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

Status
Active
Cancer Type
Gynecologic Cancers
Liver Cancer / Hepatoblastoma
Lung Cancer
Ovarian Cancer
Primary Peritoneal Cancer
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03836352
Protocol IDs
P1719-SUR-Z11 (primary)
NCI-2019-03013
Keynote 903
Study Sponsor
ImmunoVaccine Technologies, Inc. (IMV Inc.)

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.

Objectives

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.

Eligibility

  1. Subjects with advanced or metastatic solid tumours who have completed treatment with first line therapy:
  2. Epithelial ovarian, fallopian tube, or peritoneal cancer
  3. Hepatocellular carcinoma
  4. Non-small cell lung cancer
  5. Urothelial cancer
  6. Microsatellite instability high solid tumours, other than the above indications
  7. Radiologic and/or biochemical evidence of disease progression
  8. Completion of pre-treatment tumour biopsy
  9. Must have measurable disease by RECIST v1.1
  10. Ambulatory with an ECOG 0-1
  11. Life expectancy = 6 months
  12. Meet protocol-specified laboratory requirements

Treatment Sites in Georgia

Emory Clinic


1365 Clifton Road NE
Atlanta, GA 30322
www.emoryhealthcare.org

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.