Epithelial Ovarian CancerPhase 1NCT03332576
Phase 1b Study of a Cancer Vaccine to Treat Patients With Advanced Stage Ovarian, Fallopian or Peritoneal Cancer
A Phase 1 study testing DPX-Survivac, DPX-Survivac(Aqueous) and Cyclophosphamide in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by ImmunoVaccine Technologies, Inc. (IMV Inc.) at 3 sites in 2 countries.
Trial summary
As a follow-on study to NCT01416038, this study is designed to identify the optimal dosage of immunotherapeutic survivin vaccine DPX-Survivac and low dose oral cyclophosphamide. The combination treatment is being evaluated in a non-randomized, multi-cohort study as post-chemotherapy treatment for patients with… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- What is being tested?
- DPX-Survivac, DPX-Survivac(Aqueous) and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 23 Aug 2013to 9 Sep 2019
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed stage IIc-IV epithelial ovarian, fallopian tube or peritoneal cancer
- Complete or partial response following standard of care surgery and first line chemotherapy
- May have one disease recurrence with complete or partial response or stable disease following standard of care second line care treatment
- Previous investigational biologic therapy allowed, must be more than 56 days prior to first injection
- Previous treatment with bisphosphonate allowed, must be completed 14 days prior to first injection
- Ambulatory with an ECOG 0-1
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- Life expectancy > 6 months
- Meet protocol-specified lab requirements
- Provide informed consent and have ability to comply with protocol requirements
Who cannot join
- Concurrent chemotherapy, radiation therapy, immunotherapy are excluded (washout periods as specified in protocol)
- Prior receipt of survivin based vaccines
- Participation in prior therapeutic adjuvant ovarian cancer studies, except for platinum-based adjuvant studies
- Progressive disease (rising CA-125 acceptable)
- More than one course of chemotherapy for recurrent disease
- Concurrent bevacizumab as maintenance therapy
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- Concurrent second malignancy other than non-melanoma skin cancer, cervical carcinoma in situ, or controlled bladder cancer
- History of autoimmune disease
- Recent history of thyroiditis
- Presence of a serious acute infection or chronic infection
- Brain metastases
- Other serious intercurrent chronic or acute illness
- Ongoing treatment with steroid therapy or other immunosuppressive
- Acute or chronic skin disorders
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Winthrop University Hospital
Mineola, New York, 11501
Lenox Hill Hospital
New York, New York, 10028
About this study
Official title: Phase 1b Study of Extended Dosing of an Immunotherapeutic Vaccine, DPX-Survivac With Low Dose Cyclophosphamide in Patients With Surgically Operable or Advanced Stage Ovarian, Fallopian Tube or Peritoneal Cancer.
As a follow-on study to NCT01416038, this study is designed to identify the optimal dosage of immunotherapeutic survivin vaccine DPX-Survivac and low dose oral cyclophosphamide. The combination treatment is being evaluated in a non-randomized, multi-cohort study as post-chemotherapy treatment for patients with late-stage ovarian, fallopian tube, or peritoneal cancer.
- Being tested
- DPX-Survivac, DPX-Survivac(Aqueous), Cyclophosphamide
- Keywords
- vaccine, immunotherapy, combination therapy
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPX-SurvivacBiological
SubQ injection
DPX-Survivac(Aqueous)Biological
SubQ injection
CyclophosphamideDrug
PO BID
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 6 Doses DPX-Survivac (2 prime q3w, 4 boost q8w)
Low dose cyclophosphamide Receives: Biological: DPX-Survivac; Drug: Cyclophosphamide |
| Cohort 2 | Experimental | 6 Doses DPX-Survivac (2 prime q3w, 4 boost q8w)
Low dose cyclophosphamide Receives: Biological: DPX-Survivac; Drug: Cyclophosphamide |
| Cohort 3 | Experimental | 3 Doses DPX-Survivac (1 prime, 2 boost q8w)
Low dose cyclophosphamide Receives: Biological: DPX-Survivac; Drug: Cyclophosphamide |
| Cohort 4 | Experimental | 5 Doses DPX-Survivac (2 prime q6w, 3 boost q6w)
Low dose cyclophosphamide Receives: Biological: DPX-Survivac; Drug: Cyclophosphamide |
| Cohort 5 | Experimental | 5 Doses DPX-Survivac/DPX-Survivac(Aqueous) (2 prime q4w, 3 boost q4w)
Low dose cyclophosphamide Receives: Biological: DPX-Survivac; Biological: DPX-Survivac(Aqueous); Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as measured by adverse event reporting (CTCAE)
Measured: up to 11 months
Secondary outcomes (2)
Cell mediated immunity as measured by the antigen specific response in peripheral blood
Measured: up to 11 months
Impact on residual tumour
Evaluated by standard of care radiology and CA-125
Measured: up to 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start23 Aug 2013
- Primary completion8 Sep 2016
- Study completion9 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmunoVaccine Technologies, Inc. (IMV Inc.)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03332576
- Sponsor's protocol ID
- ONC-DPX-Survivac-03
- Status last verified
- Jun 2021
- First submitted
- 2 Nov 2017
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b Study of Extended Dosing of an Immunotherapeutic Vaccine, DPX-Survivac With Low Dose Cyclophosphamide in Patients With Surgically Operable or Advanced Stage Ovarian, Fallopian Tube or Peritoneal Cancer.
