Back to Clinical Trials

Brief Title: Study of an Immunotherapeutic, DPX-Survivac, in Combination With Low Dose Cyclophosphamide & Pembrolizumab, in Subjects With Selected Advanced & Recurrent Solid Tumors

A Phase 2, Open-label, Multicenter, Study of an Immunotherapeutic Treatment, DPX-Survivac in Combination With Low Dose Cyclophosphamide and Pembrolizumab, in Subjects With Selected Advanced and Recurrent Solid Tumours.

INTRODUCTION

  • Org Study ID: P1719-SUR-Z11
  • Secondary ID: Keynote 903
  • NTC ID: NCT03836352
  • Sponsor: ImmunoVaccine Technologies, Inc. (IMV Inc.)

BRIEF 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.

DETAILED 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.

  • Overall Status
    Recruiting
  • Start Date
    December 21, 2018
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Efficacy as measured by objective response rate

Primary Outcome 1 - Timeframe: Approximately 24 months

Primary Outcome 2 - Measure: Safety as measured by the rate of adverse events

Primary Outcome 2 - Timeframe: Approximately 24 months

CONDITION

  • Ovarian Cancer
  • Hepatocellular Carcinoma
  • Non-small Cell Lung Cancer
  • Bladder Cancer
  • Microsatellite Instability-High

ELIGIBILITY

Key Inclusion Criteria:
Subjects with advanced or metastatic solid tumours who have completed treatment with first line therapy:
Epithelial ovarian, fallopian tube, or peritoneal cancer

- Hepatocellular carcinoma

- Non-small cell lung cancer

- Urothelial cancer

- 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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact
Facility: The University of Arizona Cancer Center
Tucson, Arizona 58724
United States
Status: Recruiting Contact: Contact
Alex Wolf
520-694-9090 1014
amw8@arizona.edu
Facility: Cedars Sinai Medical Center: Samuel Oschin Comprehensive Cancer Center
Los Angeles, California 90048
United States
Status: Recruiting Contact: Principal Investigator
Rachna Shroff, MD
310-967-0694 1025
kari.kayser@cshs.org
Facility: Boca Raton Regional Hospital, Lynn Cancer Institute
Boca Raton, Florida 33486
United States
Status: Recruiting Contact: Contact
Kari Kayser
561-955-4800 8002
SGodbout@brrh.com
Facility: Comprehensive Hematology and Oncology
Saint Petersburg, Florida 33709
United States
Status: Recruiting Contact: Contact
Sylvie Godbout
727-942-7070 2297
dkisko@comphemonc.com
Facility: Winship Cancer Institute: The Emory Clinic
Atlanta, Georgia 30322
United States
Status: Recruiting Contact: Principal Investigator
Stephen Grabelsky, MD
404-778-5569 70306
lydia.g.cox@emory.edu
Facility: James Brown Graham Cancer Center:University of Louisville Hospital
Louisville, Kentucky 40202
United States
Status: Recruiting Contact: Contact
Archana Pathak
502-562-4673 87435
Jennifer.Schoenbachler@louisville.edu
Facility: Ochsner Cancer Institute
New Orleans, Louisiana 70121
United States
Status: Recruiting Contact: Contact
Deborah Kisko
504-842-7693 13727
heather.scuderi@ochsner.org
Facility: Allina Health, Virginia Piper Cancer Institute
Minneapolis, Minnesota 55407
United States
Status: Recruiting Contact: Principal Investigator
Pratibha Desai, MD
612-863-5501
jennifer.hite@allina.com
Facility: Christus St. Vincent Regional Cancer Center
Santa Fe, New Mexico 87505
United States
Status: Recruiting Contact: Contact
Lydia G Cox
505-913-8935
andrea.rodriguez@stvin.org
Facility: Montefiore Medical Center
Bronx, New York 10461
United States
Status: Recruiting Contact: Principal Investigator
Manali Bhave, MD
718-405-8535
charlotte.sklow@einsteinmed.org
Facility: NYU Winthrop Hospital
Mineola, New York 11501
United States
Status: Recruiting Contact: Contact
Jennifer Schoenbachler
516-663-1216
Jennifer.Himmel@nyulangone.org
Facility: University of Toledo
Toledo, Ohio 43614
United States
Status: Recruiting Contact: Principal Investigator
Rebecca Redman, MD
419-383-6962
stephanie.smiddy@utoledo.edu
Facility: William Osler Health System
Brampton, Ontario L6R3J7
Canada
Status: Recruiting Contact: Contact
Jennifer Hite, RN, MSN
613-737-7700
aobrien@ohri.ca
Facility: Southlake Regional Health Center
Newmarket, Ontario L3Y 2P9
Canada
Status: Recruiting Contact: Contact
Andrea Rodriguez
514-890-8000
xavier.levac.chum@ssss.gouv.qc.ca
Facility: The Ottawa Hospital
Ottawa, Ontario K1H 8L6
Canada
Status: Recruiting Contact: Principal Investigator
Olivier Rixe, MD
418-691-5781
maryse.gingras@chudequebec.ca
Facility: Sunnybrook Research Institute
Toronto, Ontario H2X 0A9
Canada
Status: Recruiting Contact: Contact
Charlotte Sklow

Facility: Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec H4A 3J1
Canada
Status: Recruiting Contact: Principal Investigator
Andreas Kaubisch, MD

Facility: CHU de Québec-Université Laval
Québec, Quebec
Canada
Status: Recruiting Contact: Principal Investigator
Eva Chalas, MD