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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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by PsiOxus Therapeutics Ltd
Bristol-Myers Squibb
INC Research
Information provided by (Responsible Party):
PsiOxus Therapeutics Ltd Identifier:
First received: November 20, 2015
Last updated: February 15, 2017
Last verified: February 2017
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, UCC, SCCHN and salivary gland cancer) not responding to standard therapy.

Condition Intervention Phase
Colorectal Cancer
Bladder Carcinoma
Squamous Cell Carcinoma of the Head and Neck
Salivary Gland Cancer
Biological: enadenotucirev
Biological: nivolumab
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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

Resource links provided by NLM:

Further study details as provided by PsiOxus Therapeutics Ltd:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • to assess the blood levels of enadenotucirev following combination treatment [ Time Frame: 12 months ]
    Enadenotucirev blood level samples will be taken on each enadenotucirev dosing day, pre-dose on pembrolizumab dosing day and at the end of study treatment visit. Measurements of enadenotucirev will be in vp/ml

  • To examine the anti-tumor activity of combination treatment with enadenotucirev and nivolumab [ Time Frame: 12 months ]
    Overall response rate according to RECIST Version 1.1

  • To examine the anti-tumor activity of combination treatment with enadenotucirev and nivolumab [ Time Frame: 12 months ]
    Overall response rate according to irRECIST Version 1.1

Estimated Enrollment: 30
Study Start Date: January 2016
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: enadenotucirev and nivolumab Biological: enadenotucirev Biological: nivolumab


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

Inclusion Criteria:

  • Adult males or females aged 18 years or over
  • Diagnosis of metastatic or advanced CRC, UCC, SCCHN, salivary gland cancer or NSCLC with tumor accessible for biopsy
  • Dose expansion only: Subjects must have at least one measurable site of disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria; this lesion must be outside a previously irradiated area
  • Disease status:

    • Dose escalation phase only: Subject not responding to standard therapy or for whom no standard treatment exists
    • Dose expansion phase: Subject not responding to standard therapy or for whom no standard treatment exists with:
    • CRC - No more than four different prior lines of systemic therapy for advanced disease
    • UCC and SCCHN and salivary gland cancer - No more than three different prior treatment regimens in the advanced/metastatic setting with a maximum of two chemotherapy-containing regimens
    • NSCLC - Prior treatment regimens must include a platinum-based therapy
  • Eastern Cooperative Oncology Group (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
  • Adequate renal function:

    • Creatinine ≤1.5 mg/dL or calculated creatinine clearance using the Cockcroft-Gault formula ≥60 mL/min or measured creatinine clearance
    • Proteinuria: dipstick ≤2+
  • Adequate hepatic function:

    • Serum bilirubin <1.5 mg/dL (except subjects with Gilbert's syndrome who may have total bilirubin <3.0 mg/mL)
    • Aspartate aminotransferase and alanine aminotransferase ≤3 x upper limit of normal (ULN)
    • Albumin ≥3 g/dL
    • Lipase: 1.5 x ULN. Subjects with lipase >1.5 x ULN may enrol if there are neither clinical or radiographic signs of pancreatitis
    • Amylase: 1.5 x ULN. Subjects with amylase >1.5 x ULN may enrol if there are neither clinical or radiographic signs of pancreatitis
  • Adequate bone marrow function:

    • Absolute neutrophil count ≥1.5 x 109/L
    • Platelets ≥100 x 109/L
    • Hemoglobin ≥90 g/L
  • Adequate coagulation tests: international normalized ratio ≤1.5
  • Normal thyroid and pituitary functions
  • For females of childbearing potential (defined as <2 years after last menstruation or not surgically sterile), a negative serum pregnancy test must be documented in the 14 days before the first dose of study treatment For females who are not postmenopausal (24 months of amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to use two adequate methods of contraception, during the study treatment period and for at least 6 months after the last dose of study treatment For males: agreement to use a barrier method of contraception during the study treatment period and for at least 6 months after the last dose of study treatment
  • Subjects must provide written informed consent to participate
  • Willing to consent to tumor biopsies during the study

Exclusion Criteria:

  • Pregnant or breastfeeding females
  • Known history or evidence of significant immunodeficiency due to underlying illness (e.g. human immunodeficiency virus [HIV]/acquired immunodeficiency syndrome [AIDS]) and/or medication (e.g. systemic corticosteroids or other immunosuppressive medications, including cyclosporine, azathioprine, interferons in the 4 weeks before the first dose of study treatment). Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisolone equivalent) or other immunosuppressive medications within 14 days of the first dose of study treatment. Inhaled or topical steroids and adrenal replacement steroid doses are permitted in the absence of autoimmune disease
  • Splenectomy
  • Prior allogeneic or autologous bone marrow or organ transplantation
  • Subjects with active, known or suspected auto-immune disease or a syndrome that requires systemic or immunosuppressive agents; subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune disease only requiring hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur in the absence of an external trigger are permitted to enrol
  • 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 (subjects with prior cytotoxic or investigational products <3 weeks prior to study treatment might be eligible after discussion between the Investigator and Medical Monitor, if toxicities from the prior treatment have been resolved to NCI CTCAE Grade 1). All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to Grade 1 or baseline before the first dose of study treatment. Subjects with toxicities attributed to prior anti-cancer therapy which are not expected to resolve and result in long lasting sequelae, such as neuropathy after platinum based therapy, are permitted to enrol
  • Other prior malignancy active within the previous 3 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). There must also be no requirement for immunosuppressive doses of systemic corticosteroids (>10 mg/day prednisone equivalent) for at least 2 weeks before the first dose of study treatment
  • 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, impair the ability of the subject to receive protocol therapy or interfere with the interpretation of study results
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02636036

Contact: PsiOxus Therapeutics

United States, Arizona
University of Arizona Cancer Center, 1515 North Campbell Ave. Recruiting
Tucson, Arizona, United States, AZ 85724
Contact: Daruka Mahadevan, MD         
Contact: Ruth Cañamar,, BA   
United States, California
City of Hope Comprehensive Cancer Center, 1500 E Duarte Str. Recruiting
Duarte, California, United States, CA 91010
Contact: Marwan Fakih, MD   
UCLA Medical Center, 10945 Le Conte Ave, Ste. 3360 Recruiting
Santa Monica, California, United States, CA 90095
Contact: Lee Rosen, MD         
Contact: Suzanne Nichols, RN   
United States, Indiana
Horizon Oncology Research, 1345 Unity Place, Suite 345 Recruiting
Layfayette, Indiana, United States, 47905
Contact: Wael Harb, MD   
United States, Michigan
Henry Ford Hospital, 2799 West Grand Blvd. Recruiting
Detroit, Michigan, United States, MI 48202
Contact: Ding Wang, MD         
Contact: Nikki Adams, RN   
Sponsors and Collaborators
PsiOxus Therapeutics Ltd
Bristol-Myers Squibb
INC Research
  More Information

Responsible Party: PsiOxus Therapeutics Ltd Identifier: NCT02636036     History of Changes
Other Study ID Numbers: ColoAd1-1003
Study First Received: November 20, 2015
Last Updated: February 15, 2017
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Colorectal Neoplasms
Head and Neck Neoplasms
Salivary Gland Neoplasms
Urinary Bladder Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Mouth Neoplasms
Mouth Diseases
Stomatognathic Diseases
Salivary Gland Diseases
Urologic Neoplasms
Urogenital Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Antineoplastic Agents processed this record on May 25, 2017