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BRIEF TITLE: 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.

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.


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

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

Primary Outcomes:

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

Condition:

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

Eligibility

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

Locations

Facility Status Contact
Comprehensive Hematology and Oncology
Saint Petersburg, Florida 33709
United States
Recruiting Gouri Deshpande
727-344-6569
gdeshpande@flhemonc.com
Ochsner Cancer Institute
New Orleans, Louisiana 70121
United States
Not yet recruiting Amanda Woolery

Amanda.woolery@ochsner.org
NYU Winthrop Hospital
Mineola, New York 11501
United States
Recruiting Jennifer Himmel
516-663-1216
Jennifer.Himmel@nyulangone.org
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
Recruiting Khanh Tran
713-794-5177
KNTran1@mdanderson.org
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
Sunnybrook Research Institute
Toronto, Ontario
Canada
Recruiting Ilda Carvalhana
(416) 480-5000
Ilda.Carvalhana@sunnybrook.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