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Melanoma Stage IIIPhase 2NCT03153085

A Study of Combination with TBI-1401(HF10) and Ipilimumab in Japanese Patients with Unresectable or Metastatic Melanoma

A Phase 2 study testing TBI-1401(HF10) and Ipilimumab in people with Melanoma Stage III and Melanoma Stage IV, run by Takara Bio Inc. at 12 sites in Japan.

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 TBI-1401(HF10) in combination with ipilimumab is effective in Japanese patients with stages IIIB, IIIC, or IV unresectable or metastatic melanoma. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Melanoma Stage III, Melanoma Stage IV
What is being tested?
TBI-1401(HF10) and Ipilimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
12 sitesJapan
Study dates
25 May 2017to 14 Dec 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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with histologically confirmed Stage IIIB, IIIC or IV unresectable or metastatic melanoma except uveal melanoma, who must have a history of treatment (chemotherapy, molecular targeted therapy, or anti PD-1 antibody therapy).
  • 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 ≥ 20 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 organ 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.
  • Creatinine ≤ 1.5 x ULN or creatinine clearance (calculated) ≥ 60 mL/min/1.73 m^2 for patients with creatinine > 1.5 x ULN.
  • Absolute neutrophil count ≥1,500/µL and
  • Platelet count ≥ 75,000/ µL
  • 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 1 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 who were previously treated with ipilimumab by intravenous infusion.
  • Patients receiving chemotherapy or molecularly targeted drug or anti-PD-1 antibody treatment or radiotherapy or immunotherapy within 4 weeks prior to initiating study treatment.
  • Patients with a history of Grade 4 adverse events caused by chemotherapy, molecularly targeted drug, anti-PD-1 antibody treatment, radiotherapy or immunotherapy conducted more than 4 weeks prior to TBI-1401(HF10) treatment, or presence of such adverse events of Grade 2 or greater, except alopecia and adverse events controlled by a treatment.
  • Patients receiving anti-herpes medication within 1 week prior to initiating TBI-1401(HF10) administration, except local treatment such as ointment.
  • 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.
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  • Patients with Grade 2 or greater 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.
  • Patients requiring systemic glucocorticoid (except 10 mg/day/body prednisolone or less) or immunosuppressive therapy because of the presence or history of autoimmune disease (e.g., Crohn's disease, ulcerative colitis) or other diseases.
  • Concurrent use of any other investigational agents within 4 weeks prior to initiating study treatment.
  • 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 (excluding the case in which breastfeeding is discontinued and will not resume it); 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

12 sites in 1 country.

12 sites in 1 country

Japan12 sites

  • Clinical Site

    Chūō, Yamanashi

  • Clinical Site

    Chūōku, Tokyo

  • Clinical Site

    Fukuoka, Fukuoka

  • Clinical Site

    Kumamoto, Kumamoto

  • Clinical Site

    Kurume, Fukuoka

  • Clinical Site

    Nagakute, Aichi-ken

  • Clinical Site

    Nagoya, Aichi-ken

  • Clinical Site

    Niigata, Niigata

  • Clinical Site

    Osaka, Osaka

  • Clinical Site

    Sapporo, Hokkaido

  • Clinical Site

    Shizuoka, Shizuoka

  • Clinical Site

    Tsukuba, Ibaraki

Other trials in Japan

About this study

Official title: A Phase II Study of Combination Treatment with TBI-1401(HF10), a Replication-competent HSV-1 Oncolytic Virus, and Ipilimumab in Japanese Patients with Stage IIIB, IIIC, or IV Unresectable or Metastatic Malignant Melanoma

The purpose of this study is to determine if TBI-1401(HF10) in combination with ipilimumab is effective in Japanese 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 TBI-1401(HF10) at 1x10^7 TCID50/mL in combination with intravenous infusions of 3mg/kg ipilimumab in Japanese patients.

This is a single arm, open label Phase II study, to evaluate the efficacy and safety of TBI-1401(HF10) treatment in combination with 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 1x10^7 TCID50/mL TBI-1401(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 (for a total of 4 intravenous infusions, each administered at 3-week intervals).

