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
Condition(s) studied
Ovarian CancerHepatocellular CarcinomaNon-small Cell Lung CancerBladder CancerMicrosatellite Instability-High
Investigational drug(s) / intervention(s)
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
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)
- Efficacy as measured by objective response rate — Approximately 24 months
Centrally evaluated using RECIST v1.1 - Safety as measured by the rate of adverse events — Approximately 24 months
Using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Trial sites (23)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 →More ImmunoVaccine Technologies, Inc. (IMV Inc.) trials in the USA
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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