Evaluate Efficacy, Immunological Response of Intratumoral/Intralesional Oncolytic Virus (OBP-301) in Metastatic Melanoma

NCT03190824 | Unknown Phase 2 DMC FDA Drug

• 2 other identifiers: TL03001Interventional
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Open-label, single-arm, multi-center, Phase IIa study to evaluate the efficacy, safety, and immunological response of OBP 301 in patients with unresectable/unresected metastatic melanoma. This proof of concept study will be undertaken in male and female patients with unresectable Stage III and IV melanoma. Patients with unresectable/unresected mucosal melanoma may be enrolled after consultation with the Medical Monitor.

Conditions

Melanoma Stage III; Melanoma Stage Iv

Keywords

melanoma; immunotherapy; immune oncology; loco regional therapy; adenovirus; oncolytic virus; unresectable; telomerase

Outcome Measures

Primary Outcomes (1)

• Evaluate objective response rate [ORR]) to OBP-301 in both injected and noninjected lesions

  Objective response rate \[ORR\]) to OBP-301 in both injected and noninjected lesions in patients with unresectable/unresected Stage III and IV melanoma. The modification is to allow the identification of up to 10 cutaneous, subcutaneous, and/or lymph node tumor lesions and identify the lesions as target and nontarget lesions.

  up to Week 24

Secondary Outcomes (8)

• Overall Response Rate at weeks 6, 12, 18, and 24 in the combined and individual injected lesions

  Week 24 and Week 48

• Best Overall Response Rate at weeks 6, 12, 18, and 24 in injected and noninjected lesions

  Week 24 and Week 48

• Time to Treatment Response from start date to end date

  Week 24 and Week 48

• Duration of response of injected and noninjected lesions

  Week 24 and Week 48

• Progression Free Survival at weeks 24 and 48

  Week 24 and Week 48

Other Outcomes (1)

• Exploratory Analysis (optional)

  Through study completion

Study Arms (1)

OBP-301

EXPERIMENTAL

Eligible patients with unresectable Stage III and IV melanoma will receive up to 13 treatments of OBP 301 at a concentration of 1 × 1012 virus particles (VP)/mL for 24 weeks.

Drug: OBP-301

Interventions

OBP-301 DRUG

A novel, replication-competent Ad5 based adenoviral construct that incorporates a human telomerase reverse transcriptase gene (hTERT) promoter.

Also known as: Telomelysin

OBP-301

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed malignant melanoma at Screening that is unresectable/unresected Stage IIIB, IIIC, IIID or IV. Patients with unresectable mucosal melanoma may be enrolled after consultation with the Medical Monitor.
• Patients must have received and failed or refused available therapy for unresectable/unresected Stage III or IV melanoma.
• Patients must be ≥ 18 years of age.
• At least 2 cutaneous, subcutaneous and/or lymph node target lesions that are greater or equal to 1 cm in the longest diameter. One of the cutaneous, subcutaneous and/or lymph node target lesions should be designated at Screening as a noninjected target lesion. Willing to have biopsy specimens taken at Screening and at Week 6.
• Life expectancy of ≥ 6 months from the first OBP-301 treatment.
• Karnofsky Performance Status Scale (KPS) score of ≥ 70.
• Adequate organ function, hematologic status, coagulation status, kidney function, and liver function as follows:
• Absolute neutrophils \> 1,500/µL
• Hemoglobin \> 9 g/dL, without transfusion or hematopoietic growth factor
• Platelets \> 100,000/µL. Patients with ≤ 100,000 platelet count may be allowed into the study on a case-by-case basis after consultation with the Medical Monitor.
• Serum creatinine \< 2 × upper limit of normal (ULN)
• Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2 × ULN except for patients with known liver metastases, in which case aspartate transaminase or alanine transaminase may be ≤ 5.0 × ULN
• Total bilirubin \< 2.0 mg/dL (≤ 3.0 mg/dL for patients with known Gilbert's syndrome)
• Serum lactate dehydrogenase (LDH) levels \< 1.5 × ULN
• Understand the study requirements and the treatment procedures, and is willing to comply with all specified follow-up evaluations, and provides written informed consent before any study-specific tests or procedures are performed.

You may not qualify if:

• Patients who have had administration of chemotherapy, target therapy, and/or immunotherapy within the last 4 weeks before the first OBP-301 administration.
• Patients who have received other investigational medication within the last 4 weeks or a period of its 5 half-lives (whichever is shorter) before the first OBP-301 administration.
• Patients who have had radiotherapy within the last 4 weeks before the first OBP-301 administration.
• Effects of any other prior therapies not reverted to ≤ Grade 1 (or ≤ Grade 2 for alopecia and peripheral neuropathy).
• Patients who have any liver metastases or visceral metastasis of ≥ 3 cm, plus evidence of progression meeting irRC 1.0 within 1 month before the first OBP-301 administration.
• Patients with clinically active brain metastases. However, patients with previously currently stable brain metastases on medication (i.e., steroids and/or anti-seizure medications) may be enrolled after consultation with the Medical Monitor.
• Patients known to have acute or chronic active hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
• Patients diagnosed with additional malignancy within 3 years before the first OBP-301 administration with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or curatively resected in situ cervical and/or breast cancers.
• Patients requiring chronic systemic immunosuppressive medication including pharmacologic dose of glucocorticoids or cyclosporine should be evaluated by the Medical Monitor for enrollment eligibility.
• Uncontrolled intercurrent illness including, but not limited to, uncontrolled diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/psychological incompetence, whereby in the opinion of the Investigator the patient is assessed as being unable to provide information, consent, or comply with the study requirements and procedures.
• Patients who are pregnant or breastfeeding, or expecting to conceive or father children within the projected timeframe of the study, starting from the time of the Screening Visit through 3 months (90 days) after the last OBP-301 administration. Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at each visit before administration of OPB-301. A female not of childbearing potential is one who has undergone bilateral oophorectomy or who has had no menses for 12 consecutive months.

Sponsors & Collaborators

• Syneos Health: lead
• Oncolys BioPharma Inc: collaborator

Study Sites (1)

Research Site

Morristown, New Jersey, 07962, United States

Location

MeSH Terms

Conditions

Melanoma; Adenoviridae Infections

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Principal Investigator

  Institution

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: June 19, 2017
• Study Start: December 22, 2016
• Primary Completion: June 24, 2021
• Study Completion: October 31, 2021
• Last Updated: April 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)