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Metastatic Breast CancerPhase 2NCT01516307

Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Metastatic Breast Cancer Subjects

A Phase 2 study testing OPT-822/OPT-821(30 μg/100 μg), Phosphate Buffer Saline (PBS) and Cyclophosphamide in people with Metastatic Breast Cancer, run by OBI Pharma, Inc at 43 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare active immunotherapy (OPT-822/OPT-821) with PBS in combination with low dose cyclophosphamide, in post-treated metastatic breast cancer subjects with stable disease or response to treatment. Read more about this study

Who is it for?
Ages 21 years and older, women only
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
OPT-822/OPT-821(30 μg/100 μg), Phosphate Buffer Saline (PBS) and Cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
349 participants
Where
43 sitesin 5 countries
Study dates
Dec 2011to Aug 2019
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 21 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female subjects ≥ 21 years of age with histological or cytological diagnosis of breast carcinoma.
  • Subjects with metastatic breast cancer who have achieved stable disease (SD), partial response (PR), or complete response (CR) after at least 1 regimen of anticancer therapy (i.e. chemotherapy or target therapy, either alone or in any combination). Involvement of supraclavicular lymph node is considered metastasis.
  • Subjects must have recovered from toxicities of prior therapies. (i.e. CTCAE ≤ grade 2).
  • Performance status: ECOG ≤ 1 and life expectancy ≥ 3 months.
  • Organ Function Requirements - Subjects must have adequate organ functions as defined below:
  • AST/ALT ≤ 3X ULN (upper limit of normal)
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  • AST/ALT ≤ 5X ULN [with underlying Liver Metastasis]
  • Total Bilirubin ≤ 2.0 X ULN
  • Serum Creatinine ≤ 1.5X ULN
  • ANC ≥ 1500 /μL
  • Platelets > 100,000/μL
  • No Symptomatic Congestive Heart Failure (Ejection Fraction EF ≥ 50%)
  • Ability to understand and the willingness to sign a written informed consent document according to institutional guidelines.
  • All positive or negative ER (estrogen receptor), PR (progesterone receptor), and HER-2 subjects are eligible for this study.
  • However, subjects who are HER-2 positive and responsive to anti-HER-2 therapy (e.g. Herceptin), are encouraged to remain on anti-HER-2 therapy and not enroll in this trial.
  • Subjects who desire to enroll in this study and for whom anti-HER-2 therapy is not available or contraindicated, may be eligible to enroll in this trial.
  • In countries where continuous anti-HER2 therapy is considered standard of care for HER-2 positive metastatic disease, HER-2 positive subjects are not eligible.
  • Women of childbearing potential must be willing to implement adequate contraception during the study. An adequate method of contraception will be at the investigator's discretion.

Who cannot join

  • Subjects are pregnant or breast-feeding at entry.
  • Subjects with more than 2 events of disease progression after the development of metastatic breast cancer.
  • Subjects who are currently receiving any other concomitant anticancer therapy with the EXCEPTION of bisphosphonates and hormone therapy.
  • During the study period, subjects using hormonal therapy and bisphosphonates should maintain a constant dose and should not change existing regimen.
  • However, if a change in hormonal therapy is indicated, e.g. due to intolerable adverse effects, the regimen may be modified but change should be minimized thereafter.
  • Subjects with metastasis limited to the bone only are excluded. However, subjects with current metastasis limited to the bone only and with a history of distant metastasis are eligible. Subjects with current metastasis limited to the bone only and with current breast tissue lesion are eligible.
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  • Subjects who have any history of other malignancy (except non-melanoma skin carcinoma and carcinoma-in-situ of the uterine cervix) within 5 years of study entry.
  • Subjects with splenectomy.
  • Subjects with HIV infection.
  • Subjects with any major autoimmune diseases or autoimmune disorders requiring systemic iv/oral steroids or immunosuppressive or immunomodulatory therapies.
  • e.g. Type 1 juvenile onset diabetes mellitus, antibody positive for rheumatoid arthritis, Grave's disease, Hashimoto's thyroiditis, lupus, scleroderma, systemic vasculitis, hemolytic anemia, immune mediated thrombocytopenia, etc
  • Autoimmune disorders confined to the skin (e.g. psoriasis) are eligible, and topical steroids are allowed for the treatment of such skin disorders.
  • Subjects with any known uncontrolled inter-current illness including ongoing or active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Subjects with any of the following MEDICATIONS within 4 weeks prior to randomization:
  • Anti-neoplastic agents
  • Immunotherapy [mAbs, Interferons, Cytokines (except GCSF)]
  • Immunosuppressants (e.g. Cyclosporin, Rapamycin, Tacrolimus, Rituximab, Alemtuzumab, Natalizumab, etc.).
  • Another investigational drug
  • Subjects with pleural effusions and/or ascites, due to malignancy, requiring paracentesis every 2 weeks or more frequently.
  • Subjects with any known severe allergies (e.g. anaphylaxis) to any active or inactive ingredients in the study drugs.
  • Subjects with bladder inflammation and urinary outflow obstruction.

Trial locations and contacts

43 sites in 5 countries.

