Description:
The purpose of this study is to find out if a new treatment called SCIB1 can be used safely
when added to pembrolizumab (Keytruda), a standard therapy approved for the treatment of
advanced melanoma (skin cancer). Pembrolizumab is an antibody treatment for cancer.
The study will also look to see if SCIB1 can increase the likelihood that melanoma patients
will respond to pembrolizumab, and also if SCIB1 can help to make those responses last
longer. Pembrolizumab is considered a standard treatment for patients with advanced melanoma.
SCIB1 is considered experimental. SCIB1 has been given to melanoma patients in an earlier
study. It was generally well-tolerated, and researchers saw some signs that it may help to
stimulate the immune system, which is a way in which the body can fight the cancer.
This study is expected to enroll up to 44 melanoma patients worldwide.
Title
- Brief Title: A Phase 2, Multicenter, Open-Label Study of SCIB1 in Patients With Advanced Unresectable Melanoma Receiving Pembrolizumab
- Official Title: A Phase 2, Multicenter, Open-Label Study of SCIB1 in Patients With Advanced Unresectable Melanoma Receiving Pembrolizumab
Clinical Trial IDs
- ORG STUDY ID:
SCIB1-002
- NCT ID:
NCT04079166
Conditions
Interventions
Drug | Synonyms | Arms |
---|
SCIB1 administered with a small, hand-held electroporation device (TriGrid™ delivery system version 2.0 [TDS-IM v2.0]). | | SCIB1 |
Purpose
The purpose of this study is to find out if a new treatment called SCIB1 can be used safely
when added to pembrolizumab (Keytruda), a standard therapy approved for the treatment of
advanced melanoma (skin cancer). Pembrolizumab is an antibody treatment for cancer.
The study will also look to see if SCIB1 can increase the likelihood that melanoma patients
will respond to pembrolizumab, and also if SCIB1 can help to make those responses last
longer. Pembrolizumab is considered a standard treatment for patients with advanced melanoma.
SCIB1 is considered experimental. SCIB1 has been given to melanoma patients in an earlier
study. It was generally well-tolerated, and researchers saw some signs that it may help to
stimulate the immune system, which is a way in which the body can fight the cancer.
This study is expected to enroll up to 44 melanoma patients worldwide.
Detailed Description
This is an open label, single arm Phase 2 study to determine the safety and tolerability of
SCIB1 administered to patients with advanced melanoma using an electroporation device (the
TDS-IM v2.0 device) when added to pembrolizumab (Keytruda), a standard treatment already
approved for the treatment of advanced melanoma.
The plan for this study is for SCIB1 to be given for up to 85 weeks, in combination with
pembrolizumab according to the current label.
After receiving the first dose of SCIB1, the patient will receive SCIB1 at 4, 7, 13 and 25
weeks, then every 12 weeks until Week 85. Pembrolizumab treatment will be started 1 week
after the first dose of SCIB1 and given every 6 weeks up to Week 85.
Pembrolizumab will be given by an injection into the patient's vein. The injection, known as
an infusion, usually takes about 30 minutes to complete.
On each occasion, SCIB1 will be given by two injections into a muscle in a different limb,
e.g., one into the upper arm and the other into the thigh. Instead of a normal needle and
syringe, a small, hand-held device, TDS-IM v2.0, will be used to inject SCIB1 into the
muscles. The site of SCIB1 administration will alternate on each occasion.
The injection device is designed to increase the amount of SCIB1 that is delivered to the
muscle cells. The liquid containing SCIB1 will be delivered through the injection needle.
Immediately after the injection, the device will give an electrical impulse to the muscle
through the four thin wires at the site of the injection. The impulse will last for less than
one tenth of a second. A short video will be shown to the patient before the first injection
is given to show the patient what will happen.
