Trials / Active Not Recruiting
Active Not RecruitingNCT03836352
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.
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 184 (estimated)
- Sponsor
- ImmunoVaccine Technologies, Inc. (IMV Inc.) · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Ovarian Cancer
- Hepatocellular Carcinoma
- Non-small Cell Lung Cancer
- Bladder Cancer
- Microsatellite Instability-High
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | DPX-Survivac | SubQ injection (q9w) |
| DRUG | Cyclophosphamide | PO (BID) |
| DRUG | Pembrolizumab | IV Infusion (q3w) |
Timeline
- Start date
- 2018-12-21
- Primary completion
- 2023-12-31
- Completion
- 2023-12-31
- First posted
- 2019-02-11
- Last updated
- 2022-03-31
Locations
23 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03836352. Inclusion in this directory is not an endorsement.