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Recurrent Epithelial Ovarian CancerPhase 1/2NCT02785250

Study of DPX-Survivac Therapy in Patients With Recurrent Ovarian Cancer

A Phase 1/2 study testing DPX-Survivac, Cyclophosphamide and Epacadostat (INCB024360) in people with Recurrent Epithelial Ovarian Cancer and Recurrent Fallopian Tube Cancer, run by ImmunoVaccine Technologies, Inc. (IMV Inc.) at 9 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

T cell activating therapy DPX-Survivac, low dose oral cyclophosphamide, and IDO1 inhibitor epacadostat will be tested together for the first time in patients with recurrent ovarian, fallopian tube, or peritoneal cancer to determine the safety and potential immune-modulating activity of the combination of these agents. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
DPX-Survivac, Cyclophosphamide and Epacadostat (INCB024360)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
9 sitesin 2 countries
Study dates
Apr 2016to May 2025
Phase
Phase 1/2
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
  • Platinum-resistant or -sensitive subjects after completing first-line treatment (debulking surgery and adjuvant or neoadjuvant treatment with standard of care treatment such as carboplatin and paclitaxel). Subjects may have had any number of subsequent lines of chemotherapy.
  • Must have evidence of progressive disease with either biochemical (i.e. rising CA-125) and/or radiologic progression
  • Must have measurable disease by RECIST v1.1, a successful pre-treatment tumor biopsy, and be willing to undergo tumor biopsy during treatment
  • Ambulatory with an ECOG 0-1
  • Life expectancy ≥ 6 months
  • Meet protocol-specified laboratory requirements

Who cannot join

  • Eligible for otherwise curative treatment or undergoing concurrent therapy
  • Prior receipt of survivin based vaccines or immune checkpoint inhibitors (e.g. anti-CTLA-4, anti-PD-1, anti-PD-L1, or any other antibody or drug specifically targeting T cell co-stimulation) or an IDO inhibitor
  • Concurrent second malignancy other than non-melanoma skin cancer, cervical carcinoma in situ, or controlled bladder cancer
  • Clinical ascites
  • Any single lesion greater than or equal to 4 cm (per RECIST v1.1)
  • Malignant bowel obstruction
Show all 17Show fewer
  • History of autoimmune disease requiring treatment within the last two years (except vitiligo or diabetes)
  • Recent history of thyroiditis
  • Presence of a serious acute infection or chronic infection
  • Active central nervous system (CNS) or leptomeningeal metastasis (brain metastases)
  • GI condition that might limit absorption of oral agents
  • Other serious intercurrent chronic or acute illness, including myocardial infarction or cerebrovascular event within 6 months
  • Ongoing treatment with steroid therapy or other immunosuppressive
  • Receipt of monoamine oxidase inhibitors (MAOIs) or UGT1A9 inhibitors
  • Receipt of live attenuated vaccines
  • Acute or chronic skin and/or microvascular disorders
  • Edema or lymphedema in the lower limbs > grade 2

Trial locations and contacts

9 sites in 2 countries.

9 sites in 2 countries

United States6 sites

  • Georgia Cancer Center at Augusta University

    Augusta, Georgia, 30912

  • Mary Crowley Cancer Research Center

    Dallas, Texas, 75230

  • Lenox Hill Hospital

    New York, New York, 10028

  • Stanford University

    Palo Alto, California, 94304

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Oregon Health & Sciences University, Knight Cancer Institute

    Portland, Oregon, 97239

Other trials in United States

Canada3 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta

  • Centre Hospitalier de l'Université de Montréal (CHUM)

    Montreal, Quebec, H2X 3E4

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: A Phase 1b/2 Study of an Immunotherapeutic Vaccine, DPX-Survivac With Low Dose Cyclophosphamide and Epacadostat (INCB024360) in Patients With Recurrent Ovarian Cancer

T cell activating therapy DPX-Survivac, low dose oral cyclophosphamide, and IDO1 inhibitor epacadostat will be tested together for the first time in patients with recurrent ovarian, fallopian tube, or peritoneal cancer to determine the safety and potential immune-modulating activity of the combination of these agents.

Read the detailed description

The Phase 1b component is a multicenter, non-randomized, open label, uncontrolled, safety and effectiveness study to identify the recommended Phase 2 dose (R2PD) of epacadostat in combination with DPX-Survivac and cyclophosphamide.

The Phase 2 component was initially a multicenter, randomized, open-label study to evaluate the safety and effectiveness of DPX-Survivac + cyclophosphamide with or without the RP2D of epacadostat. The design of the study has been amended to a single arm study in which up to 16 evaluable subjects will be enrolled to received DPX-Survivac plus intermittent low dose cyclophosphamide (i.e. treatment arm 2).

Being tested
DPX-Survivac, Cyclophosphamide, Epacadostat (INCB024360)
Keywords
T cell activation, immunotherapy, ovarian, fallopian tube, peritoneal, cancer, recurrent, tumor, measurable
Medical subject headings
Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms, Neoplasms, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DPX-SurvivacOther

    SubQ injection

  • CyclophosphamideDrug

    PO BID

  • Epacadostat (INCB024360)Drug

    PO BID

Study groups in NCT02785250
Study groupRoleWhat they receive
Arm 1ExperimentalDPX-Survivac, Cyclophosphamide, Epacadostat (Phase 1 and initially Phase 2)
Receives: Other: DPX-Survivac; Drug: Cyclophosphamide; Drug: Epacadostat (INCB024360)
Arm 2ExperimentalDPX-Survivac, Cyclophosphamide (in Phase 2 only)
Receives: Other: DPX-Survivac; Drug: Cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety as measured by adverse event reporting (CTCAE)

    Measured: up to 13 months

  2. Objective Response Rate (Phase 2 only)

    Evaluated using modified RECIST v1.1

    Measured: up to 13 months

Secondary outcomes (6)

  1. Objective Response Rate (for each treatment group)

    Evaluated using modified RECIST v1.1

    Measured: up to 13 months

  2. Duration of Response

    Measured: up to 13 months

  3. Cell mediated immunity as measured by the antigen specific response in peripheral blood

    Measured: bimonthly for up to 13 months

  4. Evaluation of treatment-induced changes in tumor infiltrating lymphocytes

    Measured: at 8 to 10 weeks

  5. Time to Progression

    Measured: up to 13 months

  6. Overall Survival

    Measured: up to 13 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionOct 2020
  4. Study completionMay 2025 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
85 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02785250
Sponsor's protocol ID
ONC-DPX-Survivac-06
Other IDs
DeCidE1
Status last verified
Jun 2021
First submitted
18 May 2016
Last updated
18 Jun 2021
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing DPX-Survivac, Cyclophosphamide and Epacadostat (INCB024360) in people with Recurrent Epithelial Ovarian Cancer and Recurrent Fallopian Tube Cancer, run by ImmunoVaccine Technologies, Inc. (IMV Inc.) at 9 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 7 inclusion and 17 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: status not confirmed, 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 9 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

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?

Safety as measured by adverse event reporting (CTCAE) (time frame: up to 13 months). The study lists 2 primary outcomes in all. 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 NCT02785250.

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.

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