43 sites in 5 countries

Taiwan16 sites

  • Changhua Christian Hospital

    Changhua

  • Chang Gung Memorial Hospital-KS

    Kaohsiung City

  • Kaohsiung Medical University Hospital

    Kaohsiung City

  • Kaohsiung Veterans General Hospital

    Kaohsiung City

  • Chang Gung Memorial Hospital -Linkou

    Linkou District

  • Mackay Memorial Hospital

    New Taipei City

  • China Medical University Hospital

    Taichung

  • Taichung Veterans General Hospital

    Taichung

  • Chi Mei Medical Center

    Tainan

  • National Cheng Kung University Hospital

    Tainan

  • Chang Gung Memorial Hospital-Taipei

    Taipei

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei

  • National Taiwan University Hospital

    Taipei

  • Shuang-Ho Hospital

    Taipei

  • Taipei Veterans General Hospital

    Taipei

  • Tri-Service General Hospital

    Taipei

Other trials in Taiwan

United States13 sites

  • Hope Women's Cancer Center

    Asheville, North Carolina, 28801

  • The University of Alabama at Birmingham (UAB)

    Birmingham, Alabama, 35294

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • St. Jude Heritage Healthcare, Virginia K. Crosson Cancer Center

    Fullerton, California, 92835

  • Memorial Regional Hospital

    Hollywood, Florida, 33021

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of California, San Diego (UCSD)

    La Jolla, California, 92093

  • Weill Cornell Medical College

    New York, New York, 10065

  • University of California, Irvine (UCI)

    Orange, California, 92868

  • University of California, San Francisco (UCSF)

    San Francisco, California, 94115

  • Coastal Integrative Cancer Care

    San Luis Obispo, California, 93401

  • Central Coast Medical Oncology Corporation

    Santa Maria, California, 93454

  • University of California, Los Angeles (UCLA)

    Santa Monica, California, 90404

Other trials in United States

South Korea11 sites

  • Dong-A University Hospital

    Busan

  • Pusan National University Hospital

    Busan

  • Inha University Hospital

    Chungcheongbuk-Do

  • National Cancer Center

    Chungcheongbuk-Do

  • Kyungpook National University Medical Center

    Daegu

  • Yeungnam University Medical Center

    Daegu

  • Asan Medical Center

    Seoul

  • Korea University Anam Hospital

    Seoul

  • Seoul National University Hospital ,

    Seoul

  • Seoul St. Mary's Hospital

    Seoul

  • Severance Hospital

    Seoul

Other trials in South Korea

India2 sites

  • HCG, Bangalore Institute of Oncology

    Bengaluru

  • Curie Manavata Cancer Centre

    Mumbai

Other trials in India

China1 site

  • UNIMED Medical Institute

    Hong Kong

Other trials in China

About this study

Official title: A Double-blind, Randomized Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Subjects With Metastatic Breast Cancer

The purpose of this study is to compare active immunotherapy (OPT-822/OPT-821) with PBS in combination with low dose cyclophosphamide, in post-treated metastatic breast cancer subjects with stable disease or response to treatment.

Being tested
OPT-822/OPT-821(30 μg/100 μg), Phosphate Buffer Saline (PBS), Cyclophosphamide
Medical subject headings
Breast Neoplasms

What participants receive

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

  • OPT-822/OPT-821(30 μg/100 μg)Biological

    Subcutaneously on week 1, 2, 3, 5, 9, 13, 17, 25, and 37. OPT-822 and OPT-821 are combined at time of injection.

  • Phosphate Buffer Saline (PBS)Biological

    Subcutaneously on week 1, 2, 3, 5, 9, 13, 17, 25, and 37.

  • CyclophosphamideDrug

    Subcutaneously on week 1, 2, 3, 5, 9, 13, 17, 25, and 37.

Study groups in NCT01516307
Study groupRoleWhat they receive
OPT-822/OPT-821 (30 μg/100 μg) and CyclophosphamideExperimentalPatients will be randomized 2:1 to receive OPT-822/OPT-821(30 μg/100 μg) plus Cyclophosphamide IV (300mg/m2).
Receives: Biological: OPT-822/OPT-821(30 μg/100 μg); Drug: Cyclophosphamide
Phosphate Buffer Saline (PBS) and CyclophosphamidePlacebo comparatorPatients will receive Phosphate Buffer Saline (PBS) plus Cyclophosphamide IV (300mg/m2).
Receives: Biological: Phosphate Buffer Saline (PBS); Drug: Cyclophosphamide

What is being measured

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

  1. Progression Free Survival (PFS)

    Measured: Progression or up to 2 years

Secondary outcomes (1)

  1. Overall Survival (OS)

    Measured: 5 years

Timeline

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

  1. First posted24 Jan 2012 (estimated)
  2. Study startDec 2011
  3. Primary completionAug 2016
  4. Study completionAug 2019

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
349 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01516307
Sponsor's protocol ID
OPT-822-001
Status last verified
Sep 2020
First submitted
19 Jan 2012
Last updated
16 Sep 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Huang CS, Yu AL, Tseng LM, Chow LWC, Hou MF, Hurvitz SA, Schwab RB, L Murray J, Chang HK, Chang HT, Chen SC, Kim SB, Hung JT, Ueng SH, Lee SH, Chen CC, Rugo HS. Globo H-KLH vaccine adagloxad simolenin (OBI-822)/OBI-821 in patients with metastatic breast cancer: phase II randomized, placebo-controlled study. J Immunother Cancer. 2020 Jul;8(2):e000342. doi: 10.1136/jitc-2019-000342.

    PubMed 32718986

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OPT-822/OPT-821(30 μg/100 μg), Phosphate Buffer Saline (PBS) and Cyclophosphamide in people with Metastatic Breast Cancer, run by OBI Pharma, Inc at 43 sites in 5 countries.

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 18 inclusion and 21 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: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in Taiwan, United States, South Korea, India, China. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Progression Free Survival (PFS) (time frame: Progression or up to 2 years). 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 NCT01516307, which also lists 1 linked publication.

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 Sep 2020.

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