Description:
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.
Title
- Brief Title: Study of an Immunotherapeutic, DPX-Survivac, in Combination With Low Dose Cyclophosphamide & Pembrolizumab, in Subjects With Selected Advanced & Recurrent Solid Tumors
- Official 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.
Clinical Trial IDs
- ORG STUDY ID:
P1719-SUR-Z11
- SECONDARY ID:
Keynote 903
- NCT ID:
NCT03836352
Conditions
- Ovarian Cancer
- Hepatocellular Carcinoma
- Non-small Cell Lung Cancer
- Bladder Cancer
- Microsatellite Instability-High
Interventions
Drug | Synonyms | Arms |
---|
Cyclophosphamide | | Arm 1 (All cohorts) |
Pembrolizumab | MK-3475 | Arm 1 (All cohorts) |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Arm 1 (All cohorts) | Experimental | DPX-Survivac, Cyclophosphamide, Pembrolizumab | - Cyclophosphamide
- Pembrolizumab
|
Arm 2 (Ovarian cohort only) | Experimental | DPX-Survivac, Pembrolizumab | |
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
- 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Efficacy as measured by objective response rate |
Time Frame: | Approximately 24 months |
Safety Issue: | |
Description: | Centrally evaluated using RECIST v1.1 |
Secondary Outcome Measures
Measure: | Objective response rate |
Time Frame: | Approximately 24 months |
Safety Issue: | |
Description: | Centrally evaluated using iRECIST |
Measure: | Duration of response |
Time Frame: | Approximately 24 months |
Safety Issue: | |
Description: | |
Measure: | Disease control rate |
Time Frame: | Approximately 24 months |
Safety Issue: | |
Description: | |
Measure: | Progression Free Survival |
Time Frame: | Approximately 24 months |
Safety Issue: | |
Description: | |
Measure: | Overall survival |
Time Frame: | Approximately 24 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | ImmunoVaccine Technologies, Inc. (IMV Inc.) |
Trial Keywords
- T cell activation
- Immunotherapy
- Ovarian
- Hepatocellular Carcinoma
- Non-small Cell Lung
- Bladder
- Microsatellite Instability-High
- Survivin
- Anti-PD-1
- MK-3475
Last Updated
June 28, 2021