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

Phase 2

Active, not recruiting

• Conditions: Hepatocellular Carcinoma; Bladder Cancer; Microsatellite Instability-High; Ovarian Cancer; Non-small Cell Lung Cancer
• Interventions: Other: DPX-Survivac; Drug: Pembrolizumab; Drug: Cyclophosphamide

• Registration Number: NCT03836352
• Lead Sponsor: ImmunoVaccine Technologies, Inc. (IMV Inc.)

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 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.

Study Timeline

• Study Start: 2018-12-21
• Study First Submitted: 2019-02-07
• Study First Submitted QC: 2019-02-07
• Study First Posted: 2019-02-11
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-28
• Last Update Posted: 2022-03-31
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 184

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1 (All cohorts)	DPX-Survivac	DPX-Survivac, Cyclophosphamide, Pembrolizumab
Arm 2 (Ovarian cohort only)	Pembrolizumab	DPX-Survivac, Pembrolizumab
Arm 1 (All cohorts)	Pembrolizumab	DPX-Survivac, Cyclophosphamide, Pembrolizumab
Arm 1 (All cohorts)	Cyclophosphamide	DPX-Survivac, Cyclophosphamide, Pembrolizumab
Arm 2 (Ovarian cohort only)	DPX-Survivac	DPX-Survivac, Pembrolizumab

Primary Outcome Measures

Name	Time	Method
Efficacy as measured by objective response rate	Approximately 24 months	Centrally evaluated using RECIST v1.1
Safety as measured by the rate of adverse events	Approximately 24 months	Using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	Approximately 24 months
Disease control rate	Approximately 24 months
Objective response rate	Approximately 24 months	Centrally evaluated using iRECIST
Duration of response	Approximately 24 months
Overall survival	Approximately 24 months

Trial Locations

Locations (23)

Boca Raton Regional Hospital, Lynn Cancer Institute; 🇺🇸 Boca Raton, Florida, United States

William Osler Health System; 🇨🇦 Brampton, Ontario, Canada

Sunnybrook Research Institute; 🇨🇦 Toronto, Ontario, Canada

NYU Winthrop Hospital; 🇺🇸 Mineola, New York, United States

Allina Health, Virginia Piper Cancer Institute; 🇺🇸 Minneapolis, Minnesota, United States

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada

The University of Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

Ochsner Cancer Institute; 🇺🇸 New Orleans, Louisiana, United States

Comprehensive Hematology and Oncology; 🇺🇸 Saint Petersburg, Florida, United States

Cedars Sinai Medical Center: Samuel Oschin Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

Centre hospitalier de l'Université de Montréal (CHUM); 🇨🇦 Montreal, Quebec, Canada

CHU de Québec-Université Laval; 🇨🇦 Québec, Quebec, Canada

Hematology Oncology Associates of the Treasure Coast; 🇺🇸 Port Saint Lucie, Florida, United States

James Brown Graham Cancer Center:University of Louisville Hospital; 🇺🇸 Louisville, Kentucky, United States

Juravinski Cancer Center; 🇨🇦 Hamilton, Ontario, Canada

Southlake Regional Health Center; 🇨🇦 Newmarket, Ontario, Canada

McGill University Health Center; 🇨🇦 Montreal, Quebec, Canada

University of Toledo; 🇺🇸 Toledo, Ohio, United States

Winship Cancer Institute: The Emory Clinic; 🇺🇸 Atlanta, Georgia, United States

Christus St. Vincent Regional Cancer Center; 🇺🇸 Santa Fe, New Mexico, United States

Mary Crowley Cancer Research Center; 🇺🇸 Dallas, Texas, United States

MD Anderson; 🇺🇸 Houston, Texas, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States