Clinical Trials /

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

NCT03836352

Description:

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.

Related Conditions:
  • Bladder Carcinoma
  • Colorectal Carcinoma
  • Fallopian Tube Carcinoma
  • Gastric Carcinoma
  • Hepatocellular Carcinoma
  • Malignant Ovarian Epithelial Tumor
  • Malignant Solid Tumor
  • Non-Small Cell Lung Carcinoma
  • Peritoneal Carcinoma
  • Urothelial Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: P1719-SUR-Z11
  • SECONDARY ID: Keynote 903
  • NCT ID: NCT03836352

Conditions

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

Interventions

DrugSynonymsArms
CyclophosphamideArm 1 (All cohorts)
PembrolizumabMK-3475Arm 1 (All cohorts)

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Arm 1 (All cohorts)ExperimentalDPX-Survivac, Cyclophosphamide, Pembrolizumab
  • Cyclophosphamide
  • Pembrolizumab
Arm 2 (Ovarian cohort only)ExperimentalDPX-Survivac, Pembrolizumab
  • Pembrolizumab

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Efficacy as measured by objective response rate
Time Frame:Approximately 24 months
Safety Issue:
Description:Centrally evaluated using RECIST v1.1

Secondary Outcome Measures

Measure:Objective response rate
Time Frame:Approximately 24 months
Safety Issue:
Description:Centrally evaluated using iRECIST
Measure:Duration of response
Time Frame:Approximately 24 months
Safety Issue:
Description:
Measure:Disease control rate
Time Frame:Approximately 24 months
Safety Issue:
Description:
Measure:Progression Free Survival
Time Frame:Approximately 24 months
Safety Issue:
Description:
Measure:Overall survival
Time Frame:Approximately 24 months
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:ImmunoVaccine Technologies, Inc. (IMV Inc.)

Trial Keywords

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

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