Immunotherapy for Ovarian Cancer

Recruiting at 8 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 1 & 2

Sponsor: ImmunoVaccine Technologies, Inc. (IMV Inc.)

Must not be taking: Steroids, Immunosuppressives, MAOIs, others

Disqualifiers: Autoimmune, CNS metastasis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

85 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for patients with recurrent ovarian, fallopian tube, or peritoneal cancer who have completed first-line treatment and may have had subsequent chemotherapy. They should be able to perform daily activities (ECOG 0-1), have a life expectancy of at least 6 months, measurable disease, and no history of certain autoimmune diseases or other serious conditions.

Inclusion Criteria

You meet the specific lab test requirements outlined in the study.

My cancer is getting worse, shown by tests or scans.

My cancer can be measured and I agree to have tumor biopsies before and during treatment.

Exclusion Criteria

I have not received vaccines or drugs targeting immune checkpoints or IDO inhibitors.

I have received a live vaccine recently.

I have a skin or blood vessel disorder.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1b Treatment

Participants receive DPX-Survivac, low dose cyclophosphamide, and epacadostat to determine the recommended Phase 2 dose

Duration not specified

Phase 2 Treatment

Participants receive DPX-Survivac and cyclophosphamide, with or without epacadostat, to evaluate safety and effectiveness

up to 13 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Cyclophosphamide
• DPX-Survivac
• Epacadostat (INCB024360)

Trial Overview The study tests the combination of DPX-Survivac therapy with low dose oral cyclophosphamide and IDO1 inhibitor epacadostat in patients. It aims to assess safety and how well these treatments can modulate the immune system against cancer cells.

Participant Groups

Group I: Arm 2 Experimental Treatment 2 Interventions

DPX-Survivac, Cyclophosphamide (in Phase 2 only)

Group II: Arm 1 Experimental Treatment 3 Interventions

DPX-Survivac, Cyclophosphamide, Epacadostat (Phase 1 and initially Phase 2)

DPX-Survivac is already approved in United States, European Union, Canada for the following indications:

Approved in United States as DPX-Survivac for:

• None approved yet; under investigation for various cancers including ovarian cancer and diffuse large B-cell lymphoma

Approved in European Union as DPX-Survivac for:

• None approved yet; under investigation for various cancers including ovarian cancer and diffuse large B-cell lymphoma

Approved in Canada as DPX-Survivac for:

• None approved yet; under investigation for various cancers including ovarian cancer and diffuse large B-cell lymphoma

Who Is Running the Clinical Trial?

ImmunoVaccine Technologies, Inc. (IMV Inc.)

Lead Sponsor

Trials

11

Recruited

580+

Incyte Corporation

Industry Sponsor

Trials

408

Recruited

66,800+

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School