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

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ClinicalTrials.gov Identifier: NCT03836352
Recruitment Status : Recruiting
First Posted : February 11, 2019
Last Update Posted : February 12, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Hepatocellular Carcinoma Non-small Cell Lung Cancer Bladder Cancer Microsatellite Instability-High Other: DPX-Survivac Drug: Cyclophosphamide Drug: Pembrolizumab Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 232 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : December 21, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022


Arm Intervention/treatment
Experimental: Arm 1 (All cohorts)
DPX-Survivac, Cyclophosphamide, Pembrolizumab
Other: DPX-Survivac
SubQ injection (q9w)

Drug: Cyclophosphamide
PO (BID)

Drug: Pembrolizumab
IV Infusion (q3w)
Other Name: MK-3475

Experimental: Arm 2 (Ovarian cohort only)
DPX-Survivac, Pembrolizumab
Other: DPX-Survivac
SubQ injection (q9w)

Drug: Pembrolizumab
IV Infusion (q3w)
Other Name: MK-3475




Primary Outcome Measures :
  1. Efficacy as measured by objective response rate [ Time Frame: Approximately 24 months ]
    Centrally evaluated using RECIST v1.1

  2. Safety as measured by the rate of adverse events [ Time Frame: Approximately 24 months ]
    Using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0


Secondary Outcome Measures :
  1. Objective response rate [ Time Frame: Approximately 24 months ]
    Centrally evaluated using iRECIST

  2. Duration of response [ Time Frame: Approximately 24 months ]
  3. Disease control rate [ Time Frame: Approximately 24 months ]
  4. Progression Free Survival [ Time Frame: Approximately 24 months ]
  5. Overall survival [ Time Frame: Approximately 24 months ]

Other Outcome Measures:
  1. Cell mediated immunology [ Time Frame: Approximately 24 months ]
    As measured by antigen specific immune response in peripheral blood

  2. Changes in immune cell infiltration [ Time Frame: Approximately 24 months ]
    As measured by multiplex immunohistochemistry



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Subjects with advanced or metastatic solid tumours who have disease progression

    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
  • Subjects with HCC, NSCLC, BlCa, or MSI-H subjects other than those with gastric or colorectal cancer must have evidence of survivin expression in their pre-treatment biopsy sample
  • 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:

  • Eligible for otherwise curative treatment or undergoing concurrent therapy
  • 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
  • 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 metastatic pleural fluid
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03836352


Locations
United States, New York
NYU Winthrop Hospital Not yet recruiting
Mineola, New York, United States, 11501
Contact: Jennifer Brown    516-663-3115    Jennifer.Brown@nyulangone.org   
Principal Investigator: Eva Chalas, MD         
United States, Texas
Mary Crowley Cancer Research Center Recruiting
Dallas, Texas, United States, 75230
Contact: Referral Office    972-566-3000    referral@marycrowley.org   
Principal Investigator: James Strauss, MD         
Canada, Ontario
William Osler Health System Recruiting
Brampton, Ontario, Canada, L6R3J7
Contact: Dr Henry Conter, MD    905-494-2120 ext 57264    Henry.Conter@williamoslerhs.ca   
Principal Investigator: Henry Conter, MD         
Sponsors and Collaborators
ImmunoVaccine Technologies, Inc. (IMV Inc.)
Merck Sharp & Dohme Corp.

Responsible Party: ImmunoVaccine Technologies, Inc. (IMV Inc.)
ClinicalTrials.gov Identifier: NCT03836352     History of Changes
Other Study ID Numbers: P1719-SUR-Z11
Keynote 903 ( Other Identifier: Sponsor )
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ImmunoVaccine Technologies, Inc. (IMV Inc.):
T cell activation
Immunotherapy
Ovarian
Hepatocellular Carcinoma
Non-small Cell Lung
Bladder
Microsatellite Instability-High
Survivin
Anti-PD-1
MK-3475

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Hepatocellular
Microsatellite Instability
Carcinoma, Bronchogenic
Lung Diseases
Respiratory Tract Diseases
Adenocarcinoma
Carcinoma
Digestive System Diseases
Liver Diseases
Urinary Bladder Diseases
Urologic Diseases
Genomic Instability
Pathologic Processes
Cyclophosphamide
Pembrolizumab
Immunosuppressive Agents