Study of an Immunotherapeutic, DPX-Survivac, in Combination With Low Dose Cyclophosphamide & Pembrolizumab, in Subjects With Selected Advanced & Recurrent Solid Tumors
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.
Checked against the public recordLast updated Mar 31, 2022 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- ImmunoVaccine Technologies, Inc. (IMV Inc.)
- Interventions being studied
- Other: DPX-Survivac; Drug: Cyclophosphamide; Drug: Pembrolizumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- The University of Arizona Cancer CenterTucson, Arizona
- Cedars Sinai Medical Center: Samuel Oschin Comprehensive Cancer CenterLos Angeles, California
- Boca Raton Regional Hospital, Lynn Cancer InstituteBoca Raton, Florida
- Hematology Oncology Associates of the Treasure CoastPort Saint Lucie, Florida
- Comprehensive Hematology and OncologySt. Petersburg, Florida
- Winship Cancer Institute: The Emory ClinicAtlanta, Georgia
- James Brown Graham Cancer Center:University of Louisville HospitalLouisville, Kentucky
- Ochsner Cancer InstituteNew Orleans, Louisiana
- Allina Health, Virginia Piper Cancer InstituteMinneapolis, Minnesota
- Christus St. Vincent Regional Cancer CenterSanta Fe, New Mexico
- NYU Winthrop HospitalMineola, New York
- Montefiore Medical CenterThe Bronx, New York
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 31, 2022. Always confirm current availability with the study team.