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.
This study is a Phase 2 with safety lead-in study to assess the safety and efficacy of
DPX-Survivac, low dose cyclophosphamide, and pembrolizumab combination therapy in subjects
with selected advanced and recurrent solid tumours. Two ovarian cancer arms will be recruited
and randomized in this study, one with and one without cyclophosphamide. All other cohorts
will be single arm, receiving treatment with the triple combination.
Up to 20 subjects, from any cohort, will be enrolled to assess the safety of study treatments
before the study moves to the expansion phase. Once the safety lead-in is completed, the five
cohorts will be expanded to recruit additional subjects following a Simon two stage design.
Enrollment in the ovarian cancer cohort will be randomized 1:1 into two arms.
Overal Status | Start Date | Phase | Study Type |
---|---|---|---|
Recruiting | December 21, 2018 | Phase 2 | Interventional |
Primary Outcome 1 - Measure: Efficacy as measured by objective response rate
Primary Outcome 1 - Time Frame: Approximately 24 months
Primary Outcome 2 - Measure: Safety as measured by the rate of adverse events
Primary Outcome 2 - Time Frame: Approximately 24 months
Criteria:
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
- Subjects with HCC, NSCLC, BlCa, or MSI-H subjects other than those with gastric or
colorectal cancer must have evidence of survivin expression in their pre-treatment
biopsy sample
- 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
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Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Facility | Status | Contact |
---|---|---|
Cedars Sinai Medical Center: Samuel Oschin Comprehensive Cancer Center Los Angeles, California 90048 United States |
Recruiting |
Kari Kayser 310-967-0694 kari.kayser@cshs.org |
Boca Raton Regional Hospital, Lynn Cancer Institute Boca Raton, Florida 33486 United States |
Recruiting |
Sylvie Godbout 561-955-4800 SGodbout@brrh.com |
Hematology Oncology Associates of the Treasure Coast Port Saint Lucie, Florida 34952 United States |
Recruiting |
Christine Gerges 772-408-5159 cgerges@hemoncfl.com |
Comprehensive Hematology and Oncology Saint Petersburg, Florida 33709 United States |
Recruiting |
Archana Pathak 727-344-6569 apathak@comphemonc.com |
Winship Cancer Institute: The Emory Clinic Atlanta, Georgia 30322 United States |
Recruiting |
Lydia G Cox 404-778-5569 lydia.g.cox@emory.edu |
James Brown Graham Cancer Center:University of Louisville Hospital Louisville, Kentucky 40202 United States |
Recruiting |
Jennifer Schoenbachler 502-562-4673 Jennifer.Schoenbachler@louisville.edu |
Ochsner Cancer Institute New Orleans, Louisiana 70121 United States |
Recruiting |
Heather Scuderi 504-842-7693 heather.scuderi@ochsner.org |
Christus St. Vincent Regional Cancer Center Santa Fe, New Mexico 87505 United States |
Recruiting |
Christopher Lee 505-913-8965 christopher.lee@stvin.org |
NYU Winthrop Hospital Mineola, New York 11501 United States |
Recruiting |
Jennifer Himmel 516-663-1216 Jennifer.Himmel@nyulangone.org |
University of Toledo Toledo, Ohio 43614 United States |
Recruiting |
Stephanie Smiddy 419-383-6962 stephanie.smiddy@utoledo.edu |
Mary Crowley Cancer Research Center Dallas, Texas 75230 United States |
Recruiting |
Referral Office 972-566-3000 referral@marycrowley.org |
MD Anderson Houston, Texas 77030 United States |
Active, not recruiting | |
William Osler Health System Brampton, Ontario L6R3J7 Canada |
Recruiting |
Dr Henry Conter, MD 905-494-2120 Henry.Conter@williamoslerhs.ca |
Juravinski Cancer Center Hamilton, Ontario L8V 5C2 Canada |
Recruiting |
Yvonne Kinrade 905-387-9711 ykinrade@hhsc.ca |
Southlake Regional Health Center Newmarket, Ontario L3Y 2P9 Canada |
Recruiting |
Liselle Chieverton 905-895-4521 lchieverton@southlakeregional.org |
The Ottawa Hospital Ottawa, Ontario K1H 8L6 Canada |
Recruiting |
Anna O'Brien 613-737-7700 aobrien@ohri.ca |
Sunnybrook Research Institute Toronto, Ontario Canada |
Recruiting |
Ilda Carvalhana (416) 480-5000 Ilda.Carvalhana@sunnybrook.ca |
Centre hospitalier de l'Université de Montréal (CHUM) Montreal, Quebec H2X 0A9 Canada |
Recruiting |
Xavier Levac 514-890-8000 xavier.levac.chum@ssss.gouv.qc.ca |
McGill University Health Center Montreal, Quebec H4A 3J1 Canada |
Recruiting |
Taylor Grant 514-934-1934 Taylor.Grant@MUHC.MCGILL.CA |
CHU de Québec-Université Laval Québec, Quebec G1R 2J6 Canada |
Recruiting |
Maryse Gingras 418-691-5781 maryse.gingras@chudequebec.ca |