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.
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)
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)
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.
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