Clinical trial · Interventional
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.
NCT03836352CI-TRIAL-00057409active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Microsatellite Instability-High | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| DPX-Survivac | Other | — | UNRESOLVED |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1 (All cohorts)
- description
- DPX-Survivac, Cyclophosphamide, Pembrolizumab
- interventionNames
- Other: DPX-Survivac
- Drug: Cyclophosphamide
- Drug: Pembrolizumab
- type
- EXPERIMENTAL
- label
- Arm 2 (Ovarian cohort only)
- description
- DPX-Survivac, Pembrolizumab
- interventionNames
- Other: DPX-Survivac
- Drug: Pembrolizumab
Primary outcomes (2)
- measure
- Efficacy as measured by objective response rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.