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Study of DPX-Survivac Therapy in Patients With Recurrent Ovarian Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE1/PHASE2

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

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

NCT02785250•ImmunoVaccine Technologies, Inc. (IMV Inc.)

View on ClinicalTrials.gov

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.

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).

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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
•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)
+7 more criteria

Locations (9)

Stanford University

Palo Alto, California, United States

Georgia Cancer Center at Augusta University

Augusta, Georgia, United States

Lenox Hill Hospital

New York, New York, United States

Oregon Health & Sciences University, Knight Cancer Institute

Portland, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Mary Crowley Cancer Research Center

Dallas, Texas, United States

Tom Baker Cancer Centre

Calgary, Alberta, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Key Dates

Start Date

April 1, 2016

Primary Completion Date

October 1, 2020

Completion Date

May 1, 2025

Last Updated

June 18, 2021

Enrollment

ESTIMATED participants

Conditions

Recurrent Epithelial Ovarian CancerRecurrent Fallopian Tube CancerRecurrent Peritoneal Cancer

Interventions

DPX-Survivac

OTHER

Cyclophosphamide

DRUG

Epacadostat (INCB024360)

DRUG

A Clinical Study Evaluating a Combination of Oregovomab and Niraparib in Adult Women With Platinum Sensitive Recurrent Ovarian Cancer.

NCT05335993

Recurrent Ovarian CancerRecurrent Epithelial Cancer of Ovary+5 more

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ACTIVE_NOT_RECRUITINGPHASE2

Metformin and Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

NCT02122185

Brenner TumorMalignant Ascites+26 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 18, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Clinical Study Evaluating a Combination of Oregovomab and Niraparib in Adult Women With Platinum Sensitive Recurrent Ovarian Cancer.

Metformin and Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Paclitaxel and Ganetespib in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Carboplatin, Gemcitabine Hydrochloride, and Mifepristone in Treating Patients With Advanced Breast Cancer or Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer