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

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ImmunoVaccine Technologies, Inc. (IMV Inc.)
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Cyclophosphamide; Pembrolizumab

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