Study of an Immunotherapeutic, DPX-Survivac, in Combination With Low Dose Cyclophosphamide & Pembrolizumab, in Subjects With Selected Advanced & Recurrent Solid Tumors
NCT ID: NCT03836352
Last Updated: 2022-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
184 participants
INTERVENTIONAL
2018-12-21
2023-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1 (All cohorts)
DPX-Survivac, Cyclophosphamide, Pembrolizumab
DPX-Survivac
SubQ injection (q9w)
Cyclophosphamide
PO (BID)
Pembrolizumab
IV Infusion (q3w)
Arm 2 (Ovarian cohort only)
DPX-Survivac, Pembrolizumab
DPX-Survivac
SubQ injection (q9w)
Pembrolizumab
IV Infusion (q3w)
Interventions
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DPX-Survivac
SubQ injection (q9w)
Cyclophosphamide
PO (BID)
Pembrolizumab
IV Infusion (q3w)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
ImmunoVaccine Technologies, Inc. (IMV Inc.)
INDUSTRY
Responsible Party
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Locations
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The University of Arizona Cancer Center
Tucson, Arizona, United States
Cedars Sinai Medical Center: Samuel Oschin Comprehensive Cancer Center
Los Angeles, California, United States
Boca Raton Regional Hospital, Lynn Cancer Institute
Boca Raton, Florida, United States
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, United States
Comprehensive Hematology and Oncology
St. Petersburg, Florida, United States
Winship Cancer Institute: The Emory Clinic
Atlanta, Georgia, United States
James Brown Graham Cancer Center:University of Louisville Hospital
Louisville, Kentucky, United States
Ochsner Cancer Institute
New Orleans, Louisiana, United States
Allina Health, Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States
Christus St. Vincent Regional Cancer Center
Santa Fe, New Mexico, United States
NYU Winthrop Hospital
Mineola, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
University of Toledo
Toledo, Ohio, United States
Mary Crowley Cancer Research Center
Dallas, Texas, United States
MD Anderson
Houston, Texas, United States
William Osler Health System
Brampton, Ontario, Canada
Juravinski Cancer Center
Hamilton, Ontario, Canada
Southlake Regional Health Center
Newmarket, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Sunnybrook Research Institute
Toronto, Ontario, Canada
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada
McGill University Health Center
Montreal, Quebec, Canada
CHU de Québec-Université Laval
Québec, Quebec, Canada
Countries
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Other Identifiers
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Keynote 903
Identifier Type: OTHER
Identifier Source: secondary_id
P1719-SUR-Z11
Identifier Type: -
Identifier Source: org_study_id
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