- ClinicalTrials.gov ID
- NCT03332576
- Acronym / sponsor ID
- ONC-DPX-Survivac-03
- Keywords
- vaccine, immunotherapy, combination therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- ImmunoVaccine Technologies, Inc. (IMV Inc.)Industry (pharma, biotech, devices)
- Study start
- 23 Aug 2013 (actual)
- Primary completion
- 8 Sep 2016 (actual)
- Study completion
- 9 Sep 2019 (actual)
- First posted
- 6 Nov 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.
As a follow-on study to NCT01416038, this study is designed to identify the optimal dosage of immunotherapeutic survivin vaccine DPX-Survivac and low dose oral cyclophosphamide. The combination treatment is being evaluated in a non-randomized, multi-cohort study as post-chemotherapy treatment for patients with late-stage ovarian, fallopian tube, or peritoneal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: DPX-Survivac, Drug: Cyclophosphamide6 Doses DPX-Survivac (2 prime q3w, 4 boost q8w) Low dose cyclophosphamide |
| Cohort 2 | Experimental | Biological: DPX-Survivac, Drug: Cyclophosphamide6 Doses DPX-Survivac (2 prime q3w, 4 boost q8w) Low dose cyclophosphamide |
| Cohort 3 | Experimental | Biological: DPX-Survivac, Drug: Cyclophosphamide3 Doses DPX-Survivac (1 prime, 2 boost q8w) Low dose cyclophosphamide |
| Cohort 4 | Experimental | Biological: DPX-Survivac, Drug: Cyclophosphamide5 Doses DPX-Survivac (2 prime q6w, 3 boost q6w) Low dose cyclophosphamide |
| Cohort 5 | Experimental | Biological: DPX-Survivac, Biological: DPX-Survivac(Aqueous), Drug: Cyclophosphamide5 Doses DPX-Survivac/DPX-Survivac(Aqueous) (2 prime q4w, 3 boost q4w) Low dose cyclophosphamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed stage IIc-IV epithelial ovarian, fallopian tube or peritoneal cancer
- Complete or partial response following standard of care surgery and first line chemotherapy
- May have one disease recurrence with complete or partial response or stable disease following standard of care second line care treatment
- Previous investigational biologic therapy allowed, must be more than 56 days prior to first injection
- Previous treatment with bisphosphonate allowed, must be completed 14 days prior to first injection
Key exclusion criteria (14 listed)
- Concurrent chemotherapy, radiation therapy, immunotherapy are excluded (washout periods as specified in protocol)
- Prior receipt of survivin based vaccines
- Participation in prior therapeutic adjuvant ovarian cancer studies, except for platinum-based adjuvant studies
- Progressive disease (rising CA-125 acceptable)
- More than one course of chemotherapy for recurrent disease
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 |
|---|---|---|
| DPX-SurvivacSubQ injection | Biological | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
| DPX-Survivac(Aqueous)SubQ injection | Biological | Cohort 5 |
| CyclophosphamidePO BID | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
Primary outcome
Safety as measured by adverse event reporting (CTCAE)
Time frame: up to 11 months
2 secondary outcomes
Cell mediated immunity as measured by the antigen specific response in peripheral blood
Time frame: up to 11 months
Impact on residual tumour
Time frame: up to 11 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DPX-Survivac, DPX-Survivac(Aqueous) and Cyclophosphamide in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by ImmunoVaccine Technologies, Inc. (IMV Inc.) at 3 sites in 2 countries.
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 9 inclusion and 14 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: finished, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety as measured by adverse event reporting (CTCAE) (time frame: up to 11 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2021.