Melanoma Stage IIIPhase 2NCT03190824

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

A Phase 2 study testing OBP-301 in people with Melanoma Stage III and Melanoma Stage Iv, run by Syneos Health at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Melanoma Stage III, Melanoma Stage Iv
What is being tested?: OBP-301
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 1 siteUnited States
Study dates: 22 Dec 2016to 31 Oct 2021
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

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.

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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.
Patients of reproductive potential must use effective contraception for the duration of the study and for 3 months (90 days) after the last administered injection of OBP-301. Effective contraception includes oral contraceptives, implantable hormonal contraception, double-barrier method or intrauterine device.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Research Site
Morristown, New Jersey, 07962

Other trials in United States

About this study

Official title: Open-label, Multi-center Phase IIa Study to Evaluate the Efficacy, Safety, and Immunological Response of OBP-301, Telomerase Specific Replication-competent Oncolytic Adenovirus in Patients With Unresectable Metastatic Melanoma

Read the detailed description

Primary Objective:

The primary objective of this study is to evaluate the overall tumor sites response (objective response rate [ORR]) to OBP-301 in both injected and noninjected lesions up to and including Week 24 in patients with unresectable/unresected Stage III and IV melanoma. The ORR is defined as the rate of complete response (CR) and partial response (PR) based on the modified immune-related response criteria (irRC) 1.0. 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.

Secondary Objectives:

To evaluate the ORR up to and including Week 24 in injected target lesions based on the modified irRC 1.0 and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
To evaluate the ORR up to and including Week 24 in noninjected target lesions based on modified irRC 1.0 and RECIST 1.1
To evaluate the ORR in both injected and noninjected target lesions at Week 12 based on the modified irRC 1.0 and RECIST 1.1
To evaluate duration of response and time to response
To evaluate progression free survival (PFS) at Week 24 and Week 48
To evaluate overall survival (OS) at Week 24 and Week 48
To evaluate the safety of OBP 301

Exploratory Objective (optional):

The optional exploratory objective of this study is to investigate the tumor immunological response in blood and tumor tissue following treatment with OBP-301.

Conditions: Melanoma Stage III, Melanoma Stage Iv
Being tested: OBP-301
Keywords: melanoma, immunotherapy, immune oncology, loco regional therapy, adenovirus, oncolytic virus, unresectable, telomerase
Medical subject headings: Melanoma, Adenoviridae Infections

What participants receive

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

OBP-301Drug
Also called Telomelysin
A novel, replication-competent Ad5 based adenoviral construct that incorporates a human telomerase reverse transcriptase gene (hTERT) promoter.

Study groups in NCT03190824
Study group	Role	What they receive
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. Receives: Drug: OBP-301

What is being measured

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

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.
Measured: up to Week 24

Secondary outcomes (8)

Overall Response Rate at weeks 6, 12, 18, and 24 in the combined and individual injected lesions
ORR at Weeks 6, 12, 18, and 24 in the combined and the individual injected and noninjected target lesions according to the modified irRC v1.0 and RECIST 1.1.
Measured: Week 24 and Week 48
Best Overall Response Rate at weeks 6, 12, 18, and 24 in injected and noninjected lesions
Best overall response rate (ORR in injected and noninjected target lesions) based on the modified irRC 1.0 and the RECIST 1.1.
Measured: Week 24 and Week 48
Time to Treatment Response from start date to end date
Time to Treatment Response (TTR): the start date is the date of first treatment (Injection 1, Day 1) and the end date is the date of first documented response (CR or PR).
Measured: Week 24 and Week 48
Duration of response of injected and noninjected lesions
Duration of response (injected and noninjected lesions): applies only to patients whose best overall response is CR or PR. The start date is the date of first documented response (CR or PR) and the end date is the date of first documented disease progression or the date of death due to underlying cancer.
Measured: Week 24 and Week 48
Progression Free Survival at weeks 24 and 48
PFS at Week 24 and Week 48
Measured: Week 24 and Week 48
Overall Survival at weeks 24 and 48
OS at Week 24 and Week 48
Measured: Week 24 and Week 48
Safety of OBP-301 as assessed by incidence of AEs and SAEs
Incidence of AEs and serious adverse events (SAEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; version 4.03). Changes in clinical laboratory parameters (serum chemistry, coagulation parameters, hematology, urinalysis) from Baseline.Vital signs. Physical examination. Electrocardiogram (ECG).
Measured: Through study completion
Safety of OBP-301 as assessed by changes in clinical laboratory parameters
Changes in clinical laboratory parameters (serum chemistry, coagulation parameters, hematology, urinalysis) from Baseline.
Measured: Through study completion