Before treatment starts and after consent has been given, all patients will undergo screening
tests (to be completed within 28 days of treatment initiation) to ensure the patient is
eligible to take part. For screening, the patient will need to undergo tissue typing, a
melanoma tumor biopsy will be required if an adequate sample for testing was not previously
performed, an eye examination, blood and urine samples taken for clinical laboratory tests,
pregnancy status (for female patients only), tests of their immune functions, a physical
examination including their vital signs, performance status and an electrocardiogram (ECG), a
computerized tomography (CT) or magnetic resonance imaging (MRI) scan plus a visual
inspection and photographing of any skin lesions, skin fold thickness measurement, and
medical history collection.
Over the 85-week treatment period, the patient will visit the hospital 25 times and have two
telephone/video calls. They will then have an end of treatment (EOT) visit approximately 4
weeks after the last dose of SCIB1 or pembrolizumab (whichever occurs last) and a final
post-treatment follow-up visit 12 weeks after the last dose of study treatment (SCIB1 or
pembrolizumab, whichever occurs last). The evaluations and procedures that will be carried
out at each visit are all detailed in the study information sheets given to the patient
before consent is taken. At some of these visits, blood samples will be taken for
immunological tests. Female participants of childbearing potential will undergo pregnancy
testing during screening, at the start of treatment, 7 weeks after the first dose of SCIB1,
every 6 weeks until the end of the treatment period and at the EOT visit.
At certain visits, all patients will have physical examinations and have their skin lesions
assessed and photographed. At all visits, patients will be asked about other medications they
are taking and about any adverse effects they might have experienced since their previous
clinic visit.
In response to the COVID-19 pandemic, the treatment burden for patients has also been reduced
where possible by conducting remote assessments via telephone or video conference.
After receiving their last dose of SCIB1 or pembrolizumab (whichever occurs last), all
surviving participants will be followed up by attending clinic visits for tumor assessments
(including CT/MRI scans) every 12 weeks for a period of 97 weeks (~2 years) from the first
dose of SCIB1, unless disease progression occurs or a new anticancer treatment is initiated.
If disease progression does occur or a new anticancer treatment is initiated, follow-up every
12 weeks (up to Week 97) may be conducted by a healthcare professional by telephone/video
conference call or during a routine clinic visit. At each assessment questions will be asked
about the following: survival, development of infection, immunological reactions,
participation in any other clinical trials and subsequent exposure to highly potent
treatments.
Trial Arms
Name | Type | Description | Interventions |
---|
SCIB1 | Experimental | SCIB1 administered using the TDS-IM v2.0 device | - SCIB1 administered with a small, hand-held electroporation device (TriGrid™ delivery system version 2.0 [TDS-IM v2.0]).
|
Eligibility Criteria
Inclusion Criteria:
- Patient has histologically confirmed, unresectable Stage III or Stage IV melanoma as
defined by the American Joint Committee on Cancer (8th Edition; Gershenwald et al
2017).
- Patient has not received prior systemic treatment for advanced disease. Prior adjuvant
treatment, defined as treatment following resection of all detectable disease, is
permitted; last dose must be at least 4 weeks before the first dose of SCIB1.
- Patient has been clinically evaluated and pembrolizumab has been determined to be an
appropriate treatment for their advanced disease.
- Patient's BRAF status must be known; patients with BRAF mutation positive disease may
be enrolled without BRAF inhibitor treatment at the discretion of the Investigator,
provided that they have no evidence of rapidly progressing disease (LDH above normal
range, clinically significant tumor-related symptoms).
- Patient has at least one measurable lesion per RECIST 1.1 criteria by CT scan or MRI.
- Patient has an archival (< 5 years of age) or fresh biopsy sample of tumor available
for analysis of programmed death-ligand 1 (PD-L1) expression.
- Patient is human leukocyte antigen (HLA)-A2 positive.[*]
- Patient is positive for HLA-DR4, HLA-DR7, HLA-DR53 or HLA-DQ6.[*]
- Patient is at least 18 years of age.
- Patient has a life expectancy of more than 3 months.
- Patient has an ECOG performance status of 0 or 1.
- Patient has adequate organ function as determined by protocol laboratory values.
- Patient must be able and willing to provide written Institutional Review
Board/Research Ethics Committee (IRB/REC) approved informed consent prior to any study
related procedure. (In the event that the patient is re-screened for study
participation or if a protocol amendment alters the care of an ongoing patient, a new
IRB/REC-approved informed consent form must be signed.)
- Women of child-bearing potential (including women ≤ 12 months from last menstrual
period) must have a negative serum pregnancy test during Screening (within the 72
hours before planned administration of the first dose of study drug on Day 1) and be
neither breastfeeding nor intending to become pregnant during study participation, and
shall be warned of potential fetal harm from pembrolizumab. Women of child-bearing
potential must agree to use highly effective contraceptive methods prior to study
entry, for the whole duration of study treatment, and for 120 days after
discontinuation of SCIB1 or pembrolizumab, whichever is last.
- Men who are potentially fertile with partners of childbearing potential must agree to
use highly effective contraceptive methods for the whole duration of study treatment
and for 120 days after discontinuation of SCIB1 or pembrolizumab, whichever is last.
- Patient must be willing and able to comply with scheduled visits, treatment plan,
laboratory tests and other study procedures.
[*] HLA testing will be conducted at accredited laboratories by molecular (DNA) typing.
Exclusion Criteria:
- Patient has a diagnosis of uveal or ocular melanoma.
- Patient has active central nervous system metastases or carcinomatous meningitis
(patients with a response to previous treatment for brain metastases are eligible
provided that they are stable without MRI evidence of progression for at least 4 weeks
prior to the first dose of study treatment, and systemic steroids have been withdrawn
for at least 2 weeks).
- Patient has previously received a treatment to block cytotoxic T lymphocyte associated
protein 4, programmed cell death protein 1, PD-L1, or programmed death-ligand 2 with
the following exception: patients who have received adjuvant treatment with these
treatments are eligible.
- Patient is expected to require any other form of systemic or localized antineoplastic
therapy while on study.
- Patient is taking any systemic steroid therapy within 1 week of the first dose of
study drug or is receiving any other form of immune suppressant medication.
Physiological doses of systemic steroids such as those for the management of adrenal
insufficiency, and topical and inhaled steroids, such as those for the management of
asthma, are permitted.
- Patient is receiving treatment with any investigational product within 28 days (or 5
half-lives of the treatment concerned) prior to the first dose of study treatment.
- Patient has a previous (within 5 years) or current malignancy with the exception of
melanoma, and curatively treated local tumors such as carcinoma-in-situ of the breast,
cervix, basal or squamous cell carcinoma of the skin, prostate cancer with Gleason
grade < 6 and prostate-specific antigen within normal range.
- Patient has a concurrent illness which would preclude study conduct and assessment,
including, but not limited to uncontrolled medical conditions, uncontrolled and active
infection (considered opportunistic, life threatening, or clinically significant),
uncontrolled risk of bleeding, or uncontrolled diabetes mellitus, or pulmonary disease
(including obstructive pulmonary disease, pulmonary fibrosis, and history of
symptomatic bronchospasm), or alcoholic liver disease, or primary biliary cirrhosis.
Caution should be used for patients with suspected or diagnosed epilepsy.
- Patient has any electronic stimulation device that cannot be removed during the
administration procedure, such as cardiac demand pacemaker, automatic implantable
cardiac defibrillator, nerve stimulator or deep brain stimulator.
- Patient has a skin-fold measurement of the cutaneous and subcutaneous tissue for all
eligible injection sites (deltoid or quadriceps muscles with intact lymph drainage)
that is > 50 mm.
- Patient has New York Heart Association class III or IV heart disease, myocardial
infarction within previous 6 months, a heart rate of ≤ 50 beats per minute, a history
of significant cardiac abnormality and/or clinically significant abnormal baseline ECG
reading, active ischemia, or any other uncontrolled cardiac condition such as angina
pectoris, clinically significant arrhythmia requiring therapy including
anticoagulants, uncontrolled hypertension (> 140/90 mm Hg), significant
cerebrovascular disease, or congestive heart failure.
- Patient has a history of severe hypersensitivity reaction to treatment with a
monoclonal antibody.
- Patient has an active autoimmune disease or a documented history of autoimmune disease
or syndrome that requires systemic steroids or immunosuppressive agents (patients with
vitiligo or resolved childhood asthma/atopy are an exception and are not excluded for
these conditions). The following patients are not excluded from the study: patients
who require intermittent use of bronchodilators or local steroid injections, patients
with hypothyroidism stable on hormone replacement, and patients who receive
physiological doses of steroids as replacement therapy, such as those for the
management of adrenal insufficiency. In such cases the recruiting investigator should
discuss the patients' eligibility with the study Medical Monitor prior to enrolment.
- Patient has received a vaccine within the 28 days prior to first dose of study
treatment.
- Patient has a known history of human immunodeficiency virus or has any positive test
for hepatitis B virus or hepatitis C virus indicating active acute or chronic
infection.
- Patient has a known current or recent history (within the last year) of substance
abuse including illicit drugs or alcohol.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by the recording of adverse events (AEs) (Run-In Cohort: first 6 participants enrolled) |
Time Frame: | From enrollment through last recorded assessment of safety, 2 years (Week 97) from the first dose of study drug |
Safety Issue: | |
Description: | National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events; CTCAE v5.0. |
Secondary Outcome Measures
Measure: | Effect on duration of response of SCIB1 in patients receiving pembrolizumab relative to historical data for pembrolizumab alone in this patient population (Main Study) |
Time Frame: | From enrollment through last recorded assessment of response, up to 2 years (Week 97) from the first dose of study drug |
Safety Issue: | |
Description: | Duration of response, measured from the point of first response (complete response or partial response) to the date of disease progression (per RECIST 1.1) or death due to any cause. |
Measure: | ORR of SCIB1 in participants receiving pembrolizumab relative to historical data for pembrolizumab alone in this patient population, based on the modified RECIST 1.1 for immune-based therapeutics (iRECIST) (Main Study) |
Time Frame: | From enrollment through last recorded assessment of response, up to 2 years (Week 97) from the first dose of study drug |
Safety Issue: | |
Description: | ORR as determined by iRECIST criteria. |
Measure: | Progression Free Survival (PFS) rate. |
Time Frame: | At 1 year (Week 49) and 2 years (Week 97) from the first dose of study drug |
Safety Issue: | |
Description: | PFS rate is defined as the proportion of participants who have not progressed (per RECIST 1.1 and iRECIST), or started new anticancer therapy, or died. |
Measure: | Overall survival (OS) rate. |
Time Frame: | At 1 year (Week 49) and 2 years (Week 97) from the first dose of study drug |
Safety Issue: | |
Description: | OS rate is defined as the proportion of participants who remain alive. |
Measure: | Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by the recording of AEs (Main Study) |
Time Frame: | From enrollment through last recorded assessment of safety, 2 years (Week 97) from the first dose of study drug |
Safety Issue: | |
Description: | [NCI] CTCAE v5.0. |
Measure: | Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by the recording of vital signs (temperature) (Main Study) |
Time Frame: | From enrollment through end of treatment (28 days after the final dose of study treatment) |
Safety Issue: | |
Description: | Temperature (°C). |
Measure: | Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by the recording of vital signs (pulse) (Main Study) |
Time Frame: | From enrollment through end of treatment (28 days after the final dose of study treatment) |
Safety Issue: | |
Description: | Pulse (beats per minute). |
Measure: | Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by the recording of vital signs (respiratory rate) (Main Study) |
Time Frame: | From enrollment through end of treatment (28 days after the final dose of study treatment) |
Safety Issue: | |
Description: | Respiratory rate (breaths per minute). |
Measure: | Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by the recording of vital signs (blood pressure) (Main Study) |
Time Frame: | From enrollment through end of treatment (28 days after the final dose of study treatment) |
Safety Issue: | |
Description: | Systolic and diastolic blood pressure (mm Hg). |
Measure: | Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by a physical examination of the participant (Main Study) |
Time Frame: | From enrollment through end of treatment (28 days after the final dose of study treatment) |
Safety Issue: | |
Description: | Physical examination of eyes, neurological and cardiovascular systems, lungs, abdomen, head, neck, ears, nose, mouth, throat, thyroid, lymph nodes, extremities, and other areas with signs and symptoms of disease (binary classification: normal or abnormal). |
Measure: | Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by serum chemistry (creatinine, bilirubin, uric acid) (Main Study) |
Time Frame: | From enrollment through end of treatment (28 days after the final dose of study treatment) |
Safety Issue: | |
Description: | Creatinine, bilirubin - total, bilirubin - direct (if clinically indicated), uric acid (urate) (μmol/L). |
Measure: | Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by serum chemistry (including blood urea nitrogen) (Main Study) |
Time Frame: | From enrollment through end of treatment (28 days after the final dose of study treatment) |
Safety Issue: | |
Description: | Blood urea nitrogen, bicarbonate (or carbon dioxide), calcium, chloride, potassium, sodium, non-fasting glucose, phosphorus (measured as phosphate), uric acid (urate) (mmol/L). |
Measure: | Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by serum chemistry (including Alanine aminotransferase) (Main Study) |
Time Frame: | From enrollment through end of treatment (28 days after the final dose of study treatment) |
Safety Issue: | |
Description: | Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, LDH (international units/L). |
Measure: | Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by serum chemistry (Albumin) (Main Study) |
Time Frame: | From enrollment through end of treatment (28 days after the final dose of study treatment) |
Safety Issue: | |
Description: | Albumin, total protein (g/L). |
Measure: | Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by serum chemistry (Thyroid-stimulating hormone) (Main Study) |
Time Frame: | From enrollment through end of treatment (28 days after the final dose of study treatment) |
Safety Issue: | |
Description: | Thyroid-stimulating hormone (mIU/L). |
Measure: | Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by serum chemistry (Free thyroxine, triiodothyronine) (Main Study) |
Time Frame: | From enrollment through end of treatment (28 days after the final dose of study treatment) |
Safety Issue: | |
Description: | Free thyroxine, triiodothyronine (pmol/L). Free thyroxine, triiodothyronine (pmol/L). |
Measure: | Safety and tolerability of SCIB1 in participants as assessed by hematology (red blood cell count) (Main Study) |
Time Frame: | From enrollment through end of treatment (28 days after the final dose of study treatment) |
Safety Issue: | |
Description: | Red blood cell count (10⌃12/L). |
Measure: | Safety and tolerability of SCIB1 in participants as assessed by hematology (including hematocrit) (Main Study) |
Time Frame: | From enrollment through end of treatment (28 days after the final dose of study treatment) |
Safety Issue: | |
Description: | Hematocrit (%). |
Measure: | Safety and tolerability of SCIB1 in participants as assessed by hematology (Main Study) |
Time Frame: | From enrollment through end of treatment (28 days after the final dose of study treatment) |
Safety Issue: | |
Description: | Absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, absolute basophils, absolute platelets (10⌃9/L).
