Status:
ACTIVE_NOT_RECRUITING
Study of an Immunotherapeutic, DPX-Survivac, in Combination With Low Dose Cyclophosphamide & Pembrolizumab, in Subjects With Selected Advanced & Recurrent Solid Tumors
Lead Sponsor:
ImmunoVaccine Technologies, Inc. (IMV Inc.)
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Ovarian Cancer
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- Key
- Subjects with advanced or metastatic solid tumours who have completed treatment with first line therapy:
- Epithelial ovarian, fallopian tube, or peritoneal cancer
- Hepatocellular carcinoma
- Non-small cell lung cancer
- Urothelial cancer
- 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
- 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
Key Trial Info
Start Date :
December 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT03836352
Start Date
December 21 2018
End Date
December 31 2023
Last Update
March 31 2022
Active Locations (23)
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1
The University of Arizona Cancer Center
Tucson, Arizona, United States, 58724
2
Cedars Sinai Medical Center: Samuel Oschin Comprehensive Cancer Center
Los Angeles, California, United States, 90048
3
Boca Raton Regional Hospital, Lynn Cancer Institute
Boca Raton, Florida, United States, 33486
4
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, United States, 34952