The Safety and Antitumor Activity of the Combination of Oregovomab and Hiltonol in Recurrent Advanced Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT03162562|
Recruitment Status : Active, not recruiting
First Posted : May 22, 2017
Last Update Posted : May 22, 2019
This is a Phase Ib study to look at the combination of an antibody immunization vaccine strategy using oregovomab and an investigational stage immune booster (poly ICLC / Hiltonol), both of which have previously been used in combination with other cancer treatments and demonstrated to be active in advanced cancer, but which have not previously been used together. This study will assess the approach as to whether these two drugs can safely add to the response seen with either drug alone, both of which have doses that are based on prior studies.
Subjects with stable disease for whom a 12 week break from therapy for their persistent and progressive advanced ovarian cancer is appropriate, who have signed informed consent and for whom baseline clinical information is completed, will receive 4 cycles of oregovomab/Hiltonol immunization every three weeks (weeks 0, 3, 6, and 9). Blood will be obtained for to look for a CA125 specific T cell response at 12 weeks before initiating any additional therapy according to the best clinical judgment of the investigator. At week 16 the subjects will receive a final dose of the combination of oregovomab/Hiltonol and at week 17 will have an additional blood draw for analysis of T-cell response.
|Condition or disease||Intervention/treatment||Phase|
|Cancer of Ovary Neoplasms, Ovarian Ovarian Cancer Stage IV Ovarian Cancer Recurrent Ovarian Cancer Stage III Ovary Cancer||Biological: Oregovomab Drug: Poly ICLC||Phase 1|
This is a Phase Ib evaluation of the combination of an antibody immunization vaccine strategy using oregovomab and an investigational stage immune adjuvant (poly ICLC / Hiltonol), both of which have previously been used in combination with other cancer treatments and demonstrated to be bioactive in advanced cancer, but which have not previously been combined together. The doses selected for each agent have been selected previously through human clinical study for use in immunization protocols as a well-tolerated and bioactive immune stimulatory dose. For immunization purposes a maximum tolerated dose is not a relevant pharmacologic objective. Rather this is an exercise in efficiently assessing a preliminary immunization protocol as a cost effective product development strategy assessing the ability of the combination to safely augment the immune signals measurable with either agent alone, both of which have been titrated to the current dose based on the principle of bell shaped dose response in immunization in prior studies.
Subjects with stable disease for whom a 12 week break from cytotoxic therapy for their persistent and progressive advanced ovarian cancer is appropriate, who have signed informed consent and for whom baseline clinical information including laboratory, radiologic and physical documentation of their status is completed, will receive 4 cycles of oregovomab/Hiltonol immunization every three weeks (weeks 0, 3, 6, and 9). Blood will be obtained for the measurement of CA125 specific T cell immunity at 12 weeks before initiating continuing salvage therapy according to the best clinical judgment of the investigator. At week 16 the subjects will receive a final immunization with oregovomab/Hiltonol and at week 17 an additional blood draw for analysis of T-cell immunity.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Phase Ib Clinical Trial to Evaluate the Safety and Efficacy of Oregovomab and Hiltonol® as a Combinatorial Immunotherapy Strategy in Patients With Recurrent Advanced Epithelial Cancer of Ovarian, Tubal, or Peritoneal Origin|
|Actual Study Start Date :||May 30, 2017|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2021|
Experimental: Oregovomab plus Poly ICLC (Hiltonol)
Oregovomab Solution, 2 mg IV, every three weeks (weeks 0, 3, 6, and 9) and then once at week 16 plus poly ICLC Suspension, 2 mg IM, 30 minutes post-oregovomab infusion and 48 hours post-oregovomab infusion (total 10 doses)
Monoclonal antibody against CA 125
Drug: Poly ICLC
Other Name: Hiltonol
- Change in laboratory values, physical findings (physical examination), vital signs, subjective patient experience and treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Week 0 to Week17+30 days ]The primary outcome is to establish the preliminary safety regarding the combination of the anti-CA-125 monoclonal antibody oregovomab and the TLR3 agonist immune adjuvant poly ICLC (Hiltonol ®) as a strategy to induce CA125 specific anti-tumor immunity in heavily pretreated subjects with progressive ovarian cancer.
- Evaluation of cellular immune response to oregovomab. [ Time Frame: Week 0, Week 12, Week 17 ]Evaluation of the cellular immune response to oregovomab by a CA125 specific cellular immune response assay
- Evaluation of human anti-mouse antibody (HAMA) response to oregovomab. [ Time Frame: Week 0, Week 12, Week 17 ]Evaluation of HAMA response to oregovomab by a commercial HAMA assay.
- Time to overall survival [ Time Frame: Up to Week 173 ]Evaluation of overall survival up to three years after study completion.
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): NCT03162562
|United States, Florida|
|Florida Hospital Cancer Institute|
|Orlando, Florida, United States, 32804|
|United States, Virginia|
|VCU Massey Cancer Center, Dalton Oncology Clinic|
|Richmond, Virginia, United States, 23298|
|Study Director:||Shawn Du, MD||OncoQuest Inc.|
|Study Director:||Christopher Nicodemus, MD FACP||AIT Strategies|