Cancer of OvaryPhase 1NCT03162562
The Safety and Antitumor Activity of the Combination of Oregovomab and Hiltonol in Recurrent Advanced Ovarian Cancer
A Phase 1 study testing Oregovomab and Poly ICLC in people with Cancer of Ovary and Neoplasms, Ovarian, run by CanariaBio Inc. at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Cancer of Ovary, Neoplasms, Ovarian, Ovarian Cancer Stage IV
- What is being tested?
- Oregovomab and Poly ICLC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 May 2017to 5 Nov 2020
- Phase
- Phase 1
- 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 subjects with CA125-associated, advanced ovarian cancer (FIGO Stage III/IV) previously treated and now presenting with recurrent or persistent disease.
- Must have a histological diagnosis of epithelial adenocarcinoma of ovarian, tubal or peritoneal origin that is persistent or progressive following multiple rounds of prior standard of care and experimental therapy.
- Must have had an elevated serum CA125 level twice the upper limit of normal (per reference lab normal range) measured within 4 weeks of enrollment.
- Must have measurable disease by radiographic or physical criteria suitable for evaluation according to RECIST v1.1 for documentation of disease response or progression.
- Must have a Functional Performance Status of less than or equal to 2 on the ECOG scale (Appendix VII).
- Must have reached legal age to consent.
- Must have medical assessment consistent with prognosis for an expected survival of at least 6 months and be clinically appropriate to receive a 12 week hiatus from any cytotoxic treatment according to the best clinical judgement of the treating investigator.
- Must have voluntarily agreed to participate and have signed the informed consent, and are willing to complete all study procedures.
Who cannot join
- Compromised hematopoietic function (hemoglobin <8.0 g/dL; lymphocyte count <300 mm3; neutrophil count <1000 mm3; platelet count <100,000 mm3).
- Hepatic dysfunction defined as a bilirubin >1.5 times the upper normal limits, LDH, SGOT and SGPT>2 times upper limits of normal or albumin <3.5 g/dL.
- Renal dysfunction defined as a serum creatinine >1.6 mg/dL.
- Pregnant or breast-feeding. (While pregnancy is unlikely in view of the disease and previous surgery, subjects whom the investigator considers may be at risk of pregnancy will have a pregnancy [beta-HCG] test and will be using a medically approved contraceptive method).
- Have an active autoimmune disease (e.g., rheumatoid arthritis, SLE, ulcerative colitis, Crohn's Disease, MS, ankylosing spondylitis) requiring continuing immune suppressive therapy.
- Known allergy to murine proteins or have had a documented anaphylactic reaction to any drug, or a known hypersensitivity to diphenhydramine or other antihistamines of similar chemical structure.
Show all 15Show fewer
- Chronically treated with systemic doses of immunosuppressive drugs such as cyclosporin, ACTH, or corticosteroids.
- Active infection causing fever.
- Recognized immunodeficiency condition including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; subjects who have acquired, hereditary, or congenital immunodeficiencies, including HIV infection or have been splenectomized.
- Uncontrolled diseases other than cancer will be excluded. Subjects with chronic diseases that are well controlled (e.g., diabetes mellitus, hypertension) are eligible.
- Have received other investigational drugs within 30 days of enrollment.
- Have contraindications to the use of pressor agents (e.g., SC epinephrine), notably monoamine oxidase inhibitor (MAOI) use.
- Unable to read or understand, and/or unwilling to sign a written consent form which must be obtained prior to treatment.
- Known to have recent history of drug abuse or alcoholism.
- Have participated in a prior oregovomab clinical trial. Prior treatment with Hiltonol® does not exclude a subject from participation.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Florida Hospital Cancer Institute
Orlando, Florida, 32804
VCU Massey Cancer Center, Dalton Oncology Clinic
Richmond, Virginia, 23298
About this study
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
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.
Read the detailed description
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.
- Conditions
- Cancer of Ovary, Neoplasms, Ovarian, Ovarian Cancer Stage IV, Ovarian Cancer Recurrent, Ovarian Cancer Stage III, Ovary Cancer
- Being tested
- Oregovomab, Poly ICLC
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OregovomabBiological
Monoclonal antibody against CA 125
Poly ICLCDrug
Also called Hiltonol
Immune adjuvant
| Study group | Role | What they receive |
|---|---|---|
| Oregovomab plus Poly ICLC (Hiltonol) | Experimental | 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) Receives: Biological: Oregovomab; Drug: Poly ICLC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in laboratory values, physical findings (physical examination), vital signs, subjective patient experience and treatment-related adverse events as assessed by CTCAE v4.0
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.
Measured: Week 0 to Week17+30 days
Secondary outcomes (3)
Evaluation of cellular immune response to oregovomab.
Evaluation of the cellular immune response to oregovomab by a CA125 specific cellular immune response assay
Measured: Week 0, Week 12, Week 17
Evaluation of human anti-mouse antibody (HAMA) response to oregovomab.
Evaluation of HAMA response to oregovomab by a commercial HAMA assay.
