 37203|