Timeline

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

22 Dec 201631 Oct 2021

First posted19 Jun 2017
Study start22 Dec 2016
Primary completion24 Jun 2021 (estimated)
Study completion31 Oct 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Melanoma Stage IIIStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03190824
Sponsor's protocol ID: TL03001
Other IDs: Interventional
Status last verified: Apr 2019
First submitted: 7 Mar 2017
Last updated: 16 Apr 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Melanoma Stage III trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-label, Multi-center Phase IIa Study to Evaluate the Efficacy, Safety, and Immunological Response of OBP-301, Telomerase Specific Replication-competent Oncolytic Adenovirus in Patients With Unresectable Metastatic Melanoma
ClinicalTrials.gov ID: NCT03190824
Acronym / sponsor ID: TL03001
Conditions: Melanoma Stage III, Melanoma Stage Iv
Keywords: melanoma, immunotherapy, immune oncology, loco regional therapy, adenovirus, oncolytic virus, unresectable, telomerase
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 4 participants (actual)
Lead sponsor: Syneos HealthUniversity, hospital or other
Collaborators: Oncolys BioPharma Inc
Study start: 22 Dec 2016 (actual)
Primary completion: 24 Jun 2021 (estimated)
Study completion: 31 Oct 2021 (estimated)
First posted: 19 Jun 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Primary Objective:

Secondary Objectives:

To evaluate the ORR up to and including Week 24 in injected target lesions based on the modified irRC 1.0 and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
To evaluate the ORR up to and including Week 24 in noninjected target lesions based on modified irRC 1.0 and RECIST 1.1
To evaluate the ORR in both injected and noninjected target lesions at Week 12 based on the modified irRC 1.0 and RECIST 1.1
To evaluate duration of response and time to response
To evaluate progression free survival (PFS) at Week 24 and Week 48
To evaluate overall survival (OS) at Week 24 and Week 48
To evaluate the safety of OBP 301

Exploratory Objective (optional):

The optional exploratory objective of this study is to investigate the tumor immunological response in blood and tumor tissue following treatment with OBP-301.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
OBP-301	Experimental	Drug: OBP-301Eligible 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

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.

Key exclusion criteria (11 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OBP-301Also: TelomelysinA novel, replication-competent Ad5 based adenoviral construct that incorporates a human telomerase reverse transcriptase gene (hTERT) promoter.	Drug	OBP-301

Primary outcome

Evaluate objective response rate [ORR]) to OBP-301 in both injected and noninjected lesions
Time frame: up to Week 24
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.

8 secondary outcomes

Overall Response Rate at weeks 6, 12, 18, and 24 in the combined and individual injected lesions
Time frame: Week 24 and Week 48
Best Overall Response Rate at weeks 6, 12, 18, and 24 in injected and noninjected lesions
Time frame: Week 24 and Week 48
Time to Treatment Response from start date to end date
Time frame: Week 24 and Week 48
Duration of response of injected and noninjected lesions
Time frame: Week 24 and Week 48
Progression Free Survival at weeks 24 and 48
Time frame: Week 24 and Week 48
Overall Survival at weeks 24 and 48
Time frame: Week 24 and Week 48
Safety of OBP-301 as assessed by incidence of AEs and SAEs
Time frame: Through study completion
Safety of OBP-301 as assessed by changes in clinical laboratory parameters
Time frame: Through study completion

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
Individual participant dataSharing planned: No

Related trials for Melanoma Stage III

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BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Principal Investigator principal investigator

Institution

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OBP-301 in people with Melanoma Stage III and Melanoma Stage Iv, run by Syneos Health at 1 site 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 16 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

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?

Evaluate objective response rate [ORR]) to OBP-301 in both injected and noninjected lesions (time frame: up to Week 24). 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 NCT03190824.

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 16 Apr 2019.