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Clinical Trials in the USA / NCT03836352
Active, not recruiting Phase 2

Study of an Immunotherapeutic, DPX-Survivac, in Combination With Low Dose Cyclophosphamide & Pembrolizumab, in Subjects With Selected Advanced & Recurrent Solid Tumors

NCT03836352 · tracked via the Priya Life Science USA tracker
Sponsor
ImmunoVaccine Technologies, Inc. (IMV Inc.)
Phase
Phase 2
Started
2018-12-21
Last updated
2022-03-31

Condition(s) studied

Ovarian CancerHepatocellular CarcinomaNon-small Cell Lung CancerBladder CancerMicrosatellite Instability-High

Investigational drug(s) / intervention(s)

DPX-SurvivacCyclophosphamidePembrolizumab

DPX-Survivac: SubQ injection (q9w)

Cyclophosphamide: PO (BID)

Pembrolizumab: IV Infusion (q3w)

Study summary

This study will assess the safety and efficacy of DPX-Survivac and low dose cyclophosphamide with pembrolizumab in subjects with selected advanced and recurrent solid tumours.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria: * Subjects with advanced or metastatic solid tumours who have completed treatment with first line therapy: 1. Epithelial ovarian, fallopian tube, or peritoneal cancer 2. Hepatocellular carcinoma 3. Non-small cell lung cancer 4. Urothelial cancer 5. Microsatellite instability high solid tumours, other than the above indications * Radiologic and/or biochemical evidence of disease progression * Completion of pre-treatment tumour biopsy * Must have measurable disease by RECIST v1.1 * Ambulatory with an ECOG 0-1 * Life expectancy ≥ 6 months * Meet protocol-specified laboratory requirements Key Exclusion Criteria: * Chemotherapy or immunotherapy within treatment within 28 days of start of study treatment * Radiotherapy within treatment within 2 weeks of start of study treatment * Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T cell receptor where subject was discontinued from that treatment due to a Grade 3 or higher immune-related toxicity * For NSCLC subjects: Known EGFR mutations or ALK rearrangements * Prior receipt of survivin-based vaccine(s) and/or immunotherapies * Concurrent second malignancy other than non-melanoma skin cancer, cervical carcinoma in situ, or controlled bladder cancer * Clinical ascites or pleural fluid that cannot be managed * Malignant bowel obstruction or recent history of bowel obstruction * For OvCa, subjects with any single lesion greater than 5 cm * Autoimmune disease requiring treatment within the last two years (except replacement therapy) * Recent history of thyroiditis * Any history of (non-infectious) pneumonitis that required steroid therapy or current pneumonitis * Presence of a serious acute or chronic infection * Active CNS metastases and/or carcinomatous meningitis * GI condition that might limit absorption of oral agents * Allogenic tissue/solid organ transplant * 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 live attenuated vaccines * Acute or chronic skin and/or microvascular disorders * Edema or lymphedema in the lower limbs \> grade 2 * Severe hypersensitivity (≥ Grade 3) to pembrolizumab

Primary outcome measure(s)

Trial sites (23)

FacilityCityRegionStatus
The University of Arizona Cancer Center Tucson Arizona
Cedars Sinai Medical Center: Samuel Oschin Comprehensive Cancer Center Los Angeles California
Boca Raton Regional Hospital, Lynn Cancer Institute Boca Raton Florida
Hematology Oncology Associates of the Treasure Coast Port Saint Lucie Florida
Comprehensive Hematology and Oncology St. Petersburg Florida
Winship Cancer Institute: The Emory Clinic Atlanta Georgia
James Brown Graham Cancer Center:University of Louisville Hospital Louisville Kentucky
Ochsner Cancer Institute New Orleans Louisiana
Allina Health, Virginia Piper Cancer Institute Minneapolis Minnesota
Christus St. Vincent Regional Cancer Center Santa Fe New Mexico
NYU Winthrop Hospital Mineola New York
Montefiore Medical Center The Bronx New York
University of Toledo Toledo Ohio
Mary Crowley Cancer Research Center Dallas Texas
MD Anderson Houston Texas
William Osler Health System Brampton Ontario
Juravinski Cancer Center Hamilton Ontario
Southlake Regional Health Center Newmarket Ontario
The Ottawa Hospital Ottawa Ontario
Sunnybrook Research Institute Toronto Ontario
Centre hospitalier de l'Université de Montréal (CHUM) Montreal Quebec
McGill University Health Center Montreal Quebec
CHU de Québec-Université Laval Québec Quebec

On this site

📄 Keytruda (pembrolizumab) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03836352 on ClinicalTrials.gov ↗ ← All trials in the USA