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Trial record 1 of 1 for:    NCT02636036
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Phase I Study of Enadenotucirev and PD-1 Inhibitor in Subjects With Metastatic or Advanced Epithelial Tumors (SPICE)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02636036
Recruitment Status : Recruiting
First Posted : December 21, 2015
Last Update Posted : April 13, 2020
Bristol-Myers Squibb
Syneos Health
Information provided by (Responsible Party):
PsiOxus Therapeutics Ltd

Brief Summary:
This is a Phase I multicenter, open label, nonrandomized study of enadenotucirev administered in combination with nivolumab in subjects with metastatic or advanced epithelial tumors (with focus on CRC, SCCHN, escalation phase), not responding to standard therapy.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Squamous Cell Carcinoma of the Head and Neck Epithelial Tumor Biological: enadenotucirev Biological: nivolumab Phase 1

Detailed Description:

To characterise the safety and tolerability of enadenotucirev administered in combination with nivolumab in subjects with metastatic or advanced epithelial tumours.

A dose escalation phase is conducted in subjects with solid tumors of epithelial origin not responding to standard therapy to establish the MTD/MFD and optimum dosing schedule of the enadenotucirev and nivolumab combination treatment.

A dose expansion phase will further outline the dose level and schedule of enadenotucirev and nivolumab combination treatment and investigate signals of efficacy in three cohorts of subjects with specific epithelial tumour types.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Multicenter, Open Label Study of Enadenotucirev Combined With PD-1 Inhibitor in Subjects With Metastatic or Advanced Epithelial Tumors
Actual Study Start Date : January 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: enadenotucirev and nivolumab Biological: enadenotucirev
Biological: nivolumab

Primary Outcome Measures :
  1. Incidence, nature and severity of adverse events (safety and tolerability) in study of enadenotucirev administered in combination with a PD-1 inhibitor [ Time Frame: 12 months ]
    Review of adverse events including serious adverse events (SAEs), adverse events meeting protocol defined DLT criteria, adverse events leading to study treatment or study discontinuation, and adverse events resulting in death

  2. Maximum Tolerated and/or Maximum Feasible Dose [ Time Frame: 12 months ]
    Maximum tolerated dose (MTD) / maximum feasible dose (MFD) of enadenotucirev administered IV in combination with nivolumab.

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

Inclusion Criteria:

  • Adult males or females aged 18 years or over
  • Disease status:

    • Diagnosis of metastatic or advanced CRC, UCC and SCCHN not responding to standard therapy or for whom no standard treatment exists
  • Prior palliative radiotherapy completed at least 3 weeks before study treatment administration
  • ECOG performance status 0 or 1
  • Predicted life expectancy of 3 months or more
  • Ability to comply with study procedures in the Investigator's opinion
  • Recovered to Grade 1 from the effects (excluding alopecia) of any prior therapy for their malignancies
  • Non-impaired renal function
  • Adequate hepatic function
  • Adequate bone marrow function:
  • Adequate coagulation tests: international normalized ratio (INR) ≤1.5
  • Meeting reproductive status requirements
  • Subjects must provide written informed consent to participate
  • Willing to consent to tumor biopsies during the study
  • Serum complement (C3/C4 proteins) above the lower limit of normal range

Exclusion Criteria:

  • Pregnant or breastfeeding females
  • Known history or evidence of significant immunodeficiency due to underlying illness
  • Splenectomy
  • Prior allogeneic or autologous bone marrow or organ transplantation
  • Any history of renal disease, renal injury or auto-immune disease.
  • History of idiopathic pulmonary fibrosis, drug induced pneumonitis, evidence of active pneumonia or pneumonitis on computed tomography scan
  • Active infections requiring antibiotics, physician monitoring or recurrent fevers >100.4˚F (38.0˚C) associated with a clinical diagnosis of active infection
  • Active viral disease or positive test for hepatitis B virus using hepatitis B surface antigen test or positive test for hepatitis C virus (HCV) using HCV ribonucleic acid or HCV antibody test indicating acute or chronic infection. Positive test for HIV or AIDS; testing is not required in the absence of history
  • Use of the following antiviral agents: ribavirin, adefovir, lamivudine or cidofovir within 7 days prior to the first dose of study treatment; or pegylated interferon in the 14 days before the first dose of study treatment
  • Prior treatment with PD-1 and programmed death ligand (PD-L)1 inhibitors
  • Administration of an investigational drug in the 28 days before the first dose of study treatment
  • Major surgery or treatment with any chemotherapy, radiation therapy, biologics for cancer or investigational therapy in the 28 days before the first dose of study treatment
  • Other prior malignancy active within the previous 2 years except for local or organ confined early stage cancer that has been definitively treated with curative intent, does not require ongoing treatment, has no evidence of residual disease and has a negligible risk of recurrence and is therefore unlikely to interfere with the primary and secondary endpoints of the study, including response rate and safety
  • Symptomatic brain metastases or any leptomeningeal metastasis that is symptomatic and/or requires treatment. Subjects with brain metastases are eligible if these have been locally treated (surgery, radiotherapy).
  • Any serious or uncontrolled medical disorder that, in the opinion of the Investigator or the Medical Monitor, may increase the risk associated with study participation or study treatment administration.
  • Known allergy to enadenotucirev, nivolumab or their excipients
  • Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
  • Dependence on continuous supplemental oxygen use
  • History of myocardial infarction or significant cardiovascular or cerebrovascular event in the 12 months before the first dose of study treatment

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 identifier (NCT number): NCT02636036

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Contact: PsiOxus Therapeutics

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United States, Arizona
University of Arizona Cancer Center, 1515 North Campbell Ave. Recruiting
Tucson, Arizona, United States, 85724
Contact: Hani Babikar, MD   
Contact: Ruth Cañamar, BA   
United States, California
City of Hope Comprehensive Cancer Center, 1500 E Duarte Str. Recruiting
Duarte, California, United States, 91010
Contact: Marwan Fakih, MD   
Contact: Mengsha Li, MS, CCRP   
UCLA Medical Center, 10945 Le Conte Ave, Ste. 3360 Recruiting
Santa Monica, California, United States, 90095
Contact: Lee Rosen, MD   
Contact: Suzanne Nichols, RN   
United States, Indiana
Horizon Oncology Research, 1345 Unity Place, Suite 345 Recruiting
Lafayette, Indiana, United States, 47905
Contact: Wael Harb, MD   
United States, Michigan
Henry Ford Hospital, 2799 West Grand Blvd. Recruiting
Detroit, Michigan, United States, 48202
Contact: Ding Wang, MD   
Contact: Karie Gignac, RN   
United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232-6307
Contact: Jordan Berlin, MD   
Contact: Tom Leonard-Martin, PhD, MPH   
Sponsors and Collaborators
PsiOxus Therapeutics Ltd
Bristol-Myers Squibb
Syneos Health
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Study Director: Naftali Bechar, MD Psioxus Theraputics
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Responsible Party: PsiOxus Therapeutics Ltd Identifier: NCT02636036    
Other Study ID Numbers: ColoAd1-1003
First Posted: December 21, 2015    Key Record Dates
Last Update Posted: April 13, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PsiOxus Therapeutics Ltd:
metastatic; epithelial; advanced
Additional relevant MeSH terms:
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Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Site
Carcinoma, Squamous Cell
Neoplasms by Histologic Type
Head and Neck Neoplasms
Antineoplastic Agents, Immunological
Antineoplastic Agents