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Colorectal CancerPhase 1SPICENCT02636036

Phase I Study of Enadenotucirev and PD-1 Inhibitor in Subjects With Metastatic or Advanced Epithelial Tumors

A Phase 1 study testing enadenotucirev and nivolumab in people with Colorectal Cancer and Squamous Cell Carcinoma of the Head and Neck, run by Akamis Bio at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
enadenotucirev and nivolumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
6 sitesUnited States
Study dates
25 Jan 2016to 8 Oct 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult males or females aged 18 years or over
  • Disease status: - Diagnosis of metastatic or advanced CRC, UCC, SCCHN, salivary gland cancer or NSCLC not responding to standard therapy or for whom no standard treatment exists
  • For patients who have received prior PD-1 / PD-L1 therapy (Cohorts 7A and 7B and dose expansion phase only): Prior PD-1 / PD-L1 inhibitor therapy in current line of treatment for ≥6 weeks and ≤4 months, with best response of stable disease or progressive disease
  • 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
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  • Recovered to Grade 1 from the effects (excluding alopecia) of any prior therapy for their malignancies Adequate lung function
  • Adequate renal function
  • Adequate hepatic function
  • Adequate bone marrow function
  • Adequate coagulation tests: PT and aPTT within normal range or international normalized ratio (INR) ≤1.5
  • Meeting reproductive status requirements
  • Subjects must provide written informed consent to participate
  • Willing to consent to tumour biopsies during the study

Who cannot join

  • 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
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  • Clinically or radiologically suspected, or evidence of, lymphangitic carcinomatosis
  • 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 4 weeks before the first dose of study treatment
  • For Cohort 1 to 6:Prior treatment with PD-1 and programmed death ligand (PD-L)1 inhibitors
  • For Cohorts 7A and 7B and dose expansion phase: History of Grade >2 or currently uncontrolled immune-related AEs while being treated with PD-1 / PD-L1 inhibitors
  • For Cohorts 7A and 7B and dose expansion phase: Patients with progressive disease with ≥50% increase in disease burden from start of PD-1 / PD-L1 inhibitor therapy in the most recent line of treatment are excluded
  • Major surgery or treatment with any chemotherapy (bisphosphonate therapy or treatment with receptor activator of nuclear factor kappa-Β l(RANK)-ligand inhibitors for metastatic bone disease is permitted), biologics for cancer or investigational therapy in the 28 days before the first dose of study treatment (patients 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 and decision is supported by the half-life of previous therapy). All toxicities attributed to prior anti-cancer therapy other than alopecia must have resolved to Grade 1 or baseline before the first dose of study treatment. Patients 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 enroll Note: This does not apply to anti-PD-1 / PD-L1 if in the patient's current line of therapy, and anti-PD-1 / PD-L1 treatment may continue during screening
  • 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. Patients 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 14 days before the first dose of study treatment. Both surgery and or radiotherapy must have been completed at least 2 weeks before 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 patient 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
  • History of myocardial infarction or significant cardiovascular or cerebrovascular event in the 12 months before the first dose of study treatment
  • An increased risk due to tumour flare, as assessed by the Investigator (e.g. an initial increase in tumour size that may lead to intestinal obstruction, obstruction of the ureter or airway)
  • Penetrating tumour infiltration of major blood vessels, pericardium, gastrointestinal tract or other hollow organs that may lead to perforation due to tumour necrosis
  • History of DVT or pulmonary embolus in the 12 months before the first dose of study treatment
  • History of significant bleeding requiring hospitalization in the 12 months before the first dose of study treatment
  • Patients receiving therapeutic or prophylactic anticoagulation therapy

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Henry Ford Hospital, 2799 West Grand Blvd.

    Detroit, Michigan, 48202

  • City of Hope Comprehensive Cancer Center, 1500 E Duarte Str.

    Duarte, California, 91010

  • Horizon Oncology Research, 1345 Unity Place, Suite 365

    Lafayette, Indiana, 47905

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-6307

  • UCLA Medical Center, 10945 Le Conte Ave, Ste. 3360

    Santa Monica, California, 90095

  • University of Arizona Cancer Center, 1515 North Campbell Ave.

    Tucson, Arizona, 85724

Other trials in United States

About this study

Official title: A Phase I Multicenter, Open Label Study of Enadenotucirev Combined With PD-1 Inhibitor in Subjects With Metastatic or Advanced Epithelial Tumors

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.

Read the 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.

Being tested
enadenotucirev, nivolumab
Keywords
metastatic; epithelial; advanced
Medical subject headings
Colorectal Neoplasms, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02636036
Study groupRoleWhat they receive
enadenotucirev and nivolumabExperimentalNot described
Receives: Biological: enadenotucirev; Biological: nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence, nature and severity of adverse events (safety and tolerability) in study of enadenotucirev administered in combination with a PD-1 inhibitor

    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

    Measured: 12 months

  2. Maximum Tolerated and/or Maximum Feasible Dose

    Maximum tolerated dose (MTD) / maximum feasible dose (MFD) of enadenotucirev administered IV in combination with nivolumab.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2015 (estimated)
  2. Study start25 Jan 2016
  3. Primary completion8 Oct 2021
  4. Study completion8 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02636036
Sponsor's protocol ID
ColoAd1-1003
Acronym
SPICE
Status last verified
Nov 2021
First submitted
20 Nov 2015
Last updated
9 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fakih M, Harb W, Mahadevan D, Babiker H, Berlin J, Lillie T, Krige D, Carter J, Cox C, Patel M, Parfitt L, Powell M, Rosen L. Safety and efficacy of the tumor-selective adenovirus enadenotucirev, in combination with nivolumab, in patients with advanced/metastatic epithelial cancer: a phase I clinical trial (SPICE). J Immunother Cancer. 2023 Apr;11(4):e006561. doi: 10.1136/jitc-2022-006561.

    PubMed 37094988

  • Khalil DN, Prieto Gonzalez-Albo I, Rosen L, Lillie T, Stacey A, Parfitt L, Soff GA. A tumor-selective adenoviral vector platform induces transient antiphospholipid antibodies, without increased risk of thrombosis, in phase 1 clinical studies. Invest New Drugs. 2023 Apr;41(2):317-323. doi: 10.1007/s10637-023-01345-8. Epub 2023 Mar 10.

    PubMed 36897458

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing enadenotucirev and nivolumab in people with Colorectal Cancer and Squamous Cell Carcinoma of the Head and Neck, run by Akamis Bio at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02636036, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.

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