A Study of Combination Treatment With HF10 and Ipilimumab in Patients With Unresectable or Metastatic Melanoma
This trial is active, not recruiting.
|Treatment||hf10 plus ipilimumab|
|Sponsor||Takara Bio Inc.|
|Start date||October 2014|
|End date||October 2016|
|Trial size||46 participants|
|Trial identifier||NCT02272855, T14-10682|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|San Francisco, CA||UCSF Medical Center-Mount Zion||no longer recruiting|
|Atlanta, GA||Emory University / Winship Cancer Institute||terminated|
|Portland, OR||OHSU Knight Cancer Institute||no longer recruiting|
|Bethlehem, PA||Clinical Site||no longer recruiting|
|Hershey, PA||Clinical Site||no longer recruiting|
|Dallas, TX||Clinical Site||no longer recruiting|
|Houston, TX||M D Anderson Cancer Center||no longer recruiting|
|Salt Lake, UT||Clinical Site||no longer recruiting|
|Salt Lake City, UT||Huntsman Cancer Institute / University of Utah||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
Best overall response rate (BORR)
time frame: at 24 weeks
Adverse Event Summaries, Vital Signs, and Laboratory Parameters as a Measure of Safety and Tolerability
time frame: until Week 24
Objective response rate (ORR)
time frame: at Weeks 12, 18, and 24
Progression-free survival (PFS)
time frame: for 1 year
Durable response rate (DRR)
time frame: for 1 year
1-year survival rate
time frame: at 1 year
Accumulation of Lymphocytes in the Tumor by using Core Biopsy Samples
time frame: pre-treatment screening and Week 24
Change in Cytokine Profiles by using Peripheral Blood Samples
time frame: pre-treatment screening and Week 24
Male or female participants at least 18 years old.
- 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
- 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.
- 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.
- 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.
|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|
|Principal investigator||Robert Andtbacka|
|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.|
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