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Malignant MelanomaPhase 2NCT02272855

A Study of Combination Treatment With HF10 and Ipilimumab in Patients With Unresectable or Metastatic Melanoma

A Phase 2 study testing HF10 plus Ipilimumab in people with Malignant Melanoma, run by Takara Bio Inc. at 8 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

The purpose of this study is to determine if HF10 in combination with ipilimumab is effective in patients with stages IIIB, IIIC, or IV unresectable or metastatic melanoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Melanoma
What is being tested?
HF10 plus Ipilimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
8 sitesUnited States
Study dates
30 Apr 2014to Aug 2018
Phase
Phase 2
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

  • Patients must have Stage IIIB, IIIC or IV melanoma, which is unresectable/unresected or histologically confirmed diagnosis of metastatic malignant melanoma.
  • Patients must have measurable non-visceral lesion(s) that are evaluable by the modified World Health Organization (mWHO) criteria and immune-related response criteria (irRC).
  • Patients must be ≥ 18 years of age.
  • Patients must have a life expectancy ≥ 24 weeks.
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • Patients must have adequate hepatic function, defined as
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  • Total bilirubin levels ≤ 1.5 x upper limit of normal [ULN] (except for patients with Gilbert's Syndrome, who must have a total bilirubin of less than 3.0 mg/dL)
  • AST/ALT levels ≤ 2.5 x ULN, or ≤ 5 x ULN if liver metastases are present.
  • Patients must have adequate renal function, defined as serum creatinine ≤ 1.5 x ULN or creatinine clearance (calculated) ≥ 60 mL/min/1.73 m2 for patients with creatinine > 1.5 x ULN.
  • Patients must have adequate bone marrow function, defined as
  • Absolute neutrophil count ≥1,500/µL and
  • Platelet count ≥ 75,000/ µL
  • Patients must have no known bleeding diathesis or coagulopathy that would make intratumoral injection or biopsy unsafe.
  • Patients must be ipilimumab-eligible. (This includes: 1) patients previously untreated with ipilimumab; 2) patients previously treated (more than 1 year previously) with ipilimumab using a route of administration other than intravenous infusion; and 3) patients previously treated with antitumor agents other than intravenous ipilimumab).
  • Men and women of childbearing potential must agree to use adequate contraception from the time of consent through 30 days after final study treatment.
  • Females of childbearing potential must have a negative urine or serum pregnancy test within one week prior to start of treatment.
  • Patients must be able to understand and willing to sign a written informed consent document.

Who cannot join

  • Patients receiving chemotherapy or radiotherapy within 4 weeks of injection of HF10, or history of Grade 4 adverse events or presence of adverse events Grade 2 or greater, except alopecia, resulting from anticancer agents administered more than 4 weeks prior to HF10 injection.
  • Patients receiving anti-herpes medication within 1 week prior to initiating HF10 treatment.
  • Patients with a history of significant tumor bleeding, or coagulation or bleeding disorders.
  • Patients with target tumors that could potentially invade a major vascular structure (e.g., innominate artery, carotid artery), based on unequivocal imaging findings.
  • Patients with Grade 2 or greater pre-existing neurologic abnormalities (CTCAE version 4.0), including Grade 2 or greater peripheral neuropathy caused by previous treatments.
  • Patients with clinically evident Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C virus (HCV), or Epstein-Barr virus (EBV) infection are excluded.
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  • Medical history of autoimmune disease (e.g., Crohn's disease, ulcerative colitis) or other diseases requiring systemic glucocorticoid or immunosuppressive therapy.
  • Patients who were previously treated with ipilimumab administered by intravenous infusion.
  • Concurrent use of any other investigational agents.
  • Patients with active CNS metastases or carcinomatous meningitis, except patients with CNS lesions that have been treated and have no evidence of progression in the brain on CT/MRI for ≥ 3 months.
  • Pregnant or breastfeeding women; women desiring to become pregnant within the timeframe of the study are also excluded.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, as determined by the investigator.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Clinical Site

    Atlanta, Georgia, 30322

  • Clinical Site

    Bethlehem, Pennsylvania, 18015

  • Clinical Site

    Dallas, Texas, 75230

  • Clinical Site

    Hershey, Pennsylvania, 17033

  • Clinical Site

    Houston, Texas, 77030

  • Clinical Site

    Portland, Oregon, 97239

  • Clinical Site

    Salt Lake City, Utah, 84112

  • Clinical Site

    San Francisco, California, 94115

Other trials in United States

About this study

Official title: A Phase II Study of Combination Treatment With HF10, a Replication-competent HSV-1 Oncolytic Virus, and Ipilimumab in Patients With Stage IIIB, Stage IIIC, or Stage IV Unresectable or Metastatic Malignant Melanoma

The purpose of this study is to determine if HF10 in combination with ipilimumab is effective in patients with stages IIIB, IIIC, or IV unresectable or metastatic melanoma.

