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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03562637




Registration number
NCT03562637
Ethics application status
Date submitted
6/06/2018
Date registered
19/06/2018

Titles & IDs
Public title
Study of Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Globo H Positive TNBC
Scientific title
The GLORIA Study: A Phase 3, Randomized, Open-Label Study of the Anti-Globo H Vaccine Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With High Risk, Early Stage Globo H-Positive Triple Negative Breast Cancer
Secondary ID [1] 0 0
OBI-822-011
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Triple Negative Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - adagloxad simolenin combined with OBI-821
Treatment: Devices - Globo H IHC Assay
Other interventions - Standard of care treatment

Experimental: Adagloxad simolenin + OBI-821 in conjunction with SOC - Participants will be administered adagloxad simolenin combined with OBI-821 for up to a total of 21 subcutaneous injections over a period of 100 weeks.

Patient will also receive standard of care (SOC) treatment.

Active comparator: Standard of Care treatment - Study visit intervals will be identical to those in Arm 1.

Patient will receive standard of care (SOC) treatment.


Treatment: Other: adagloxad simolenin combined with OBI-821
In the neoadjuvant and adjuvant phases of the study for a total of 100 weeks; subcutaneously injections.

Treatment: Devices: Globo H IHC Assay
The Globo H IHC assay will be used to identify eligible patients who may clinically benefit from the OBI-822 treatment, defined by Globo H expression.

Other interventions: Standard of care treatment
Standard of care treatment consisting of observation alone, adjuvant capecitabine or platinum monotherapy over a 100 week period.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Devices
Intervention code [3] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Measuring the effect of adagloxad simolenin (OBI-822)/OBI-821 treatment on improving invasive disease free survival (IDFS) in the study population.
Timepoint [1] 0 0
5 years
Secondary outcome [1] 0 0
Measuring the impact of adagloxad simolenin (OBI-822)/OBI-821 treatment in the study population on Overall Survival (OS).
Timepoint [1] 0 0
7 years
Secondary outcome [2] 0 0
Measuring the impact of adagloxad simolenin (OBI-822)/OBI-821 treatment in the study population on Quality of Life (QoL).
Timepoint [2] 0 0
7 years
Secondary outcome [3] 0 0
Measuring the impact of adagloxad simolenin (OBI-822)/OBI-821 treatment in the study population on Breast cancer-free interval (BCFI).
Timepoint [3] 0 0
7 years
Secondary outcome [4] 0 0
Measuring the impact of adagloxad simolenin (OBI-822)/OBI-821 treatment in the study population on Distant disease-free survival (DDFS).
Timepoint [4] 0 0
7 years
Secondary outcome [5] 0 0
Incidence and severity of adverse events (AEs) [Time Frame: AEs will be noted as it occurs, with a timeframe from beginning of randomization to 4 weeks after last dose of study treatment.]
Timepoint [5] 0 0
2 years

Eligibility
Key inclusion criteria
* Documented radiographic and histopathologic confirmed primary localized invasive breast cancer.
* Histologically documented TNBC (estrogen receptor negative [ER-]/progesterone receptor negative [PR-]/human epidermal growth factor 2 negative [HER2-]) defined as ER-negative and PR-negative (=5% positive cells stain by IHC for both ER and PR), and negative HER2/neu- status, confirmed on tumor sample.
* HER2/neu negative will be defined as one of the following criteria:

* IHC 0 or 1+
* Single-probe average HER2 gene copy number of <6 signals/nucleus
* Dual-probe fluorescent in-situ hybridization (FISH) HER2/neu chromosome 17 (CEP17) non-amplified ratio of <2
* Globo H IHC H-score =15 from the residual primary site/or lymph node (if primary site is not available) tumor obtained at time of definitive surgery or initial diagnosis (only if surgical tumor sample is not available). Globo H expression will be determined during pre-screening by Central lab. Instructions for submission of slides/tumor tissue blocks are provided in the protocol and study Lab Manual.
* No evidence of metastatic disease in chest, abdomen and pelvis by CT or other adequate imagining during the Screening Phase. Imaging within 3 months prior to randomization is acceptable as baseline scan. Bone scans and imaging of the brain at screening is optional, and should be symptom directed.
* High risk patients with no evidence of disease after completing standard treatment and meeting ONE of the following criteria:

* Neoadjuvant chemotherapy followed by definitive surgery: Residual invasive disease following neoadjuvant chemotherapy defined as: A contiguous focus of residual invasive cancer in the surgical breast specimen measuring =1 cm in diameter and/or with residual invasive cancer in at least one axillary node (micrometastases or macrometastases), as determined by local pathology review.
* Definitive surgery followed by adjuvant chemotherapy: Pathological Prognostic Stage IIB, Stage IIIA , Stage IIIB, or Stage IIIC disease according to the 8th edition of the American Joint Committee on Cancer (AJCC) Cancer Staging Manual.
* Must have completed at least 4 cycles of a standard taxane and anthracycline-based multi-agent chemotherapy regimen (or a taxane-only regimen if the patient is ineligible for anthracycline treatment) either in the neoadjuvant or adjuvant setting (e.g., National Comprehensive Cancer Network recommended regimens):.

* Randomization must occur (a) within 16 weeks after definitive surgery and radiation therapy (if radiation therapy administered) in patients who received neoadjuvant multiagent chemotherapy or, (b) for patients receiving adjuvant multiagent chemotherapy (not including capecitabine, immune checkpoint inhibitor), within 16 weeks after the completion of the adjuvant multiagent chemotherapy and radiation therapy (if radiation therapy administered). Note: patients may be randomized and initiate study treatment concurrent with adjuvant SOC therapy (observation, capecitabine, immune checkpoint inhibitor ± capecitabine).
* Randomization must occur (a) within 16 weeks after definitive surgery and radiation therapy (if radiation therapy administered) in patients who received neoadjuvant multiagent chemotherapy or, (b) for patients receiving adjuvant multiagent chemotherapy (not including capecitabine, immune checkpoint inhibitor), within 16 weeks after the completion of the adjuvant multiagent chemotherapy and radiation therapy (if radiation therapy administered). Note: patients may be randomized and initiate study treatment concurrent with adjuvant SOC therapy (observation, capecitabine, immune checkpoint inhibitor ± capecitabine).
* All treatment-related toxicities resolved to Grade <1 on National cancer institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version 5.0) criteria (except hair loss and =Grade 2 neuropathy, which are acceptable).
* Eastern Cooperative Oncology Group (ECOG) performance status = 1.
* Females must be either of non-childbearing potential, i.e., surgically sterilized (have documented sterilization, bilateral oophorectomy/salpingectomy at least 3 months before the start of the trial and/or hysterectomy), or one year postmenopausal; or if of childbearing potential must have a negative pregnancy test (urine or serum) at screening.
* Males and females of childbearing potential and their partners must be willing to use effective contraception during the entire Treatment Phase and for at least 4 weeks (28 days) after the last dose of study treatment.
* Adequate hematological, hepatic and renal function as defined below:

