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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.)

Tracking Information
First Submitted Date  ICMJE February 7, 2019
First Posted Date  ICMJE February 11, 2019
Last Update Posted Date February 12, 2019
Actual Study Start Date  ICMJE December 21, 2018
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2019)
  • Efficacy as measured by objective response rate [ Time Frame: Approximately 24 months ]
    Centrally evaluated using RECIST v1.1
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03836352 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2019)
  • Objective response rate [ Time Frame: Approximately 24 months ]
    Centrally evaluated using iRECIST
  • Duration of response [ Time Frame: Approximately 24 months ]
  • Disease control rate [ Time Frame: Approximately 24 months ]
  • Progression Free Survival [ Time Frame: Approximately 24 months ]
  • Overall survival [ Time Frame: Approximately 24 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE
 (submitted: February 8, 2019)
  • Cell mediated immunology [ Time Frame: Approximately 24 months ]
    As measured by antigen specific immune response in peripheral blood
  • Changes in immune cell infiltration [ Time Frame: Approximately 24 months ]
    As measured by multiplex immunohistochemistry
Original Other Outcome Measures  ICMJE
 (submitted: February 7, 2019)
  • Cell mediated immunity [ Time Frame: Approximately 24 months ]
  • Changes in immune cell infiltration [ Time Frame: Approximately 24 months ]
 
Descriptive Information
Brief Title  ICMJE Study of an Immunotherapeutic, DPX-Survivac, in Combination With Low Dose Cyclophosphamide & Pembrolizumab, in Subjects With Selected Advanced & Recurrent Solid Tumors
Official Title  ICMJE 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.
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 Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Ovarian Cancer
  • Hepatocellular Carcinoma
  • Non-small Cell Lung Cancer
  • Bladder Cancer
  • Microsatellite Instability-High
Intervention  ICMJE
  • Other: DPX-Survivac
    SubQ injection (q9w)
  • Drug: Cyclophosphamide
    PO (BID)
  • Drug: Pembrolizumab
    IV Infusion (q3w)
    Other Name: MK-3475
Study Arms
  • Experimental: Arm 1 (All cohorts)
    DPX-Survivac, Cyclophosphamide, Pembrolizumab
    Interventions:
    • Other: DPX-Survivac
    • Drug: Cyclophosphamide
    • Drug: Pembrolizumab
  • Experimental: Arm 2 (Ovarian cohort only)
    DPX-Survivac, Pembrolizumab
    Interventions:
    • Other: DPX-Survivac
    • Drug: Pembrolizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 7, 2019)
232
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date December 31, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03836352
Other Study ID Numbers  ICMJE P1719-SUR-Z11
Keynote 903 ( Other Identifier: Sponsor )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party ImmunoVaccine Technologies, Inc. (IMV Inc.)
Study Sponsor  ICMJE ImmunoVaccine Technologies, Inc. (IMV Inc.)
Collaborators  ICMJE Merck Sharp & Dohme Corp.
Investigators  ICMJE Not Provided
PRS Account ImmunoVaccine Technologies, Inc. (IMV Inc.)
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP