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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03836352
Recruitment Status : Active, not recruiting
First Posted : February 11, 2019
Last Update Posted : March 31, 2022
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
ImmunoVaccine Technologies, Inc. (IMV Inc.)

Study Description
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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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 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, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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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


Eligibility Criteria
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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 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
Contacts and Locations
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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
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Sponsors and Collaborators
ImmunoVaccine Technologies, Inc. (IMV Inc.)
Merck Sharp & Dohme LLC
More Information
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Responsible Party: ImmunoVaccine Technologies, Inc. (IMV Inc.)
ClinicalTrials.gov Identifier: NCT03836352    
Other Study ID Numbers: P1719-SUR-Z11
Keynote 903 ( Other Identifier: Sponsor )
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022

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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:
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Carcinoma, Hepatocellular
Microsatellite Instability
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Liver Diseases
Genomic Instability
 Pathologic Processes
Cyclophosphamide
Pembrolizumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological