Colorectal CancerPhase 1MYPHISMONCT03287427

MYPHISMO: MYB and PD-1 Immunotherapies Against Multiple Oncologies Trial

A Phase 1 study testing TetMYB Vaccine and BGB-A317 in people with Colorectal Cancer and Adenoid Cystic Carcinoma, run by Peter MacCallum Cancer Centre, Australia at 1 site in Australia.

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 research study is to look at the effects, good or bad, of TetMYB Vaccine in combination with BGB-A317 in patients with advanced or metastatic solid cancers (including colorectal or adenoid cystic cancer). The immune system is the body's defence against cancer, bacteria and viruses. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Colorectal Cancer, Adenoid Cystic Carcinoma
What is being tested?: TetMYB Vaccine and BGB-A317
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 1 siteAustralia
Study dates: 22 Aug 2018to 14 Dec 2022
Phase: Phase 1
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

Male or female aged 18 years or older at screening.
Patients with advanced/metastatic colorectal or adenoid cystic carcinoma; for which no effective standard therapy is available.
Patient has been fully informed about the study and is willing to participate in the study, and has provided written informed consent prior to any trial specific screening procedures.
Measurable disease as per irRECIST criteria 1.1.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Life expectancy greater than 3 months.

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Adequate haematological, renal and hepatic functions as defined by:
Neutrophil count >1.5 x 109/L
Platelets >100 x 109/L
Hb >100 g/L (Patients can be transfused in the lead-in period, providing they do not have active bleeding or require regular transfusions)
Total bilirubin <1.5x upper limit of normal (ULN)
ALT and AST <2.5x ULN (<5.0x ULN for patients with hepatic metastasis)
Serum creatinine <1.5x ULN or Creatinine Clearance >50 mL/min (Cockcroft-Gault or Nuclear GFR method)
Willing to provide study specific pre-treatment biopsy of tumour and allow use of archival tumour biopsies. This is optional for adenoid cystic carcinoma patients.
Willing to consent to the use of their collected fresh tumour and archival FFPE specimen and blood samples as detailed in the protocol for research including but not limited to DNA, RNA and protein based biomarker detection.
Men and women of childbearing potential must use adequate contraception to prevent pregnancy during the study. Adequate contraception is defined in the study as any medically recommended method (or combination of methods) as per standard of care. An adequate contraception includes hormonal contraception with implants or combined oral, transdermal or injectable contraceptives, certain intrauterine devices, bilateral tubal ligation, hysterectomy, or vasectomy of partner. Combinations of male condom with either cap, diaphragm or sponge with spermicide are also considered acceptable. For women of childbearing age, a negative pregnancy test needs to be confirmed before inclusion.

Who cannot join

Prior therapy with an anti-cancer vaccine; or anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
Chemotherapy, radioactive, biological cancer therapy, or tyrosine kinase inhibitor (TKI) therapy, within four weeks prior to the first dose of study drug. All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to Grade 1 (NCI CTCAE v4.03) or baseline before administration of study drug.
Patient has had a prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast, or localized prostate cancer.
Uncontrolled or significant intercurrent or recent illness including:
Autoimmune disorder or history of autoimmune disease requiring immunosuppressive treatment
Cardiac disorder such as uncontrolled cardiac failure, unstable angina or non-ST segment elevation myocardial infarction (NSTEMI) or myocardial infarction, uncontrolled arrhythmia less than 3 months before screening

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Active or uncontrolled severe infection
History of solid organ transplantation or any condition requiring chronic treatment with corticosteroids or other immunosuppressive agents.
Active coagulopathy/bleeding diathesis.
Cirrhosis, chronic active or untreated persistent hepatitis.
Active Hepatitis B: (defined as having a positive Hepatitis B surface antigen [HBsAg] test at screening). Patients with past or resolved Hepatitis B infection (defined as having a negative HBsAg test and a positive IgG antibody to Hepatitis B core antigen [anti-HBc]) are eligible. Hepatitis B virus (HBV) DNA must be obtained in these patients prior to Cycle 1, Day 1, and must demonstrate no active infection.
Active Hepatitis C: Patients positive for Hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
History of adverse reactions to peptide vaccines.
Patients who are pregnant or lactating.
Has received an investigational drug within 4 weeks prior to first dose of study drug, or unless other has been agreed with the SSC.
Is currently receiving any agent with a known effect on the immune system, unless at dose levels that is not immunosuppressive (e.g. prednisone at 10 mg/day or less or as inhaled steroid at doses used for the treatment of asthma).
Known history of positive tests for HIV/AIDS.
Prior treated brain metastases must be without evidence of progression (through magnetic resonance imaging [MRI] with contrast - preferred method or contrast enhanced computed tomography [CT]) for at least 4 weeks and off immunosuppressive doses of systemic medications, such as steroids (doses > 10 mg/day prednisone or equivalent) for at least 2 weeks before study drug administration to be eligible
Receipt of live, attenuated vaccine within 28 days prior to the first dose of study drug (Note: Subjects, if enrolled, should not receive live vaccine during the study and 180 days after the last dose of study drug).
Any contraindication to receiving anti-PD-1 antibody (BGB-A317) or hypersensitivity to the constituents of BGB-A317.
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

