A Study of Combination With TBI-1401(HF10) and Ipilimumab in Japanese Patients With Unresectable or Metastatic Melanoma
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|ClinicalTrials.gov Identifier: NCT03153085|
Recruitment Status : Active, not recruiting
First Posted : May 15, 2017
Last Update Posted : February 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Melanoma Stage Iii Melanoma Stage Iv||Biological: TBI-1401(HF10) Drug: Ipilimumab||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||May 25, 2017|
|Estimated Primary Completion Date :||June 30, 2018|
|Estimated Study Completion Date :||December 31, 2018|
Experimental: TBI-1401(HF10) + Ipilimumab
1x10^7 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.
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.
Other Name: HF10Drug: Ipilimumab
3 mg/kg ipilimumab (for a total of 4 intravenous infusions, each administered at 3-week intervals).
Other Name: anti CTLA-4 antibody
- Best overall response rate (BORR) by irRC [ Time Frame: at 24 weeks ]Determine the efficacy of TBI-1401(HF10) in combination with Ipilimumab evaluated by irRC (immuno-related response criteria)
- Best overall response rate (BORR) by mWHO response criteria [ Time Frame: at weeks 24 ]Determine the efficacy of TBI-1401(HF10) in combination with Ipilimumab evaluated by modified WHO (mWHO) response criteria
- Objective response rate (ORR) by irRC [ Time Frame: at weeks 6, 12, 18, and 24 ]Overall tumor response evaluated by irRC in the measurable target lesion(s) and unmeasurable/evaluable target lesion(s).
- Objective response rate (ORR) by mWHO [ Time Frame: at weeks 6, 12, 18, and 24 ]Overall tumor response evaluated by mWHO response criteria in the measurable target lesion(s) and unmeasurable/evaluable target lesion(s).
- Adverse event summaries, vital signs, and laboratory parameters to evaluate the safety and tolerability. [ Time Frame: through study completion, up to 1 year ]Adverse events will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE version 4.0).
- Progression-free survival (PFS) [ Time Frame: through disease progression, up to 3 years ]Evaluation the time to progression during and after the treatment.
- Durable response rate (DRR) [ Time Frame: for 1 year ]Evaluation the length of time after a partial or complete response.
- 1 year survival rate [ Time Frame: at 1 year ]Determine the 1 year survival rate of patient who received treatment.
- Levels of antibody to HSV-1 [ Time Frame: up to weeks 24 ]Evaluate the change of anti-HSV-1 antibody levels.
- Change in immunologic parameters in serum [ Time Frame: up to weeks 24 ]Analysis the change of cytokine profiles, antitumor T-cell reactivity and regulatory T-cell (Treg) population by immunoassay and flow cytometry.
- Histopathological response with TBI-1401(HF10) administrated tumor [ Time Frame: up to weeks 24 ]Biopsies will be performed to evaluate the histopathological response with TBI-1401(HF10) administrated tumor.
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 ClinicalTrials.gov identifier (NCT number): NCT03153085
|Nagakute, Aichi, Japan|
|Nagoya, Aichi, Japan|
|Kurume, Fukuoka, Japan|
|Sapporo, Hokkaido, Japan|
|Tsukuba, Ibaraki, Japan|
|Sunto-Gun, Shizuoka, Japan|
|Chūōku, Tokyo, Japan|
|Chūō, Yamanashi, Japan|
|Principal Investigator:||Naoya Yamazaki||National Cancer Center Hospital|