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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03836352
Other study ID # P1719-SUR-Z11
Secondary ID Keynote 903
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date December 21, 2018
Est. completion date December 31, 2023

Study information

Verified date March 2022
Source ImmunoVaccine Technologies, Inc. (IMV Inc.)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 184
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Other:
DPX-Survivac
SubQ injection (q9w)
Drug:
Cyclophosphamide
PO (BID)
Pembrolizumab
IV Infusion (q3w)

Locations

Country Name City State
Canada William Osler Health System Brampton Ontario
Canada Juravinski Cancer Center Hamilton Ontario
Canada Centre hospitalier de l'Université de Montréal (CHUM) Montreal Quebec
Canada McGill University Health Center Montreal Quebec
Canada Southlake Regional Health Center Newmarket Ontario
Canada The Ottawa Hospital Ottawa Ontario
Canada CHU de Québec-Université Laval Québec Quebec
Canada Sunnybrook Research Institute Toronto Ontario
United States Winship Cancer Institute: The Emory Clinic Atlanta Georgia
United States Boca Raton Regional Hospital, Lynn Cancer Institute Boca Raton Florida
United States Montefiore Medical Center Bronx New York
United States Mary Crowley Cancer Research Center Dallas Texas
United States MD Anderson Houston Texas
United States Cedars Sinai Medical Center: Samuel Oschin Comprehensive Cancer Center Los Angeles California
United States James Brown Graham Cancer Center:University of Louisville Hospital Louisville Kentucky
United States NYU Winthrop Hospital Mineola New York
United States Allina Health, Virginia Piper Cancer Institute Minneapolis Minnesota
United States Ochsner Cancer Institute New Orleans Louisiana
United States Hematology Oncology Associates of the Treasure Coast Port Saint Lucie Florida
United States Comprehensive Hematology and Oncology Saint Petersburg Florida
United States Christus St. Vincent Regional Cancer Center Santa Fe New Mexico
United States University of Toledo Toledo Ohio
United States The University of Arizona Cancer Center Tucson Arizona

Sponsors (2)

Lead Sponsor Collaborator
ImmunoVaccine Technologies, Inc. (IMV Inc.) Merck Sharp & Dohme Corp.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Cell mediated immunology As measured by antigen specific immune response in peripheral blood Approximately 24 months
Other Changes in immune cell infiltration As measured by multiplex immunohistochemistry Approximately 24 months
Primary Efficacy as measured by objective response rate Centrally evaluated using RECIST v1.1 Approximately 24 months
Primary Safety as measured by the rate of adverse events Using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Approximately 24 months
Secondary Objective response rate Centrally evaluated using iRECIST Approximately 24 months
Secondary Duration of response Approximately 24 months
Secondary Disease control rate Approximately 24 months
Secondary Progression Free Survival Approximately 24 months
Secondary Overall survival Approximately 24 months
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