Active Not RecruitingPhase 2NCT03836352

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

StatusActive Not Recruiting
PhasePhase 2
U.S. locations23
SponsorImmunoVaccine Technologies, Inc. (IMV Inc.)
01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

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