Following combination therapy, patients may continue to receive the 1x10^7 TCID50/mL TBI-1401(HF10) 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
TBI-1401(HF10), Ipilimumab
Keywords
Unresectable melanoma, Metastatic melanoma, Recurrent Melanoma, TBI-1401(HF10), HF10, HSV-1, Oncolytic virus, Oncolytic viral immunotherapy, Ipilimumab, Intratumoral administration, canerpaturev
Medical subject headings
Melanoma

What participants receive

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

  • TBI-1401(HF10)Biological

    Also called HF10, canerpaturev

    1x10^7 TCID50/mL TBI-1401(HF10) (for a total of 6 injections; the first 4 injections at 1-week intervals; the remaining 2 injections at 3-week intervals).

    Following combination therapy, patients may continue to receive the 1x10^7 TCID50/mL TBI-1401(HF10) alone for up to an additional 13 injections (total of 19 injections = 1 year) if eligible for administration.

  • IpilimumabDrug

    Also called anti CTLA-4 antibody

    3 mg/kg ipilimumab (for a total of 4 intravenous infusions, each administered at 3-week intervals).

Study groups in NCT03153085
Study groupRoleWhat they receive
TBI-1401(HF10) + IpilimumabExperimental1x10^7 TCID50/mL TBI-1401(HF10) administered to a single or multiple eligible tumors in a total volume up to 5.0 mL (injection volume will be adjusted based on the size of tumor mass) by intratumoral injection and 3 mg/kg ipilimumab administered by intravenous infusions.
Receives: Biological: TBI-1401(HF10); Drug: Ipilimumab

What is being measured

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

  1. Best overall response rate (BORR) by irRC

    Determine the efficacy of TBI-1401(HF10) in combination with Ipilimumab evaluated by irRC (immuno-related response criteria)

    Measured: at 24 weeks

Secondary outcomes (9)

  1. Best overall response rate (BORR) by mWHO response criteria

    Determine the efficacy of TBI-1401(HF10) in combination with Ipilimumab evaluated by modified WHO (mWHO) response criteria

    Measured: at weeks 24

  2. Best overall response rate (BORR) by RECIST version 1.1

    Determine the efficacy of TBI-1401(HF10) in combination with Ipilimumab evaluated by RECIST version 1.1

    Measured: at weeks 24

  3. Objective response rate (ORR) by irRC

    Overall tumor response evaluated by irRC in the measurable target lesion(s) and unmeasurable/evaluable target lesion(s).

    Measured: at weeks 6, 12, 18, and 24

  4. Objective response rate (ORR) by mWHO

    Overall tumor response evaluated by mWHO response criteria in the measurable target lesion(s) and unmeasurable/evaluable target lesion(s).

    Measured: at weeks 6, 12, 18, and 24

  5. Objective response rate (ORR) by RECIST version 1.1

    Overall tumor response evaluated by RECIST version 1.1 in the measurable target lesion(s) and unmeasurable/evaluable target lesion(s).

    Measured: at weeks 6, 12, 18, and 24

  6. Adverse event summaries, vital signs, and laboratory parameters to evaluate the safety and tolerability.

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

    Measured: through study completion, up to 1 year

  7. Progression-free survival (PFS)

    Evaluation the time to progression during and after the treatment.

    Measured: through disease progression, up to 3 years

  8. Durable response rate (DRR)

    Evaluation the length of time after a partial or complete response.

    Measured: for 1 year

  9. 1 year survival rate

    Determine the 1 year survival rate of patient who received treatment.

    Measured: at 1 year

Timeline

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

  1. First posted15 May 2017
  2. Study start25 May 2017
  3. Primary completion30 Jun 2018
  4. Study completion14 Dec 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
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03153085
Sponsor's protocol ID
TBI1401-02
Status last verified
Dec 2024
First submitted
8 May 2017
Last updated
9 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TBI-1401(HF10) and Ipilimumab in people with Melanoma Stage III and Melanoma Stage IV, run by Takara Bio Inc. at 12 sites in Japan.

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 13 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 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Japan. 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) by irRC (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 NCT03153085.

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 Dec 2024.

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