Trial locations and contacts

1 site in 1 country.

Australia1 site

Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000

Other trials in Australia

About this study

Official title: First-in-human Phase I Clinical Trial of a Combined Immune Modulatory Approach Using TetMYB Vaccine and Anti-PD1 Antibody in Patients With Advanced Solid Cancer Including Colorectal or Adenoid Cystic Carcinoma.

The immune system is the body's defence against cancer, bacteria and viruses. TetMYB Vaccine is a vaccine that helps your immune system to recognise the cancer cells. BGB-A317 is an antibody (a type of protein made in the body in response to a foreign substance) that helps to stop or reverse the growth of tumour cells.

Up to 32 participants may take part in this study, which is divided into 2 stages: dose escalation (different doses will be tested in small groups of patients) and dose expansion (one or more doses may be tested in a larger group of patients). Which stage you participate in will depend on which is open at the time. Your study doctor will discuss this with you.

During dose escalation, study patients will receive increasing doses of the TetMYB Vaccine, starting at a low dose. During dose expansion, study patients will receive the dose determined as safe in dose escalation.

The study design is as follows:

In the dose finding stage, the first patient of each dose level will receive 6 consecutive weekly doses of intradermal TetMYB monotherapy for safety evaluation. If there are no reported DLTs, the next 2 patients of the same dose level will also receive 6 consecutive weekly intradermal doses of TetMYB, however with 3 weekly doses of BGB-A317 commencing with the fourth TetMYB dose. The dosage of TetMYB are as follows:

Dose level 1: 100 ug in 100 uL of sterile dH2O containing 5% DMSO
Dose level 2: 500 ug in 100 uL of sterile dH2O containing 5% DMSO
Dose level 3: 1000 ug in 100 uL of sterile dH2O containing 5% DMSO.

In the dose expansion stage, the dosage will be the maximum tolerated dose (MTD) identified in the dose-finding stage and in combination with BGB-A317.

TetMYB Vaccine is being developed and manufactured by the Peter MacCallum Cancer Centre according to Good Manufacturing Practice (GMP) and in accordance with guidelines provided by the Food and Drug Administration (FDA) in the USA and Therapeutic Goods Administration (TGA) in Australia. TetMYB Vaccine is an experimental treatment and is currently not approved for use in any country. This means that it is not an approved treatment for cancer in Australia. This will be the first time that the TetMYB vaccine is given to humans.

BGB-A317 is being developed by BeiGene, a biopharmaceutical company. BGB-A317 is an experimental treatment. This means that it is not an approved treatment for solid cancers in Australia.

Conditions: Colorectal Cancer, Adenoid Cystic Carcinoma
Being tested: TetMYB Vaccine, BGB-A317
Keywords: Advanced, Metastatic
Medical subject headings: Colorectal Neoplasms, Carcinoma, Adenoid Cystic, Neoplasm Metastasis

What participants receive

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

TetMYB VaccineDrug
Weekly intra-dermal injections of either 0.1mg, 0.5mg or 1.0mg on day 1 for week 1 to week 6.
BGB-A317Drug
3 weekly IV injections of 200mg commencing from Week 4.

Study groups in NCT03287427
Study group	Role	What they receive
TetMYB Vaccine & BGB-A317	Experimental	Not described Receives: Drug: TetMYB Vaccine; Drug: BGB-A317

What is being measured

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

The incidence of Grade 3 or 4 or greater adverse events (AEs) according to CTCAE v4.03 criteria and clinical laboratory abnormalities defined as dose-limiting toxicities (DLTs).
Measured: End of Week 6

Secondary outcomes (9)

Tolerability of the treatment as defined as receiving a minimum of 4 doses of TetMYB Vaccine within 6 weeks of starting treatment.
Measured: End of Week 6
The occurrence, type, severity and relationship to treatment of adverse events occurring after the first 6 weeks of treatment, described according to CTCAE v4.03 criteria.
Measured: Week 7 and through study completion, an average of 12 months.
The objective response as defined by the achievement of a complete (irCR) or partial (irPR) response, based on irRECIST criteria within 12 weeks of first vaccination.
Measured: End of Week 12
Clinical benefit as defined by wither the achievement of a complete (irCR) or partial (irPR) response as per irRECIST criteria; or the maintenance of stable disease (irSD), as per irRECIST criteria, at 12 weeks after commencement of treatment.
Measured: End of Week 12.
Progression free survival (PFS) as defined as the time from first vaccination to the earliest of date of disease progression as assessed by irRECIST or death from any cause.
Measured: From the date of treatment commencement to until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months.
Overall survival (OS) as defined as the time from first vaccination to date of death from any cause.
Measured: From the date of treatment commencement to the date of death from any cause, whichever came first, assessed up to 48 months..
To demonstrate a MYB-specific immune response through epitope stimulation of PBMCs and assessment with CBA, FACS for IFN-γ and TNF-α production, and via the evaluation of changes in tumour microenvironment in pre- and post-treatment biopsies.
Measured: Through study completion, an average of 48 months.
To assess metabolic response, as assessed by FDG-PET scan.
Measured: Week 4, at the time of disease progression and 4 weeks after treatment is ceased.
The objective immune response as defined by achievement of a complete or partial response (irCR or irPR), based on irRECIST criteria.
Measured: End of week 12.

Timeline

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

22 Aug 201814 Dec 2022

First posted19 Sep 2017
Study start22 Aug 2018
Primary completion14 Dec 2022
Study completion14 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Colorectal CancerStudies 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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03287427
Sponsor's protocol ID: MYPHISMO
Acronym: MYPHISMO
Status last verified: Feb 2023
First submitted: 12 Sep 2017
Last updated: 15 Feb 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Pham T, Pereira L, Roth S, Galletta L, Link E, Akhurst T, Solomon B, Michael M, Darcy P, Sampurno S, Heriot A, Ramsay R, Desai J. First-in-human phase I clinical trial of a combined immune modulatory approach using TetMYB vaccine and Anti-PD-1 antibody in patients with advanced solid cancer including colorectal or adenoid cystic carcinoma: The MYPHISMO study protocol (NCT03287427). Contemp Clin Trials Commun. 2019 Jul 10;16:100409. doi: 10.1016/j.conctc.2019.100409. eCollection 2019 Dec.
PubMed 31650066

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?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: First-in-human Phase I Clinical Trial of a Combined Immune Modulatory Approach Using TetMYB Vaccine and Anti-PD1 Antibody in Patients With Advanced Solid Cancer Including Colorectal or Adenoid Cystic Carcinoma.
ClinicalTrials.gov ID: NCT03287427
Acronym / sponsor ID: MYPHISMO / MYPHISMO
Conditions: Colorectal Cancer, Adenoid Cystic Carcinoma
Keywords: Advanced, Metastatic
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Peter MacCallum Cancer Centre, AustraliaUniversity, hospital or other
Study start: 22 Aug 2018 (actual)
Primary completion: 14 Dec 2022 (actual)
Study completion: 14 Dec 2022 (actual)
First posted: 19 Sep 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.

The study design is as follows:

Dose level 1: 100 ug in 100 uL of sterile dH2O containing 5% DMSO
Dose level 2: 500 ug in 100 uL of sterile dH2O containing 5% DMSO
Dose level 3: 1000 ug in 100 uL of sterile dH2O containing 5% DMSO.

In the dose expansion stage, the dosage will be the maximum tolerated dose (MTD) identified in the dose-finding stage and in combination with BGB-A317.

BGB-A317 is being developed by BeiGene, a biopharmaceutical company. BGB-A317 is an experimental treatment. This means that it is not an approved treatment for solid cancers in Australia.

Study design

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

Arm	Type	Receives
TetMYB Vaccine & BGB-A317	Experimental	Drug: TetMYB Vaccine, Drug: BGB-A317

Who may qualify

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

Key inclusion criteria (16 listed)

Male or female aged 18 years or older at screening.
Patients with advanced/metastatic colorectal or adenoid cystic carcinoma; for which no effective standard therapy is available.
Patient has been fully informed about the study and is willing to participate in the study, and has provided written informed consent prior to any trial specific screening procedures.
Measurable disease as per irRECIST criteria 1.1.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.

