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

NCT03836352 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: P1719-SUR-Z11Keynote 903
• Study Type: interventional
• Target: 184
• Locations: 2 countries
• Sites: 23

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.

Conditions

Ovarian Cancer; Hepatocellular Carcinoma; Non-small Cell Lung Cancer; Bladder Cancer; Microsatellite Instability-High

Keywords

T cell activation; Immunotherapy; Ovarian; Hepatocellular Carcinoma; Non-small Cell Lung; Bladder; Microsatellite Instability-High; Survivin; Anti-PD-1; MK-3475

Outcome Measures

Primary Outcomes (2)

• Efficacy as measured by objective response rate

  Centrally evaluated using RECIST v1.1

  Approximately 24 months

• Safety as measured by the rate of adverse events

  Using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  Approximately 24 months

Secondary Outcomes (5)

• Objective response rate

  Approximately 24 months

• Duration of response

  Approximately 24 months

• Disease control rate

  Approximately 24 months

• Progression Free Survival

  Approximately 24 months

• Overall survival

  Approximately 24 months

Other Outcomes (2)

• Cell mediated immunology

  Approximately 24 months

• Changes in immune cell infiltration

  Approximately 24 months

Study Arms (2)

Arm 1 (All cohorts)

EXPERIMENTAL

DPX-Survivac, Cyclophosphamide, Pembrolizumab

Other: DPX-Survivac; Drug: Cyclophosphamide; Drug: Pembrolizumab

Arm 2 (Ovarian cohort only)

EXPERIMENTAL

DPX-Survivac, Pembrolizumab

Other: DPX-Survivac; Drug: Pembrolizumab

Interventions

DPX-Survivac OTHER

SubQ injection (q9w)

Arm 1 (All cohorts); Arm 2 (Ovarian cohort only)

Cyclophosphamide DRUG

PO (BID)

Arm 1 (All cohorts)

Pembrolizumab DRUG

IV Infusion (q3w)

Also known as: MK-3475

Arm 1 (All cohorts); Arm 2 (Ovarian cohort only)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ImmunoVaccine Technologies, Inc. (IMV Inc.): lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (23)

The University of Arizona Cancer Center

Tucson, Arizona, 58724, United States

Location

Cedars Sinai Medical Center: Samuel Oschin Comprehensive Cancer Center

Los Angeles, California, 90048, United States

Location

Boca Raton Regional Hospital, Lynn Cancer Institute

Boca Raton, Florida, 33486, United States

Location

Hematology Oncology Associates of the Treasure Coast

Port Saint Lucie, Florida, 34952, United States

Location

Comprehensive Hematology and Oncology

St. Petersburg, Florida, 33709, United States

Location

Winship Cancer Institute: The Emory Clinic

Atlanta, Georgia, 30322, United States

Location

James Brown Graham Cancer Center:University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

Ochsner Cancer Institute

New Orleans, Louisiana, 70121, United States

Location

Allina Health, Virginia Piper Cancer Institute

Minneapolis, Minnesota, 55407, United States

Location

Christus St. Vincent Regional Cancer Center

Santa Fe, New Mexico, 87505, United States

Location

NYU Winthrop Hospital

Mineola, New York, 11501, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

University of Toledo

Toledo, Ohio, 43614, United States

Location

Mary Crowley Cancer Research Center

Dallas, Texas, 75230, United States

Location

MD Anderson

Houston, Texas, 77030, United States

Location

William Osler Health System

Brampton, Ontario, L6R3J7, Canada

Location

Juravinski Cancer Center

Hamilton, Ontario, L8V 5C2, Canada

Location

Southlake Regional Health Center

Newmarket, Ontario, L3Y 2P9, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Sunnybrook Research Institute

Toronto, Ontario, Canada

Location

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 0A9, Canada

Location

McGill University Health Center

Montreal, Quebec, H4A 3J1, Canada

Location

CHU de Québec-Université Laval

Québec, Quebec, G1R 2J6, Canada

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Hepatocellular; Carcinoma, Non-Small-Cell Lung; Urinary Bladder Neoplasms

Interventions

Cyclophosphamide; pembrolizumab

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Urologic Neoplasms; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: February 11, 2019
• Study Start: December 21, 2018
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

CA (8); US (15)