* Absolute neutrophil count (ANC) =1,500/µL
* Platelets =75,000/µL
* Hemoglobin =8.5g/dL
* Serum creatinine =1.5 × upper limit of normal (ULN) or calculated creatinine clearance =55 mL/min for subjects with creatinine levels >1.5 × institutional ULN (glomerular filtration rate can also be used in place of creatinine or creatinine clearance may be calculated per institutional standard)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =3 × ULN
* Alkaline Phosphatase (ALP) =2.5 × ULN
* Serum total bilirubin =1.5 × ULN (unless Gilbert's disease is documented)
* Consent to participate with a signed and dated Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved patient informed consent for the study prior to beginning any specific study procedures.
* Ability to understand and willingness to complete all protocol required procedures.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Local recurrence of or previous history of ipsilateral or contralateral invasive breast cancer within 10 years prior to randomization [for synchronous tumors see Exclusion criteria #3]
* Definitive clinical or radiologic evidence of metastatic disease
* Synchronous bilateral breast cancer, unless both tumors are confirmed as TNBC.
* Have received any anti-cancer vaccines
* Concomitant treatment with anticancer therapy other than adjuvant SOC therapy (capecitabine; immune checkpoint inhibitor), or other investigational therapy, if expected during the study
* A history of other malignancies (except appropriately treated melanoma in situ, non melanoma skin carcinoma, carcinoma in situ of the uterine cervix, follicular or papillary thyroid cancer or other non-breast malignancies with a similar outcome to those mentioned above) within 5 years prior to randomization.
* Have any active autoimmune disease or disorder that requires systemic immunosuppressive/immunomodulatory therapy. NOTE: Autoimmune diseases that are confined to the skin (e.g., psoriasis) that can be treated with topical steroids alone are allowed during the study.
* Oral/parenteral corticosteroid treatment (>5 mg/day of prednisone/equivalent), within 2 weeks prior to randomization or anytime during the study. NOTE: inhaled steroids for treatment of asthma; and topical steroids are allowed during the study.
* Any known uncontrolled concurrent illness that would limit compliance with study requirements, including but not limited to ongoing or active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric disorders, or substance abuse.
* Any known hypersensitivity to active/inactive ingredients in the study drug formulation or known severe allergy or anaphylaxis to fusion proteins.
* Prior receipt of a glycoconjugate vaccine for cancer immunotherapy.
* Known history or positive for human immunodeficiency virus (HIV positive), unless on effective anti-retroviral therapy with undetectable viral load within 6 months of therapy (note: HIV testing not required for study entry).
* Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection prior to randomization. Patients who have completed curative therapy and have undetectable viral load for HCV are eligible. For patients with evidence of chronic HBV infection, the HBV viral load must be undetectable on suppressive therapy. (note: HBV/HCV testing is not required for study entry).
* Any condition, including significant diseases and/or laboratory abnormalities that would place the patient at unacceptable risk for study participation.
* Currently pregnant or breastfeeding women.
* Currently participating in or has participated in a breast cancer therapeutic clinical trial within 4 weeks (28 days) prior to randomization.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/12/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2027
Actual
Sample size
Target
668
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment hospital [2] 0 0
Cancer Care Service, Hervey Bay Hospital - Urraween
Recruitment hospital [3] 0 0
Slade Pharmacy - East Melbourne
Recruitment hospital [4] 0 0
Cabrini Malvern - Malvern
Recruitment hospital [5] 0 0
Breast Cancer Research Centre - Nedlands
Recruitment hospital [6] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [7] 0 0
Gosford Hospital - Gosford
Recruitment hospital [8] 0 0
St John of God Murdoch Hospital - Murdoch
Recruitment hospital [9] 0 0
Eastern Health - Maroondah Hospital - Ringwood East
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4655 - Urraween
Recruitment postcode(s) [3] 0 0
3002 - East Melbourne
Recruitment postcode(s) [4] 0 0
3144 - Malvern
Recruitment postcode(s) [5] 0 0
- Nedlands
Recruitment postcode(s) [6] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [7] 0 0
2250 - Gosford
Recruitment postcode(s) [8] 0 0
6150 - Murdoch
Recruitment postcode(s) [9] 0 0
3135 - Ringwood East
Recruitment outside Australia
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United States of America
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California
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Florida
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Illinois
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Maryland
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Michigan
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Mississippi
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New Jersey
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Texas
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Virginia
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Washington
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Brazil
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Bahia
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Ceara
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Espirito Santo
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Parana
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Para
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Piaui
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Rondona
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Jilin
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Lódz
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Moscow
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Nizhny Novgorod
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Omsk
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Orenburg
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St. Petersburg
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Tomsk
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Russian Federation
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Volzhskiy
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Russian Federation
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Yaroslavl
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South Africa
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Gauteng
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Taiwan
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Changhua
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Taiwan
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Kaohsiung
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Taichung
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Tainan
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Taiwan
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Taipei
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Ukraine
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Dnipro
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Ukraine
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Ivano-Frankivsk
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Ukraine
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Kharkiv
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Ukraine
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Kherson
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Ukraine
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Kryvyi Rih
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Ukraine
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Kyiv
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Ukraine
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Lutsk
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Ukraine
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Odesa
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Ukraine
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Zaporizhzhia
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Ukraine
State/province [87] 0 0
Zhytomyr

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
OBI Pharma, Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Hope Rugo, MD
Address 0 0
University of California, San Francisco
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
OBI Pharma CT.gov Assistant
Address 0 0
Country 0 0
Phone 0 0
1-619-537-7821
Fax 0 0
Email 0 0
ClinicalTrials.gov-queries@obipharmausa.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03562637