Measured: Week 0, Week 12, Week 17
Time to overall survival
Evaluation of overall survival up to three years after study completion.
Measured: Up to Week 173
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start30 May 2017
- Primary completion5 Nov 2020
- Study completion5 Nov 2020
Why it stopped: Sponsor Decision to discontinue long-term follow-up
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer of OvaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- CanariaBio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Nicodemus, MD FACP, Study director, AIT Strategies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162562
- Sponsor's protocol ID
- QPT-ORE-003H
- Status last verified
- Dec 2020
- First submitted
- 4 May 2017
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nicodemus CF, Wang L, Lucas J, Varghese B, Berek JS. Toll-like receptor-3 as a target to enhance bioactivity of cancer immunotherapy. Am J Obstet Gynecol. 2010 Jun;202(6):608.e1-8. doi: 10.1016/j.ajog.2009.12.001. Epub 2010 Jan 18.
PubMed 20080226
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03162562
- Acronym / sponsor ID
- QPT-ORE-003H
- Conditions
- Cancer of Ovary, Neoplasms, Ovarian, Ovarian Cancer Stage IV, Ovarian Cancer Recurrent, Ovarian Cancer Stage III, Ovary Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision to discontinue long-term follow-up
- Enrolment
- 10 participants (actual)
- Lead sponsor
- CanariaBio Inc.Industry (pharma, biotech, devices)
- Study start
- 30 May 2017 (actual)
- Primary completion
- 5 Nov 2020 (actual)
- Study completion
- 5 Nov 2020 (actual)
- First posted
- 22 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oregovomab plus Poly ICLC (Hiltonol) | Experimental | Biological: Oregovomab, Drug: Poly ICLCOregovomab 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) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female subjects with CA125-associated, advanced ovarian cancer (FIGO Stage III/IV) previously treated and now presenting with recurrent or persistent disease.
- Must have a histological diagnosis of epithelial adenocarcinoma of ovarian, tubal or peritoneal origin that is persistent or progressive following multiple rounds of prior standard of care and experimental therapy.
- Must have had an elevated serum CA125 level twice the upper limit of normal (per reference lab normal range) measured within 4 weeks of enrollment.
- Must have measurable disease by radiographic or physical criteria suitable for evaluation according to RECIST v1.1 for documentation of disease response or progression.
- Must have a Functional Performance Status of less than or equal to 2 on the ECOG scale (Appendix VII).
Key exclusion criteria (15 listed)
- Compromised hematopoietic function (hemoglobin <8.0 g/dL; lymphocyte count <300 mm3; neutrophil count <1000 mm3; platelet count <100,000 mm3).
- Hepatic dysfunction defined as a bilirubin >1.5 times the upper normal limits, LDH, SGOT and SGPT>2 times upper limits of normal or albumin <3.5 g/dL.
- Renal dysfunction defined as a serum creatinine >1.6 mg/dL.
- Pregnant or breast-feeding. (While pregnancy is unlikely in view of the disease and previous surgery, subjects whom the investigator considers may be at risk of pregnancy will have a pregnancy [beta-HCG] test and will be using a medically approved contraceptive method).
- Have an active autoimmune disease (e.g., rheumatoid arthritis, SLE, ulcerative colitis, Crohn's Disease, MS, ankylosing spondylitis) requiring continuing immune suppressive therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OregovomabMonoclonal antibody against CA 125 | Biological | Oregovomab plus Poly ICLC (Hiltonol) |
| Poly ICLCAlso: HiltonolImmune adjuvant | Drug | Oregovomab plus Poly ICLC (Hiltonol) |
Primary outcome
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.
3 secondary outcomes
Evaluation of cellular immune response to oregovomab.
Time frame: Week 0, Week 12, Week 17
Evaluation of human anti-mouse antibody (HAMA) response to oregovomab.
Time frame: Week 0, Week 12, Week 17
Time to overall survival
Time frame: Up to Week 173
Results and safety
The study was stopped early (reason given: Sponsor Decision to discontinue long-term follow-up). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Background: PubMed 20080226Nicodemus CF, Wang L, Lucas J, Varghese B, Berek JS. Toll-like receptor-3 as a target to enhance bioactivity of cancer immunotherapy. Am J Obstet Gynecol. 2010 Jun;202(6):608.e1-8. doi: 10.1016/j.ajog.2009.12.001. Epub 2010 Jan 18.
- Individual participant dataSharing planned: No
Related trials for Cancer of Ovary
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 3
Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Non-Homologous Recombination Deficiency (Non-HRD) Positive Advanced Epithelial Ovarian Cancer
Epithelial Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Nicodemus, MD FACP study director
AIT Strategies
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oregovomab and Poly ICLC in people with Cancer of Ovary and Neoplasms, Ovarian, run by CanariaBio Inc. at 2 sites in United States.
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 15 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: stopped early, as of the sponsor's last update on 22 Dec 2020. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor Decision to discontinue long-term follow-up). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 NCT03162562, which also lists 1 linked publication.
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 22 Dec 2020.