Read the detailed description

The study is designed to assess efficacy and safety with repeated administration of intratumoral injections of HF10 at 1x10^7 TCID50/mL in combination with intravenous infusions of 3mg/kg ipilimumab. This is a single arm, open label Phase II trial, to evaluate the efficacy, safety and tolerability of HF10 treatment in combination with administration of the immunologic checkpoint inhibitor, ipilimumab (anti-CTLA-4 monoclonal antibody). The study population will include patients with Stage IIIB, IIIC or IV unresectable or metastatic malignant melanoma who are ipilimumab-eligible.

Patients will receive the dose of 1 x 10^7 TCID50/mL HF10 (for a total of 6 injections; the first 4 injections at 1-week intervals; the remaining 2 injections at 3-week intervals) + ipilimumab at 3 mg/kg ipilimumab (for a total of 4 intravenous infusions, each administered at 3-week intervals).

Following combination therapy, patients may continue to receive the same dose level of HF10 (1 x 10^7 TCID50/mL) alone for up to an additional 13 injections (total of 19 injections = 1 year) if they have tolerated the study treatment, are responding, have stable disease, or have progressive disease that is not clinically significant in the judgment of the Investigator.

Being tested
HF10 plus Ipilimumab
Keywords
HF10, HSV-1, Ipilimumab, Oncolytic virus, Phase II, Stage IIIB melanoma, Stage IIIC melanoma, Stage IV melanoma, Unresectable malignant melanoma, Metastatic malignant melanoma, Combination treatment, Intratumoral injection
Medical subject headings
Melanoma

What participants receive

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

  • HF10 plus IpilimumabBiological

    Also called YERVOY (for ipilimumab)

    Patients will receive the dose of 1 x 10^7 TCID50/mL HF10 (for a total of 6 injections; the first 4 injections at 1-week intervals; the remaining 2 injections at 3-week intervals) and ipilimumab at 3 mg/kg ipilimumab (for a total of 4 intravenous infusions, each administered at 3-week intervals).

Study groups in NCT02272855
Study groupRoleWhat they receive
HF10 plus ipilimumabExperimentalNot described
Receives: Biological: HF10 plus Ipilimumab

What is being measured

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

  1. Best overall response rate (BORR)

    Measured: at 24 weeks

Secondary outcomes (7)

  1. Adverse Event Summaries, Vital Signs, and Laboratory Parameters as a Measure of Safety and Tolerability

    Adverse events will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE version 4.0).

    Measured: until Week 24

  2. Objective response rate (ORR)

    Measured: at Weeks 12, 18, and 24

  3. Progression-free survival (PFS)

    Measured: for 1 year

  4. Durable response rate (DRR)

    Measured: for 1 year

  5. 1-year survival rate

    Measured: at 1 year

  6. Accumulation of Lymphocytes in the Tumor by using Core Biopsy Samples

    Measured: pre-treatment screening and Week 24

  7. Change in Cytokine Profiles by using Peripheral Blood Samples

    Measured: pre-treatment screening and Week 24

Timeline

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

  1. First posted23 Oct 2014 (estimated)
  2. Study start30 Apr 2014
  3. Primary completionOct 2016
  4. Study completionAug 2018

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02272855
Sponsor's protocol ID
T14-10682
Status last verified
Sep 2018
First submitted
9 Oct 2014
Last updated
26 Sep 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Watanabe D, Goshima F. Oncolytic Virotherapy by HSV. Adv Exp Med Biol. 2018;1045:63-84. doi: 10.1007/978-981-10-7230-7_4.

    PubMed 29896663

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HF10 plus Ipilimumab in people with Malignant Melanoma, run by Takara Bio Inc. at 8 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 17 inclusion and 12 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 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Best overall response rate (BORR) (time frame: at 24 weeks). 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 NCT02272855, which also lists 1 linked publication.

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 26 Sep 2018.

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