Differential neutrophils, differential lymphocytes, differential monocytes, differential eosinophils, differential basophils, differential platelets (%). |
Measure: | Safety and tolerability of SCIB1 in participants as assessed by hematology (corpuscular volume) (Main Study) |
Time Frame: | From enrollment through end of treatment (28 days after the final dose of study treatment). |
Safety Issue: | |
Description: | Mean corpuscular volume (fL). |
Measure: | Safety and tolerability of SCIB1 in participants as assessed by hematology (corpuscular hemoglobin) (Main Study) |
Time Frame: | From enrollment through end of treatment (28 days after the final dose of study treatment) |
Safety Issue: | |
Description: | Mean corpuscular hemoglobin (pg). |
Measure: | Safety and tolerability of SCIB1 in participants as assessed by hematology (hemoglobin, corpuscular hemoglobin) (Main Study) |
Time Frame: | From enrollment through end of treatment (28 days after the final dose of study treatment) |
Safety Issue: | |
Description: | Hemoglobin, mean corpuscular hemoglobin concentration (g/L). |
Measure: | Safety and tolerability of SCIB1 in participants as assessed by coagulation testing (Main Study) |
Time Frame: | From enrollment through end of treatment (28 days after the final dose of study treatment) |
Safety Issue: | |
Description: | International normalised ratio, activated partial prothrombin time (s). |
Measure: | Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by urinalysis (protein, glucose) (Main Study) |
Time Frame: | From enrollment through end of treatment (28 days after the final dose of study treatment) |
Safety Issue: | |
Description: | Protein, glucose (negative/trace/1+/2+/3+/4+). |
Measure: | Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by urinalysis (ketones, blood, nitrites, leukocytes, bilirubin) (Main Study) |
Time Frame: | From enrollment through end of treatment (28 days after the final dose of study treatment) |
Safety Issue: | |
Description: | Ketones, blood, nitrites, leukocytes, bilirubin (negative/trace/1+/2+/3+). |
Measure: | Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by urinalysis (pH) (Main Study) |
Time Frame: | From enrollment through end of treatment (28 days after the final dose of study treatment) |
Safety Issue: | |
Description: | pH (pH units). |
Measure: | Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by urinalysis (specific gravity) (Main Study) |
Time Frame: | From enrollment through end of treatment (28 days after the final dose of study treatment) |
Safety Issue: | |
Description: | Specific gravity. |
Measure: | Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by urinalysis (white blood cells, red blood cells) (Main Study) |
Time Frame: | From enrollment through end of treatment (28 days after the final dose of study treatment) |
Safety Issue: | |
Description: | If clinically indicated: white blood cells and red blood cells (cells per high power field). |
Measure: | Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by urinalysis (bacteria, casts and crystals) (Main Study) |
Time Frame: | From enrollment through end of treatment (28 days after the final dose of study treatment) |
Safety Issue: | |
Description: | If clinically indicated: microscopic examination for bacteria, casts and crystals (binary classification: positive or negative). |
Measure: | Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by 12-lead ECG (Main Study) |
Time Frame: | At 4 and 7 weeks after the first dose of study drug, and at end of treatment (28 days after the final dose of study treatment) |
Safety Issue: | |
Description: | Evaluation of standard components of the 12-lead ECG. Information regarding standard components of the ECG will not be collected systematically; however, in cases where an ECG abnormality is identified, the abnormality will be reported as an AE, and all details of the identified abnormality will be provided. |
Measure: | Safety and tolerability of SCIB1 in participants as assessed by performance status (Main Study) |
Time Frame: | From enrollment through end of treatment (28 days after the final dose of study treatment) |
Safety Issue: | |
Description: | Grading of performance status as defined by ECOG Performance Status score on a 6-point scale, where 0 = 'fully active, able to carry on all pre-disease performance without restriction' and 5 = 'dead'. |
Measure: | Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by the injection site reaction (Main Study) |
Time Frame: | From the first dose of study drug to last post-study drug assessment (3 weeks after the last dose of study drug) |
Safety Issue: | |
Description: | Clinician assessment of the injection site reaction using a 3-point scale where 1 = 'mild' and 3 = 'severe'. |
Measure: | Safety and tolerability of SCIB1 in participants receiving pembrolizumab as assessed by the use of concomitant medications (Main Study) |
Time Frame: | From the first dose of study drug through last recorded assessment of safety, approximately 2 years (Week 97) |
Safety Issue: | |
Description: | |
Measure: | Tolerability of SCIB1 in participants as assessed by a tolerability questionnaire (Main Study) |
Time Frame: | From the first dose of study drug to last post-study drug assessment (3 weeks after the last dose of study drug) |
Safety Issue: | |
Description: | Patient assessment of the tolerability of the injection using a 5-point scale where 1 = 'no sensation' and 5 = 'extreme pain'. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Scancell Ltd |
Last Updated
August 19, 2021