Key exclusion criteria (22 listed)

Prior therapy with an anti-cancer vaccine; or anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
Chemotherapy, radioactive, biological cancer therapy, or tyrosine kinase inhibitor (TKI) therapy, within four weeks prior to the first dose of study drug. All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to Grade 1 (NCI CTCAE v4.03) or baseline before administration of study drug.
Patient has had a prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast, or localized prostate cancer.
Uncontrolled or significant intercurrent or recent illness including:
History of solid organ transplantation or any condition requiring chronic treatment with corticosteroids or other immunosuppressive agents.

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
TetMYB VaccineWeekly intra-dermal injections of either 0.1mg, 0.5mg or 1.0mg on day 1 for week 1 to week 6.	Drug	TetMYB Vaccine & BGB-A317
BGB-A3173 weekly IV injections of 200mg commencing from Week 4.	Drug	TetMYB Vaccine & BGB-A317

Primary outcome

The incidence of Grade 3 or 4 or greater adverse events (AEs) according to CTCAE v4.03 criteria and clinical laboratory abnormalities defined as dose-limiting toxicities (DLTs).
Time frame: End of Week 6

9 secondary outcomes

Tolerability of the treatment as defined as receiving a minimum of 4 doses of TetMYB Vaccine within 6 weeks of starting treatment.
Time frame: End of Week 6
The occurrence, type, severity and relationship to treatment of adverse events occurring after the first 6 weeks of treatment, described according to CTCAE v4.03 criteria.
Time frame: Week 7 and through study completion, an average of 12 months.
The objective response as defined by the achievement of a complete (irCR) or partial (irPR) response, based on irRECIST criteria within 12 weeks of first vaccination.
Time frame: End of Week 12
Clinical benefit as defined by wither the achievement of a complete (irCR) or partial (irPR) response as per irRECIST criteria; or the maintenance of stable disease (irSD), as per irRECIST criteria, at 12 weeks after commencement of treatment.
Time frame: End of Week 12.
Progression free survival (PFS) as defined as the time from first vaccination to the earliest of date of disease progression as assessed by irRECIST or death from any cause.
Time frame: From the date of treatment commencement to until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months.
Overall survival (OS) as defined as the time from first vaccination to date of death from any cause.
Time frame: From the date of treatment commencement to the date of death from any cause, whichever came first, assessed up to 48 months..
To demonstrate a MYB-specific immune response through epitope stimulation of PBMCs and assessment with CBA, FACS for IFN-γ and TNF-α production, and via the evaluation of changes in tumour microenvironment in pre- and post-treatment biopsies.
Time frame: Through study completion, an average of 48 months.
To assess metabolic response, as assessed by FDG-PET scan.
Time frame: Week 4, at the time of disease progression and 4 weeks after treatment is ceased.
The objective immune response as defined by achievement of a complete or partial response (irCR or irPR), based on irRECIST criteria.
Time frame: End of week 12.

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
Derived from this study: PubMed 31650066Pham T, Pereira L, Roth S, Galletta L, Link E, Akhurst T, Solomon B, Michael M, Darcy P, Sampurno S, Heriot A, Ramsay R, Desai J. First-in-human phase I clinical trial of a combined immune modulatory approach using TetMYB vaccine and Anti-PD-1 antibody in patients with advanced solid cancer including colorectal or adenoid cystic carcinoma: The MYPHISMO study protocol (NCT03287427). Contemp Clin Trials Commun. 2019 Jul 10;16:100409. doi: 10.1016/j.conctc.2019.100409. eCollection 2019 Dec.

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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.

Jayesh Desai principal investigator

Peter MacCallum Cancer Centre, Australia

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TetMYB Vaccine and BGB-A317 in people with Colorectal Cancer and Adenoid Cystic Carcinoma, run by Peter MacCallum Cancer Centre, Australia at 1 site in Australia.

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 22 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 15 Feb 2023. 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 Australia. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The incidence of Grade 3 or 4 or greater adverse events (AEs) according to CTCAE v4.03 criteria and clinical laboratory abnormalities defined as dose-limiting toxicities (DLTs). (time frame: End of Week 6). 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 NCT03287427, 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 15 Feb 2023.